复方南星止痛凝胶的制备及评价

Preparation and Evaluation of Compound Nanxing Pain Relief Gel

目的制备复方南星止痛凝胶(Compound Nanxing Pain Relief Gel,CNPRG),并对其进行质量及致敏性评价。方法CNPRG以Carbopol 980 NF为基质,将外观、黏度、涂展性、离心稳定性、低温稳定性、高温稳定性作为综合考察指标,采用单因素试验结合Box-Behnken效应面法优化处方,从而制备CNPRG;初步建立CNPRG的外观、pH、黏度、稳定性、挥发性成分气相鉴别、次乌头碱及丁香酚含量测定等质量评价方法;采用主动皮肤过敏试验对CNPRG进行致敏性评价研究。结果所得CNPRG最佳处方为:Carbopol 980 NF用量0.35 g,载药量1.02 g,甘油量5.00 g,pH=6.20。其外观如果冻,表面光滑、均匀、细腻;pH=6.20±0.03;黏度68.43±1.14 Pa·s;离心、高温、低温稳定性均良好,无分层、析出药液现象;气相鉴别检出樟脑、冰片、桂皮醛、丁香酚、丹皮酚等挥发性成分;检出次乌头碱含量0.2981±0.0072μg·g^(-1);检出丁香酚含量155.66±0.96μg·g^(-1);CNPRG确认无致敏性。结论CNPRG外观良好、质量稳定、无致敏性,可为复方南星止痛膏以缓解致敏性为导向开发新剂型提供选择。

Objective To prepare Compound Nanxing Pain Relief Gel(CNPRG)and evaluate its quality and sensitization.Methods CNPRG uses Carbopol 980 NF as the matrix;Appearance,viscosity,coating,centrifugal stability,cold stability,thermal stability as comprehensive indicators,single test and Box-Behnken effector method to optimize the prescription;The quality evaluation methods of appearance,pH,viscosity,stability,vapor phase identification of volatile components,and determination of diaconitine and eugenol content of CNPRG were preliminarily established;CNPRG sensitization was assessed by Active Cutaneous Anaphylaxis.Results The best prescription for CNPRG was Carbopol 980 NF 0.35 g,drug 1.02 g,glycerol 5.00 g,and pH 6.20.CNPRG's appearance likes jelly,is smooth,uniform and delicate;pH=6.20±0.03;viscosity 68.43±1.14 Pa·s;Centrifugation,high,low temperature stability,no stratification and precipitation;Identify camphor,(±)-Borneol and(±)-Isoborneol,Cinnamaldehyde,eugenol,phenol;Hypaconitine content 0.2983±0.0073μg·g^(-1);Eugenol content 155.66±0.97μg·g^(-1);CNPRG confirmed no sensitization.Conclusion CNPRG has good appearance,stable quality and no sensitization,and it can provide a choice for the development of new dosage forms of compound Nanxing pain relief cream to alleviate sensitization.