摘要
目的优选逐瘀止痛凝胶膏剂的基质处方及成型工艺。方法以揭贴性、皮肤追随性等感官指标;持粘力、初粘力等物理指标为考察指标综合评分,在单因素试验考察辅料种类及部分辅料用量的基础上,采用星点设计-效应面法对辅料之间及辅料与药膏的配比进行优化筛选。结果逐瘀止痛凝胶膏剂的基质最佳配比为:卡波姆-PVA-丙二醇-甘氨酸铝-PVPK-30-PVPK-90-微粉硅胶-水-药膏(3.9∶0.5∶22∶0.7∶1.2∶3.6∶5∶30.21∶13.4),该基质分次混合后加入提取稠膏,45～50℃条件下涂布于无纺布背衬上,涂布厚度约为1.5～2.0mm,于40℃干燥箱中干燥12h,加盖保护膜,置封口袋中密封保存。采用以上制备方法制备的凝胶膏剂3批小试进行质量测定,得到初黏力12号球,持黏力5min,剥离强度0.4N,综合感官指标良好,得分均高,最终综合评分分别为172.4、169.8、173.5。结论该法制备的凝胶膏剂易于涂布、膏面光洁、皮肤追随性良好、黏度适中,揭帖无痛感。该法优选的基质及成型工艺科学合理,稳定可行,适合生产中使用。
[Abatract] Objective To optimize the matrix prescription and preparation process of Zhuyu Zhitonggel paste.Methods CCD-RSM was used to investigate the preparation process with the adhesion,physical properties,appearance of film remnants,transdermal absorption property and spreadability as sensory and physical indexes of the total score.The ratio of accessories to the paste was optimized by CCD-RSM on the basis of the single factor experiment.Results The optimal ratio among substrates-carbomerpolyvinyl-propylene glycol-glycine-povidone K-30-povidone K-90-silica powder-water and ointment was3.9∶0.5∶22∶0.7∶1.2∶3.6∶5∶30.21∶13.4.The substrates were mixed and divided into two parts.Ointments and matrices were coated on a nonwoven fabric backing 1.5-2 mm thick under 45-50℃.The gel paste was dried at 40 ℃for 12 h,covered with a protective film,and placed in a sealed bag for storage.The gel paste prepared with this method was tested in three batches.The initial adhesion strength of 12 balls was obtained.The adhesive strength was 5 min and the peeling strength was 0.4 N.The comprehensive sensory indexes were good and the scores were 172.4,169.8 and 173.5 respectively.Conclusion The gel paste is easy tocoat,with a smooth cream surface,consistent color,good transdermal absorption property,but without any leakage.The preparation process is rational and suitable for production.
作者
毕建云
张震宇
BI Jian-yun;ZHANG Zhen-yu(Shandong University of Traditional Chinese Medieine,Jinan 250355,China)
出处
《解放军药学学报》
CAS
CSCD
2018年第6期498-501,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
山东中医药大学科学基金项目优秀青年基金
No.2018zk43
山东中医药大学教育科学研究实验教学专项
No.sy2016021
