Liu Yan, Zhao An-Yi, Ni Feng-Yan, Yu Hai-Chao, Cheng Jin-Tang, DI Ji-Peng, Liu Yu-Zhen, Wang Zhi-Guang, Liu An
Institute of Chinese Materia Medica, China Academy of Chinese Medical Science Beijing 100700, China.
Institute of Chinese Materia Medica, China Academy of Chinese Medical Science Beijing 100700, China Shanxi Medical University Taiyuan 300301, China.
Zhongguo Zhong Yao Za Zhi. 2020 Mar;45(5):1194-1201. doi: 10.19540/j.cnki.cjcmm.20191221.303.
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.
六味地黄丸是一种典型的“多厂家同产品”的传统中药。各厂家生产的产品质量和价格差异明显。本研究基于本研究组前期建立的“以质量为核心的中成药评价标准”，从原料、生产过程、质量控制及上市后再研究等多维度、全生产周期对六味地黄丸的质量差异进行评价。研究结果表明，各厂家产品质量差异显著，产品质量与企业市场份额呈正相关，即市场份额越大的企业越重视产品质量；且销量决定企业对产品的关注程度，这与一般认知相符。在六味地黄丸单项评价中，原料选择得分较低，企业对初始原料重视程度不足。整体生产过程较好，国家强制推行的“药品生产质量管理规范”（GMP）对提升产品质量有积极作用。质量控制基本能保证产品质量。政府推动的智能制造有利于确保产品一致性。“质量评价”项得分率基本合格，表明六味地黄丸整体质量控制水平尚可，但仍有提升空间。“再评价与品牌建设”得分最低，反映出企业对“多厂家同产品”的深入研究和再评价重视不够。评价结果符合预期，为高质量中成药评价提供了参考范例，为中成药优质优价提供了依据，为完善医保招标提供了科学数据，从而有助于推动中药产业健康发展。
