市售Lysozyme製劑之品質調查

QUALITY INVESTIGATION OF LYSOZYME PREPARATIONS

Lysozyme製劑，是較不安定的藥品製劑之一；為瞭解一般市售Lys02Vme製劑的品質情況，於北部地區，共抽樣貳拾肆件檢體，就重量差異，崩散度及力價等製劑學試驗，分析其品質，結果顯示：一重量差異試驗：日偏差在2％以內者，佔抽樣總數之75％。日偏差在2％～7.5％間者，佔25％。二崩散度試驗：日五分鐘以內崩散者佔抽樣總數之35％。口5～10分鐘間崩散者，佔60％。自10～15分鐘間崩散者，佔5％。三力價試驗：日對標示含量上85～115％者，佔62.5％。口對標示含量比：70～85％者，佔8.3％。日對標示含量比：70％以下者，佔29.2％。由上述數據得知：市售Lysozyme製劑，於重量差異及崩散度方面之品質管制，均極為良好。惟於力價方面，則有不安定之現象。吾人認為，於製程及貯存條件，均有加強管理之必要。 Lysozyme preparations are unstable pharmaceutical products. A total 24 cases of marketpurchased Lysozyme preparations for understanding the quality condition were sampled in random from the different pharmacies in the North Taiwan. In this study we analyzed its quality with weight variation test, disintegration test and activity test. The results are shown as follows: 1. Weight Variation Test: (1) Below 2% is 75%. (2) Between 2% and 7.5% is 25%. 2. Disintegration Test: (1) Below 5 min. is 35%. (2) Between 5 min. and 10 min. is 60%. (3) Between 10 min. and 15 min. is 5%. 3. Activity Test: the percentage of recovery to the labled amount (1) Between 85% and 115% is 62.5%. (2) Between 70% and 85% is 8.3%. (3) Below 70% is 29.2%. The results reviewed that the activity of Lysozyme preparations was very unstable. It is necessary to control seriously its quality during the manufacturing process and storage period.