Sterilization method of aluminum-magnesium suspension

A sterilization method and technology of adding aluminum and magnesium, applied in the field of medicine, can solve the problems of high energy consumption, influence of aluminum-plastic inner packaging, influence on the stability of the suspension system, etc. The effect of stability

Pending Publication Date: 2022-04-12
YANGZHOU YIYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] (1) It may affect the system stability of the suspension;
[0010] (2) repeated hea

Method used

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  • Sterilization method of aluminum-magnesium suspension
  • Sterilization method of aluminum-magnesium suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The sterilizing process of embodiment 1 aluminum-magnesium suspension

[0044] Preparation prescription: aluminum magnesium plus, microcrystalline cellulose-sodium carboxymethyl cellulose, sodium carboxymethyl cellulose, sucrose, glycerin, etc.

[0045] Production equipment: batching kettle (with filter, external circulation and homogenizer), storage kettle, saccharification kettle, etc.

[0046] Sterilization method:

[0047] (1) Cleaning of equipment and utensils

[0048] (1-1) Cleaning pretreatment

[0049] (1-1-1) Use purified water to continuously wash the inside of the batching kettle, saccharification kettle and storage kettle under high pressure, and discharge the cleaning water, so that all visible residual material traces disappear, and the welded parts of the pipeline are bright and clean;

[0050] (1-1-2) Add purified water to make the liquid level exceed the stirring paddle, stir and rinse for 20 minutes, drain the cleaning water, and repeat again to mak...

Embodiment 2

[0062] The quality stability of embodiment 2 Al-Mg plus

[0063] 2.1 Materials and test methods

[0064] Take the aluminum-magnesium plus raw material before feeding, the semi-finished product after step (2), and the semi-finished product after step (3), detect the content of aluminum-magnesium plus in them, and convert them into finished products for calculation respectively. After long-term heating, the aluminum-magnesium plus Will it be broken down.

[0065] The content determination method of aluminum magnesium plus refers to the finished product inspection:

[0066] Take about 20g of this product, weigh it accurately, put it in a 200ml measuring bottle, add 10ml of hydrochloric acid, shake to dissolve, add water to the mark, shake well, filter, and take the subsequent filtrate to measure according to the following method:

[0067] Accurately measure 20ml of the filtrate, add 20ml of water, neutralize the test solution with ammonia until a white precipitate just precipit...

Embodiment 3

[0073] Embodiment 3 The hygienic index detection of aluminum-magnesium plus suspension

[0074] According to the "Chinese Pharmacopoeia" 2020 Edition, the microbial limit inspection of non-sterile products: microbial counting method (general rule 1105), the microbial limit inspection of non-sterile products: control bacteria inspection method (general rule 1106) and the microbial limit standard of non-sterile drugs (general rule 1107), detect the washing water after the step (1) of the present invention, and the hygienic index of the aluminum-magnesium suspension.

[0075] Test result is shown in Table 2, and result shows, adopts cleaning of the present invention, disinfection process, and the hygienic index of production equipment meets the requirement; listing requirements.

[0076] Table 3 Hygienic Index Detection of Cleaning Water and Aluminum-Magnesium Plus Suspension

[0077]

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Abstract

The invention relates to a sterilization method of an aluminum-magnesium suspension. The sterilization method comprises the following steps: (1) cleaning equipment and appliances; (2) heating during feeding of aluminum and magnesium; (3) heating when the auxiliary materials are added; (4) heating during volume metering and the like. According to the invention, a non-final sterilization process is adopted, the sterilization effect is excellent, the process flow is short, the production cost is low, the medicine quality is stable, and the produced aluminum-magnesium suspension meets the hygiene requirements of medicine marketing.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a method for sterilizing an aluminum-magnesium suspension. Background technique [0002] Almagate Suspension (Almagate Suspension) is a drug approved for marketing in the People's Republic of China, which is a drug for neutralizing gastric acid. The quality control of the aluminum-magnesium plus suspension is carried out in accordance with the national drug standard YBH05852018 of the Food and Drug Administration of the People's Republic of China. [0003] In the prior art, every 15ml of aluminum-magnesium suspension contains 1.5g of aluminum-magnesium suspension. [0004] Aluminum magnesium plus (Almagate), its chemical name is: fourteen hydroxy aluminum magnesium carbonate hydrate. Molecular formula: Al 2 Mg 6 (OH) 14 (CO 3 ) 2 4H 2 O. Molecular weight: 630.02. [0005] Aluminum-magnesium plus is an antacid with fast action and strong ability to neutralize gastric a...

Claims

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Application Information

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IPC IPC(8): A61L2/18A61L2/04A61L2/26B08B9/08B08B9/093A61L101/22
Inventor 盖旭陈亚舟郑红霞
Owner YANGZHOU YIYANG PHARMA
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