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Trans-chalcone (TC) is a flavonoid precursor characterized by a wide spectrum of action, with anti-inflammatory and antioxidant effects. However, no validated methods are available in official compendia for the analysis of this substance. Thus, the aim of this work was to develop and validate a simple, fast, and reproducible spectrophotometric method for the analysis of TC in raw material, and in topical pharmaceutical formulation containing TC. The established conditions were: methanol as extracting solvent, and detection wavelength of 309 nm by UV spectrophotometer. All tests followed the rules of Resolution RDC 166, 2017. The proposed method was selective. Linearity was demonstrated in the concentration range of 1 to 8 µg/mL (r = 0.999). Repeatability and intermediate precision were confirmed by low relative standard deviation values of 1.53% and 2.70% for TC, and of 1.73% and 2.91% for formulation containing TC. Accuracy, evaluated through recovery test, was adequate, with minimum of 98.24% and maximum of 100.23% of recovery. It was observed that the small deliberate modifications done did not interfere with the results, demonstrating the method is robust. The results showed that the method was considered suitable for the intended purpose, inexpensive, easy to apply, selective, linear, precise, accurate, and robust for the determination TC, and pharmaceutical formulation containing TC. Thus, the method developed satisfies the need for an analytical method for the determination of TC, and topical formulation containing TC, being effective, innovative and able to aid in the development of the pharmaceutical field.
Trans-chalcona (TC) é um precursor de flavonoides caracterizado por um amplo espectro de ação, como efeitos anti-inflamatórios e antioxidantes. No entanto, não há método validado disponível em compêndio oficial para análise deste composto. Então, o objetivo deste trabalho foi desenvolver e validar um método espectrofotométrico, simples, rápido e reprodutível para análise de TC em matéria-prima, e em formulação farmacêutica tópica contendo TC. As condições estabelecidas foram: metanol como o solvente de extração, e detecção no comprimento de onda de 309 nm por espectrofotometria no UV. Todos os testes seguiram as normas da RDC 166, 2017. O método proposto foi seletivo. A linearidade foi demonstrada na faixa de concentração de 1 a 8 µg/mL (r = 0.999). A repetibilidade e a precisão intermediária foram confirmadas pelos valores baixos de desvio padrão relativo de 1,53% e 2,70% para a TC, e de 1,73% e 2,91% para a formulação contendo TC. A exatidão, avaliada por meio de testes de recuperação, foi adequada, com mínimo de 98,24% e máximo de 100,04% de recuperação. Observou-se que pequenas modificações no método não interferiram nos resultados, demonstrando que o método é robusto. Os resultados demonstraram que o método foi adequado para a finalidade pretendida, barato, de fácil aplicação, seletivo, linear, preciso, exato e robusto para determinação de TC, e de formulação contendo TC. Então o método desenvolvido satisfaz as necessidades de um método analítico para determinação de TC, e de formulação tópica contendo TC, e é eficaz, inovador e pode contribuir para o desenvolvimento da área farmacêutica.
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The present study evaluated the efficacy of the mineralizing action of Casearia sylvestris ethanolic extract on bovine dentin blocks in its pure form and in dental paste, through scanning electron microscopy. The dentin blocks were immersed in artificial saliva and incubat ed at 37°C for 7 days. Subsequently, six groups were treated with different test substances and analysed qualitatively and quantitatively at 30 and 60 days. The tests used were Kruskal - Wallis and Dunn's. Shapiro - Wilk and ANOVA. The qualitative analysis at 30 days showed a difference between the groups treated with ethanolic extract and toothpaste. Quantitatively, at 30 days, treatment with ethanolic extract of Casearia showed a greater number of open dentinal tubules. At 60 days, the difference persisted on ly for the blocks treated with toothpaste. The results obtained indicated that there is a positive relationship between the use of Casearia sylvestris and obliteration of dentinal tubules
El presente estudio evaluó la eficacia de la acción mineralizante del extracto etanólico de Casearia sylvestris sobre bloques de dentina bovina en su forma pura y en pasta dental, mediante microscopía electrónica de barrido. Los bloques de dentina se sumergieron en saliva artificial y se incubaron a 37°C durante 7 días. Posteriormente, se trataron seis grupos con diferentes sustancias de ensayo y se analizaron cualitativa y cuantitativamente a los 30 y 60 días. Las p ruebas utilizadas fueron Kruskal - Wallis y Dunn's. Shapiro - Wilk y ANOVA. El análisis cualitativo a los 30 días mostró una diferencia entre los grupos tratados con extracto etanólico y pasta dentífrica. Cuantitativamente, a los 30 días, el tratamiento con ex tracto etanólico de Casearia mostró un mayor número de túbulos dentinarios abiertos. A los 60 días, la diferencia persistió sólo para los bloques tratados con pasta dentífrica. Los resultados obtenidos indicaron que existe una relación positiva entre el us o de Casearia sylvestris y la obliteración de los túbulos dentinarios
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Animais , Bovinos , Extratos Vegetais/administração & dosagem , Casearia/química , Sensibilidade da Dentina/tratamento farmacológico , Dessensibilizantes Dentinários/administração & dosagem , Salicaceae , Dentina/efeitos dos fármacos , EtanolRESUMO
ObjectiveTo draft the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials for standardizing thedata collection, storage, transmission, exchange, analysis, and evaluation of traditional Chinese medicine (TCM) studies. In addition to the application of conventional systematic review and meta-analysis, this draft will provide strong support for the development of automated systematic review, facilitate the efficient utilization of TCM clinical evidence, and underpin the evidence-based rapid decision-making in TCM. MethodThis study was structured into three stages. During the first stage (pre-research), suggestions for formulating new standards were proposed based on comprehensive research and demonstration of views obtained from literature investigation and expert interviews. The second stage concentrated on drafting the standard by assembling a working group and crafting a draft solicitation document for metadata standards. At the third stage, feedback was sought from relevant institutions, organizations, and experts and scholars outside the research group via mail or other means to finalize the draft standard. ResultDuring the pre-research stage, a preliminary examination was conducted to assess the characteristics and current status of clinical research metadata standards, and the information was identified regarding the significance of formulating the standard, principles guiding metadata formulation, reference materials, and suggestions for metadata subset establishment. After establishing a working group and drafting the initial version of the standard, opinions from external experts were sought via email. Based on the comments, a third round of revisions was conducted, resulting in the finalization of a draft for the standard. The finalized version of the standard draft comprised 12 sections: preface, introduction, scope, normative reference documents, terms and abbreviations, principles and composition, metadata description method, metadata summary representation, metadata dictionary description, Extensible Markup Language (XML) markup example, JavaScript Object Notation (JSON) markup example, and references. Of these, the section of metadata summary representation/metadata dictionary description contained 6 metadata subsets, involving 20 metadata entities and 141 metadata elements. ConclusionThrough literature research, expert interviews, questionnaire surveys, standard drafting, and opinion solicitation, this study drafts the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials. This draft plays a crucial role in standardizing TCM clinical research and advancing objective scientific evaluation and effective utilization of TCM.
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OBJECTIVE To prepare the Eriodictyol chewable tablet and to evaluate its quality. METHODS The chewable tablet was prepared by the wetting granulation method by using microcrystalline cellulose (MCC) and mannitol as fillers, polyvinylpyrrolidone (PVP) as adhesive, citric acid and sucralose as flavor correction agents, magnesium stearate as lubricant. The comprehensive evaluation was conducted on Eriodictyol chewable tablets with the dosage of each excipient as a factor using the appearance, taste, flavor and texture as indicators. The ratio of excipients was optimized by orthogonal test, and the quality of Eriodictyol chewable tablets prepared by optimized formulation was evaluated in terms of appearance, weight difference, hardness, fragility, eriodictyol content, dissolution and content uniformity. RESULTS The optimal formulation was as follows: 26.4% eriodictyol (50 mg each piece), 45% mannitol, 25% MCC, 0.3% citric acid, 0.3% sucralose, 1% magnesium stearate, 2% PVP (preparing 5% solution using purified water). The scores of 3 batches of Eriodictyol chewable tablets in the validation test were 8.76, 8.75 and 8.80 (RSD=0.30%, n=3), respectively. The Eriodictyol chewable tablet had a complete appearance and a smooth surface; the average tablet weight was 192.57 mg, the average hardness was 57.36 N, the fragility was 0.09%, the average content of eriodictyol per tablet was 50.74 mg, the cumulative dissolution within 30 min was exceeding 80%, and the content uniformity was 5.51. CONCLUSIONS Eriodictyol chewable tablet prepared by optimal formulation conforms to the requirements of the 2020 edition of Chinese Pharmacopoeia.
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El tratamiento del defecto epitelial refractario es un reto y está sujeto al desarrollo de estudios preclínicos y clínicos con el objetivo de obtener tratamientos eficaces, entre los que emerge la insulina tópica. El objetivo del presente artículo fue describir la respuesta cicatrizal del epitelio corneal bajo tratamiento con colirio de insulina. Se presentan dos pacientes con diagnóstico de defecto epitelial persistente posúlcera corneal. Se indicó insulina tópica una gota cada 6 horas, con evolución hacia la epitelización corneal total a los 10 días de iniciado el tratamiento. Se sugiere el mecanismo por el cual la insulina promueve la cicatrización corneal al lograr la restauración de los nervios corneales y favorecer la migración de células epiteliales. En ambos casos el colirio de insulina logró la promover la cicatrización epitelial total de la córnea por lo que se es útil en el tratamiento de defecto epitelial persistente(AU)
The treatment of refractory epithelial defect is a challenge and depends upon the development of preclinical or clinical studies aimed at obtaining effective treatments, among which topical insulin emerges. The objective of this article was to describe the healing response of the corneal epithelium under treatment with insulin eye drops. The cases are presented of two patients with a diagnosis of persistent post-corneal ulcer epithelial defect. Topical insulin was prescribed at one drop every six hours, with evolution towards total corneal epithelialization ten days after the treatment started. The mechanism is suggested by which insulin promotes corneal healing, thus restoring corneal nerves and favoring epithelial cell migration. In both cases, the insulin eye drops were able to promote total epithelial healing of the cornea, making it useful in the treatment of persistent epithelial defect(AU)
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Humanos , Soluções Oftálmicas/uso terapêutico , Células EpiteliaisRESUMO
This study evaluated the oligosaccharides, phytochemicals, dietary fiber, microbial count, pH and acidity of fonio (Digitaria exilis)/ricebean (Vigna umbellata) based complementary foods in order to ascertain the safety of the formulations. A 3 by 4 by 4 factorial design was used. A 70:30 (treated fonio): (72 h sprouted and dehulled ricebean) blend containing 30 % peeled dried carrot and 30 % crayfish (FNBN) was formulated. A similar blend with additional 20 % milk (FNBP), a third blend containing unsprouted and undehulled ricebean (FNBU) and a fourth containing only treated fonio and sprouted ricebean (FNBM) were also formulated. The level of stachyose and raffinose in the diets ranged from 0.21±0.00 -0.40±0.02 % and 0.05±0.00 -0.10±0.01 % respectively. The levels of stachyose and raffinose in the sprouted samples (FNBP, FNBN and FNBM) were comparable (p>0.05) and low suggesting absence of flatulence. The residual phytochemicals in the formulations ranged from 0.160±0.00-0.28±0.00 % (alkaloid), 0.17±0.02-0.35±0.01 % (flavonoid) and 0.39±0.02-0.530±0.01 % (saponin). These low values indicate absence of allergy. The dietary fiber contents of the blends were lower (p<0.05) than the recommended 5 % for complementary food indicating that the digestive system of the infants can handle it. The low bacterial load and zero fungal growth observed in the products depict high level of hygiene and sanitary quality while the near neutral pH and low acidity suggest caution during handling and feeding of the infant. These conditions favour growth of spoilage and pathogenic microorganisms. Results of the study show a high measure of safety of the formulations.
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The aim of the present study was to assess the antipyretic activity of Siddha herbo-mineral formulation Surangusa Parpam at the dose level of 15mg/kg and 35mg/kg body weight, orally, in brewer yeast induced fever model Wistar rats. Fever was induced by subcutaneous injection of 10ml/kg of 20% w/v aqueous suspension of brewer’s yeast into the nape of the rat's neck. After eighteen hours feverish animals were treated with Surangusa Parpam 15mg/kg and 35mg/kg body weight, orally, and rectal temperatures were evaluated at 0, 1, 2 and 3 hours post-treatment by inserting a well-lubricated bulb of the clinical thermometer. Surangusa Parpam showed a significant decrease in the elevated body temperature of rats that remained sustained throughout the tested time points from 1 to 3 hours in the used model. 35mg/kg body weight dose level showed significant inhibition of elevated body temperature when compared with the standard control. These results indicate that the Antipyretic activity of Surangusa Parpam and in addition to its well-established anti-inflammatory activity possesses significant antihistamine activity that may be beneficial in symptomatic relief when it is used in the therapy of allergic and inflammatory disorders.
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Major loss in agricultural crops is caused by insect pests. In India, various synthetic insecticides are used against pests. These are much expensive and cause environmental hazards. The nanoparticles, as an alternative approach is gaining considerable interest in this field. In the present study, we explored the biological synthesis of zinc oxide nanoparticles using Giant milkweed, Calotropis procera (Aiton) Dryand. and its effects on the tobacco cutworm, Spodoptera litura. The reduction of zinc ions (Zn2+) to zinc nanoparticles (ZnO NPs) was prepared by mixing 50 g of C. procera leaves with 100 mL of single distilled water in a 250 mL glass beaker. To synthesize nanoparticles, 50 mL of C. procera leaf extract was taken using a stirrer-heater and 5 g of zinc oxide was added at 60ºC, boiled, then kept in a hot air oven at 70ºC for 24 h. Finally, the obtained light yellow coloured powder was carefully collected and characterized using X-ray diffraction (XRD) analysis. The results revealed that the biologically synthesized zinc oxide nanoparticles pesticide was highly effective against the pest. The weight of the pest decreased from low concentration to high concentration. It is concluded that the Calotropis Procera based zinc oxide nanoparticles could be used for the control of Spodoptera litura.
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Buccal tablets
Diclofenac sodium
Drug release
Mucoadhesion
Mucoadhesive tablets
Release kinetics
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Polycystic Ovary Syndrome (PCOS) is one of the most prevalent endocrine disorder in women of reproductive age characterized by hyperandrogenism (HA). Current treatment options for PCOS are either with adverse effects or ineffective. Saptasaram kashayam (SK), an ayurvedic formulation is often been a safe traditional alternative medicine to improve the PCOS symptoms as well as its pathological development. However, its principle phytoconstituents or underlying mechanisms have not been investigated. In order to achieve this, the current study systematically utilized computational tools, network pharmacology approaches and molecular docking studies. All identified phytoconstituents of SK were screened by QikProp ADME prediction and 47 were selected based on oral bioavailability and drug likeliness scores. Their 3D structures were submitted to three online target fishing webservers PharmMapper, ChemMapper and Swiss Target Prediction which produced 1084 biological targets for SK comprehensively. 350 known PCOS therapeutic targets were retreived as common targets from three different interrogative disease centric bioinformatic platforms DisGeNET, OMIM and GeneCards. Intersection of 1084 biological targets of SK and 350 PCOS therapeutic targets produced, 88 potential therapeutic targets of SK against PCOS. STRING PPI and Compound-Target-Pathway networks were constructed and analysed using Cytoscape software. GO & KEGG pathway enrichment analysis was performed using DAVID database. 15 PCOS therapeutic target proteins were short listed from network analysis report- PIK3CA, PDPK1, AKT1, PIK3R1, STAT3, MAPK1, MAPK3, EGFR, AR, ESR1, ESR2, SHGB, NOS3, F2 & CREBBP. Targets that were likely to be inhibited/modulated by SK for treatment of PCOS were docked against the screened phytoconstituents and their respective standard inhibitors using GLIDE-SP of Schrodinger suite, Maestro version- 13.0. Results showed that Quercetin, Catechin, Boeravinone J, Genistein, Protocatechuic Acid, Gentisic Acid, Xanthoarnol, Luteolin, Boeravinone F, Tyrosine, Kaempferol, Dalbergioidin, etc exhibited good binding affinities when compared to standard drugs and might be responsible for synergistic/additive protective effect of SK against PCOS. Meanwhile PI3K-Akt signaling pathway, Prolactin signaling pathway, AGE-RAG diabetic complications, HIF-1 signaling pathway and Estrogen signaling pathway were found to be involving the hub genes of interest and in this way, they might be intervened during treatment of PCOS by SK. Present study succeeded in identifying the drug like principle phytoconstituents, probable PCOS therapeutic targets and the underlying molecular mechanism of SK apart from providing reliable evidence for therapeutic potential of SK against PCOS. However further validation by in vitro and in vivo investigations is necessary.
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Polycystic Ovary Syndrome (PCOS) is one of the most prevalent endocrine disorder in women of reproductive age characterized by hyperandrogenism (HA). Current treatment options for PCOS are either with adverse effects or ineffective. Saptasaram kashayam (SK), an ayurvedic formulation is often been a safe traditional alternative medicine to improve the PCOS symptoms as well as its pathological development. However, its principle phytoconstituents or underlying mechanisms have not been investigated. In order to achieve this, the current study systematically utilized computational tools, network pharmacology approaches and molecular docking studies. All identified phytoconstituents of SK were screened by QikProp ADME prediction and 47 were selected based on oral bioavailability and drug likeliness scores. Their 3D structures were submitted to three online target fishing webservers PharmMapper, ChemMapper and Swiss Target Prediction which produced 1084 biological targets for SK comprehensively. 350 known PCOS therapeutic targets were retreived as common targets from three different interrogative disease centric bioinformatic platforms DisGeNET, OMIM and GeneCards. Intersection of 1084 biological targets of SK and 350 PCOS therapeutic targets produced, 88 potential therapeutic targets of SK against PCOS. STRING PPI and Compound-Target-Pathway networks were constructed and analysed using Cytoscape software. GO & KEGG pathway enrichment analysis was performed using DAVID database. 15 PCOS therapeutic target proteins were short listed from network analysis report- PIK3CA, PDPK1, AKT1, PIK3R1, STAT3, MAPK1, MAPK3, EGFR, AR, ESR1, ESR2, SHGB, NOS3, F2 & CREBBP. Targets that were likely to be inhibited/modulated by SK for treatment of PCOS were docked against the screened phytoconstituents and their respective standard inhibitors using GLIDE-SP of Schrodinger suite, Maestro version- 13.0. Results showed that Quercetin, Catechin, Boeravinone J, Genistein, Protocatechuic Acid, Gentisic Acid, Xanthoarnol, Luteolin, Boeravinone F, Tyrosine, Kaempferol, Dalbergioidin, etc exhibited good binding affinities when compared to standard drugs and might be responsible for synergistic/additive protective effect of SK against PCOS. Meanwhile PI3K-Akt signaling pathway, Prolactin signaling pathway, AGE-RAG diabetic complications, HIF-1 signaling pathway and Estrogen signaling pathway were found to be involving the hub genes of interest and in this way, they might be intervened during treatment of PCOS by SK. Present study succeeded in identifying the drug like principle phytoconstituents, probable PCOS therapeutic targets and the underlying molecular mechanism of SK apart from providing reliable evidence for therapeutic potential of SK against PCOS. However further validation by in vitro and in vivo investigations is necessary.
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Siddhars said about various diseases and the treatment methods with herbs, minerals and animal products. In Siddha literatures viral fevers can be compared to Vatha Kapha Suram and therefore decoction for this Suram is taken from classical Siddha text book and the ingredients are searched for pharmacological activity and toxicity study from 118 published journal papers from Pubmed, Scopus, Google Scholar, Research Gate and Science Direct. Collected data is entered in MS excel and analysed using RFC score. All together there are 51 pharmacological activities are published for these nine ingredients. In which Anti-inflammatory has RFC=1, other properties like antipyretic, anti-tussive, bronchodialator, anti-asthmatic, analgesic, neuro-regenerative, neuroprotective, anti-diarrhoeal, anti-emetic, neuroprotective, analgesic, sedative has more than 0.55 RFC score. More than this cardioprotective, renoprotective, hepatoprotective, and other protective properties are present in more than 50% of ingredients. In toxicity studies no toxic effects are seen in in vivo studies for the ingredients The Suvai, Thanmai, Pirivu, in Siddha aspect, of these ingredients can highly reduces Vatha and Kapha disorders. Therefore, the decoction shows significant pharmacological activity for the sign and symptoms of viral infections.
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The concept of ethnic medicine is divided into a broad sense and a narrow sense. The broad concept refers to the traditional medicine of the Chinese nation, and the narrow concept refers to the traditional medicine of Chinese ethnic minorities. The external medicine is one of the main forms of ethnic medicine, and it is also the important content of ethnic medicine for external use, which is widely used in clinical practice. As the theory of ethnic medicine is unique, the application methods have certain characteristics, which are the key technical parts of clinical practice. However, the existing traditional Chinese medicine consensus formulation me-thods cannot meet the needs of the consensus formulation of the external ethnic medicine. Therefore, the methods suitable for expert consensus on external ethnic medicine are required. This article took Expert opinion on clinical application of Baimai Ointment as an exa-mple, and explorde a reasonable, effective, multi-dimensional, and multi-stage method to formulate expert consensus on the external ethnic medicine. In this research, three-dimensional sources of information, including ancient classics, clinical research evidence, and expert application experiences, were systematically and scientifically collected. After organization and analysis, the information was formed into comprehensive evidence. In a formal consensus meeting, part of the recommendations reached consensus. As to the issues that did not reach agreement, in-depth interviews were used to explore the reasons for the differences and resolve the disagreements. Finally, unanimous recommendations were reached. There are common problems during the formulation process of Expert opinion on clinical application of Baimai Ointment. This study is expected to provide references for the formulation of expert consensus on other external ethnic medicine.
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Humanos , Produtos Biológicos , Consenso , Medicamentos de Ervas ChinesasRESUMO
Objective:To explore the contents and methods of clinical comprehensive evaluation of microecologics, with the example of Bifidobacterium quadruple viable tablet, in order to provide evidence for clinical rational use of microecologics, and microecologics research, development and related decision-making, and to promote rational use of medications. Methods:Based on the research data collected from systematic literature search, health technology assessment methods such as evidence-based medicine and pharmacoeconomics evaluation were used to estimate the safety, efficacy, economics, suitability, accessibility and innovation of Bifidobacterium quadruple viable tablet. Results:In terms of efficacy, Bifidobacterium quadruple viable tablet showed significant therapeutic effects in the treatment of pediatric diarrhea, antibiotic-related diarrhea, diarrhea-predominant irritable bowel syndrome, and secondary diarrhea caused by diseases such as ulcerative colitis, as well as constipation and functional dyspepsia. It can also be used in the treatment of various diseases such as Helicobacter pylori related gastritis, liver cirrhosis, non-alcoholic fatty liver disease. In terms of safety, the incidence of adverse effects of this medication was low, and most were mild to moderate and transient symptoms. In terms of economics, compared with mesalazine alone in the treatment of ulcerative colitis, the incremental cost-effectiveness ratio of combination of Bifidobacterium quadruple viable tablet and mesalazine was 1 743.2. Besides, the daily treatment cost of Bifidobacterium quadruple viable tablet was lower than that of combination of Bifidobacterium triple viable and Bacillus licheniformis (1.87 to 2.80 yuan vs. 2.08 to 5.78 yuan). In terms of innovation, this medication had multiple patents and had been identified as a high-tech product in Zhejiang Province. In terms of suitability, the overall suitability of use and technical characteristics of medication were good. It could be further improved in the aspects of dosage form and system. In terms of accessibility, the price of the medication was stable, affordable and accessible to the general public. Conclusions:Based on the existing evidence, Bifidobacterium quadruple viable tablet presented effective with supported evidences, good safety, accessibility and innovation. The suitability can be further optimized. However, more in-depth and targeted research is needed in terms of economics and innovation in different clinical applications, and there is space for optimization in medication suitability.
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Objective Screening of modified Foshou San to improve cerebral ischemia,determine the best prescription composition and the proper dose.Methods Using data mining method,the traditional Chinese medicine for hypertensive intracerebral hemorrhage(HICH)were screened,and cluster analysis was carried out to obtain Jiawei Foshou San combinations;According to the mixed uniform design U14(42×33×22),the auricular artery dilatation experiment and acute cerebral ischemia induced by saturated magnesium chloride in mice were used to observe the auricular artery dilatation index and survival time of mice,and the pharmacological effects of each prescription to improve cerebral ischemia were evaluated.On the basis of visual analysis of pharmacodynamics,stepwise multiple regression analysis was carried out,and the regression equation was used to calculate the best prescription composition and dose of Jiawei Foshou San.The optimized prescription was verified by acute cerebral ischemia experiment in mice.Results A total of 51 prescriptions that may be used for the treatment of HICH were selected by data mining,including 103 Chinese herbs,with a total frequency of 535 times.The results of mixed uniform design U14(42×33×22)test showed that the auricular artery index of mice in each prescription group of Jiawei Foshou San increased to varying degrees.The differences between prescription 4,8,12 and 13 were significant(P<0.05),and the differences between prescription 3,7,9,11 and 14 were extremely significant(P<0.01).The survival time of acute cerebral ischemia in mice was prolonged to varying degrees in each group of Jiawei Foshou San,and the difference between prescription 2-14 groups and the blank group was statistically significant(P<0.01).The prescription of the new Jiawei Foshou San was determined as 60 g of Astragalus membranaceus,60 g of Angelica sinensis,24 g of Ligusticum chuanxiong,15 g of Paeonia lactiflora and 9 g of Dilong from the intuitive analysis.The validation results showed that the high and middle dosage of the new Jiawei Foshou San could significantly prolong the breathing time,increase the number of breaths,and prolong the time of normal pressure hypoxia tolerance in mice with acute cerebral ischemia(P<0.01,P<0.05).Conclusion Using mixed uniform design combined with improving cerebral ischemia effect index can determine the best prescription composition and the best dose of Jiawei Foshou San,and the effect of improving cerebral ischemia is certain.
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Objective:To analyze the evolution of China′s national-level healthcare sector regulatory policies between 2003 and 2021, and explore the characteristics and patterns of the use of policy instruments at different stages, for references in policy optimization.Methods:The policy documents related to the regulation of the healthcare sector released by the central government were searched from 2003 to 2021 from the policy document database of the State Council using the keywords " medical" " regulation" and " health" " regulation". Based on the analysis framework of " formulation subject-implementation subject-policy tools", such methods as content analysis, social network analysis, and policy tool analysis were used to analyze policy documents and conduct descriptive analysis of data.Results:A total of 236 policies were included in the study.From 2003 to 2008, according to the time progression, a total of 27 documents were issued, with the State Council as the main formulation subject (77.78%, 21/27), and the government as the main implementation subject (100.00%, 27/27). 191 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 21.46% (41/191), 30.37% (58/191), and 48.17% (92/191). From 2009 to 2017, a total of 48 policies were issued, the formulation subject was mostly the State Council (93.75%, 45/48), and the implementation subject was still mostly the government (100.00%, 48/48), but the proportion of institutions (25.00%, 12/48), industry organizations (43.75%, 21/48) and the society (37.50%, 18/48) has increased. 500 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 17.40% (87/500), 32.00% (160/500), and 50.60% (253/500), respectively.From 2018 to 2021, a total of 161 documents were issued, with the formulation subjects featuring multiple subjects (38.51%, 62/161), with a decrease in the percentage of the State Council′s issuance (22.36%, 36/161), and 157 (97.52%) policies were implemented by the government. 1 140 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments being 18.42% (210/1 140), 34.74% (396/1 140), and 46.84% (534/1 140), respectively.Conclusions:From 2003 to 2021, there was an upward trend in the number of policies issued in the field of healthcare sector regulation in China, and the subjects of formulation and implementation were diversified. But the use of different types of policy instruments was uneven.
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OBJECTIVE To optimize the formulation of a porcine fibrin patch (abbreviated as “DBT”). METHODS Based on single-factor tests, with the contents of fibrinogen, thrombin and collagen before freeze-drying as the factors, with the overall desirability (OD) value of adhesion strength, holding viscosity and water absorption as response value, the formulation of DBT was optimized by Box-Behnken-response surface methodology, and the verification tests were conducted. RESULTS According to the results of the single factor tests and Box-Behnken-response surface methodology, combined with the actual production, the optimal formulation of DBT was 6.5 mg/cm2 of fibrinogen, 8.0 IU/cm2 of thrombin and 5.6 mg/mL of collagen. The average OD value of 3 validation tests was 0.726 6 (RSD=0.58%, n=3), and the relative error of which with the predicted value (0.733 0) was -0.87%. CONCLUSIONS The optimal formulation of DBT is stable and feasible.
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Licorzine granules are common preparations for children zinc deficiency. Considering the long course of treatment, the taste of licorzine granules may become a main factor affecting medication adherence. To date there have been no taste evaluation research into licorzine granules yet. In this study, both sensory evaluation and electronic tongue method were utilized to optimize licorzine granules formulations, evaluate the tastes of licorzine, excipients, optimized formulation in vivo and in vitro. As the results show, bitterness and astringency are the main unpleasant tastes generating from licorzine. Xanthan gum is the main taste-masking excipient, lowering down the bitterness and astringency of licorzine by at least one grade. Good correlation exists between the results of sensory evaluation and electronic tongue method, and an integrated combination of the two helps to obtain objective and rational research conclusions. The adult sensory evaluation study was a research-based clinical trial conducted with informed consent from all subjects in accordance with the ethical requirements of Good Clinical Practice.
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Chloral hydrate is a commonly used central sedative drug before pediatric clinical examination, but its clinical safety and medication adherence are needed to focus on normally because of its poor stability and palatability. Under the premise of investigating the stability of different formulations, their palatability were also screened by using both human sensory and electronic tongue evaluation techniques. Human sensory evaluation has been conducted with the informed consent of all participants in accordance with the ethical requirements of the Good Clinical Practice for Drug Trials. The results showed that the addition of sorbitol and sucralose could effectively ensure the stability of the oral solution. Sorbitol is the main taste-masking component, and the ratio of 40% sorbitol and 0.5% sucralose can effectively mask the bitterness, astringency and spicy taste of 10% chloral hydrate oral solution. The results detected by human sensory and electronic tongue have good correlation and complementarity, and the combination of these two methods is more conducive to getting objective and reasonable conclusions.
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Molecular dynamics simulation technology relies on Newtonian mechanics to simulate the motion of molecular system of the real system by computer simulation. It has been used in the research of self-assembly processes illustration and macroscopic performance prediction of self-assembly nano-drug delivery systems (NDDS) in recent years, which contributes to the facilitation and accurate design of preparations. In this review, the definitions, catalogues, and the modules of molecular dynamics simulation techniques are introduced, and the current status of their applications are summarized in the acquisition and analysis of microscale information, such as particle size, morphology, the formation of microdomains, and molecule distribution of the self-assembly NDDS and the prediction of their macroscale performances, including stability, drug loading capacity, drug release kinetics and transmembrane properties. Moreover, the existing applications of the molecular dynamic simulation technology in the formulation prediction of self-assembled NDDS were also summarized. It is expected that the new strategies will promote the prediction of NDDS formulation and lay a theoretical foundation for an appropriate approach in NDDS studies and a reference for the wider application of molecular dynamics simulation technology in pharmaceutics.