人工胃液 (ChP)是模拟胃液的组分和pH值的一种溶液 ,采用中国药典表述,人工胃液 (ChP, 无酶)主要由稀酸、去离子水等组成,不含胃蛋白酶,未经无菌处理,可用于胶囊剂、肠溶片、滴丸剂等检测,尤其适用于以明胶为基质的软胶囊和滴丸的检测。该试剂仅用于科研领域,不适用于临床诊断或其他用途。
操作步骤 (仅供参考):
1、如果是检测胶囊剂、肠溶片、滴丸剂等,一般采用升降式崩解仪,主要由金属支架、带有挡板的吊篮组成。
2、将待测的胶囊剂、肠溶片、滴丸剂6粒或片浸于人工胃液中,1小时内完全崩解,如有1粒或片不能完全崩解,应另取6粒或片复试,均应符合要求。
3、如果进行其他实验,应根据具体实验要求操作。
注意事项:
1、人工胃液 (ChP, 无酶)) 为非无菌溶液,如有无菌要求,可高压灭菌或过滤除菌。
2、如需含酶 (胃蛋白酶)的产品可购买人工胃液 (ChP)、人工胃液 (USP)等相关产品。
3、为了您的安全和健康,请穿实验服并戴一次性手套操作。
Simulated Gastric Fluid (ChP) is a solution formulated to mimic the composition and pH value of natural gastric juice, in compliance with the specifications of the Chinese Pharmacopoeia. Simulated Gastric Fluid (ChP, Enzyme-free) is mainly composed of dilute acid and deionized water, contains no pepsin, and is non-sterile processed. It can be used for the testing of capsules, enteric-coated tablets, dropping pills and other preparations, and is particularly suitable for the testing of soft capsules and dropping pills with gelatin as the matrix. This reagent is for research use only and not intended for clinical diagnosis or any other applications.
Operating Procedures (For Reference Only)
1. For the testing of capsules, enteric-coated tablets, dropping pills and other preparations, a lifting disintegration tester is generally adopted, which is mainly composed of a metal support and a basket with baffles.
2. Immerse 6 units of the test capsules, enteric-coated tablets or dropping pills in the Simulated Gastric Fluid. They should disintegrate completely within 1 hour. If 1 unit fails to disintegrate fully, another 6 units shall be taken for retesting, and all of the retested samples must meet the requirements.
3. For other experiments, operations shall be performed in accordance with the specific experimental requirements.
Precautions
1. Simulated Gastric Fluid (ChP, Enzyme-free) is a non-sterile solution. If sterility is required, autoclaving or sterile filtration can be performed.
2. If you need products containing enzymes (pepsin), you can purchase related products such as Artificial Gastric Fluid (ChP) and Artificial Gastric Fluid (USP).
3. For your safety and health, please wear a lab coat and disposable gloves during operation.