Zidovudine capsule -- evaluation of drug quality consistency

The consistency evaluation of generic drugs has entered the practical stage, and the Chinese orange peel book (folk Edition) has been officially published The author takes zidovudine capsule as an example to talk about what information the Chinese orange peel book covers 1 At the same time, China orange peel book provides an extension, click to get the basic information of active ingredients; 2 Reference preparation 2.1 domestic listing situation at present, there are 9 approval numbers of qiduofuding capsule in China, among which the specifications of Shandong new era Pharmaceutical Co., Ltd are 0.3g and those of other enterprises are 0.1g Except that Meiji Pharmaceutical (Xiamen) Co., Ltd holds two approval numbers, other enterprises only have one approval number 2.2 domestic imports at present, there are two imports of zidovudine capsules, all of which are products of vivhealthcareuklimitted company, with two specifications of 0.25g and 0.1g The country of import is the United Kingdom and the trade name is retrovir 2.3 overseas listing situation: retrovir (AZT) is a pyrimidine nucleoside analogue reverse transcriptase inhibitor, initially developed by GlaxoSmithKline The capsule was approved by FDA on March 19, 1987, and sold on the market by viivhealthcare At the same time, the zidovudine capsule is also available in Japan and the UK 2.4 the reference preparation of FDA is 100 mg capsule of viivhlthcar company with the trade name of retro vir The reference preparation in Japan is 100 mg capsule of vivhealthcare K.K., with the trade name retrovircap.100 mg Yaozhi.com recommends the use of 0.1g zidovudine capsule imported from China, trade name: retrovir as the reference preparation At the same time, considering that although the drug is held by the British company Viiv healthcare UK Limited, but the origin is Romania, it is suggested that the enterprise can also consider purchasing the varieties listed in the United States for comparative study 3 Properties of APIs Chinese orange peel book collates the biopharmaceutical classification system (BCS) published by the United States and who for user's reference, and gives out the source document: dissociation constant (25 ℃): PKA = 9.72 (for imide group, determined by titration method) dissolution in each dissolution medium (37 ℃): ph1.2:28.5mg/ml ph4.0:28.6mg/ml ph6.8:28.3mg/ml water: 29.4mg/ml Four standard dissolution curves (PMDA): dissolution test conditions: paddle method / 50 revolutions, no surfactant added in the dissolution medium Quality standard: take this product, according to the dissolution measurement method (paddle method, using settling basket), take 900ml of water as the solvent, rotate at 50 revolutions per minute, operate according to the law, after 30 minutes, take a proper amount of solution and filter it, discard at least 10ml of primary filtrate, precisely measure a proper amount of continuous filtrate, dilute with water to make a solution containing 17 μ g per 1ml as the test solution In addition, precisely weigh 0.017g of zidovudine reference substance which has been determined by coulometric titration, put it into a 100ml measuring flask, add water to dissolve and dilute it to the scale, shake it up, precisely measure 5ml, put it into a 50ml measuring flask, add water to dilute it to the scale, shake it up, as the reference solution Take the above two solutions for UV-VIS spectrophotometry, measure the absorbance at the wavelength of 267nm, and calculate the dissolution amount of each particle The limit is 80% of the labeled amount, which should meet the requirements Information source: China orange book (http://db.yaozh.com/orange book); if you want to know which drug consistency evaluation information, please leave a message, and the author will share it with you in time At the same time, what suggestions do you have for this article? Welcome to put forward!