1. Physical property test: The appearance and physical properties of enteric hollow capsules directly affect their use effect. First, the appearance inspection should ensure that the capsules have no obvious defects, such as cracks, bubbles, discoloration or impurities. Defects may cause the capsules to rupture during use, affecting the drug release effect. Secondly, the consistency of size and weight is crucial, and manufacturers should follow strict standards to ensure the accuracy and repeatability of the dosage of each capsule. Using professional equipment for dimensional measurement and weight testing can ensure the consistency of the product. It is also important to conduct disintegration tests. This test is usually conducted in a simulated gastric acid environment to evaluate whether the capsule can maintain its integrity within two hours. The ability of the capsule not to rupture under acidic conditions ensures that the drug can work in the intestine, which is particularly important for enteric capsules for gastric sensitive or unstable drugs.

2. Solubility test: Solubility is one of the key indicators for evaluating the performance of enteric capsules. By conducting a dissolution test in simulated intestinal fluid, the time and speed of drug release are studied to ensure that it meets the standards specified in the pharmacopoeia. For example, the percentage of drug that should be released within a specific time (such as 30 minutes) can be set to ensure its efficacy in the intestine. In the test, different temperature and pH conditions can be used to more comprehensively evaluate the performance of the capsule under different physiological environments. The use of modern analytical techniques such as high performance liquid chromatography (HPLC) can accurately determine the release rate and release curve of the drug, thereby judging the dissolution characteristics of the capsule. These tests help optimize the capsule formulation and ensure the effective release of the drug in clinical applications.

3. Chemical stability test: Chemical stability is an important aspect to ensure that the quality of enteric-coated capsules is maintained during storage and transportation. The stability of capsules in high temperature and high humidity environments can be evaluated through accelerated aging tests. Usually, the capsules are placed under different storage conditions (such as 25°C/60% RH, 40°C/75% RH), and samples are taken regularly and analyzed for changes in their chemical composition. Special attention is paid to the formation of drug degradation products and their effects on capsule materials. By comparing the data before and after the test, the stability and shelf life of the capsule can be evaluated. It is also crucial to conduct long-term stability studies (usually 6 months to 1 year of testing) to ensure that the performance of the capsules under actual storage conditions meets the requirements. This stability test not only helps to confirm the effectiveness of the capsules during the shelf life, but also provides an important basis for the marketing of the product.

4. Biocompatibility testing: Biocompatibility testing is an important part of evaluating the safety of enteric hollow capsules. First, through in vitro cell culture experiments, the effects of capsule materials on cells are evaluated to ensure that they are non-toxic and non-irritating to cells. This usually involves contacting the capsule material with cells and observing the growth and metabolism of cells. Animal experiments are also an important means of evaluating biocompatibility. By testing the safety and effectiveness of capsules in animals, more clinically meaningful data can be obtained. Implementing ISO 10993 standard biocompatibility testing can provide a reliable basis for the clinical application of products. These tests ensure that the capsules do not cause adverse reactions in actual use, thereby protecting the health of patients.

5. Microbial limit testing: It is crucial to ensure the microbial safety of enteric hollow capsules during production. Through microbial limit testing, it is verified that the microbial load of the capsules meets the pharmacopoeia standards. This process usually includes testing of raw materials, semi-finished products and finished products to ensure that there is no bacterial, fungal or other microbial contamination. Using standard test methods, such as culture medium method and membrane filtration method, potential microbial contamination can be effectively identified. Ensuring the sterility of the production environment is also very critical. This includes production in clean rooms, regular disinfection of equipment, and strict hygiene training for employees. These measures can minimize the risk of microbial contamination, thereby ensuring the safety and effectiveness of the capsules.

6. Long-term stability study: Long-term stability study is an important part of evaluating enteric hollow capsules in actual use. By observing the performance changes of the capsules under real storage conditions (such as room temperature and humidity), its effectiveness throughout the shelf life can be evaluated. Physical, chemical and biological performance tests of samples are performed regularly to ensure that the performance of the capsules meets the standards at different time periods. Generally speaking, the duration of long-term stability studies is more than 12 months, and key parameters such as appearance, weight, solubility and drug content need to be monitored during the test. With this data, manufacturers can promptly identify potential problems and make necessary adjustments. The results of long-term stability studies can provide strong support for the marketing of products and ensure the safety and effectiveness of consumers when using the products.