應用葡萄糖制備注射劑的工藝？
來源：http://www.nttdr.com 日期：2020-08-24 發布人：admin
根據葡萄糖在不同行業的應用，它可以分為工業葡萄糖和食用葡萄糖兩類，而根據所含結晶水的不同，又可以分為無水葡萄糖、一水葡萄糖和七水葡萄糖等多種種類。了解了它的分類，下面我們再來了解一下應用無水葡萄糖制備注射劑的工藝吧。
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.
工藝一：原輔料葡萄糖、無水葡萄糖、濃鹽酸（優級純）、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適量熱注射用水中，配制成50%濃溶液，用濃鹽酸調pH值為三點八到四，加活性炭0.3%（g/ml），攪勻，加熱煮沸十五分鐘，用濾棒抽濾至澄明，濾液加人注射用水至全量，攪拌均勻，測pH值及含量，合格后灌封，一百一十五攝氏度四十五分鐘。
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.
工藝二：取注射用無水葡萄糖粉溶于熱注射用水中，邊加邊攪拌至溶解，使成30%濃溶液，加活性炭0.1%（g/m）及濃鹽酸適量調pH值至3.8~4.0，混勻10min后用濾棒抽濾至澄明，溶液加人注射用水至全量，攪勻，測pH值及含量，合格后，灌封，一百一十五攝氏度滅菌四十五分鐘。
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.
使用該產品按處方2的工藝配制葡萄糖注射劑共100批次，各批次經檢驗，其性狀、鑒別、pH值、5-羥甲基糠醛、重金屬、不溶性微粒、細菌內毒素、無菌、含量測定等項目均符合現代藥典2000年版規定，制劑用于臨床后，沒有出現熱原及其它不良反應。
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.
由于無水葡萄糖不含結晶水，配制時應先放水再放糖，否則易結塊，并應不斷攪拌，濃度以百分之三十為宜，在五十到六十攝氏度可即刻溶解。它的純度高，因此配制時活性炭用量可減少三分之二。盡管它的價格稍高于葡萄糖，但它以D-（+）-吡喃葡萄糖計含量高于葡萄糖，其投料量僅為葡萄糖的百分之九十，更加節藥成本。
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.
以上就是應用無水葡萄糖制備注射劑的兩種工藝的配比、操作方法和特點的介紹，相信會讓你有所認識和了解。這種葡萄糖產品通常都是以溶液的形式作用于各個行業的，在配制方面的要求很高，所以需要我們將其制備工藝多多了解，才能很好地掌握。想要了解更多葡萄糖資訊請繼續關注我們的http://www.nttdr.com網站。
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. This kind of glucose product is usually used in various industries in the form of solution, so we need to know more about its preparation process to master it well. For more information on glucose, please keep an eye on our http://www.nttdr.com Website.