中藥丸劑重量差異試驗法及規格制訂之探討

WEIGHT VARIATION TEST FOR PILLS OF CHINESE TRADITIONAL DRUGS

中藥丸劑重量差異試驗法及規格於中華藥典第三版暨行政院衛生署之查驗登記準則目前均未規定，本實驗經由製藥公會，調劑公會提供及本局蒐集之九劑檢體共計108件予以個別稱重後，由其重量分佈經統計分析，依檢體之單位重量分成四種，即100mg以上至300mg，300mg以上至600mg，600mg以上至1000mg及1000mg以上者，擬建議訂定其規定偏差及最大規定偏差分別為±10%、±20%；±9%、±18%；8%、±16%及±7%、±14%。

Weight variation test and its specification for pills of Chinese traditional drugs are not included in Ch. P. III. In order to establish a test method and its specification, 108 samples, collected by Taiwan Pharma- ceutical Industry Association, Taiwan Prescribing Association and our laboratories were studied. The pills were weighed and divided into 4 groups: group A, pill weight from 100 to 300mg; group B, 301 mg to 600 mg; group C, 601 mg to 1 gram; group D, more that 1 gram. Determination method was conducted according to Weight Variation Test for Tablets in Ch. P. III. From the data obtained, the percentage deviations for group A, B, C and D were calculated as 10, 9, 8 and 7%, respectively. The requirements were considered met if not more than two out of 20 pills exhibited individual deviated weights exceeding the weight corresponding to their percentage deviation, and none deviated by more than twice that percentage.