Most of the solid preparations of traditional Chinese medicine in the purification workshop are used for oral administration. It is convenient and safe to use. It is often a clinically inevitable choice. The cleansing requirements of the production process are generally 300,000, which is far lower than the injection, so the cost is low and the output is large. Here we mainly introduce the production environment requirements for capsules in solid preparations of traditional Chinese medicines. Capsules are divided into hard capsules, soft capsules and enteric capsules.
The hard capsule of the purification workshop is an oral agent. The exposure process, including the preparation of raw materials, capsules, packaging materials, ingredients, mixing granulation and drying, filling, lighting, inner packaging, etc. It is in a 300,000-level environment. The content of the content of the hard capsule shall not exceed 9%, and the water content is too high, which may soften or even leak the shell of the capsule after filling, and on the other hand affect the fluidity of the filled particles, thereby affecting the difference in the loading of the capsule; The wettable drug particles should be prevented from wetting when filled, and appropriate excipients can be added as needed. Hard capsules should completely disintegrate in water at (37 ± 1) ° C for 30 min; enteric capsules should not dissolve in artificial gastric juice, (37 ± 1) ° C for 2 h, then at pH 6.8 Phosphate buffer solution, completely disintegrated within 1h at (37±1) degrees Celsius; need to pay attention to the disintegration time of hollow hard capsules, excellent product ≤10min, first level ≤15min, qualified product ≤20min, if hard capsule The disintegration time is too long, and the disintegration time of the air hard capsule itself should be fully considered. The difference in the loading capacity of the hard capsules in the purification workshop is related to the fluidity and viscosity of the filled particles. The main ones are the filling process, manual, semi-mechanical and semi-automatic filling processes. The latter is accurate, and the manual filling is fundamental. It is difficult to solve the difference in loading. Zhongjing Global Purification can provide consulting, planning, design, construction and decoration services for the purification workshop.
Purification workshop soft capsules and hard capsules can mask the bad odor of the drug, reduce irritation, prevent oxidative decomposition and increase the stability of the drug. All exposure processes for soft capsule production should also be in a clean environment of 300,000. The cleanliness of low-humidity air for dehumidification of soft capsules at room temperature should also be the same clean level. The drying of the soft capsule in the purification workshop cannot be carried out at a higher temperature. Therefore, the current process is to wet with a low-humidity air convection at normal temperature. To obtain a low-humidity air, a lithium chloride rotary dehumidifier can be used. Soft capsules are packaged in the same form as hard capsules, either in bottles or in aluminum-plastic blister packs. The production process of soft capsules can be roughly divided into the steps of plasticizing, compounding, filling, washing, drying, packaging, etc. Soft capsules are slightly thicker than the hard capsule shells and have high elasticity and plasticity, depending on the formula of the capsule, ie Appropriate ratio of dry gelatin, plasticizer and water.