三宝垄某私立医院临时配制曲马多和扑热息痛胶囊复方的质量检验

Paulus Unggul Wikan Prabandono, Michael Raharja Gani, S. Yuliani
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引用次数: 0

摘要

曲马多和扑热息痛是一种镇痛药物,通常以临时制备的胶囊剂型组合制成,用于治疗中度至重度疼痛。本研究旨在确定从三宝垄一家私立医院获得的临时制备的曲马多和扑热息痛胶囊组合处方药的质量,包括重量均匀性、水分含量、崩解性和含量均匀性。这种类型的研究是一种描述性的观察横断面设计。样本是在三宝垄一家私人医院的制药厂使用简单的随机抽样方法采集的。将四种测试的观察结果与《印度尼西亚药典五》中列出的每种测试参数的标准值进行比较。结果是,样品符合重量均匀性测试,验收值为7.34%;满足水分含量测试,第一天的平均水分含量为2.647%,第七天的平均湿度为3.04%;满足分解试验,分解时间小于15分钟;并且不符合对乙酰氨基酚和曲马多的验收值分别为34.06%和34.30%的均匀性测试。可以得出的结论是,来自三宝垄一家私人医院的即兴制备胶囊样品的处方药除含量均匀性测试外,均符合《印度尼西亚药典五》中列出的标准值。
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Quality Test of Extemporaneously Prepared Tramadol and Paracetamol Capsules Combination Derived From a Private Hospital in Semarang
Tramadol and paracetamol are analgesic drugs that are often combined and made in the form of extemporaneously prepared capsules dosage form to treat moderate to severe pain management. This study aims to determine the quality of prescribed medication of extemporaneously prepared tramadol and paracetamol capsules combination taken from a private hospital in Semarang covering weight uniformity, moisture content, disintegration, and content uniformity. This type of research is a descriptive observational cross-sectional design. Samples were taken using simple random sampling at a pharmaceutical installation in a private hospital in Semarang. The observation result from four types of testing was compared against the standard values of each test’s parameter listed in the Indonesian Pharmacopoeia V. The results are, samples meet the weight uniformity test with an acceptance value of 7.34%; meet the moisture content test with an average moisture content of 2.647% for the first day and 3.04% for the seventh day; meet the disintegration test with a breakdown time of fewer than 15 minutes; and did not meet the uniformity test with acceptance value of 34.06% for paracetamol and 34.30% for tramadol. It can be concluded that the prescribed medication of extemporaneously prepared capsule samples derived from a private hospital in Semarang can fulfill the standard values listed in the Indonesian Pharmacopoeia V except for the content uniformity test.
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