| Objective:In order to promote the quality improvement of Chinese patent medicine and reveal the stability of quality uniformity of Chinese patent medicine of the same variety and different manufacturers at the present stage,an innovative quality consistency evaluation method was established,which was applied to the quality consistency evaluation of Liuwei Dihuang pills(concentrated pill),Shuanghuanglian oral liquid and Yangyin Qingfei pills.Based on consistency,the quality evaluation of Yangyin Qingfei preparations from different manufacturers was carried out to provide reference for guiding doctors and patients to use drugs rationally and promoting the quality improvement of Chinese patent medicines.Methods:1.To establish a consistency evaluation method for the quality of proprietary Chinese medicines.Firstly,the consistency parameters in three dimensions of intra-batch content difference(P_A),inter-batch content difference(P_B)and fingerprint similarity(P_C)were constructed,secondly,the consistency parameters were statistically analyzed and modeled by principal component analysis(PCA),finally,the samples were classified into quality classes according to the modeling results.2.Three kinds of Chinese patent medicine samples,Liuwei Dihuang Concentrated Pill,Shuanghuanglian Oral Liquid and Yangyin Qingfei Pill,were tested for multiple indexes and determined to be qualified according to the standard,and the consistency evaluation method was used to evaluate the quality consistency of each manufacturer’s sample based on the consistency differentiation factor(P).3.Adopting the"High-quality evaluation criteria with the quality as core for Chinese patent medicine",we analyzed and evaluated three preparations of Yangyin Qingfei Syrup,Yangyin Qingfei Granules and Yangyin Qingfei ointment from the perspectives of raw material selection,production process,quality control,post-marketing research and other items of materials,to selecte the products with high quality.Results:(1)The thirty-five batches of Liuwei Dihuang Concentrated Pills from seven manufacturers all met the requirements of the Pharmacopoeia of the People’s Republic of China(2020 edition)and all samples were qualified,and the results of methodological validation showed that the established method for quantification of gallic acid and other 6 components in the samples was scientific,with P_A of 4.2～15.1%,P_B of 26.4～49.5%,P_C≥92.9;the range of consistency differentiation factor values for the seven manufacturers was 64.5～75.8,and the seven manufacturers were classified into two categories according to the P value,LB and LJ manufacturers were in one category,and LZ,LF,LX,LR and LS manufacturers were in one category.(2)All forty batches of Shuanghuanglian oral liquid from eight manufacturers met the requirements of the Pharmacopoeia of the People’s Republic of China(2020 version),all samples were qualified,and the results of methodological validation showed that the established method for quantification of six components in the samples,including neocyanuric acid,was scientific,and the P_A of eight manufacturers was1.2～7.7%,P_B was 16.6～39.1%,P_C≥99.3%,and the consistency differentiation factor value of the eight manufacturers was 26.2～37.0.According to the P value eight manufacturers were classified into two categories,SL,SJ and SZ manufacturers were in one category,and SX,SS,SF,ST and SR manufacturers were in the other category.(3)All the twenty-two batches of Yangyin Qingfei Pills from six manufacturers met the requirements of the Pharmacopoeia of the People’s Republic of China(2020 edition),all samples were qualified,and the results of methodological validation showed that the established methods for quantification of six components in the samples,including paeoniflorin,were scientific;the P_A of six manufacturers was 2.5～19.0%,the P_B was12.3～34.2%,only two manufacturers P_C≥90%,four manufacturers P_C<90%;the consistency differentiation factor score of the 8 manufacturers was-16.2～-35.5,according to the P value 6 manufacturers were classified into three categories,YS manufacturers one category,YG,YJ two manufacturers as one category YB,YZ,and YF manufacturers were classified as one category.(4)The relative quality constants of Yangyin Qingfei Syrup were 90%,Yangyin Qingfei Granules were 59%and Yangyin Qingfei Ointment were 41%,according to the grade classification standard,Yangyin Qingfei syrup was the first grade product,Yangyin Qingfei granules and Yangyin Qingfei ointment were the third grade product,that is,Yangyin Qingfei Syrup was a relatively high quality product.Conclusions:1.The consistency evaluation method includes intra-batch and inter-batch content consistency variation values and fingerprint similarity rate,assessing the quality of proprietary Chinese patent medicine from both quantitative and qualitative aspects,and establishes a new method for consistent quality rating of proprietary Chinese patent medicine that was simple and practical to operate.2.Different manufacturers of Liuwei Dihuang Concentrated pills,Shuanghuanglian oral liquid and Yangyin Qingfei Pills had different classifications,indicating that there was a certain degree of quality difference among the manufacturers of these three Chinese patent medicine in the pharmaceutical market at this stage,which also indicates that uniform and stable quality is a key part of the current high-quality development of Chinese patent medicine that needs to be addressed.3.The evaluation method was applied to map the product quality of different manufacturers of three varieties of Chinese patent medicine,and the experimental results will have a guiding role in guiding doctors and patients to choose their medicines rationally,and it was of reference significance for pharmaceutical manufacturers and relevant government units to understand the quality status of different manufacturers of Chinese patent medicine at this stage. |
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