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目的制备多西他赛纳米乳注射液,并对其质量进行控制。方法采用高压均质法制备多西他赛纳米乳注射液;在最佳处方的基础上,考察工艺因素对纳米乳剂的性质及稳定性的影响,并对其理化性质进行考察。结果多西他赛纳米乳注射液载药量为2 g.L-1,粒径为(46.7±35.0)nm,含量质量分数为96.69%;与质量分数为0.9%的氯化钠配伍后24 h内使用安全;在(4±2)℃条件下,稳定性良好。结论该处方及工艺可行,所制备的多西他赛纳米乳注射液质量稳定,使用方便,具有临床应用价值。
Objective To prepare docetaxel nanoemulsion injection and control its quality. Methods The docetaxel nanoemulsion injection was prepared by high pressure homogenization method. Based on the best prescription, the influence of technological factors on the properties and stability of nanoemulsion was investigated and its physico-chemical properties were investigated. Results The docetaxel nanoemulsion had a drug loading of 2 gL-1 and a particle size of (46.7 ± 35.0) nm with a mass fraction of 96.69%. Within 24 h after compatibility with sodium chloride with a mass fraction of 0.9% Safe to use; good stability at (4 ± 2) ° C. Conclusion The prescription and technique are feasible. The prepared docetaxel nanoemulsion injection has stable quality, convenient use and clinical value.