中国执业药师
中國執業藥師
중국집업약사
CHINA LICENSED PHARMACIST
2013年
12期
21-22
,共2页
人参糖肽注射液%肽含量%含量测定
人參糖肽註射液%肽含量%含量測定
인삼당태주사액%태함량%함량측정
Ginseng Glycopeptide Injection%Peptide Content%Content Determination
目的:改进人参糖肽注射液肽含量测定方法。方法:参照《中国药典》(2005年版)一部附录VA“紫外-可见分光光度法”,将对照品溶液牛血清白蛋白浓度0.05 mg/mL改为0.1 mg/mL,供试品由“精密量取本品5 mL,置50 mL量瓶中”改为“精密量取本品10 mL ,置50 mL量瓶中”,使供试品溶液的吸光度(A)值在0.3~0.7之间。结果:3批样品的检测结果显示,将供试品的测定浓度及对照品的浓度提高1倍后,供试品溶液的A值均在0.3~0.7之间。结论:改良的测定方法稳定可行,符合药品检验的规定。
目的:改進人參糖肽註射液肽含量測定方法。方法:參照《中國藥典》(2005年版)一部附錄VA“紫外-可見分光光度法”,將對照品溶液牛血清白蛋白濃度0.05 mg/mL改為0.1 mg/mL,供試品由“精密量取本品5 mL,置50 mL量瓶中”改為“精密量取本品10 mL ,置50 mL量瓶中”,使供試品溶液的吸光度(A)值在0.3~0.7之間。結果:3批樣品的檢測結果顯示,將供試品的測定濃度及對照品的濃度提高1倍後,供試品溶液的A值均在0.3~0.7之間。結論:改良的測定方法穩定可行,符閤藥品檢驗的規定。
목적:개진인삼당태주사액태함량측정방법。방법:삼조《중국약전》(2005년판)일부부록VA“자외-가견분광광도법”,장대조품용액우혈청백단백농도0.05 mg/mL개위0.1 mg/mL,공시품유“정밀량취본품5 mL,치50 mL량병중”개위“정밀량취본품10 mL ,치50 mL량병중”,사공시품용액적흡광도(A)치재0.3~0.7지간。결과:3비양품적검측결과현시,장공시품적측정농도급대조품적농도제고1배후,공시품용액적A치균재0.3~0.7지간。결론:개량적측정방법은정가행,부합약품검험적규정。
Objective: To improve the method for the content determination of peptide of ginseng glycopeptide in-jection . Methods: Referring to the requirements of UV-Vis spectrophotometry set forth in Appendix VA of Chinese Pharmacopoeia ( 2005 edition ) , the control solution concentration of bovine serum albumin was changed from 0 . 05 mg/mL to 0 . 1 mg/mL and the samples taken into 50 mL volumetric flask was changed from 5 mL to 10 mL , and mak-ing the absorbance values of the test solution in the range of 0 . 3 ~ 0 . 7 . Results: The test results of 3 batches of sam-ples showed if the concentrations of the samples and control to be test were increased by 1 time , the absorbance val-ues of the test solutions were all in the range of 0 . 3 ~ 0 . 7 . Conclusion: The modified method for content determina-tion is stable and feasible , and in compliance with the requirements for drug testing .