舒林酸壳聚糖凝胶的制备与临床应用

Preparation and Clinical Application of Sulindac Chitosan Gel

目的制备舒林酸壳聚糖凝胶剂并应用于临床。方法用紫外分光光度法测定含量,并用对照法观察临床疗效。结果含量测定平均回收率为100.3%,RSD为1.8%(n=5)。应用舒林酸壳聚糖凝胶剂治疗类风湿性关节炎患者75例,总有效率93.3%。结论该制剂符合凝胶剂的要求,可试用于临床。

Objective To prepare sulindac chitosan gel and apply the drug to the clinic. Methods Add 5.0 g of sulindac and 50.0 g of glycerin to 500 mL of methanol with stirring for dissolution. Add 400 mL of pure water to the solution for dilution. Cast 10.0 g of chitosan and 5.0 g of carbemer on the surface of the liqid for full-blown swelling followed by the addition of 5.0 g of laurocapram and triethanolarnine qs with strring. Add pure water to 1000 mL with stirring and the gel was completed. Ultraviolet spectrophotometry was used to determine the content of sulindae in the gel. 135 patients with rheumatoid arthritis （RA） were randomly divided into 2 groups： the trial group （n =75） and control group （n =60）. The affected joints in patients of the trial group were smeared with 0.1 - 0.5 g of the sulindal chitosan gel per joint according to the size of the joints t. i.d.. Patients of the control group were given each 0.2 g of sulindac PO, b. i. d.. The course of treatment in beth groups lasted 8 weeks. Results The average rate of recovery in content determination of sulindac was 100.3% with an RSD of 1.8% （ n = 5）. The overall effective rates in patients of the trial group and control group were 93.3% and 81.7%, respectively （P 〈 0.05 ）. Conclusions The quality of the preparation accords with the relevant regulations of gel preparation of the Chinese Pharmacopoeia. It may thus be used in the clinic.