重楼总皂苷巴布剂的基质处方优化及含量测定

Optimization of Matrix Formulation and Content Determination of Paridis Rhizoma Total Saponins Cataplasms

摘要:

目的: 优选重楼总皂苷巴布剂的基质处方并建立其含量测定方法.方法: 以涂展性、透布性、均匀性、赋形性、皮肤追随性、黏附性、反复揭帖性为综合评价指标,在预试验基础上,选择明胶、聚丙烯酸钠、甘油及聚乙烯吡咯烷酮-K30用量为考察因素,采用均匀设计法优选重楼总皂苷巴布剂的基质处方;利用HPLC测定重楼皂苷Ⅱ,Ⅶ含量,流动相乙腈(A)-水(B)梯度洗脱(0~40 min,30%~60%A;40~50 min,60%~30%A;50~55 min,30%A),流速1.0 mL ·min^-1,检测波长203 nm.结果: 最佳基质处方为明胶-聚丙烯酸钠-聚乙烯吡咯烷酮-K30-甘油-甘羟铝-氮酮-重楼总皂苷(2.0:4.0:1.25:15:0.16:1.2:4);重楼皂苷Ⅱ,Ⅶ线性范围分别为0.055~5.5,0.086 8~8.68 μg,质量分数分别为1.06,3.79 mg ·g^-1.结论: 制备的巴布剂载药量大,具有良好的黏附性和外观.建立的含量测定方法简便、准确可靠、重复性好,适用于该制剂的质量评价.

Abstract:

Objective:To optimize matrix formulation of Paridis Rhizoma total saponins cataplasms and establish its determination. Method: With ductility, fabric penetration, uniformity, shaped type, skin following nature, adhesion and repeated exposing paste as comprehensive evaluation indicators, on the basis of preliminary experiments, taking dosages of gelatin, sodium polyacrylate, glycerine and polyvinylpyrrolidone-K30(PVP-K30) as factors, matrix formulation of this preparation was optimized by uniform design.HPLC was adopted to determine contents of polyphyllin Ⅱ and polyphyllin Ⅶ with mobile phase of acetonitrile(A)-water(B) for gradient elution(0-40 min, 30%-60%A;40-50 min, 60%-30%A;50-55 min, 30%A), flow rate of 1.0 mL · min^-1 and detection wavelength at 203 nm. Result: Optimum matrix formulation was gelatin-sodium polyacrylate-PVP-K30-glycerine-glycinate aluminum-azone-total saponins from Paridis Rhizoma(2.0: 4.0: 1.25: 15: 0.16: 1.2: 4);polyphyllin Ⅱ and polyphyllin Ⅶ had good liner relationship in the ranges of 0.055-5.5 μg and 0.086 8-8.68 μg, respectively;contents of them in this cataplasms were 1.06, 3.79 mg · g^-1, respectively. Conclusion: Prepared cataplasms have great drug loading capacity, good adhesion and appearance.Established HPLC method is convenient, accurate and reliable with good reproducibility, which can be suitable for quality evaluation of this preparation.