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目的:研究可注射硫酸延胡索总碱原位凝胶的制备方法及其体外释药特性。方法:以泊洛沙姆407为载体材料制备注射用硫酸延胡索总碱温敏型原位凝胶制剂;采用高效液相色谱法测定释放介质中药物含量,考察凝胶体外释放特性;并对制剂进行评价。结果:原位凝胶最佳配方为:16%泊洛沙姆407、11%泊洛沙姆188、0.2%壳聚糖、0.5%硫酸延胡索总碱,该原位凝胶在室温下为流体,在体温下发生相转变形成凝胶;药物在48 h释放了88.4%,无突释现象,释药规律符合H iguchi方程;凝胶属Ostwald流体。结论:可注射硫酸延胡索总碱原位凝胶制备工艺简便,有良好的缓释作用,为研究中药植入型给药系统提供了依据。
Objective: To study the preparation and in vitro release characteristics of injectable corynebacil sulfate in situ gel. METHODS: Poloxamer 407 was used as a carrier to prepare the thermostatic in situ gel formulation of coryntal sulfate sulfate for injection. The content of drug in the release medium was determined by high performance liquid chromatography (HPLC) and the in vitro release characteristics of the gel were investigated. Evaluation. Results: The best in-situ gel formulations were: poloxamer 16%, poloxamer 188, poloxamer 188, chloramphenicol 0.2%, and tacrolimus 0.5%, the in situ gel was fluid at room temperature , The phase transition occurred at body temperature to form a gel; the drug released 88.4% at 48 h without burst release and the drug release was in accordance with the Higuchi equation; the gel belongs to the Ostwald fluid. CONCLUSION: The preparation process of injectable corynebacterium sulfate alkali in situ gel is simple and has good sustained-release effect, which provides the basis for the study of implanted drug delivery system of traditional Chinese medicine.