RESUMO
Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
Assuntos
Medicina Tradicional Tibetana , Pesquisa Farmacêutica , Tibet , Controle de Qualidade , Indústria FarmacêuticaRESUMO
In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.
Assuntos
Medicamentos de Ervas Chinesas , Preparações Farmacêuticas , China , Medicina Tradicional Chinesa , PesquisaRESUMO
To improve the administration of local crude drug quality standard, the administration history, and current administration situation of local crude drugs were reviewed, the legal orientation and positive effect of local crude drugs were analyzed, and the existing problems were summarized. It was found that many problems existed in the administration of local crude drug quality standards, especially the phenomenon of homonym and synonym on their names. The suggestions on improving the administration of local crude drug quality standards were proposed. First of all, the construction of legal system should be strengthened to improve the administration methods. Secondly, the coordination mechanism should be developed to solve the outstanding problems. Thirdly, the basic research should be enhanced to resolve the general technical problems. Lastly, the channels to transfer the local crude drugs into pharmacopeia standards should be developed to achieve dynamic administration.
Assuntos
Preparações Farmacêuticas/normas , Controle de Qualidade , Medicina Tradicional Chinesa , Padrões de ReferênciaRESUMO
BACKGROUND: Raw Moutan Cortex (RMC), derived from the root bark of Paeonia suffruticosa, and Processed Moutan Cortex (PMC) is obtained from RMC by undergoing a stir-frying process. Both of them are indicated for different pharmacodynamic action in traditional Chinese medicine, and they have been used in China and other Asian countries for thousands of years. OBJECTIVE: To establish a method to study the RMC and PMC, revealing their different chemical composition by fingerprint, qualitative, and quantitative ways. MATERIALS AND METHODS: High-performance liquid chromatography coupled with diode array detector and electrospray mass spectrometry (HPLC-DAD-ESIMS) were used for the analysis. Therefore, the analytes were separated on an Ultimate TM XB-C18 analytical column (250 mm × 4.6 mm, 5.0 µm) with a gradient elution program by a mobile phase consisting of acetonitrile and 0.1% (v/v) formic acid water solution. The flow rate, injection volume, detection wavelength, and column temperature were set at 1.0 mL/min, 10 µL, 254 nm, and 30°C, respectively. Besides, principal components analysis and the test of significance were applied in data analysis. RESULTS: The results clearly showed a significant difference among RMC and PMC, indicating the significant changes in their chemical compositions before and after the stir-frying process. CONCLUSION: The HPLC-DAD-ESIMS coupled with chemometrics analysis could be used for comprehensive quality evaluation of raw and processed Moutan Cortex. SUMMARY: The experiment study the RMC and PMC by HPLC-DAD-ESIMS couple with chemometrics analysis. The results of their fingerprints, qualitative, and quantitative all clearly showed significant changes in their chemical compositions before and after stir-frying processed. Abbreviation used: HPLC-DAD-ESIMS: High-performance Liquid Chromatography-Diode Array Detector-Electrospray Mass Spectrometry, RMC: Raw moutan cortex, PMC: Processed moutan cortex, TCM: Traditional Chinese medicine, PCA: Principal components analysis, LOD: Limit of detection, LOQ: Limit of quantitation, RSD: Relative standard deviation.
RESUMO
Chinese herbal decoction pieces are the basic approaches for clinical traditional Chinese medicine (TCM), reflecting the features and advantages of TCM. In order to investigate the clinical application status and features of Chinese herbal decoction pieces, the questionnaire on application of commonly used Chinese herbal decoction pieces was designed in this study for analysis of the application situations of Chinese herbal decoction pieces from 56 medical institutions in 10 provinces. The results showed 549 varieties of Chinese herbs and 801 varieties of decoction pieces were used on clinic. They can be classified into 19 categories according to their effects. The varieties of Gancao (Glycyrrhizae Radix et Rhizoma), Huangqi (Astragali Radix), Dihuang (Rehmanniae Radix), Chuanxiong (Chuanxiong Rhizoma), Baizhu (Atractylodis Macrocephale Rhizima), Huangqin (Scutellariae Radix), Danggui (Angelicae Sinenses Radix), Baishao (Paeoniae Radix Alba) and Maidong (Ophiopogonis Radix) were most common ones; the application of Chinese herbal decoction pieces from different medical institutions was differentiated from areas to areas. The survey results reflected the general situation about application of decoction pieces, providing the basic data for recording and completing Chinese herbal decoction pieces in essential drug system, with certain reference significance for the production of Chinese medicinal materials and the allocation of the varieties of Chinese herbal decoction pieces.
Assuntos
Uso de Medicamentos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Medicina Tradicional Chinesa , Inquéritos e QuestionáriosRESUMO
To establish a new method for simultaneously determining the content of five gingerol compounds in different processing degrees of ginger charcoal and PCA principal component analysis was conducted for analysis. Samples were analyzed on Ultimate TM XB-C18 column (4.6 mm x 250 mm, 5 µm) , with acetonitrile (A) -0.1% phosphoric acid solution (B) as mobile phase for gradient elution. Detection wavelength was set at 280 nm. The flow rate was 0.6 mL x min(-1) and the column temperature was 30 degrees C. The five compounds were separated well and showed good linearity (r ≥ 0.999 7) within the concentration ranges tested. The average value for recoveries was between 98.86% - 101.5% (RSD 1.4% - 2.9%). The contents of five compounds showed difference among different processing degrees of ginger charcoal. Zingiberone had the highest content in the standard carbon, and the content of gingerol was decreased as the deepening of processing degree. Different processing degrees of ginger charcoal were classified into three groups with PCA, and provided scientific basis for establishing the quality standards of ginger charcoal.
Assuntos
Catecóis/química , Química Farmacêutica/métodos , Cromatografia Líquida de Alta Pressão/métodos , Medicamentos de Ervas Chinesas/química , Álcoois Graxos/química , Análise de Componente Principal/métodos , Zingiber officinale/química , Carvão Vegetal/químicaRESUMO
Traditional Chinese medicine (TCM) reference standards plays an important role in the quality control of Chinese herbal pieces. This paper overviewed the development of TCM reference standards. By analyzing the 2010 edition of Chinese pharmacopoeia, the application of TCM reference standards in the quality control of Chinese herbal pieces was summarized, and the problems exiting in the system were put forward. In the process of improving the quality control level of Chinese herbal pieces, various kinds of advanced methods and technology should be used to research the characteristic reference standards of Chinese herbal pieces, more and more reasonable reference standards should be introduced in the quality control system of Chinese herbal pieces. This article discussed the solutions in the aspect of TCM reference standards, and future development of quality control on Chinese herbal pieces is prospected.
Assuntos
Medicamentos de Ervas Chinesas/normas , Medicina Tradicional Chinesa/normas , Humanos , Controle de Qualidade , Padrões de ReferênciaRESUMO
General regulations for the processing are the important part of processing procedures of prepared slices of Chinese crude drugs. It has an important significance on enhancing the operability of actual production, regulating production of prepared slices of Chinese crude drugs, improving quality and establishing drug safety. The article could provides suggestions and reference for future compilation work on "National processing procedures of prepared slices of Chinese crude drugs" by comparative analysis and summary on general regulations for the processing of different processing procedures of prepared slices of Chinese crude drugs in China.