中药素片质量对薄膜包衣裂片率的影响及相关性分析  

Effect and Correlation Analysis of the Quality of Traditional Chinese Medicine Plain Tablets on the Cracking Rate of Film-Coating

作　　者：吴建程 周朝忠 汪佳星 肖勋立 李小锋 WU Jiancheng;ZHOU Chaozhong;WANG Jiaxing;XIAO Xunli;LI Xiaofeng(Affiliated Hospital of Jinggangshan University,Ji′an,Jiangxi,China 343000;Jiangxi Puzheng Pharmaceutical Co.,Ltd.,Ji′an,Jiangxi,China 343000)

机构地区：[1]井冈山大学附属医院,江西吉安343000 [2]江西普正制药股份有限公司,江西吉安343000

出　　处：《中国药业》2024年第15期48-51,共4页China Pharmaceuticals

基　　金：江西省中医药管理局科技计划项目[2021B609]。

摘　　要：目的 考察中药素片质量对薄膜包衣裂片率的影响。方法 以素片硬度、重量和脆碎度为指标评价素片质量。随机测定不同批次中药素片的重量、硬度、脆碎度,在相同生产工艺下测定薄膜包衣裂片率,对素片质量和薄膜包衣裂片率进行Pearson和Spearman相关性分析,采用聚类分析对素片硬度进行分类。结果 中药素片薄膜包衣裂片率与素片硬度、重量和脆碎度的Pearson相关系数分别为-0.568(P <0.01)、-0.021(P> 0.05)、0.263(P> 0.05);Spearman相关系数分别为-0.455(P <0.05)、0.075(P> 0.05)、0.090(P> 0.05)。以素片硬度为一般变量进行聚类分析,可将30批素片聚为4类,即素片质量优(素片硬度≥99 N)、良(89 N≤素片硬度<99 N)、合格(72 N≤素片硬度<89 N)、不合格(素片硬度<72 N)。素片硬度<72 N时,薄膜包衣裂片率为0.927‰。结论 在其他条件一定时,素片硬度是薄膜包衣裂片率的主要影响因素。素片硬度越高,薄膜包衣裂片率越低。素片硬度<72 N时,在同等操作水平下中药素片薄膜包衣裂片率易超过企业标准操作规程的上限要求。Objective To investigate the effect of the quality of traditional Chinese medicine (TCM) plain tablets on the cracking rate of film-coating.Methods The quality of plain tablets was evaluated with the hardness,weight and fragility as the indexes.The weight,hardness and fragility of different batches of TCM plain tablets were measured randomly,and the cracking rates of filmcoating were measured under the same production process.Pearson correlation and Spearman correlation analysis were performed on the quality of plain tablets and the cracking rates of film-coating.Cluster analysis was used to classify and optimize the hardness of plain tablets.Results The Pearson correlation coefficients among the cracking rate of film-coating and the hardness,weight,and fragility of plain tablets were-0.568 (P<0.01),-0.021 (P>0.05),and 0.263 (P>0.01),respectively.The Spearman correlation coefficients among the cracking rate of film-coating and the hardness,weight,and fragility of plain tablets were-0.455 (P<0.05),0.075 (P>0.05),and 0.090 (P>0.05),respectively.Cluster analysis was conducted with the hardness of plain tablets as a general variable,and 30 batches of plain tablets were clustered into four categories.According to the quality of plain tablets,they were classified as excellent (hardness of the plain tablet≥99 N),good (89 N≤hardness of the plain tablet<99 N),qualified(72 N≤hardness of the plain tablet<89 N),and unqualified(hardness of the plain tablet<72 N).When the hardness of the plain tablet was less than 72 N,the cracking rate of the film-coating was 0.927‰.Conclusion When other conditions are constant,the hardness of the plain tablet is the main influencing factor on the cracking rate of the filmcoating.The higher the hardness of the plain tablet,the lower the cracking rate of the film-coating.Plain tablets with a hardness of<72 N are prone to cracking rates of the film-coating exceeding the upper limit requirements of the enterprise′s standard operating procedures at the same operating level.

关 键 词：中药素片 薄膜包衣 裂片率 质量控制 

分 类 号：R932[医药卫生—生药学] R283[医药卫生—药学]