征集收载多个溶出度方法的制剂？盐酸普鲁卡因胺片 USP 第一法：Medium: 0.1 N hydrochloric acid; 900 mL. Apparatus 2: 50 rpm. Times: 1（30%~60%）, 4（60%~90%）, and 6 hours.（≥75%） 第二法：ACID STAGE: 0.1 N hydrochloric acid; 900 mL for 1 hour. BUFFER STAGE: 0.05 M phosphate buffer, pH 7.5; 900 mL (see Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours. Apparatus 2: 50 rpm, with sinkers. Times: 1（30%~60%）, 4（60%~90%）, and 8 hours（≥80%）. 第三法：Medium—Proceed as directed under Test 2. Apparatus 2: 50 rpm, with sinkers. Times: 1（25%~50%）, 3（40%~75%）, 6（65%~90%）, and 8 hours（≥80%） 第四法 Medium: 0.1 N hydrochloric acid; 900 mL. Apparatus 1: 50 rpm. Times: 1（≤30%）, 2（25%~45%）, 4（45%~75%）, 8（70%~90%）, and 14 hours（≥80%）. 第五法：Medium— Proceed as directed for Method B under Delayed Release Dosage Forms. ACID STAGE: 0.1 N hydrochloric acid; 1000 mL for 1 hour. BUFFER STAGE: 0.05 M phosphate buffer, pH 7.5; 1000 mL (see Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours. Apparatus 2: 50 rpm, with sinkers 500mg规格 Times: 1（30%~45%）, 4（55%~75%）, 6（≥65%）, and 8 hours.（≥75%） 750mg与1000mg规格片剂： Times: 1（30%~50%）, 4（60%~80%）, 6（70%~90%）, and 8 hours.（≥75%） 第六法：Medium—Proceed as directed for Test 2. Apparatus 2: 50 rpm. Times: 1, 4, and 8 hours. 规格不同，溶出标准也有不同 第七法：Medium— Proceed as directed for Method B under Delayed- Release Dosage Forms. ACID STAGE: 0.1 N hydrochloric acid; 900 mL for 1 hour. BUFFER STAGE: 0.05 M phosphate buffer, pH 7.5; 900 mL (see the Buffer Solutions under Reagents, Indicators, and Solutions) for not less than 8 hours. Apparatus 2: 50 rpm, with sinkers. . Times: 1, 4, 6, and 8 hours. Procedure—Proceed as directed for Procedure in Test 1. Tolerances—Proceed as directed for Tolerances in Test 2.查看更多
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