消肿止痛巴布膏的制备、质量控制及临床应用

Preparation,Quality Control and Clinical Application of Xiaozhong Zhitong Cataplasma

目的:制备消肿止痛巴布膏,建立其质量控制方法,并观察其对30例骨科患者的临床疗效。方法:根据协定处方消肿止痛散,以水溶性高分子材料为基质,将处方中各药材提取物与基质均匀混合,涂布于无纺布上制得巴布膏剂;测定该巴布膏的含膏量和稳定性。将消肿止痛巴布膏组(治疗组)与消肿止痛散组(对照组)进行疗效对比观察。结果:制得的消肿止痛巴布膏膏面光洁,厚薄均匀;含膏量为0.7156g.100cm-2,3个月内稳定性良好;治疗组总有效率为93.3%,显著高于对照组的76.7%(P<0.05)。结论:该制备方法简便、可行,临床疗效显著,适合在临床推广应用。

OBJECTIVE：To prepare Xiaozhong zhitong cataplasma,establish a method for its quality control and to observe its clinical efficacy on orthopedic patients（30 cases）. METHODS： Based on the precompounded prescription order of Xiaozhong zhitong powder with water soluble polymer substance as base material which were evenly mixed with the drug extractives before being applied on non woven fabric to prepare Xiaozhong zhitong cataplasma.The clinical efficacy was compared between the trial group（Xiaozhong zhitong cataplasma） and the control group（Xiaozhong zhitong powder） .RESULTS： The prepared Xiaozhong zhitong cataplasma had smooth surface and uniform thickness,with a satisfactory stability achieved within 3 months at a dosage of （0.7156g·100cm^-2.The total effective rate in the trial group（93.3% ） was significantly higher than in the control group（76.7% ） （P〈0.05） .CONCLUSION： The preparation technology is simple and feasible , and the preparation showed a remarkable clinical efficacy thus worthy to be popularized in clinical practice.