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目的探讨复色1号凝胶剂的制备,考察复色1号凝胶剂的稳定性及安全性。方法以复色1号方水提取物为药物,卡波姆940、聚乙二醇4000等为辅料按凝胶的制备方法制成凝胶剂,采用恒温培养箱、冰箱、室温贮存及离心等方法考察凝胶的稳定性;用pH计测定复色1号方凝胶剂的pH值,并通过动物皮肤刺激实验和皮肤变态反应实验初步评价本制剂的安全性。结果制作的凝胶剂质地均匀,性质稳定,常温及耐寒、耐热实验凝胶的外观色泽、稠度无明显变化,无分层和变色现象;离心实验凝胶无变粗、分层和沉淀现象,pH值的平均值为(5.96±0.012)。皮肤刺激试验显示,本制剂对豚鼠皮肤无红斑、水肿和脱屑等刺激反应,皮肤变态反应试验对大鼠皮肤无红斑、水肿等过敏反应。结论本配方制成的凝胶剂性状稳定,无明显皮肤刺激性及致敏性。
Objective To study the preparation of Fucai No.1 gel and to study the stability and safety of Fucai No.1 gel. Methods The complex color No.1 square water extract was taken as medicine, carbomer 940, polyethylene glycol 4000 as the excipients, and then the gelatin was made according to the preparation method of the gel. The incubator was kept in constant temperature incubator, refrigerator, room temperature storage and centrifugation Methods The stability of gel was investigated. The pH value of complex No.1 gel was measured by pH meter. The safety of the preparation was preliminarily evaluated by animal skin irritation test and skin allergy test. Results The gels prepared were uniform in texture and stable in nature. The appearance color and consistency of normal temperature and cold-resistant and heat-resistant experimental gels showed no obvious changes, no delamination and discoloration. The gels of centrifuge gel did not become coarse, delaminated and precipitated , the average value of pH was (5.96 ± 0.012). Skin irritation test showed that the preparation had no irritation to erythema, edema and desquamation of guinea pig skin. Skin allergy test had no allergic reaction to erythema and edema on rat skin. Conclusion The gel made from this formula is stable without obvious skin irritation and sensitization.