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Compound vitamin injection liquid and preparation method thereof

A technology for compound vitamins and injections, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The problem of low level of sterilization guarantee by filtration and sterilization can reduce the energy consumption of equipment and personnel, improve the level of sterility guarantee, and ensure the effectiveness and safety.

Inactive Publication Date: 2018-11-16
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent uses a freeze-drying process to prepare the pharmaceutical composition of compound vitamin (3). Freeze-drying needs to sublimate the product at a low temperature, and then heat up to dry. This process has a long production cycle and consumes a lot of energy, manpower and equipment.
[0007] There are the following problems in the above preparation method: ① The sterilization method adopted is filter sterilization, the sterility guarantee level of filter sterilization is low, and there is a risk of bacterial contamination, which seriously affects the safety of clinical medication
② After using activated carbon to remove pyrogens, the concentrated solution containing the drug will be lost, and the remaining water will be added, which will not guarantee the content of the main drug of the product and may cause the product to be polluted by microorganisms and heat sources again, affecting the safety and effectiveness of the product
③ There are many types of raw and auxiliary materials, the process is cumbersome, and the preparation time is long, which can lead to increased costs and microbial contamination
Seriously affect the safety of the product
④Using the freeze-drying process, the production cycle is long, and the cost of energy, manpower and equipment is high
None of the existing literature technologies can solve this problem at the same time. This study has carried out innovative research on the above problems

Method used

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  • Compound vitamin injection liquid and preparation method thereof
  • Compound vitamin injection liquid and preparation method thereof
  • Compound vitamin injection liquid and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050]

[0051] Preparation Process:

[0052] ①Weigh the prescribed amount of antioxidants and vitamin B 1 Add 80% water for injection, stir to dissolve, add the prescribed amount of riboflavin sodium phosphate and vitamin C and stir to dissolve to obtain medicinal solution A;

[0053] ② Add water for injection to liquid A to a total of 5000ml, stir and mix evenly, stir and adsorb with activated carbon 0.03% (w / v) for 20 minutes to remove pyrogens, and filter the obtained liquid through a 0.22 μm polyvinylidene fluoride filter element, Filled into 1000 pieces, filled with nitrogen, and sealed by fusion;

[0054] ③The melt-sealed product is sterilized by high temperature and humidity at 121°C for 12 minutes.

Embodiment 2

[0056]

[0057] Preparation Process:

[0058] ①Weigh the prescribed amount of antioxidants and vitamin B 1 Add 80% water for injection, stir to dissolve, add the prescribed amount of riboflavin sodium phosphate and vitamin C and stir to dissolve to obtain medicinal solution A;

[0059] ② Add water for injection to liquid A to a total of 5000ml, stir and mix evenly, stir and adsorb with activated carbon 0.03% (w / v) for 20 minutes to remove pyrogens, and filter the obtained liquid through a 0.22 μm polyvinylidene fluoride filter element, Filled into 1000 pieces, filled with nitrogen, and sealed by fusion;

[0060] ③The melt-sealed product is sterilized by high temperature and humidity at 121°C for 8 minutes.

Embodiment 3

[0062]

[0063] Preparation Process:

[0064] ①Weigh the prescribed amount of antioxidants and vitamin B 1 Add 80% water for injection, stir to dissolve, add the prescribed amount of riboflavin sodium phosphate and vitamin C and stir to dissolve to obtain medicinal solution A;

[0065] ② Add water for injection to liquid A to a total of 5000ml, stir and mix evenly, stir and adsorb with activated carbon 0.03% (w / v) for 20 minutes to remove pyrogens, and filter the obtained liquid through a 0.22 μm polyvinylidene fluoride filter element, Fill into 1000 pieces, fill with nitrogen, and melt seal.

[0066] ③The melt-sealed product is sterilized by high temperature and humidity at 121°C for 13 minutes.

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Abstract

The invention provides a compound vitamin injection liquid pharmaceutical composition and a preparation method thereof. The composition is an injection liquid containing vitamin B1, sodium riboflavinphosphate and vitamin C. The preparation method comprises agent preparation, filtration, loading and sterilization. The compound vitamin injection liquid contains a less amount of accessories and hashigh safety and a simple formula. The preparation method has simple processes, has high production efficiency and realizes a low production cost. The product has good main drug stability, a high levelof sterility assurance and few impurities during storage and has high clinical medication safety.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a compound vitamin injection pharmaceutical composition and a preparation method. Background technique [0002] Compound vitamin injection for vitamin B 1 , riboflavin sodium phosphate (riboflavin also known as vitamin B 2 ) and vitamin C compound preparation, Japan Fuso Pharmaceutical Co., Ltd. researched and developed the compound vitamin injection (Plevita SInjection), which was launched in Japan in August 1985. It is suitable for vitamin deficiency caused by various reasons, such as insufficient dietary intake , consumptive diseases, pregnant women and lactating women, etc., to supplement the vitamins contained in this product. A convenient route of administration is provided for patients who need to supplement such nutrients. After more than 20 years of clinical research, it has been proved to be safe and effective. [0003] Regarding the compound vitamin injection, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/525A61K9/08A61K47/02A61K47/18A61P3/02A61K31/375A61K31/51
CPCA61K9/0019A61K9/08A61K31/375A61K31/51A61K31/525A61K47/02A61K47/183A61P3/02A61K2300/00
Inventor 高扬张颖王丽伟李鹏张作平彭艳丽姜明明厉芳李娟娟
Owner JINAN KANGHE MEDICAL TECH
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