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1.
Yao Xue Xue Bao ; 51(1): 116-21, 2016 Jan.
Artículo en Chino | MEDLINE | ID: mdl-27405172

RESUMEN

Decoction is one of the most commonly used dosage forms of traditional Chinese medicine. The stability of chemical constituents in decoction is closely related to the clinical efficacy and safety. There were few reports about the influence of metal ions in the stability of chemical constituents in traditional Chinese medicine. However, there is no evidence that metal ions in decoction water need to be controlled. In this study, 2,3,5,4'-tetrahydroxy stilbene-2-O-ß-D-glucoside (THSG), one of the main constituents in Polygoni Multiflori Radix was studied. Ordinary tap water, deionized water, and water containing different metal ions were used to investigate and compare the influence on THSG. The results showed that after storage in a dark place at the room temperature for 10 days, the degradation of THSG was 7% in deionized water, while undetectable in tap water. The content of THSG could be decreased by different kinds of metal ions, and the effect was concentration-dependent. Moreover, Fe3+ and Fe2+ showed the greatest influence at the same concentration; and our study has shown that THSG decreased more than 98% in Fe and Fe2+ solutions at 500 ppm concentration. In the same time we found out p-hydroxybenzaldehyde (molecular weight: 122.036 7) and 2,3,5-trihydroxybenzaldehyde-2-O-glycoside (molecular weight: 316.079 4) were the main degradation products of THSG in tap water and water containing Cu2+, Ca2+, Zn2+, Mg2+ and Al3+. The product of THSG dimer with a water molecule was found in water containing Fe3+ and Fe2+. The above results showed that the metal ions in water could significantly influence the stability of THSG in water, indicating that the clinical efficacy and safety of decoction would be affected if the metal ions in water were not under control. It's suggested that deionized water should be used in the preparation of decoction containing Polygoni Multiflori Radix in the clinic to avoid degradation of THSG. Meanwhile, decoction prepared by tap water should be taken by patients in a short time. Our investigation provides important information and reference about the influence of metal ions on the stability of decoctions in other traditional Chinese medicine that have unstable groups such as hydroxyls and unsaturated bonds, etc.


Asunto(s)
Medicamentos Herbarios Chinos/química , Glucósidos/química , Iones/química , Metales/química , Polygonaceae/química , Estilbenos/química , Raíces de Plantas/química
2.
Zhongguo Zhong Yao Za Zhi ; 40(8): 1620-3, 2015 Apr.
Artículo en Chino | MEDLINE | ID: mdl-26281610

RESUMEN

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Medicamentos Herbarios Chinos/efectos adversos , China/epidemiología , Evaluación de Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Medicamentos Herbarios Chinos/uso terapéutico , Humanos , Vigilancia de Productos Comercializados
3.
Zhongguo Zhong Yao Za Zhi ; 40(5): 985-8, 2015 Mar.
Artículo en Chino | MEDLINE | ID: mdl-26087568

RESUMEN

Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.


Asunto(s)
Medicamentos Herbarios Chinos/historia , Medicina Tradicional China/historia , Polygonum/efectos adversos , China , Medicamentos Herbarios Chinos/efectos adversos , Historia Antigua , Humanos , Medicina en la Literatura , Medición de Riesgo
4.
Yao Xue Xue Bao ; 50(1): 28-33, 2015 Jan.
Artículo en Chino | MEDLINE | ID: mdl-25924471

RESUMEN

The liver injury induced by Polygonum multiflorum Thunb. (PM) was investigated based on idiosyncratic hepatotoxicity model co-treated with lipopolysaccharide (LPS) at a non-hepatotoxic dose. Sprague-Dawley (SD) rats were intragastrically administered with three doses (18.9, 37.8, 75.6 g crude drug per kg body weight) of 50% alcohol extracts of PM alone or co-treated with non-toxic dose of LPS (2.8 mg·kg(-1)) via tail vein injection. The plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities were assayed and the isolated livers were evaluated for histopathological changes. The dose-toxicity relationships of single treatment of PM or co-treatment of LPS were investigated comparatively to elucidate the idiosyncratic hepatotoxicity of PM. The results showed that no significant alterations of plasma ALT and AST activities were observed in the groups of solo-administration of LPS (2.8 mg·kg(-1), i.v.) or different dosage (18.9, 37.8 and 75.6 g·kg(-1), i.g.) of PM, compared to normal control group (P > 0.05); while significant elevations were observed in the co-administration groups of PM and LPS. Treatment with LPS alone caused slight infiltration of inflammatory cells in portal area but no evident hepatocytes injury. Co-treatment with LPS and PM (75.6 g·kg(-1), i.g.) caused hepatocyte focal necrosis, loss of central vein intima and a large number of inflammatory cell infiltration in portal areas. When further reduce the dosage of PM, significant increases of plasma ALT and AST activities (P < 0.05) were still observed in co-administration groups of LPS and PM (1.08 or 2.16 g·kg(-1)), but not in LPS or PM solo-administration groups. Nevertheless, the co-treatment of low dosage of PM (0.54 g·kg(-1)) with LPS did not induce any alteration of plasma ALT and AST. In conclusion, intragastric administration with 75.6 g·kg(-1) of PM did not induce liver injury in normal rats model; while the 2 folds of clinical equivalent dose of PM (1.08 g·kg(-1)) could result in liver injury in the LPS-based idiosyncratic hepatotoxicity model, which could be used to evaluate the idiosyncratic hepatotoxicity of PM.


Asunto(s)
Enfermedad Hepática Inducida por Sustancias y Drogas/patología , Polygonum/toxicidad , Alanina Transaminasa/sangre , Animales , Aspartato Aminotransferasas/sangre , Hepatocitos/patología , Lipopolisacáridos , Ratas , Ratas Sprague-Dawley
5.
Zhongguo Zhong Yao Za Zhi ; 40(18): 3693-6, 2015 Sep.
Artículo en Chino | MEDLINE | ID: mdl-26983223

RESUMEN

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Medicamentos Herbarios Chinos/efectos adversos , Medicina de Hierbas/legislación & jurisprudencia , Vigilancia de Productos Comercializados , Ensayos Clínicos como Asunto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Medicamentos Herbarios Chinos/química , Medicamentos Herbarios Chinos/economía , Medicamentos Herbarios Chinos/uso terapéutico , Medicina de Hierbas/economía , Humanos , Patentes como Asunto , Control de Calidad
6.
Zhongguo Zhong Yao Za Zhi ; 39(18): 3427-9, 2014 Sep.
Artículo en Chino | MEDLINE | ID: mdl-25532372

RESUMEN

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.


Asunto(s)
Evaluación de Medicamentos/métodos , Medicina Tradicional China , Medicamentos Herbarios Chinos , Humanos
7.
Zhongguo Zhong Yao Za Zhi ; 39(12): 2246-50, 2014 Jun.
Artículo en Chino | MEDLINE | ID: mdl-25244753

RESUMEN

The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.


Asunto(s)
Aristolochia/química , Ácidos Aristolóquicos/toxicidad , Medicamentos Herbarios Chinos/toxicidad , Animales , Aristolochia/efectos adversos , Ácidos Aristolóquicos/análisis , Ácidos Aristolóquicos/uso terapéutico , Quimioterapia , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Medicamentos Herbarios Chinos/análisis , Medicamentos Herbarios Chinos/uso terapéutico , Humanos
8.
Zhongguo Zhong Yao Za Zhi ; 39(1): 5-9, 2014 Jan.
Artículo en Chino | MEDLINE | ID: mdl-24754159

RESUMEN

Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.


Asunto(s)
Biomarcadores Farmacológicos/metabolismo , Enfermedad Hepática Inducida por Sustancias y Drogas/diagnóstico , Medicina Tradicional China/efectos adversos , Animales , Biopsia/métodos , Enfermedad Hepática Inducida por Sustancias y Drogas/metabolismo , Enfermedad Hepática Inducida por Sustancias y Drogas/patología , Diagnóstico Precoz , Humanos , Hígado/efectos de los fármacos , Hígado/patología , Ratas
9.
Zhongguo Zhong Yao Za Zhi ; 37(18): 2686-8, 2012 Sep.
Artículo en Chino | MEDLINE | ID: mdl-23285908

RESUMEN

The newly revised Regulations for the Administration of Adverse Drug Reaction Reporting and monitoringhas been implemented since July 1, 2011. It is the most important regulation on adverse drug reaction (ADR) monitoring. This article will intensively read the regulation and analysis its significance on the traditional Chinese medicine adverse reaction monitoring, so as to make the revised content more clear and guide the ADR monitoring working better.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos/normas , Monitoreo de Drogas/normas , Quimioterapia/normas , Medicamentos Herbarios Chinos/efectos adversos , Medicina Tradicional China/normas , China , Medicamentos Herbarios Chinos/uso terapéutico , Humanos
10.
Acta Pharmaceutica Sinica ; (12): 193-197, 2011.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-348977

RESUMEN

This paper is to report the investigation on the metabolic behavior of Staphylococcus aureus (S. aureus) after given Qingkailing injection, and with the aim of seeking for a new quality control method based on biological assessment. The growth thermogenic curves of S. aureus were determined by microcalorimetry and analyzed by computer. The results showed that in the concentration range of (0-5.00%), the growth thermogenic curves of S. aureus were declined and removed back with increasing dosage of Qingkailing injection; the main parameters (T1, T2, k1, P1, P2 and I) and the dosage of Qingkailing injection have good correlation. The 50% inhibiting dosage is 3.26 %, and the optimal inhibiting dosage is 5.47%. Difference could be detected among the Qingkailing injection samples from different factories and different batches. It is proved that Qingkailing injection could inhibit the metabolic behavior of S. aureus, and microcalorimetry might be applied in the quality assessment of Qingkailing injection.


Asunto(s)
Calorimetría , Métodos , Relación Dosis-Respuesta a Droga , Combinación de Medicamentos , Medicamentos Herbarios Chinos , Farmacología , Plantas Medicinales , Química , Control de Calidad , Staphylococcus aureus , Metabolismo , Termodinámica
11.
Guang Pu Xue Yu Guang Pu Fen Xi ; 29(11): 3112-6, 2009 Nov.
Artículo en Chino | MEDLINE | ID: mdl-20101997

RESUMEN

A method was established for simultaneous determination of ten active components in Qingkailing injection (QKL), and could be used as a feasible method for the quality control of QKL. HPLC-DAD-ELSD was employed for the determination at the optimal wavelength (255 nm). Fifteen samples of QKL at different batches from different factories were analyzed by the means. The results show that the method is corresponding with specified standard. The contents from different samples (QKL from different factories and different batches) have great disparity (The RSD values range from 2.17% to 65.54%). It is concluded that the method is reliable and convenient for the quality control of QKL. The key point of QKL quality control is to control the chief activity components as much as possible.


Asunto(s)
Medicamentos Herbarios Chinos/química , Cromatografía Líquida de Alta Presión , Medicamentos Herbarios Chinos/normas , Control de Calidad
12.
Zhongguo Zhong Yao Za Zhi ; 33(19): 2212-4, 2008 Oct.
Artículo en Chino | MEDLINE | ID: mdl-19166009

RESUMEN

OBJECTIVE: To establish HPLC fingerprints of cordyceps and mycelium of cultured cordy for quality control. METHOD: The analysis was carried out on a Diamonsil C18 column eluted with phosphate buffer (pH 6.5) and methanol as mobile phase, the gradient elution program was used, and the detection wavelength was 260 nm; The similarity of fingerprints was evaluated, then, cluster analysis was studied. RESULT: The method of HPLC fingerprint analysis was validated and in keeping with the requirement. Ten common peaks were found in HPLC fingerprint. Cordyceps from different areas and mycelium of cultured cordy could be distinguished by the HPLC fingerprint. CONCLUSION: All results above exhibit that this method is practicable, reproducible, and reliable as a method for the quality control of cordyceps and mycelium of cultured cordy at present.


Asunto(s)
Cromatografía Líquida de Alta Presión/métodos , Cordyceps/química , Micelio/química , Reproducibilidad de los Resultados
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