中国医药指南
中國醫藥指南
중국의약지남
CHINA MEDICINE GUIDE
2014年
17期
80-81
,共2页
乙酰半胱氨酸胶囊%处方筛选%含量测定%HPLC
乙酰半胱氨痠膠囊%處方篩選%含量測定%HPLC
을선반광안산효낭%처방사선%함량측정%HPLC
Acetylcysteine-capsules%Prescription-screening%Content-determination%HPLC
目的：对乙酰半胱氨酸胶囊的处方进行筛选，制备乙酰半胱氨酸胶囊，测定其含量。方法对乙酰半胱氨酸胶囊的处方进行筛选，高效液相色谱法测定含量，流动相：0.68%磷酸氢二钾溶液（用磷酸调节pH值至3.0）-甲醇=95∶5；检测波长为214 nm，进样量：10μL。结果乙酰半胱氨酸200 g、微晶纤维素50 g，0.5%羟丙基甲基纤维素（75%乙醇溶）为最佳处方。乙酰半胱氨酸在0.1274～0.4248 mg/mL之间呈良好的线性关系（r=0.9996，n=5），平均回收率为99.53%，RSD%为1.60%（n=9）。结论该制剂制备工艺合理可行，含量测定方法准确可靠。
目的：對乙酰半胱氨痠膠囊的處方進行篩選，製備乙酰半胱氨痠膠囊，測定其含量。方法對乙酰半胱氨痠膠囊的處方進行篩選，高效液相色譜法測定含量，流動相：0.68%燐痠氫二鉀溶液（用燐痠調節pH值至3.0）-甲醇=95∶5；檢測波長為214 nm，進樣量：10μL。結果乙酰半胱氨痠200 g、微晶纖維素50 g，0.5%羥丙基甲基纖維素（75%乙醇溶）為最佳處方。乙酰半胱氨痠在0.1274～0.4248 mg/mL之間呈良好的線性關繫（r=0.9996，n=5），平均迴收率為99.53%，RSD%為1.60%（n=9）。結論該製劑製備工藝閤理可行，含量測定方法準確可靠。
목적：대을선반광안산효낭적처방진행사선，제비을선반광안산효낭，측정기함량。방법대을선반광안산효낭적처방진행사선，고효액상색보법측정함량，류동상：0.68%린산경이갑용액（용린산조절pH치지3.0）-갑순=95∶5；검측파장위214 nm，진양량：10μL。결과을선반광안산200 g、미정섬유소50 g，0.5%간병기갑기섬유소（75%을순용）위최가처방。을선반광안산재0.1274～0.4248 mg/mL지간정량호적선성관계（r=0.9996，n=5），평균회수솔위99.53%，RSD%위1.60%（n=9）。결론해제제제비공예합리가행，함량측정방법준학가고。
Objective To screen the prescription of acetylcysteine capsules, and to prepare the acetylcysteine capsules and to determine of its content. Method To screen the prescription of acetylcysteine capsules. The analysis was performed by HPLC, a mobile phase of 0.2mol/L buffer stock solution(pH=3.0)-methanol(95∶5)with a flow rate at 1 mL/min. The UV detective wavelength was 214 nm.Results Prescription was made up by 200g acetylcysteine, 50 g Microcrystalline cellulose and 0.5% HPMC. Acetylcysteine was linear in the range of 0.1274~0.4248 mg/mL(r=0.9996, n=5).The average recovery was 99.53%(RSD 1.60%, n=9).Conclusion Method for the preparation and quality control of acetylcysteine capsules is reliable.
