Optimum matching multiple water-soluble vitamin medicinal composition containing high-efficiency bacteriostat and preparation thereof

A technology of water-soluble vitamins and vitamins, which is applied in the direction of drug combinations, medical preparations containing active ingredients, and pharmaceutical formulas, etc. It can solve the problems of destroying water-soluble vitamins, drug deterioration, and increasing the economic burden of patients, and achieves the enhancement of lymphocyte activity. , enhance the effect of consistency, and reduce the cost of medicines

Inactive Publication Date: 2010-06-02
南京丰恺思药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention has the following deficiencies: one, the content ratio of each component is unreasonable, there is the situation that the dosage of water-soluble vitamin of all components is all excessive, although vitamin is the indispensable material of human body, vitamin should not be regarded as Nutrients, not more is better when used without restriction, excessive use of vitamins can cause adverse reactions or produce potential toxicity
2. The excess vitamins greatly increase the cost of medicines and increase the economic burden on patients
3. Because the dose required for children is very small, the large content ratio cannot be applied to infants and young children
However, this invention has the following obvious defects, which make it impossible to ensure that the preparations produced are completely sterile, thereby causing deterioration of the medicine and affecting the quality of the medicine
[0007] 1. This invention does not comply with the provisions of the General Rules for Injectable Preparations. The prescription design lacks a theoretical basis, and it cannot solve the problem that the production process is completely sterile, so that the product cannot be guaranteed to be completely sterile, which affects the safety of injections.
[0008] 2. In order to achieve absolute sterility, the fully enclosed clean production is even designed as a closed antibiotic bottle dispensing or stoppering filling machine with a 100-level laminar flow hood. However, this structure deviates from the actual production and is lost in actual production. The meaning of fully enclosed, the reasons: (1) None of the domestic equipment can automatically check the loading capacity or automatically adjust the loading control, and the actual operation process often opens the closed door; (2) Once the "sample" for manual sampling inspection Leaving the 100-level laminar flow of the machine means scrapping
[0010] 4. Water-soluble vitamins are unstable in nature and sensitive to heat, oxidants, reducing agents, and sunlight. A large number of high-temperature sterilization materials and packaging materials are used in production. If the ambient temperature is too high, water-soluble vitamins will be destroyed and quickly Decomposition, potency decline
[0011] In order to overcome the defects of the prior art, the inventor has provided a pharmaceutical composition of multiple water-soluble vitamins with an optimal ratio through long-term and large-scale experimental research, which greatly reduces the amount of vitamins in each component, but its The physiological effect is equivalent

Method used

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  • Optimum matching multiple water-soluble vitamin medicinal composition containing high-efficiency bacteriostat and preparation thereof
  • Optimum matching multiple water-soluble vitamin medicinal composition containing high-efficiency bacteriostat and preparation thereof
  • Optimum matching multiple water-soluble vitamin medicinal composition containing high-efficiency bacteriostat and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083]Add 0.15mg of sodium methylparaben and 0.05mg of sodium butylparaben into 2ml of water for injection, stir to dissolve them completely, then add vitamin B12.8mg, vitamin B24.4mg, nicotinamide 36mg, vitamin B6 4.4mg, sodium pantothenate 14.8mg, sodium vitamin C 102mg, biotin 54μg, folic acid 0.36mg and vitamin B12 4.5μg, stirred to dissolve. Use 1mol / ml hydrochloric acid solution or sodium hydroxide solution to adjust the pH value to 5.6, stir, and prepare the aqueous solution of the pharmaceutical composition of various water-soluble vitamins containing antibacterial agents. Then the 0.22um filter core is aseptically filtered, and it is filled and sealed in a filling and sealing machine, and each bottle is 2ml to prepare an injection.

Embodiment 2

[0085] The aqueous solution of the pharmaceutical composition was prepared in the same manner as in Example 1. Then add 200mg of lyophilized support agent sorbitol to the aqueous solution, stir, filter aseptically with a 0.22um filter element, fill and seal, put 2ml in each bottle, freeze-dry in a lyophilizer, and squeeze the cap to obtain 1 bottle of lyophilized agent .

Embodiment 3

[0087] Add 0.15 mg of sodium methyl p-hydroxybenzoate and 0.05 mg of sodium butyl p-hydroxybenzoate into 2ml of water for injection, and stir to dissolve them completely, then add 13.4 mg of vitamin B, 25.4 mg of vitamin B, 44 mg of nicotinamide, Vitamin B6 5.4mg, sodium pantothenate 18.1mg, vitamin C sodium 124mg, biotin 66μg, folic acid 0.44mg and vitamin B126.0μg, stirred to dissolve. Use 1mol / ml hydrochloric acid solution or sodium hydroxide solution to adjust the pH value to 6.1, stir, and prepare the aqueous solution of the pharmaceutical composition of various water-soluble vitamins containing antibacterial agents. Then the 0.22um filter core is aseptically filtered, and it is filled and sealed in a filling and sealing machine, and each bottle is 2ml to prepare an injection.

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Abstract

The invention relates to a drug combination of water-soluble multivitamins with the best proportion containing the new efficient bacteriostatic agent and a preparation method thereof. The drug combination includes, for example, the preferable weight portion ratio is: 0.1 portion of compound distributed phydroxy sodium formate, 3.1 portions of vitamin B1, 4.9 portions of vitamin B2, 40 portions ofnicotinamide, 4.9 portions of vitamin B6, 16.5 portions of sodium pantothenate, 113 portions of sodium vitamin C, 0.06 portion of biotin, 0.4 portion of folic acid and 0.005 portion of vitamin B12. Used for treating the lack of vitamins or preventing the deficiency of vitamins, the drug combination contains the new efficient bacteriostatic agent in very low amount, eliminates the side effects of the bacteriostatic agent on human bodies and ensures the safety of the bacteriostatic agent. Simultaneously, the vitamin content ratios of the components are all very low, thus solving the adverse reactions caused by the excess water-soluble multivitamins or the generated potential toxicity. The drug combination of the invention can be made into injections or lyophilized agents, produced through the conventional process and equipment and has the advantages of easy industrialization, stable quality and low cost.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing water-soluble vitamins and a preparation method thereof, more specifically, the present invention relates to a pharmaceutical composition containing various water-soluble vitamins with the optimal ratio of new high-efficiency antibacterial agents and its preparation method. Background technique [0002] Vitamins are an indispensable class of elements to maintain health, promote growth and development, and regulate life and physiological activities. The human body needs very little vitamins, but they play an amazing role. The deficiency of any vitamin will lead to the occurrence of diseases. Water-soluble vitamins are used as additives in nutritional infusions, which are suitable for daily multivitamin maintenance doses for people who take nutrition through parenteral nutrition, and can also be used in situations where nutrition is taken through veins, including postoperative, ext...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/12A61K31/714A61K31/525A61K31/51A61K31/4415A61K31/4188A61P3/02
Inventor 黄芝芳
Owner 南京丰恺思药物研发有限公司
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