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目的确定三七总皂苷鼻腔用粉雾剂的较优处方。方法以人参皂苷Rb11h、12h和人参皂苷Rg11h、12h的累积释放度、制剂的生物粘附强度及蟾蜍上腭黏膜纤毛毒性为指标,采用星点设计效应面优化法,确定较优处方。结果当三七总皂苷、微晶纤维素和中等粘度羟丙基纤维素的比例分别为31、60和9时,Rb11h、12h和Rg11h、12h的累积释放度分别为6.82、53.25和83.47、95.09,生物粘附强度为78min,蟾蜍上腭黏膜纤毛持续运动时间为为生理盐水组的94.84,几乎没有纤毛毒性。结论应用星点设计效应面优化法能够快速方便地得到三七总皂苷鼻腔用粉雾剂的较优处方。
Objective To determine the best prescription of nasal powder for total saponins of Panax notoginseng. Methods The cumulative release of ginsenosides Rb11h, 12h, and ginsenosides Rg11h and 12h, the bioadhesive strength of the preparations, and the cilia toxicity of the supraorbital mucosa were used as indicators. The star spot design effect surface optimization method was used to determine the best prescription. Results When the proportions of total saponins, microcrystalline cellulose and medium-viscosity hydroxypropyl cellulose were 31, 60 and 9 respectively, the cumulative release of Rb11h, 12h and Rg11h and 12h was 6.82, 53.25, 83.47 and 95.09, respectively. The bioadhesive strength was 78 minutes, and the continuous movement time of the iliac ciliated epithelial membrane was 94.84 in the normal saline group. There was almost no ciliary toxicity. Conclusion The optimized method for the nasal cavity spray of total saponins of Panax notoginseng can be quickly and conveniently obtained by using the star-designed effect surface optimization method.