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应用无水葡萄糖制备注射剂的工艺!

来源:http://www.jnjdbc.cn/ 日期:2020-09-14 发布人:guanli
  根据葡萄糖在不同行业的应用,它可以分为工业葡萄糖和食用葡萄糖两类,而根据所含结晶水的不同,又可以分为无水葡萄糖、一水葡萄糖和七水葡萄糖等多种种类。了解了它的分类,下面我们再来了解一下应用无水葡萄糖制备注射剂的工艺吧。
  According to the application of glucose in different industries, it can be divided into industrial glucose and edible glucose. According to the different crystal water, it can be divided into anhydrous glucose, monohydrate glucose and heptahydrate glucose. Understand its classification, let's learn about the application of anhydrous glucose injection preparation process.
  工艺一:原辅料葡萄糖、无水葡萄糖、浓盐酸(优级纯)、注射水、活性炭。
  Process 1: raw and auxiliary materials glucose, anhydrous glucose, concentrated hydrochloric acid (high grade pure), injection water, activated carbon.
  取注射用葡萄糖粉溶于适量热注射用水中,配制成50%浓溶液,用浓盐酸调pH值为三点八到四,加活性炭0.3%(g/ml),搅匀,加热煮沸十五分钟,用滤棒抽滤至澄明,滤液加人注射用水至全量,搅拌均匀,测pH值及含量,合格后灌封,一百一十五摄氏度四十五分钟。
  Dissolve glucose powder for injection into hot water for injection, prepare 50% concentrated solution, adjust pH value to 3.8-4 with concentrated hydrochloric acid, add 0.3% (g / ml) activated carbon, mix well, heat and boil for 15 minutes, filter until clear with filter rod, add water for injection to the full amount of filtrate, mix evenly, measure pH value and content, fill and seal at 115 ℃ for 45 minutes.
                 无水葡萄糖
  工艺二:取注射用无水葡萄糖粉溶于热注射用水中,边加边搅拌至溶解,使成30%浓溶液,加活性炭0.1%(g/m)及浓盐酸适量调pH值至3.8~4.0,混匀10min后用滤棒抽滤至澄明,溶液加人注射用水至全量,搅匀,测pH值及含量,合格后,灌封,一百一十五摄氏度灭菌四十五分钟。
  Process 2: dissolve anhydrous glucose powder for injection into hot water for injection, stir until dissolved, make it into 30% concentrated solution, add 0.1% activated carbon (g / M) and concentrated hydrochloric acid, adjust pH value to 3.8 ~ 4.0, mix well for 10min, filter till clear with filter rod, add water for injection to full volume, mix well, measure pH value and content, fill and seal, sterilize 45 ℃ at 115 ℃ minute.
  使用该产品按处方2的工艺配制葡萄糖注射剂共100批次,各批次经检验,其性状、鉴别、pH值、5-羟甲基糠醛、重金属、不溶性微粒、细菌内毒素、无菌、含量测定等项目均符合现代药典2000年版规定,制剂用于临床后,没有出现热原及其它不良反应。
  A total of 100 batches of glucose injection were prepared according to the process of prescription 2. The properties, identification, pH value, 5-hydroxymethylfurfural, heavy metals, insoluble particles, bacterial endotoxin, sterility, content determination and other items of each batch were in line with the requirements of the 2000 edition of modern Pharmacopoeia. No pyrogen and other adverse reactions occurred after the preparation was used in clinical practice.
  由于无水葡萄糖不含结晶水,配制时应先放水再放糖,否则易结块,并应不断搅拌,浓度以百分之三十为宜,在五十到六十摄氏度可即刻溶解。它的纯度高,因此配制时活性炭用量可减少三分之二。尽管它的价格稍高于葡萄糖,但它以D-(+)-吡喃葡萄糖计含量高于葡萄糖,其投料量仅为葡萄糖的百分之九十,更加节药成本。
  Since anhydrous glucose does not contain crystal water, water should be put first and then sugar should be added during preparation, otherwise it is easy to agglomerate and should be stirred continuously. The appropriate concentration is 30%. It can be dissolved immediately at 50-60 ℃. Because of its high purity, the amount of activated carbon can be reduced by two thirds. Although its price is slightly higher than that of glucose, its content in D - (+) - glucopyranosyl is higher than that of glucose, and its feeding amount is only 90% of that of glucose, which is more cost-effective.
  以上就是应用无水葡萄糖制备注射剂的两种工艺的配比、操作方法和特点的介绍,相信会让你有所认识和了解。
  The above is the application of anhydrous glucose injection preparation of two kinds of process ratio, operation method and characteristics of the introduction, I believe you will have some understanding and understanding.
此文关键词: 无水葡萄糖  

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