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.
Process 1: raw and auxiliary materials glucose, anhydrous glucose, concentrated hydrochloric acid (high grade pure), injection water, activated carbon.
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.
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.
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.
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.
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.