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Injectable drug combination of water-soluble vitamin and fat-soluble vitamin II

A technology of fat-soluble vitamins and water-soluble vitamins, applied in the direction of drug combinations, pharmaceutical formulas, organic active ingredients, etc., can solve problems such as vitamin deficiency, human health damage, and unsatisfactory solution clarity

Active Publication Date: 2019-08-30
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

③ Most of the vitamins cannot be synthesized by the body or the amount of synthesis is insufficient to meet the needs of the body and must be obtained from food frequently
④The human body has a very small requirement for vitamins, and the daily requirement is often calculated in milligrams (mg) or micrograms (μg), but once it is deficient, it will cause corresponding vitamin deficiency and cause damage to human health
CN1903207A solves the problem that the above-mentioned fat-soluble vitamin preparation is insoluble in water by adding polysorbate 80 and mannitol appropriately, but tests show that the clarity of the solution after reconstitution with water is not ideal (visible foreign matter and insoluble particles are unqualified)
CN101366712B then solves this problem by adding solubilizers such as Tween 80, Tween 20, ethanol, glycine, cysteine ​​hydrochloride, sodium bisulfite, EDTA-2Na, mannitol simultaneously, and the auxiliary material type that it adds is obviously too large. This not only increases the cost of the preparation, but also makes quality control more difficult, and it is difficult to fully control the interaction between the components; moreover, the more types of excipients added, the more chances of causing unknown adverse reactions ( Such as Tween-20 has a certain hemolytic property), long-term use of these solubilizers or co-solvents by patients can cause a series of adverse reactions such as allergies, nephrotoxicity, neurotoxicity, cardiovascular toxicity, etc.; so this is not a good choose

Method used

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  • Injectable drug combination of water-soluble vitamin and fat-soluble vitamin II
  • Injectable drug combination of water-soluble vitamin and fat-soluble vitamin II

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0245] Embodiment 1: preparation fat-soluble vitamin (II) composition for injection

[0246] Per bottle weight ratio:

[0247] 495μg vitamin A,

[0248] 2.5μg Vitamin D2,

[0249] 4.55mg Vitamin E,

[0250] 75μg vitamin K1,

[0251] Tween 80, wherein the weight ratio of vitamin E to Tween 80 is 1:0.75,

[0252] Lactose, wherein the weight ratio of vitamin E to lactose is 1:18,

[0253] Maltose, wherein the weight ratio of lactose and maltose is 1:0.35,

[0254] Ethanol, the weight ratio of vitamin E to ethanol is 1:4.5,

[0255] Water for injection, appropriate amount, added to 1ml.

[0256] Preparation method:

[0257] (1) vitamin A, vitamin E, vitamin K1 and Tween 80 of prescription quantity are mixed evenly;

[0258] (2) Dissolving vitamin D2 with ethanol, adding the dissolved vitamin D2 to the solution obtained in step (1), stirring evenly, and standing at a temperature of 5-10°C;

[0259] (3) Dissolving lactose and maltose with 80% water for injection, slowly addi...

Embodiment 2

[0262] Embodiment 2: Preparation of fat-soluble vitamin (II) composition for injection

[0263] Per bottle weight ratio:

[0264] 480μg vitamin A,

[0265] 2.7μg vitamin D2,

[0266] 4.4mg Vitamin E,

[0267] 80μg vitamin K1,

[0268] Tween 80, wherein the weight ratio of vitamin E to Tween 80 is 1:0.5,

[0269] Lactose, wherein the weight ratio of vitamin E to lactose is 1:20,

[0270] Maltose, wherein the weight ratio of lactose and maltose is 1:0.2,

[0271] Ethanol, the weight ratio of vitamin E to ethanol is 1:4,

[0272] Water for injection, appropriate amount, added to 1ml.

[0273] Preparation method:

[0274] (1) vitamin A, vitamin E, vitamin K1 and Tween 80 of prescription quantity are mixed evenly;

[0275] (2) Dissolving vitamin D2 with ethanol, adding the dissolved vitamin D2 to the solution obtained in step (1), stirring evenly, and standing at a temperature of 5-10°C;

[0276] (3) Dissolving lactose and maltose with 80% water for injection, slowly addi...

Embodiment 3

[0279] Embodiment 3: preparation fat-soluble vitamin (II) composition for injection

[0280] Per bottle weight ratio:

[0281] 510μg Vitamin A,

[0282] 2.3μg Vitamin D2,

[0283] 4.7mg Vitamin E,

[0284] 70μg Vitamin K1,

[0285] Tween 80, wherein the weight ratio of vitamin E to Tween 80 is 1:1,

[0286] Lactose, wherein the weight ratio of vitamin E to lactose is 1:30,

[0287] Maltose, wherein the weight ratio of lactose and maltose is 1:0.5,

[0288] Ethanol, the weight ratio of vitamin E to ethanol is 1:5,

[0289] Water for injection, appropriate amount, added to 1ml.

[0290] Preparation method:

[0291] (1) vitamin A, vitamin E, vitamin K1 and Tween 80 of prescription quantity are mixed evenly;

[0292] (2) Dissolving vitamin D2 with ethanol, adding the dissolved vitamin D2 to the solution obtained in step (1), stirring evenly, and standing at a temperature of 5-10°C;

[0293] (3) Dissolving lactose and maltose with 80% water for injection, slowly adding th...

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Abstract

The invention relates to a medicine combination of water soluble vitamin and fat-soluble vitamin II for injection, particularly relates to the medicine combination packaging of the water soluble vitamin and the fat-soluble vitamin II for injection. The medicine combination packaging of the water soluble vitamin and the fat-soluble vitamin II for injection comprises a medicine box, a water soluble vitamin freeze drying powder-injection composition for injection that is placed in the medicine box and sealed in a glass bottle and a fat-soluble vitamin II for injection freeze drying powder-injection composition for injection that is placed in the medicine box and sealed in glass bottle. The invention further relates to a preparation method of the medicine combination packaging. The medicine combination of the water soluble vitamin and the fat-soluble vitamin II for injection has the excellent effect as said in the instruction.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, and in particular relates to a powder injection drug combination of a water-soluble vitamin for injection and a fat-soluble vitamin for injection and a preparation method thereof, in particular to a water-soluble vitamin for injection and a fat-soluble vitamin for injection The powder injection drug combination of II and its preparation method. In particular, the water-soluble vitamin for injection and the fat-soluble vitamin II for injection are provided in the form of a drug combination package. Background technique [0002] Vitamins are a type of trace organic substances necessary for humans and animals to maintain normal physiological functions. They play an important role in the process of human growth, metabolism, and development. When humans and animals lack vitamins, they cannot grow normally and develop specific lesions. , the so-called vitamin deficiency. [0003] V...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/592A61K31/714A61P3/02A61K47/26A61K31/675A61K31/51A61K31/07A61K31/355A61K31/122A61K31/455A61K31/4415A61K31/197A61K31/375A61K31/4188A61K31/519
Inventor 方专陈娟吴国庆张莲莲伍隆霞赵东明
Owner CHENGDU TIANTAISHAN PHARMA