Lysine hydrochloride/zinc gluconate composite particle and preparation method of composite particle

A technology of zinc gluconate and lysine hydrochloride, which is applied in the direction of pharmaceutical formulations, drug combinations, medical preparations containing active ingredients, etc., and can solve problems such as large differences in loading, large proportions of raw and auxiliary materials, and poor fluidity , to achieve the effects of small weight ratio difference, good compression resistance and good fluidity

Inactive Publication Date: 2014-08-13
海南慧谷药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

First, the high content of sucrose makes lysine hydrochloride and zinc gluconate granules not suitable for diabetic patients; it also makes non-diabetic patients consume unnecessary high energy; second, the proportion of raw and auxiliary materials is too large, which is easy to cause The content between packages is uneven; third, the hardness of the particles is not high, and they are easy to be crushed during packaging and transportation
Fourth, the fluidity is not good, and the filling volume varies greatly. Fifth, there is no flavor in the granules, the taste is not good, and the compliance of children is poor.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] In the embodiment of the present invention, a composite particle of lysine hydrochloride and zinc gluconate comprises 125 grams of lysine hydrochloride, 35 grams of zinc gluconate, 791 grams of mannitol, 10 grams of stevia, 12.5 grams of citric acid, 18 % povidone K30 23.5 grams, cantaloupe essence 5.0. After all raw and auxiliary materials are crushed separately, pass through a 60-mesh sieve, and mix with 18% povidone K30 aqueous solution; after the solid powder is uniformly mixed by an equal-volume incremental method, use the povidone K30 aqueous solution as a binder to make a soft material; 16-mesh sieve Granulate, oven-dry at 55-65°C, granulate with a 16-mesh sieve, add essence in proportion, and mix well. The particle size of the prepared particles was 6%, the strength of the particles was 19N, the Carr index was 16%, and the angle of repose was 26°.

Embodiment 2

[0021] In the embodiment of the present invention, a composite particle of lysine hydrochloride and zinc gluconate comprises 130 g of lysine hydrochloride, 37 g of zinc gluconate, 787.5 g of mannitol, 5 g of aspartame, 10 g of citric acid, and povidone K30 20g, sweet orange flavor 5g, all the raw and auxiliary materials were crushed separately, passed through a 65 mesh sieve, and mixed with 18% povidone K30 aqueous solution; the solid powder was mixed evenly by equal volume addition method, and the povidone K30 aqueous solution was used as the binding agent Preparation of soft materials; granulate with 16 mesh sieve, oven dry at 60°C, granulate with 16 mesh sieve, add essence in proportion, and mix well. The particle size of the prepared particles is 7%, the strength of the particles is 20N, the Carr index is 17%, and the angle of repose is 32°.

Embodiment 3

[0023] In the embodiment of the present invention, a composite granule of lysine hydrochloride and zinc gluconate comprises 100 g of lysine hydrochloride, 30 g of zinc gluconate, 788 g of lactose, 12 g of stevia, 50 g of tartaric acid, 15 g of povidone K30, and strawberry essence 10g, all the raw and auxiliary materials were crushed separately, passed through a 65-mesh sieve, and mixed with 18% povidone K30 aqueous solution; the solid powder was uniformly mixed by equal volume addition method, and the povidone K30 aqueous solution was used as a binder to make a soft material; 16 Granulate with a mesh sieve, dry in an oven at 60°C, granulate with a 16-mesh sieve, add essence in proportion, and mix well. The particle size of the prepared particles is 8%, the strength of the particles is 18N, the Carr index is 18%, and the angle of repose is 31°.

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Abstract

The invention discloses a lysine hydrochloride / zinc gluconate composite particle and a preparation method of the composite particle. The lysine hydrochloride / zinc gluconate composite particle is prepared from the following components in parts by weight: 10-15 parts of lysine hydrochloride, 3-4 parts of zinc gluconate, 0.5-2 parts of sweetening agent, 1.0-2.5 parts of citric acid, 60-90 parts of filling agent, 3-5 parts of povidone K30 and 0.5-1.0 part of essence. The composite particle is free of sugar and especially suitable for patients with diabetes mellitus. In addition, the composite particle is small in difference of weight ratios between raw material amount and accessory material amount; the prepared particle is uniform; after packaging, the content in each bag is relatively uniform; the granularity is changed from 10-13% to 5-8%; due to the adoption of the povidone K30, the strength of the particle is changed from 8-13N to 15-20N; the particle is good in pressure resistance and has a small possibility of being crushed in the packaging process and the transportation process; meanwhile, the particle is excellent in mobility; a repose angle is changed from 35-45 degrees to 25-30 degrees; carr index is changed from 20-30% to 10-20%.

Description

technical field [0001] The invention relates to a compound particle of lysine hydrochloride and zinc gluconate and a preparation method thereof. Background technique [0002] Lysine is an indispensable and important element in children's growth and development; lack of appetite, slow growth, and mental retardation. Zinc gluconate is one of the important substances in the living body; during the growth of children, zinc deficiency often occurs; when lacking, anorexia, loss of appetite, listlessness, and developmental delay. In addition, lysine and zinc are also necessary for adults. [0003] According to the existing national prescription, the components of lysine hydrochloride and zinc gluconate granules according to weight percentage are: 2.5% lysine hydrochloride, 0.7% zinc gluconate, 0.25% citric acid and 96.55% sucrose. [0004] It is found through research that there are at least five problems in the lysine hydrochloride and zinc gluconate granules prepared according ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/198A61K9/16A61P3/02A61K31/191
Inventor 郭德
Owner 海南慧谷药业有限公司
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