盐酸普萘洛尔凝胶的制备及其含量测定

目的:制备盐酸普萘洛尔凝胶并测定主药的含量。方法:以羧甲基纤维素钠为凝胶基质、盐酸普萘洛尔为主药制备盐酸普萘洛尔凝胶;采用紫外分光光度法于292 nm波长处测定凝胶中盐酸普萘洛尔的含量;以离心试验和留样观察试验进行初步稳定性考察。结果:制备的凝胶均匀细腻,黏附性、涂展性良好,各项检查符合《中国药典》相关规定。盐酸普萘洛尔检测质量浓度线性范围为1.35⁴5.00μg/ml(r=0.999 4),低、中、高质量浓度平均回收率为97.08%、104.3%、102.7%(RSD=0.72%、0.36%、0.53%,n=3)。3批样品含量为100.8%45.00μg/ml(r=0.999 4),低、中、高质量浓度平均回收率为97.08%、104.3%、102.7%(RSD=0.72%、0.36%、0.53%,n=3)。3批样品含量为100.8%¹03.3%。离心试验中样品外观未见分层;留样观察试验中样品室温放置6个月时主药含量下降,但4℃冷藏条件下样品稳定。结论:该制备工艺简单、稳定,含量测定方法准确、可靠、简单、快速;样品宜冷藏,有效期暂定为6个月。

Preparation and Content Determination of Propranolol Hydrochloride Gel

OBJECTIVE： To prepare Propranolol hydrochloride gel and to establish the method for the content determination of main component. METHODS： Propranolol hydrochloride gel was prepared with carboxymethylcellulose sodium as matrix and pro- pranolol hydrochloride as main component. The content of propranolol hydrochloride was determined by UV spectrophotometry at 292 nm. The centrifugation test and sample observation test were also carried out for primary stability study. RESULTS： The pro- pranolol hydrochloride gel was well-proportioned and of good viscidity and easy to spread. All tests were in line with the regula- tions of Chinese Pharmacopeia. The linear range of propranolol hydrochloride was 1.35-45.00 μg/ml （r=0.999 4）. Average recover- ies were 97.08% （RSD=0.72%）, 104.3% （RSD=0.36%） and 102.7% （RSD=0.53%） at low, medium and high concentrations （n= 3）. The contents of 3 batches of samples were 100.8 %-103.3 %. In centrifugation test, no stratification was observed in appear- ance of samples. The content of main component decreased after keeping for 6 months under room temperature in sample observa- tion test but stable under 4 ℃. CONCLUSIONS： The technology is simple and stable. The method for content determination is ac- curate, reliable, rapid and simple. The sample should be kept in cold storage, the period of validity is temporarily set at 6 months.