[Grade evaluation of Sophorae Tonkinensis Radix et Rhizoma based on quality constant evaluation method].

The traditional Chinese medicine(TCM) quality constant herbal slices evaluation method was applied to evaluate the grade of Sophorae Tonkinensis Radix et Rhizoma based on the combination of traditional character identification and modern scientific and technological methods. The TCM quality constant evaluation method was used to determine the appearance and index content of medicinal slices, calculate the quality constant and percentile quality constant of Sophorae Tonkinensis Radix et Rhizoma from different sources, and discuss their classification. The quality constants of 15 batches of Sophorae Tonkinensis Radix et Rhizoma slices were between 0.004 and 0.063. The slices with the percentage quality constant ≥80% were classified as the first grade; those with the percentage quality constant ≥50% and <80% were classified as the second grade; and those with the percentage quality constant <50% were classified as the third grade. Then the slices with the quality constant ≥0.050 were classified as the first grade; those with the quality constant ≥0.032 and <0.050 were classified as the second grade; and those with the quality constant <0.032 were classified as the third grade. According to the results, the 15 batches of Sophorae Tonkinensis Radix et Rhizoma slices were divided into 1 batch of the first grade, 4 batches of the second grade, and 10 batches of the third grade. The quality constant evaluation method established is scientific, objective, simple and feasible. The application of the method in Sophorae Tonkinensis Radix et Rhizoma slices has reasonable results, which is helpful to promote the classification of Sophorae Tonkinensis Radix et Rhizoma and promotes the high-quality application of Sophorae Tonkinensis Radix et Rhizoma.

[Current studies on quality of Chinese patent drugs with consistency as core and discussions on new high-quality evaluation model].

The consistency of quality on Chinese patent drugs is a hotspot and difficulty in the control of traditional Chinese medicine preparations, and has become one of the bottlenecks restricting its internationalization. Based on the analysis of current studies on quality and problems of Chinese patent drugs, this paper explored relevant methods of quality evaluation on Chinese patent drugs and possible factors affecting the consistency of quality in the pharmaceutical cycle by consulting relevant literatures about quality evaluation methods and consistency control techniques of large-scale Chinese patent drugs. And it put forward the evaluation system on high-quality Chinese patent drugs with "consistency" as the core, so as to promote the overall improvement of the quality of Chinese patent drugs, guide the rational price of Chinese patent drugs of the same species, and provide a new reference model for the quality evaluation of Chinese patent drug.

[Evaluation and analysis of high-quality products of Liuwei Dihuang Pills].

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.