马来酸氯苯那敏凝胶剂的制备及质量考察

Preparation and determination of chlorpheniramine gel nasal drops

目的 :制备马来酸氯苯那敏凝胶剂及考察其质量。方法 :以卡波姆 940为乳化剂 ,乙醇为溶剂 ,三乙醇胺调节pH ,丙二醇作防腐剂 ,制备水溶性透明凝胶。采用一阶导数光谱法测定凝胶剂中马来酸氯苯那敏含量。结果 :制备的凝胶均匀细腻 ,稠度适宜。马来酸氯苯那敏的含量为 10 0 .7% ,平均回收率为 10 0 .8% ,RSD为 1.4%。结论 :该制剂性质稳定 ,无刺激性 ,是治疗过敏性鼻炎的理想新剂型。

OBJECTIVE:To prepare chlorpheniramine gel nasal drops and control the quality.METHODS:Carbopol 940 was used as emulsification agent,alcohol as dissolvent,triethanolamine as pH regulator,and propylene glycol as preservative.The hydrophilic gel was transparent.The first order derivative ultra violet spectrophotometry was used to measure the drug content of the gel.RESULTS:The gel was homogeneous,the average recovery was 100.75% , RSD was 1.4% .CONCLUSIONS:Results showed its quality can be controlled and without stimulation to nasal mucous membrane.It is an ideal and new drug to remedy allergic rhinitis.