基于优质中成药评价标准的复方丹参制剂生产质量优劣性分析

Advantages and disadvantages of production quality of Fufang Danshen Prescription based on high-quality Chinese patent medicine evaluation criteria

中成药大品种复方丹参制剂,具有活血化瘀、理气止痛功效。临床应用广泛,剂型种类和产品数量众多,而质量和价格参差不齐,给医患选用造成困扰。为阐述导致不同复方丹参产品质量差异的关键环节及质控薄弱点,该研究以“优质中成药评价标准”为基础,针对复方丹参制剂开展全生产周期的综合性评价,从得分结果分析不同产品生产和质量优劣性。研究结果表明,各产品在“原料选材”项得分差异较大,最高分(S1)和最低分(S2)差异3倍余,说明各厂家对原料选材要求不一致,将导致原料质量根本性差异;“生产过程”项得分差异较小,平均分占比66.8%,其中S8厂家得分最高(达84.0%),智能制造生产崭露头角;“质量控制”项得分相比前2项较低(平均分占比44.0%),原因是复方丹参产品多数仅满足2020年版《中国药典》要求的“合格”基准,其一致性和优质性均无法把控;“上市后研究”项得分占比最低(平均分占比仅28.5%),大部分厂家得分为0,可见普遍不重视,仅少数品牌厂家得分尚可,愿意针对性开展该品种的上市后再评价相关研究。此次评价结果明确了不同厂家复方丹参制剂产品的生产质量差异关键环节及薄弱点,期望可推动该品种质量提升,促进“优质优价”机制形成,为政府集采提供信息参考。

The big brand of Chinese patent medicine, Fufang Danshen Prescription(FDP), effective in promoting blood circulation, resolving blood stasis, regulating qi, and relieving pain, is wide in clinical application and diverse in dosage forms and products, but its quality and price are uneven, which causes problems for doctors and patients. To clarify the key links and weakness of quality control leading to the quality difference of FDP products, the present study carried out a comprehensive evaluation of the whole production cycle of FDP based on the "high-quality Chinese patent medicine evaluation criteria" and analyzed the advantages and disadvantages of production and quality of different FDP products according to scores. The results showed that the scores of various products in the "raw materials selection" varied greatly. The highest score(S1) and the lowest score(S2) differed by more than 3 times, indicating that different manufacturers had inconsistent requirements for the selection of raw materials, leading to fundamental differences in the quality of raw materials. The scores in the "production process" varied slightly, with an average score of 66.8%. The manufacturer S8 obtained the highest score(84.0%), which indicated the emergence of intelligent manufacturing production. The scores(with the average score of 44.0%) in the "quality control" were lower than those of the previous two items, which was attributed to the fact that most FDP products only met the "qualified" benchmark required by the 2020 edition of Chinese Pharmacopoeia, and their consistency and high quality were both uncontrollable. The scores in the "post-marketing research" were the lowest(with an average score of 28.5%), and most manufacturers were scored 0, which reflected little attention paid. Only a few brand manufacturers were scored acceptably and they were willing to carry out relevant research on post-marketing evaluation. The evaluation results demonstrated the key links and weakness leading to the production and quality differences of FDP from different manufacturers. It is expected to improve the quality of FDP, promote the formation of the "high quality and good price" mechanism, and provide information for the centralized procurement of governments.