Compound vitamin B granules and tablets and preparation method of compound vitamin B tablets

A technology of multivitamins and vitamins, applied in the directions of drug combinations, pharmaceutical formulations, and active ingredients of heterocyclic compounds, etc., can solve the problems of vitamin B1 being difficult to store stably, severely degraded, and fluctuated in content, so as to avoid physical separation and ensure Product quality, the effect of improving fluidity

Inactive Publication Date: 2019-05-21
HUAZHONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the compressibility and stability of multi-vitamin B tablets produced by conventional wet granulation technology are poor
[0005] Through a large number of experiments, the applicant found that the main reason for the instability of vitamin B1 and vitamin B2 in conventional multivitamin B tablets lies in the water content and pH value of the particles. When the pH value of the particles is around 4.2, vitamin B1 is relatively stable, while under alkaline conditions , vitamin B1 is not easy to store stably; and when the moisture content of the particles is ≥5.0%, in the storage process, vitamin B1 and B2 in the preparation composition are seriously degraded (degradation can reach 10%-25%)
In addition, the applicant found in the conventional granulation process that the content of vitamin B in complex vitamin B tablets is not easy to distribute evenly, especially vitamin B1 and vitamin B2. The main reason is that the conventional wet granulation cannot effectively make the material Uniform and fluid granules, in the subsequent drying and granulation process, the light raw material and the blank drug carrier are easy to separate, which causes the problem of large content fluctuations in the detection and analysis process

Method used

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  • Compound vitamin B granules and tablets and preparation method of compound vitamin B tablets
  • Compound vitamin B granules and tablets and preparation method of compound vitamin B tablets
  • Compound vitamin B granules and tablets and preparation method of compound vitamin B tablets

Examples

Experimental program
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Effect test

Embodiment 1

[0025] This embodiment provides a vitamin B complex granule, which is composed of a core material layer and a coating layer covering the core material layer, and the core material layer is formed by mixing vitamin B and a first blank drug carrier.

[0026] Among them, based on the amount of multivitamins required for 200,000 tablets of multivitamin B, the vitamin B is: 600g of vitamin B1, 300g of vitamin B2, 40g of vitamin B6, 2000g of niacinamide, and 200g of D-calcium pantothenate. The first blank drug carrier is: 20g of DL tartaric acid, 200g of magnesium stearate, 400g of colloidal silicon dioxide and 800g of precrossified starch. The coating material of the coating layer is povidone k30, and the weight of the coating layer is 0.8% of the weight of the core material layer.

[0027] The preparation method of the vitamin B complex particle of the present embodiment, comprises the steps:

[0028] S1, weigh the raw materials according to the composition of the vitamin B compl...

Embodiment 2

[0033] This embodiment provides a vitamin B complex granule, which is composed of a core material layer and a coating layer covering the core material layer, and the core material layer is formed by mixing vitamin B and a first blank drug carrier. Based on the multivitamin dosage required for 200,000 tablets of multivitamin B, vitamin B is: 600g of vitamin B1, 300g of vitamin B2, 40g of vitamin B6, 2000g of niacinamide, and 200g of D-calcium pantothenate. The first blank drug carrier is: 20g of DL tartaric acid, 200g of magnesium stearate, 400g of colloidal silicon dioxide, and 800g of precrossified starch. The coating material of the coating layer is hypromellose E-15, and the weight of the coating layer is 0.8% of the weight of the core material layer.

[0034] The preparation method of the vitamin B complex particle of the present embodiment, comprises the steps:

[0035] S1, weigh the raw materials according to the composition of the vitamin B complex granules in this exa...

Embodiment 3

[0040] This embodiment provides a vitamin B complex granule, which is composed of a core material layer and a coating layer covering the core material layer, and the core material layer is formed by mixing vitamin B and a first blank drug carrier. Based on the multivitamin dosage required for 100,000 tablets of multivitamin B, vitamin B is: 275g of vitamin B1, 160g of vitamin B2, 20g of vitamin B6, 1100g of niacinamide, and 95g of D-calcium pantothenate. The first blank drug carrier is: 10 g of DL tartaric acid, 100 g of magnesium stearate, 200 g of colloidal silicon dioxide, and 400 g of lactose. The coating material of the coating layer is polyethylene glycol, and the weight of the coating layer is 0.8% of the weight of the core material layer.

[0041]The preparation method of the vitamin B complex particle of the present embodiment, comprises the steps:

[0042] S1, weigh the raw materials according to the composition of the vitamin B complex granules in this example, mix...

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Abstract

The invention relates to compound vitamin B granules and tablets and a preparation method of the compound vitamin B tablets. The compound vitamin B granules are prepared from core material layers andcoating layers for coating the core material layers; the core material layers are formed by mixing vitamin B and first blank drug carriers, wherein vitamin B is prepared from 270-330 parts of vitaminB1, 135-165 parts of vitamin B2, 17-23 parts of vitamin B6. 900-1100 parts of nicotinamide and 90-110 parts of D-calcium pantothenate; the weight of the coating layers is 0.5%-2.0% of that of the corematerial layers. The compound vitamin B granules can effectively improve the stability of vitamin B, especially the stability of vitamin B1 and the stability of vitamin B2. Meanwhile, the overall liquidity of the compound vitamin B granules can be improved, so that it is convenient to mix the compound vitamin B granules and the blank drug carriers and press the mixture into the tablets; the compound vitamin B granules can be effectively prevented from being physically separated from the blank drug carriers, uniform distribution of the content of each active component in the tablets can be further ensured, and the quality of products is ensured.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a compound vitamin B granule, a compound vitamin B tablet and a preparation method thereof. Background technique [0002] Vitamin B (vitamin B) is a kind of trace organic substance that humans and animals must obtain from food in order to maintain normal physiological functions. The content of vitamins in the human body is very small, but it is indispensable. play an important role in. Long-term lack of certain vitamins will cause physiological dysfunction and certain diseases. [0003] There are many types of multivitamins currently on the market, but the quality and stability of the products vary. The main reason is that vitamins are usually quite sensitive to their physical and chemical environments, and are easily deteriorated or invalid. However, most vitamin additives are unstable to trace element minerals (especially mineral elements in the form of su...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/50A61K47/38A61K47/32A61K47/10A61K31/197A61K31/4415A61K31/455A61K31/51A61K31/525A61P3/02
Inventor汤伟黄艳玲申海波高洪涛陈胜
OwnerHUAZHONG PHARMA