RESUMO
BACKGROUND: Delirium is common among elderly patients in the intensive care unit (ICU) and is associated with prolonged hospitalization, increased healthcare costs, and increased risk of death. Understanding the potential risk factors and early prevention of delirium is critical to facilitate timely intervention that may reverse or mitigate the harmful consequences of delirium. AIM: To clarify the effects of pre-admission falls on ICU outcomes, primarily delirium, and secondarily pressure injuries and urinary tract infections. METHODS: The study relied on data sourced from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Statistical tests (Wilcoxon rank-sum or chi-squared) compared cohort characteristics. Logistic regression was employed to investigate the association between a history of falls and delirium, as well as secondary outcomes, while Kaplan-Meier survival curves were used to assess short-term survival in delirium and non-delirium patients. RESULTS: Study encompassed 22,547 participants. Delirium incidence was 40%, significantly higher in patients with a history of falls (54.4% vs. 34.5%, p < 0.001). Logistic regression, controlling for confounders, not only confirmed that a history of falls elevates the odds of delirium (OR: 2.11; 95% CI: 1.97-2.26; p < 0.001) but also showed it increases the incidence of urinary tract infections (OR:1.50; 95% CI:1.40-1.62; p < 0.001) and pressure injuries (OR:1.36; 95% CI:1.26-1.47; p < 0.001). Elderly delirium patients exhibited lower 30-, 180-, and 360-day survival rates than non-delirium counterparts (all p < 0.001). CONCLUSIONS: The study reveals that history of falls significantly heighten the risk of delirium and other adverse outcomes in elderly ICU patients, leading to decreased short-term survival rates. This emphasizes the critical need for early interventions and could inform future strategies to manage and prevent these conditions in ICU settings.
Assuntos
Acidentes por Quedas , Estado Terminal , Delírio , Unidades de Terapia Intensiva , Humanos , Delírio/epidemiologia , Idoso , Acidentes por Quedas/estatística & dados numéricos , Feminino , Masculino , Idoso de 80 Anos ou mais , Estudos de Coortes , Fatores de Risco , Hospitalização , Incidência , Infecções Urinárias/epidemiologiaRESUMO
BACKGROUND: Subjective memory impairment (SMI) is common in older people. The aim of this study was to investigate the factors influencing SMI among older people in China, with specific focus on the interaction effect of midday napping duration and depressive symptoms on the risk of SMI. METHODS: Using a dataset representative of the Chinese population from a longitudinal study of health and retirement in China, subjects with SMI were screened using the question "how do you feel about your memory now?" and the Mini-Mental State Examination. A logistic regression model was applied to explore the factors affecting SMI. Additive and multiplicative models were used to analyze the interaction effect of midday napping duration and depressive symptoms on the risk of SMI. RESULTS: We enrolled 8,254 subjects included and the incidence of SMI was 63.9%. Depressive symptoms, nap time, and physical activity were influencing factors of SMI. Midday napping duration and depressive symptoms had positive additive interaction effects on the risk of SMI. When extended-length naps and depressive symptoms coexisted, the risk of SMI was 1.06 times greater than that for either alone (RERI, relative excess risk due to interaction = 0.27, 95% CI = 0.07-0.43; AP, attributable proportion = 0.14, 95% CI = 0.01-0.23; S, synergy index = 1.06, 95% CI = 0.57-1.62). When short naps and depressive symptoms coexisted, the risk of SMI was 1.2 times higher than that for either alone (RERI = 0.12, 95% CI=-0.14-0.39; AP = 0.13, 95% CI=-0.07-0.22; S = 1.20, 95% CI = 0.79-1.82). LIMITATIONS: Since this was a cross-sectional study, the cause-and-effect relationships between the associated variables cannot be inferred. CONCLUSIONS: The interaction effect that exists between nap time and depressive symptoms in older people is important for the identification and early intervention of people at risk for SMI.
Assuntos
Depressão , Aposentadoria , Humanos , Idoso , Estudos Longitudinais , Fatores de Risco , Depressão/epidemiologia , Estudos Transversais , Sono , China/epidemiologiaRESUMO
The codling moth Cydia pomonella is a major pest of global significance impacting pome fruits and walnuts. It threatens the apple industry in the Loess Plateau and Bohai Bay in China. Sterile insect technique (SIT) could overcome the limitations set by environmentally compatible area-wide integrated pest management (AW-IPM) approaches such as mating disruption and attract-kill that are difficult to suppress in a high-density pest population, as well as the development of insecticide resistance. In this study, we investigated the effects of X-ray irradiation (183, 366, 549 Gy) on the fecundity and fertility of a laboratory strain of C. pomonella, using a newly developed irradiator, to evaluate the possibility of X-rays as a replacement for Cobalt60 (60Co-γ) and the expanded future role of this approach in codling moth control. Results show that the 8th-day is the optimal age for irradiation of male pupae. The fecundity decreased significantly as the dosage of radiation increased. The mating ratio and mating number were not influenced. However, treated females were sub-sterile at a radiation dose of 183 Gy (20.93%), and were almost 100% sterile at a radiation dose of 366 Gy or higher. Although exposure to a radiation dose of 366 Gy resulted in a significant reduction in the mating competitiveness of male moths, our radiation biology results suggest that this new generation of X-ray irradiator has potential applications in SIT programs for future codling moth control.
Assuntos
Infertilidade , Mariposas , Feminino , Masculino , Animais , Raios X , Raios gama , FertilidadeRESUMO
Traditional Chinese medicine(TCM) has a long history and abundant experience in external therapy, which marks human wisdom. In the early history of human, people found that fumigation, coating, and sticking of some tree branches and herb stems can help alleviate scabies and remove parasites in productive labor, which indicates the emergence of external therapy. Pathogen usually enters the body through the surface, so external therapy can be used to treat the disease. External therapy is among the major characteristic of surgery of TCM. As one of the external therapies in TCM, external application to acupoints smooths the zang-fu organs through meridians and collaterals, thereby harmonizing yin and yang. This therapy emerged in the early society, formed the Spring and Autumn Period and the Warring States Period, improved in the Song and Ming dynasties, and matured in the Qing dynasty. With the efforts of experts in history, it has had a mature theory. According to modern research, it can avoid the first-pass effect of liver and the gastrointestinal irritation and improve the bioavailability of Chinese medicine. Based on the effect of Chinese medicine and the theory of meridian and collateral, it can stimulate the acupoints, exert regulatory effect on acupoints, and give full play to the efficacy of TCM and the interaction of the two. Thereby, it can regulate qi and blood and balance yin and yang, thus being widely used in the treatment of diseases. In this paper, the use of external application to acupoints, the effect on skin immunity, the regulation of neuro-inflammatory mechanism, the relationship between acupoint application and human circulation network, and the development of its dosage form were summarized through literature review. On this basis, this study is expected to lay a foundation for further research.
Assuntos
Pontos de Acupuntura , Meridianos , Humanos , Disponibilidade Biológica , Fumigação , Medicina Tradicional ChinesaRESUMO
With the rapid development of computer technology, numerical simulation has gradually become an important method to study drying process and improve drying equipment. Using computer to simulate the drying process of traditional Chinese medicine(TCM) is characterized by intuitiveness, scientificity, and low cost, which serves as an auxiliary means for technical innovation in TCM drying. This paper summarizes the theories of different drying methods and the research status of numerical simulation in drying, introduces the modeling methods and software of numerical simulation, and expounds the significance of numerical simulation modeling in shortening the research and development cycle, improving drying equipment, and optimizing drying parameters. However, the current numerical simulation method for drying process has problems, such as low accuracy, lack of quantitative indicators for the control of simulation results on the process, and insufficient in-depth research on the mechanism of drug quality changes. Furthermore, this paper put forward the application prospect of numerical simulation in TCM drying, providing reference for the further study of numerical simulation in this field.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , DessecaçãoRESUMO
In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Controle de Qualidade , Indústria Farmacêutica , Tecnologia Farmacêutica/métodos , Preparações FarmacêuticasRESUMO
Six new lignans with various type of linkage between two C6-C3 fragments (1a, 1b, 2a, 2b, 3, 4), two new meroterpenoids (5, 6) and 24 known compounds (7-30) were isolated from an EtOH extract of the stems and leaves of Piper puberulum. The absolute configurations of enantiomers 1a and 1b were determined by single-crystal X-ray diffraction analysis, 2a and 2b were determined by comparing their calculated and experimental ECD spectra. Biogenetically, all the new lignans may come from the polymerization of two molecules of hydroxychavicol (30). In the anti-neuroinflammation activity assay, the IC50 values of fifteen compounds were lower than those of the positive control minocycline, and compound 1a showed good activity, but its enantiomer 1b showed no activity. Compound 1a have notable anti-neuroinflammatory activity, and can significantly decrease mRNA levels of proinflammatory cytokines (IL-1ß, IL-6, TNF-α) in a dose-dependent manner.
Assuntos
Anti-Inflamatórios não Esteroides/farmacologia , Lignanas/farmacologia , Óxido Nítrico/antagonistas & inibidores , Piper/química , Extratos Vegetais/farmacologia , Terpenos/farmacologia , Animais , Anti-Inflamatórios não Esteroides/química , Anti-Inflamatórios não Esteroides/isolamento & purificação , Linhagem Celular , Cristalografia por Raios X , Citocinas/antagonistas & inibidores , Citocinas/metabolismo , Relação Dose-Resposta a Droga , Lignanas/química , Lignanas/isolamento & purificação , Camundongos , Modelos Moleculares , Estrutura Molecular , Óxido Nítrico/metabolismo , Extratos Vegetais/química , Extratos Vegetais/isolamento & purificação , RNA Mensageiro/antagonistas & inibidores , RNA Mensageiro/metabolismo , Estereoisomerismo , Relação Estrutura-Atividade , Terpenos/química , Terpenos/isolamento & purificaçãoRESUMO
Due to the characteristics of confusing varieties of Chinese medicinal materials, different sources, complex chemical composition, non-standard preparation process, and non-standard pharmaceutical equipment, the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation. The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation. The "overall, dialectical, and dynamic" multi-factor engineering quality view, covering original medicinal materials, preparation technologies, pharmaceutical equipment, and Chinese medicinal preparations, ensures the traceable process, measurable procedures, and feedback quality. The quality control mode of Chinese medicinal preparation with controllable sources, standardized preparation technologies, green pharmaceutical equipment, and intelligent manufacturing is built up.
Assuntos
Medicamentos de Ervas Chinesas , Farmácia , Comércio , Medicina Tradicional Chinesa , Controle de QualidadeRESUMO
Two pairs of cycloneolignane enantiomers, piperhancins A and B (1 and 2, respectively), along with two enantiomeric pairs of biosynthetic related neolignanes, hancinone C (3) and piperhancin C (4), were isolated from the stems of Piper hancei. Compound 1 is an unprecedented 1',2:1,2'-dicyclo-8,3'-neolignane. Their structures and absolute configurations were elucidated by spectroscopic analyses, X-ray diffraction, and electronic circular dichroism calculations. Among all of the isolates, compounds (+)-1, (-)-1, (+)-2, (-)-2, and (+)-3 could significantly inhibit the production of nitric oxide secreted by lipopolysaccharide (LPS)-induced neuroinflammation in BV-2 microglial cells, with IC50 values of 1.1-26.3 µM. In addition, compound (-)-1 could decrease the mRNA levels of iNOS, IL-6, and TNF-α induced by LPS in BV-2 microglial cells.
Assuntos
Piper , Lipopolissacarídeos , Microglia , Estrutura Molecular , Óxido Nítrico , EstereoisomerismoRESUMO
Three new tyramine-type alkamides (1-3), three new natural products (4-6), five new N-acylated/formylated aporphine alkamides with different ratios of rotational isomers (7-11), and 20 known alkamides (12-31) were isolated from an EtOH extract of the stems and leaves of Piper puberulum. The absolute configurations of compounds 7, 8, and 10 were determined by single-crystal X-ray diffraction analysis. In the biological activity assay, compounds 3, 5, and 10-23 displayed inhibitory effects against lipopolysaccharide-induced NO release in BV-2 microglial cells, exhibiting IC50 values of 0.93-45 µM.
Assuntos
Aporfinas/farmacologia , Microglia/efeitos dos fármacos , Piper/química , Tiramina/farmacologia , Animais , Aporfinas/isolamento & purificação , Linhagem Celular , China , Camundongos , Estrutura Molecular , Óxido Nítrico , Compostos Fitoquímicos/isolamento & purificação , Compostos Fitoquímicos/farmacologia , Folhas de Planta/química , Caules de Planta/química , Tiramina/isolamento & purificaçãoRESUMO
Sixteen chebulic acid derivatives, including nine new (1-9) and seven known (10-16) ones, were isolated from an ethanol extract of the branches and leaves of Balakata baccata. The structures of the new compounds were elucidated by their UV, IR, HRESIMS, NMR, electronic circular dichroism (ECD) and single-crystal X-ray diffraction data. The effects of all the isolates on antineuroinflammatory and antioxidant activities were evaluated. Compared with the positive control minocycline (IC50 = 1.21 ± 0.71 µM), compounds 1-16 with IC50 values being greater than 50 µM, displayed almost no effects on the inhibition of NO production in LPS-induced BV-2 microglial cells, however, the results of antioxidant activity for compounds 1-16 showed significant DPPH-radical scavenging abilities with EC50 value ranging from 3.98 to 14.24 µM, while the EC50 value of positive control vitamin C was 14.31 µM. At last, the results of PCR (qRT-PCR) analysis showed that compound 1 could enhance the expression of antioxidases (HO-1, GCLC, and NQO1) at the mRNA levels.
Assuntos
Anti-Inflamatórios/farmacologia , Antioxidantes/farmacologia , Benzopiranos/farmacologia , Inflamação/tratamento farmacológico , Sapium/química , Animais , Anti-Inflamatórios/química , Anti-Inflamatórios/isolamento & purificação , Antioxidantes/química , Antioxidantes/isolamento & purificação , Benzopiranos/química , Benzopiranos/isolamento & purificação , Compostos de Bifenilo/antagonistas & inibidores , Linhagem Celular , Relação Dose-Resposta a Droga , Inflamação/metabolismo , Lipopolissacarídeos/antagonistas & inibidores , Lipopolissacarídeos/farmacologia , Camundongos , Estrutura Molecular , Óxido Nítrico/antagonistas & inibidores , Óxido Nítrico/biossíntese , Picratos/antagonistas & inibidores , Folhas de Planta/química , Relação Estrutura-AtividadeRESUMO
Drying is one of the most common unit operations in the production of traditional Chinese medicine. The drying process of traditional Chinese medicine materials is accompanied by the dynamic reduction of water content. As a key index to determine the end of the drying process, the moisture content of materials plays an important role in improving drying efficiency and saving energy. Recently, the drying process of traditional Chinese medicine is mostly monitored by offline detection, and there are few reports of online moisture detection applications. In this paper, the principle and current application of online inspection technology for the material drying process in different fields were introduced. The significance of online detection technology in drying of traditional Chinese medicine was also analyzed. Meanwhile, the application prospect of online detection technology in the field of drying of traditional Chinese medicine was predicted. In response to urgent transformation and upgrading of the traditional Chinese medicine manufacturing industry, the application of online moisture detection technology is expected to be a key breakthrough in the intelligent upgrading of traditional Chinese medicine drying technology and equipment.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Dessecação , Controle de Qualidade , Tecnologia FarmacêuticaRESUMO
Twenty new chebulic acid and brevifolincarboxylic acid derivatives, including eight optically pure or achiral compounds (1-7 and 14) and six pairs of enantiomers (8a/8b-13a/13b), along with nine known analogues (15-23), were isolated from an EtOH extract of the aerial parts of Euphorbia hirta. The absolute configurations of the new compounds were assigned based on single-crystal X-ray diffraction analysis and comparison of the experimental and calculated ECD data. Racemic or scalemic mixtures of 8-13 were isolated, and their enantiomers were analyzed by chiral-phase HPLC-ECD measurements. Compound 12 possesses an unprecedented 2H-cyclopenta[de]chromene-2,5(4H)-dione scaffold. Compounds 12, 20, and 23 displayed moderate inhibitory effects against lipopolysaccharide-induced nitric oxide production in BV-2 microglial cells, while all the isolates exhibited significant DPPH radical scavenging activities with EC50 values of 2.2-15.8 µM.
Assuntos
Benzopiranos/química , Benzopiranos/farmacologia , Euphorbia/química , Benzopiranos/isolamento & purificação , Ácidos Carboxílicos/química , Ácidos Carboxílicos/isolamento & purificação , Ácidos Carboxílicos/farmacologia , Linhagem Celular , Sobrevivência Celular/efeitos dos fármacos , Cromatografia Líquida de Alta Pressão , Dicroísmo Circular , Sequestradores de Radicais Livres/farmacologia , Humanos , Lipopolissacarídeos , Estrutura Molecular , Óxido Nítrico/antagonistas & inibidores , Componentes Aéreos da Planta/química , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Estereoisomerismo , Difração de Raios XRESUMO
Four new diterpenoids (1-4), three new triterpenoids (12-14), and seven known diterpenoids (5-11) were obtained from an aqueous EtOH extract of the aerial parts of Triadica rotundifolia. The structures of new compounds were determined by spectroscopic techniques. Their absolute configurations were verified via single-crystal X-ray diffraction data, Mo2(OAc)4 induced electronic circular dichroism (ECD), and ECD calculations. The antineuroinflammatory effects of the isolates were assessed by inhibiting NO production in LPS-induced BV-2 microglial cells. Compared with the positive control minocycline (IC50 = 16.1 µM), compounds 3, 8, 11 showed moderate inhibitory activities with IC50 values of 35.9, 17.0, 31.5 µM, respectively.
Assuntos
Diterpenos/química , Euphorbiaceae/química , Microglia/efeitos dos fármacos , Óxido Nítrico/metabolismo , Componentes Aéreos da Planta/química , Extratos Vegetais/química , Triterpenos/química , Anti-Inflamatórios/química , Anti-Inflamatórios/farmacologia , Diterpenos/farmacologia , Relação Dose-Resposta a Droga , Avaliação Pré-Clínica de Medicamentos , Humanos , Minociclina/farmacologia , Minociclina/uso terapêutico , Modelos Moleculares , Estrutura Molecular , Fármacos Neuroprotetores/química , Fármacos Neuroprotetores/farmacologia , Extratos Vegetais/farmacologia , Triterpenos/farmacologiaRESUMO
BACKGROUND: Coilia nasus oogenesis/spawning migration is a well-defined synchronous arrangement process. DnaJs are indispensable molecular chaperones for oogenesis process. However, how DnaJs involved the anadromous spawning migration mechanism is outstanding and plausible. RESULTS: In this regard, two DnaJs (Cn-DnaJa1 and Cn-DnaJb1) are cloned from the Coilia nasus's ovary. Their structure both contains J domain, G/F domain and ZF domain. Their mRNA transcripts were found extensively expressed in all the sampled tissues and significantly highly in gonads, which probably mean that DnaJs involved in C. nasus's gonad development basal metabolic processes. In the process of spawning migration, Cn-DnaJa1 and Cn-DnaJb1 mRNA transcripts were also expressed with significant differences during oogenesis with highest levels in the development phase, and maintaining high levels during the multiplication, mature and spawning phase. Further study showed that the DnaJa1and DnaJb1protein have high distribution in the onset phase and mainly distributed in the oocyte cytoplasm especially during the migration development phase's. CONCLUSIONS: This experiment study demonstrated that DnaJs participate in reproductive regulation during the spawning migration process in C. nasus and possibly play a vital role in the ovary development process. These findings also provided a base knowledge for further molecular mechanism study of spawning migration.
Assuntos
Migração Animal/fisiologia , Peixes/embriologia , Peixes/genética , Proteínas de Choque Térmico HSP40/genética , Oogênese/genética , Sequência de Aminoácidos , Animais , Sequência de Bases , Clonagem Molecular , Feminino , Oogênese/fisiologia , Ovário , Domínios Proteicos/genética , RNA Mensageiro/genéticaRESUMO
Decoction pieces are important raw materials in the production of traditional Chinese medicine( TCM),and their quality could directly affect the clinical efficacy and medication safety. Research on the production and processing technology of TCM is the basis for the normalization and standardization of Chinese medicine decoction pieces. At present,the production and processing standards for Scutellaria baicalensis pieces are non-regulated,lacking data foundation. In this study,with baicalin,baicalein,wogonoside and wogonin contents as evaluation indicators,single factor experiment was designed to optimize the softening,drying and cutting processes of S. baicalensis,providing a basis for the standardization of their production and processing. The effects of different softening,drying and cutting processes on the contents of the main components in S. baicalensis were comprehensively analyzed by the summation of relative differences. RESULTS:: showed that the contents of the four components and comprehensive indexes were affected by different softening methods and drying temperatures. The content of wogonin in boiling method was higher than that in boiling with cold water,and the content of glycosides in 70 â drying condition was higher than that in other groups. The content of baicalin was significantly affected by different cutting thicknesses,but not by comprehensive index. Eventually,the optimal preparation process for S. baicalensis was determined as follows: boiled in boiling water for 20 min,cut into thin slices( 1-2 mm),and then dried at 70 â in blast drier. This process was close to the actual production,practical and feasible and meanwhile,it was of great significance to improve the quality of S. baicalensis pieces.
Assuntos
Medicamentos de Ervas Chinesas/normas , Scutellaria baicalensis/química , Dessecação , Flavonoides/análise , Medicina Tradicional Chinesa , Controle de QualidadeRESUMO
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.
Assuntos
Medicamentos de Ervas Chinesas/normas , Medicina Tradicional Chinesa/normas , Controle de Qualidade , China , Tecnologia FarmacêuticaRESUMO
Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation.
Assuntos
Medicamentos de Ervas Chinesas/normas , Controle de Qualidade , Medicina Tradicional Chinesa , RiscoRESUMO
To investigate the microbial contamination in Chinese herbal decoction pieces with different functional types by studying the total aerobic microbial count (TAMC), and total yeast and mould count (TYMC) in 40 samples of 8 types of root decoction pieces; further evaluate the contamination load of bile-resistant Gram-negative bacteria, and identify the Gram-negative bacteria by using biochemical identification system for Gram-negative bacteria. Our results showed that the TAMC value was more than 1 000 CFUâ¢g⻹ in 85% (34/40) samples, and was more than 100 CFUâ¢g⻹ in 30% (12/40) samples; the contamination of bile-resistant Gram-negative bacteria was detected in 45% (18/40) of the samples. The bile-resistant Gram-negative bacteria load of seven batches of samples was N>1 000 MPNâ¢g⻹. Sixteen bacterium strains including Serratia plymouthensis, Cedecea neteri, Escherichia vulneris, Klebsiella oxytoca, Enterobacter amnigenus, E. cloacae, E. sakazakii, Proteus penneri and E. gergoviae were obtained and identified. E. cloacae was the predominant bacterium that was isolated from Salviae Miltiorrhizae Radix et Rhizoma, while E. amnigenus, Yersinia pseudotuberculosis was the typical bacterium of Ophiopogonis Radix and Codonopsis Radix, respectively. All these suggested that the contamination of bile-resistant Gram-negative bacteria was severe for the root decoction pieces in Wuhan city. Microbial species have certain selection specificity for medicinal ingredients, so the type and limit of control bacteria for detection should be formulated according to the pollution type and quantity of bile-resistant Gram-negative bacteria.
Assuntos
Antibacterianos/farmacologia , Bile , Medicamentos de Ervas Chinesas/farmacologia , Bactérias Gram-Negativas/efeitos dos fármacos , Raízes de Plantas/químicaRESUMO
The quality uniformity of traditional Chinese medicine (TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present, the quality of TCM preparation is uneven. At present, the same TCM preparation in different manufacturers, TCM preparations in the same manufacturer, and even different batches of a same TCM preparation in the same manufacturer have great differences in quality, which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition, some strategies such as standardization of cultivation of TCM, processing standardization, standardization of pharmaceutical equipment, mixed batch feeding, and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.