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tianya716
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中文翻譯成英文--翻譯文章的摘要 自己翻譯了一點，但覺得自己水平太差，需要幫助！ 很急！！因為文章就要送審了，自己已經(jīng)在上班，時間太少。 摘要 目的 本課題研制瑞格列奈分散片，目的是提高藥物的生物利用度、提高順應性和建立科學嚴謹?shù)馁|(zhì)量控制標準。研制的瑞格列奈分散片已經(jīng)轉讓與**制藥公司進行臨床試驗和上市銷售。本文研制的瑞格列奈自微乳膠囊，目的是進一步提高藥物的生物利用度和減少藥物可能存在的副作用。 方法（1）瑞格列奈分散片處方和工藝研究 采用單因素試驗，以分散均勻性和溶出度為指標，對輔料種類的進行篩選；采用正交試驗，以分散均勻性、溶出度為指標，對輔料用量進行優(yōu)化，并最終確定處方。采用單因素試驗對等量遞增混勻法-濕法制粒工藝、溶劑分散混勻法-濕法制粒工藝和等量遞增混勻法-粉末直接壓片工藝，進行比較，優(yōu)選出最佳的工藝。 （2）瑞格列奈分散片含量測定方法的研究 以回收率和pH耐用性為評價指標，對三種瑞格列奈片劑的含量測定方法進行比較，最終確定美國藥典的瑞格列奈片劑的含量測定方法較好。并依據(jù)美國藥典的瑞格列奈片劑的含量測定方法，建立了瑞格列奈分散片的含量測定方法。 （3）瑞格列奈分散片溶出度測定方法的研究 通過對瑞格列奈分散片溶出介質(zhì)和轉速的篩選，建立了科學合理的溶出度測定方法，并對瑞格列奈分散片進行了體外評價研究。 （4）瑞格列奈分散片有關物質(zhì)的研究 通過酸、堿、熱破環(huán)試驗，對瑞格列奈可能存在有關物質(zhì)進行分離，并通過二極管陣列檢測器對藥物主峰的純度進行檢查，建立科學嚴謹?shù)娜鸶窳心魏腿鸶窳心畏稚⑵挠嘘P物質(zhì)的測定方法。 （5）瑞格列奈分散片的加速穩(wěn)定性考察 對瑞格列奈分散片進行了6個月的加速穩(wěn)定性試驗，并據(jù)此預測出藥物的有效期為2年。 （6）瑞格列奈自微乳膠囊的研制 采用正交試驗和三元相圖，以溶解度、透光率、粒徑指標，篩選瑞格列奈自微乳膠囊的處方，并進行質(zhì)量評價研究和初步穩(wěn)定性考察。 結果 （1）瑞格列奈分散片 成功優(yōu)選出瑞格列奈分散片的處方，并建立了科學嚴謹?shù)馁|(zhì)量標準。自制瑞格列奈分散片比市售的普通片劑的溶出速率和30min的溶出度均明顯增加，初步達到提高藥物生物利用度的目的。 （2）瑞格列奈自微乳膠囊 成功優(yōu)選出瑞格列奈自微乳膠囊的處方，并建立了質(zhì)量控制和評價標準。瑞格列奈自微乳膠囊，與市售的普通片劑和自制的普通膠囊相比，溶出速率和30min的溶出度均明顯增加，初步達到提高藥物生物利用度的目的。 結論 篩選的瑞格列奈分散片和自微乳膠囊的處方合理，制備工藝簡單可行，質(zhì)量標準能有效控制質(zhì)量。制備的瑞格列奈分散片和自微乳膠囊符合制劑質(zhì)量要求。通過體外評價研究，所研制的瑞格列奈分散片和自微乳膠囊，與市售的普通片劑和普通膠囊相比，溶出明顯加快，初步達到提高藥物生物利用度的目的。 關鍵詞：瑞格列奈；分散片；自微乳膠囊；正交試驗；質(zhì)量標準；三元相圖；星點-效應面設計 Abstract Objective The purpose of this subject is developping repaglinide dispersible tablets, aims to improve the bioavailability of drugs, improve compliance and the establishment of scientific and strict quality control standards. Repaglinide dispersible tablets have been sold to the U.S. **Zhongshan pharmaceutical company. This article developed the microemulsion capsule of repaglinide, aims to further improve the bioavailability of the drug and reduce drug side effects that may exist. Methods (1) repaglinide dispersible tablets prescription and technology [ Last edited by tianya716 on 2010-5-18 at 18:36 ] |
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tianya716 
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3樓2010-05-18 19:40:32
mmyytiger
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tianya716(金幣+3, 翻譯EPI+1):貌是工具翻譯的 2010-05-18 22:23:13
sirljz:禁止工具直接翻譯的回帖 2010-05-20 17:32:32
sirljz:禁止工具直接翻譯的回帖 2010-05-20 17:32:32
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Abstract objective The purpose of this subject develop repaglinide, dispersible tablets, aims to improve the bioavailability of drugs, improve compliance and the establishment of scientific and strict quality control standards. Repaglinide dispersible tablets have been developed and ** transfer clinical trials and pharmaceutical companies on sale. This article developed from the microemulsion capsule repaglinide, aims to further improve the bioavailability of drugs and reduce drug side effects that may exist. Methods (1) repaglinide tablet formulation and technology of single factor experiments to spread the uniformity and dissolution rate as an index of the types of screening accessories; orthogonal test, to spread uniformity, dissolution rate for the index for accessories to optimize the dosage and ultimately determine the prescription. Single-factor test and the equivalent incremental mixing method - wet granulation process, solvent dispersion mixing method - wet granulation process and the equal incremental mixing method - the powder pellets technology, comparing the optimized process . (2) Determination of repaglinide tablet study to recovery and durability for the evaluation of pH indicator, the three methods the determination of repaglinide tablets compared to finalize the United States Pharmacopoeia repaglinide Determination tablets better. And according to the United States Pharmacopoeia method for the determination of repaglinide tablets, dispersible tablets was established method for the determination of repaglinide. (3) determination of repaglinide in tablet dissolution studies on repaglinide tablet dissolution medium and the speed of screening, the establishment of a scientific and reasonable method of dissolution test, and repaglinide were dispersible tablets In vitro evaluation. (4) repaglinide tablet related substances by acid, alkali, heat broken ring test, the material on repaglinide may be isolated by diode array detector and the main peak of the purity of the drug inspection, the establishment of rigorous science and repaglinide repaglinide tablet Determination of related substances. (5) the acceleration of dispersible tablets stability of repaglinide on repaglinide tablet was 6 months of accelerated stability test, and to predict the drug is valid for 2 years. (6) repaglinide from microemulsion capsule by orthogonal experiment and the ternary phase diagram, with solubility, light transmittance, particle size index, selection repaglinide from microemulsion capsule formulation, and evaluated the quality of Stability study and preliminary. Results (1) successfully optimized repaglinide repaglinide tablet dispersible tablets prescription, and the establishment of a scientific rigorous quality standards. Home Repaglinide dispersible tablets compared with ordinary commercial dissolution rate and dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes. (2) of repaglinide from microemulsion capsule successfully optimized microemulsion capsules from prescription repaglinide, and the establishment of quality control and evaluation criteria. Repaglinide from microemulsion capsule, and general commercial and home-made capsules, tablets compared, the release rate and the dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes. Conclusion screening repaglinide tablet and capsule from the microemulsion reasonable prescription, preparation is simple and feasible, effective quality control quality standards. Preparation of repaglinide tablet and capsule from the microemulsion formulation meet quality requirements. In vitro evaluation studies, the development of repaglinide in tablet and capsule from the microemulsion, with commercially available conventional tablets and capsules, compared to significantly speed up the dissolution, initially to improve drug bioavailability purposes. Keywords: Repaglinide; tablet; from microemulsion capsule; orthogonal test; quality standards; ternary phase diagram; Star points - response surface design |
2樓2010-05-18 18:44:13
benmao_mogu
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4樓2010-05-18 19:44:50
tianya716
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5樓2010-05-18 21:15:50
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