人工小肠液又称人工肠液,是模拟肠液的组分和pH值的一种溶液。本试剂采用中国药典表述,人工小肠液主要由磷酸盐、胰蛋白酶等组成,pH值约为6.8,未经无菌处理,可用于胶囊剂、肠溶片、滴丸剂等检测,尤其适用于肠溶胶囊的检测。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、人工小肠液为非无菌溶液,如有无菌要求,应注意0.22μm过滤除菌操作。
2、人工小肠液避免反复冻融,以免效率下降。
3、试剂开封后请尽快使用,以防影响后续实验效果。
4、为了您的安全和健康,请穿实验服并戴一次性手套操作。
Artificial Intestinal Fluid, also referred to as Artificial Intestinal Juice, is a solution formulated to simulate the composition and pH value of natural intestinal fluid. Complying with the specifications of the Chinese Pharmacopoeia, this reagent mainly consists of phosphates, trypsin, etc., with a pH value of approximately 6.8. It is not subjected to sterile processing and can be used for the testing of capsules, enteric-coated tablets, drop pills and other dosage forms, and is particularly suitable for the detection of enteric-coated capsules. This reagent is exclusively intended for research purposes and not applicable for clinical diagnosis or any other uses.
Operating Procedures (For Reference Only)
1. For the testing of capsules, enteric-coated tablets, drop pills and similar dosage forms, a lifting disintegration tester is generally adopted, which is mainly composed of a metal support and a basket equipped with baffles.
2. Immerse 6 units of the test capsules, enteric-coated tablets or drop pills in Artificial 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 them shall meet the requirements.
3. For other experiments, the operation shall be performed in accordance with the specific experimental requirements.
Precautions
1. Artificial Intestinal Fluid is a non-sterile solution. If sterility is required, sterile filtration with a 0.22 μm filter membrane should be carried out.
2. Avoid repeated freezing and thawing of Artificial Intestinal Fluid to prevent the reduction of its effectiveness.
3. Please use the reagent as soon as possible after opening to avoid affecting the results of subsequent experiments.
4. For your safety and health, wear a lab coat and disposable gloves during operation.