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.