Analysis on Prescription Research and Historical Evolution of Mahuangtang / 中国实验方剂学杂志

Based on the ancient Chinese medical literature and modern clinical application literature， Mahuangtang was systematically analyzed， including its origin， composition， processing requirements and others， in order to provide support for the development of this famous classical formula. It was found that there were some doubts about Mahuangtang， such as the original variety， the processing of decoction pieces， and the dose conversion ratio. On the basis of fully considering the actual needs of the development of famous classical formula preparations and the usage habits of modern clinical practice， the development suggestions of the author were as follows：Ephedrae Herba should be selected Ephedra sinica without removing knots， Cinnamomi Ramulus should be selected from Cinnamomum cassia， Glycyrrhizae Radix et Rhizoma should select Glycyrrhiza uralensis and be roasted with honey， and Armeniacae Semen Amarum should be selected as Dan-processed products. The total dose of Mahuangtang was 24 g after conversion according to 1 Liang equal to 3 g as following the transition phenomenon and law. The preparation and usage method was as follows：took 1.8 L of water， first added Ephedrae Herba in water for decocting， evaporated 400 mL of water， removed the upper foam， then added the other three drugs， cooked over gentle heat to 500 mL， filtered the residue， took three times a day， about 160 mL warm decoction once. The major function recorded of Mahuangtang in ancient books was exterior sthenia syndrome of exogenous wind cold， it often used in the clinical treatment of cold， acute bronchitis， bronchial asthma and other diseases through the flexible application of the later doctors.

Prescription Research and Clinical Application of Wenjingtang / 中国实验方剂学杂志

The prescription research and clinical application of Wenjingtang were summarized in order to provide reference for the formulation of material standard and the development of compound preparation. By systematically sorting out the relevant ancient medical books and modern literature reports， combined with the relevant policy requirements of the development of compound preparations of famous classical formulas， this paper expounded the existing problems and put forward some suggestions. Wenjingtang is composed of nine herbs， which is derived from Complete Effective Prescriptions for Women's Diseases written by CHEN Zi-ming in Song dynasty. The original medicinal plants and medicinal parts of the formula were basically the same as those recorded in the 2020 edition of Chinese Pharmacopoeia， for example， Paeonia lactiflora was the choice of Paeoniae Radix Alba， Cinnamomi Cortex was selected as Guixin， the rhizoma of Curcuma phaeocaulis was selected as Curcumae Rhizoma. It was suggested that raw products should be selected for decoction pieces and processed according to the methods recorded in the 2020 edition of Chinese Pharmacopoeia. According to the dosage of 1 Liang=40 g， the dosages of Angelicae Sinensis Radix， Chuanxiong Rhizoma， Paeoniae Radix Alba， Cinnamomi Cortex， Moutan Cortex and Curcumae Rhizoma were 20 g， the dosages of Ginseng Radix et Rhizoma， Glycyrrhizae Radix et Rhizoma and Achyranthis Bidentatae Radix were 40 g， the total amount of this formula was 240 g. The 9 kinds of decoction pieces were crushed （particle size<6 mm） separately and mixed， each dose was 20 g， 525 mL of water was added， and then decocted to 280 mL. After filtration， warm medicine was taken for once a day. According to ancient books， Wenjingtang has the functions of activating blood circulation， regulating menstruation，warming meridians and dispersing cold. It is mainly used to treat dysmenorrhea， irregular menstruation and other diseases in modern clinical practice. In addition， it has certain curative effect on endometriosis， pelvic inflammatory disease， acne， eczema and other skin diseases. Through the research， the historical evolution and clinical application of Wenjingtang are fully clarified， which can provide research for the later development and application of this famous classical formula.

Study on quality evaluation method of classical prescription Mahuang Decoction primary standard substances / 中国中药杂志

This study aimed to establish the HPLC characteristic chromatogram and content determination method for index components with the primary standard substances of the classical prescription Mahuang Decoction, and to provide data basis for the establishment of its quality standard and the development and utilization of compound preparations. First, HPLC was used to establish the material reference chromatograms of Mahuang Decoction, and 15 batches of standard samples of Mahuang Decoction were determined. Their similarity was calculated by the median method. Secondly, the content of the standard substances was determined and a simplecontent determination method was established by HPLC. Relevant methodology was investigated, and the extraction ratio, index component transfer rate and moisture content of 15 batches of primary standard samples were calculated. The results showed that the two sets of HPLC methods had their own characteristics. The six chromatographic peaks identified from the 10 common peaks in the former characteristic chromatogram covered all the herbal medicines in the standard substances, which can better indicate the quality characteristics of the standard substances of Mahuang Decoction. The latter method(content determination method) was simple and practical, so it was suitable for establishing the quality standard of its compound preparation. Two sets of methods were jointly used to evaluate the quality of 15 batches of Mahuang Decoction. The results were as follows: the similarity of 15 batches of samples was greater than 0.90; the average extraction ratio was 18.1%; the average moisture content was 9.7%; the average content and transfer rate of the standard ingredients ephedrine hydrochloride and total pseudoephedrine hydrochloride were 2.3% and 26.7% respectively, and the average content and transfer rate of amygdalin were 2.2% and 48.3% respectively. None of the data showed dispersion(beyond 70%-130% of the mean value), which met the application data requirements for the substance standards of ancient classical Chinese herbal compound preparations(draft for comments). Based on the above research, the primary substance quality standard of Mahuang Decoction was established in order to provide reference for the development and research of the compound preparation of Mahuang Decoction.

Evaluation and analysis of high-quality products of Liuwei Dihuang Pills / 中国中药杂志

Liuwei Dihuang Pills is a typical traditional Chinese medicine with "the same product made by many manufacturers". The quality and price of products made in various factories was different obviously. In this study, the quality differences of Liuwei Dihuang Pills were evaluated over multi-dimensions and throughout the whole production cycle involving raw materials, production process, quality control and post-marketing re-studies based on the "Chinese patent medicine evaluation standard with quality at the core" established earlier by our research group. The research results showed that the product quality of various manufacturers was significantly different, and the product quality was positively correlated with the market shares of enterprises, indicating that enterprises with more market shares paid more attention to product quality; and the sales determined the concern degree of enterprises on products, which was in line with general cognition. During the single-item evaluation of Liuwei Dihuang Pills, the score of raw material selection was relatively low, and the enterprises paid less attention to the initial raw materials. The whole production process was better, and the national compulsory implementation of "Production Quality Management Standard"(GMP) had a positive effect in improving product quality. Quality control could basically guarantee product quality. Intelligent manufacturing promoted by the government was beneficial to ensure product uniformity. The score rate of "quality evaluation" item was basically qualified, which indicated that the quality control level of Liuwei Dihuang Pills was acceptable as a whole, but there was still room for improvement. "Re-evaluation and Brand Construction" had the lowest scores, reflecting that enterprises did not pay enough attention to in-depth study and re-evaluation of "the same product made by many manufacturers". The evaluation results were in line with expectations, provided a reference example for the evaluation of high-quality Chinese patent medicine, a basis for the high-quality and good price of Chinese patent medicine, scientific data for improving medical insurance bidding, and thus facilitated promoting the healthy development of the traditional Chinese medicine industry.