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A kind of five-dimensional lysine particle and preparation method thereof

A technology of five-dimensional lysine and lysine hydrochloride, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients. High requirements for transportation and storage conditions, low stability, etc., to improve drug compliance, facilitate industrial production, and ensure stability

Active Publication Date: 2022-07-26
草仙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The main components in the five-dimensional lysine granules are water-soluble vitamins with low stability, especially vitamin B 1 Calcium pantothenate is easily affected by environmental factors such as light, high temperature and water, resulting in high requirements for transportation and storage conditions, and greatly limited applications
At present, there is no evidence for vitamin B in five-dimensional lysine granules. 1 Research reports related to the stability of calcium pantothenate

Method used

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  • A kind of five-dimensional lysine particle and preparation method thereof
  • A kind of five-dimensional lysine particle and preparation method thereof
  • A kind of five-dimensional lysine particle and preparation method thereof

Examples

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Embodiment 6

[0046] Example 1 Preparation of five-dimensional lysine particles

[0047] In the present invention, each gram of five-dimensional lysine particles includes 50 mg of lysine hydrochloride, 1.2 mg of vitamin B 1 , 0.15 mg vitamin B 2 , 0.075 mg vitamin B 6 , 2.4 mg niacinamide, 0.15 mg calcium pantothenate, 920-950 mg sucrose. Its preparation method is as follows:

[0048] (1) Adhesive preparation: Weigh anhydrous citric acid and sodium citrate and prepare them to pH 6.6 and pH 4.0 (0.1 mol.L -1 ) buffer. Measure 100 mL of buffer solution respectively, add 7 g of dextrin, heat in a water bath at 100° C. for 5 min to dissolve, and prepare 7% dextrin slurry buffer solution with pH 6.6 and pH 4.0 respectively.

[0049] (2) Preparation of A granule: Weigh 1 / 2 recipe quantity sucrose and 1 / 2 recipe quantity lysine hydrochloride (sieve 80 # ), transferred to a beaker (1L), and mixed to obtain powder. Calcium pantothenate, 1 / 2 prescription vitamin B 2 and 1 / 2 the prescribed amo...

Embodiment 7

[0055] The preparation of embodiment two five-dimensional lysine particles

[0056] In this example, the effect of buffer concentration on the stability of calcium pantothenate in five-dimensional lysine particles was investigated.

[0057] (1) Adhesive preparation: Weigh anhydrous citric acid and sodium citrate and configure them to pH 6.6 and pH 5.2 respectively (the concentration of the buffer solution under each pH condition is 0.1 mol.L -1 and 0.01mol.L -1 ) buffer. Measure 100 mL of buffer solution, add 7 g of dextrin, heat in a water bath at 100° C. for 5 min to dissolve, and prepare 7% dextrin slurry buffer solution with pH 6.6 and pH 5.2 respectively.

[0058] (2) Preparation of A granule: Weigh 1 / 2 recipe quantity sucrose and 1 / 2 recipe quantity lysine hydrochloride (sieve 80 # ), transfer to a beaker (1L). Calcium pantothenate, 1 / 2 prescription vitamin B 2 and 1 / 2 the prescribed amount of B vitamins 6 Dissolve in 1 mL of 7% dextrin buffer solution with pH 6.6,...

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Abstract

The present invention relates to five-dimensional lysine granules, comprising separately packaged A granules and B granules, the A granules comprising lysine hydrochloride, calcium pantothenate and vitamin B 2 , Vitamin B 6 , a binder, sucrose and a first buffer; the pH of the first buffer in a solution state is 6.0-7.0; the B particles include lysine hydrochloride, vitamin B 1 , Vitamin B 2 , Vitamin B 6 , nicotinamide, a binder, sucrose and a second buffer; the pH of the second buffer in solution is 3.0-5.5; the lysine hydrochloride and vitamin B in the A granule and the B granule 2 and vitamin B 6 The mass ratio is 1:1. Calcium pantothenate and vitamin B in the five-dimensional lysine granules of the present invention 1 Stability is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to five-dimensional lysine particles and a preparation method thereof. Background technique [0002] Five-dimensional lysine granules are vitamin over-the-counter compound preparations, each gram contains 50 mg of lysine hydrochloride, 1.2 mg of vitamin B 1 , 0.15 mg vitamin B 2 , 0.075 mg vitamin B 6 , 2.4 mg of nicotinamide, 0.15 mg of calcium pantothenate, and the rest are excipients sucrose, which are used to promote the normal development of children and children and nutritional supplements for the elderly and infirm. [0003] Five-dimensional lysine granules can reasonably supplement the needs of the human body according to the growth and development characteristics of children. Lysine can promote growth and development, repair damaged nerve tissue; vitamin B 1 and B 6 Participate in the formation of coenzymes in the body and promote metabolism in the body; calc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/525A61K9/16A61K31/197A61K31/198A61K31/4415A61K31/455A61K31/51A61K47/38A61K47/26A61K47/42A61P3/02
CPCA61K31/198A61K31/197A61K31/525A61K31/4415A61K31/455A61K31/51A61K9/1658A61K9/1652A61K9/1623A61P3/02A61K2300/00
Inventor 李英姬崔京浩高彬彬李洁琼文学李峰旭王茂林
Owner 草仙药业有限公司
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