目的 以羟丙甲基纤维素(HPMC)为成囊材料,添加凝胶剂、助凝剂及增塑剂,研制HPMC空心胶囊。方法 经溶胶、养胶、制胚、干燥、套合等工艺,以胶液黏度、胶囊性状、成囊率、水分等为指标,通过单因素和正交实验优化HPMC空心胶囊的最适配方及制备工艺参数。结果 空心胶囊的配方为HPMC(E5型)16.5%、κ-卡拉胶0.9%,制备参数为:90 ℃溶胶30 min、45~50 ℃养胶、45~50 ℃蘸胶制胚,于35 ℃干燥2~2.5 h。结论 研制的HPMC空心胶囊的性状、崩解时限、脆碎率和松紧度等指标均符合国家标准,该配方简单、工艺稳定,具有推广应用价值。

OBJECTIVE To prepare hypromellose(HPMC) hollow capsules by hypromellose as raw material, adding gel, coagulant and plasticizer. METHODS Using hypromellose and k-carrageenan as main material, the HPMC hollow capsules were prepared by sol preparing, glue keeping, sheet stamping, drying, cutting and superposition sequentially. Glue viscosity, properties, yield and water content of capsule were used as indicators to optimize formula and preparation parameters by single factor experiments and orthogonal experiments. RESULTS The most appropriate formula and preparation conditions were as follows HPMC (E5) 16.5%, k-carrageenan 0.9%, and sol dissolving time 30 min under 90 ℃, glue keeping temperature 45-50 ℃, sheet stamping 45-50 ℃,drying 2-2.5 hr in condition of 35 ℃. CONCLUSION The key performance indicators like apparent shape, disintegration time etc of HPMC hollow capsules meet the requirements of the national standard.The preparation is suitable for industrial production.