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目的:制备异烟肼原位凝胶,并建立其质量控制方法。方法:采用搅拌子法测定胶凝温度并用黏度计测定黏度。建立异烟肼原位凝胶的质量控制方法。结果:以泊洛沙姆407和卡波姆940为混合基质制备异烟肼原位凝胶,得到优化处方:浓度为20%的泊洛沙407,0.2%的卡波姆940,1.0%的异烟肼溶液30 ml,内含1 ml甘油(保湿剂)。搅拌子法测得胶凝温度为29℃。结论:制备的异烟肼原位凝胶处方合理,质量稳定,且具有温度敏感型反相凝胶的性质,在体温条件下可以发生相变成为凝胶,可用于结核患者病灶内注射给药,以期达到靶向及缓释给药目的。
Objective: To prepare isoniazid gel in situ and establish its quality control method. Methods: The stirring method was used to determine the gelling temperature and the viscosity was measured with a viscometer. Establishment of a quality control method for isoniazid in situ gels. Results: The isoniazid in situ gel was prepared with poloxamer 407 and carbomer 940 as the mixed matrix to obtain the optimal formulation: Poloxamer 407 at 20% concentration, Carbopol 940 at 0.2%, Carbopol 940 at 1.0% Isoniazid solution 30 ml, containing 1 ml of glycerol (humectant). The stirring method measured the gelation temperature of 29 ℃. CONCLUSION: The prepared isoniazid in situ gel has the advantages of reasonable prescription, stable quality, temperature-sensitive inverse gel, phase change into gel at body temperature, and can be used for intralesional injection of tuberculosis patients , In order to achieve the purpose of targeting and sustained release drug delivery.