Effect and Correlation Analysis of the Quality of Traditional Chinese Medicine Plain Tablets on the Cracking Rate of Film-Coating
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 film-coating 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 film-coating.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.
traditional Chinese medicine plain tabletsfilm-coatingcracking ratequality control
万方数据
维普
