Shinozawa S, Yoshimura A, Araki Y
Res Commun Chem Pathol Pharmacol. 1983 Oct;42(1):161-4.
Dissolution test of two rifampicin (RFP) products (DI and CB) was carried out by "Rotating Basket Method" on JP X, using a first and second fluid for disintegration test or a de-aerated water as dissolution medium. The dissolution ratios of the DI product in the second fluid and de-aerated water at 60 min are 72.0% and 95.0%, and the CB product ratios are 10.0% and 5.5% respectively. On their bioavailability parameters, the DI product showed higher C max and AUC value than CB, in both healthy subjects and tubercular patients, but did not show a statistically significant difference. Healthy subjects showed statistically significant high C max and AUC values as compared against tubercular patients, namely on C max of CB and DI products, and on AUC of CB and DI product.
采用“转篮法”，依据日本药局方第X版，以第一液和第二液作为崩解试验液或用脱气水作为溶出介质，对两种利福平（RFP）产品（DI和CB）进行溶出度试验。DI产品在第二液和脱气水中60分钟时的溶出率分别为72.0%和95.0%，CB产品的溶出率分别为10.0%和5.5%。在生物利用度参数方面，无论是健康受试者还是结核病患者，DI产品的Cmax和AUC值均高于CB产品，但差异无统计学意义。与结核病患者相比，健康受试者的Cmax和AUC值具有统计学显著差异，即在CB和DI产品的Cmax以及CB和DI产品的AUC方面。
