RESUMEN
Chinese patent medicine (CPM) is an important part of traditional and Chinese medicine (TCM). Its quality has direct impact on the safety and effectiveness of clinical use. The quality standard is the pivotal approach to guarantee the quality of CPM. Due to the complex material basis, multitudinous quality influencing factors and unveiled active ingredients, dose-effect relationship and action mechanism, the investigation on quality standard faces many difficulties. This paper surveys the current quality status of CPM and the general situation of CPM standards. At present, the dosing problem has the crucial impact on the quality of CPM. The current quality standard system of CPM is confirmed and the limitations are indicated. Based on the above analysis, the principles and considerations on investigation of quality standard are proposed as follows: ① Adhere to safety as the bottom line, strengthen the risk-control ability of the standard of CPM; ② Adhere to theory of TCM and comprehensive quality, improve the integrative control level of the CPM standard; ③ Emphasize technological development and innovation, promote the quality control competence of CPM standard; ④ Facilitate planning and coordination, optimize the management of the CPM standard system; ⑤ Reinforce investigation on evaluation method, develop grade evaluation standard, accelerate high-quality development of CPM. Finally, the future perspective on investigation of CPM quality standard is prospected.
RESUMEN
OBJECTIVE: To compare the limits of detection ( LODs) of TLC obtained with three evaluation approaches in Chinese Pharmacopoeia 2015, and facilitate selection of LOD evaluation approach in TLC method validation. METHODS: After development, the spots of strychnine, berberine hydrochloride, and ten chemical dyes were first detected by human eyes and then scanned by thin layer scanner to obtain the LODs based on visual evaluation, signal-to-noise, and standard deviation of the response and the slope. RESULTS: The LODs obtained by the three approaches showed no significant difference. For strychnine and 10 chemical dyes, the LODs based on the three approaches were close to each other. For berberine hydrochloride, the LOD obtained by visual evaluation was slightly lower than those obtained by the other two approaches. CONCLUSION: All the three approaches are feasible to determine LOD in TLC. The approach based on visual evaluation is rapid and reliable, which might be the first choice for LOD determination in TLC.
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The morphological identification, chemical component analysis, and DNA barcode determination were investigated on Genus Mentha (including Mentha haplocalyx Briq., Mentha piperita Linn., Mentha spicata Linn. and Mentha cultivated) in order to reveal the origin of Herba Mentha as a drug, and ensure the accuracy in clinic application. The morphological characters, chemical composition analysis by GC-MS/MS and DNA content measure by polymerase chain reaction (PCR) were reported in this study for inter- or intra- species divergence. Based on the morphology, axillary verticillasters was recognized as the typical character for Mentha haplocalyx Briq. Carvone was used as an index component for chemical composition analysis of Mentha spicata Linn. Gene clustering analysis divided 22 batches of samples into two molecular groups. Mentha haplocalyx Briq. is distinguishably different from Mentha spicata Linn. Mentha piperita Linn. and other cultivated plants were distributed between these two species. The results obtained by morphological identification, chemical composition analysis, and DNA barcode determination show good correlations, but each identification method has its limit. In view of the fact that hybridization of the plants in Genus Mentha is common, identification relying on only one method is not recommended.
RESUMEN
High price and poor stability of both crocin-1 and crocin-2 reference substance have become obstacles to HPLC assay of Croci Stigma. A new method based on reference extract was proposed. In this study, the reference extract was prepared from gardenia yellow which is cheap and easy to get The content of crocin-1 and crocin-2 in reference extract was determined and factors affecting stability of reference extract were investigated. Twelve batches of Croci Stigma were analyzed with reference extract and reference substance respectively. The results showed no difference. The presented method is feasible for quality control of Croci Stigma and reference extract is suitable to replace reference substances in assay.