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Preparation method of acetyl-L-carnitine arginine dihydrochloride moisture-proof particles

A technology of arginine dihydrochloride and acetyl-L-carnitine, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve the problem of high hygroscopicity and achieve stability Improvement, obvious decrease in hygroscopicity, solve the effect of high hygroscopicity

Inactive Publication Date: 2019-12-13
リャオニンコンセプヌトラシーオーエルティーディー
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a preparation method of acetyl-L-carnitine arginine dihydrochloride moisture-proof granules, which is used to solve the problem of high hygroscopicity of acetyl-L-carnitine arginine dihydrochloride, thereby increasing the concentration of acetyl-L-carnitine arginine dihydrochloride. Moisture-proof properties of alkali arginine dihydrochloride

Method used

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  • Preparation method of acetyl-L-carnitine arginine dihydrochloride moisture-proof particles
  • Preparation method of acetyl-L-carnitine arginine dihydrochloride moisture-proof particles

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preparation example Construction

[0024] In view of the above-mentioned design idea, the inventor researched the commonly used auxiliary materials of existing health care products, and found that not all auxiliary materials are suitable for the technical solution of the present application; Although the element can play a moisture-proof effect, but because of its water-insoluble and ethanol-soluble properties, the solubility of the granules is not good. The inventor has unexpectedly found that only the auxiliary material hydroxypropyl methylcellulose (HPMC) is suitable for the technical scheme of the application by carrying out scheme design and experimental screening to a large number of auxiliary materials, and hydroxypropyl methylcellulose and acetyl-L-carnitine essence After the acid dihydrochloride is mixed to make moisture-proof granules, the moisture-absorbing properties of the moisture-proof granules decrease significantly, and the hardness and solubility of the granules are better; at the same time, hy...

Embodiment 1

[0042] The preparation of embodiment 1 acetyl-L-carnitine arginine dihydrochloride raw material

[0043] Add 800 g of weighed ethanol into the flask, add 239.7 g (1.0 mol) of acetyl-L-carnitine hydrochloride under stirring, and heat up to 60° C. to dissolve; after completely dissolving, add 210.7 g of arginine hydrochloride ( 1.0mol), then heated up to 70°C for constant temperature reaction for 1 hour; then cooled to crystallize, kept at 10°C for 2 hours; filtered and dried to obtain 410.0 g of acetyl-L-carnitine arginine dihydrochloride as a white solid product.

[0044] Melting point: 172-194°C.

[0045] [α] D 20 =-8.0~-10.0 (c=1,H 2 O).

[0046] PH=1.9-3.9 (c=1,H 2 O).

[0047] The acetyl-L-carnitine arginine dihydrochloride raw material of Example 1 was repeatedly prepared for the following examples.

Embodiment 2

[0048] Example 2 Preparation of acetyl-L-carnitine arginine dihydrochloride moisture-proof granules

[0049] Taking hydroxypropyl methylcellulose as a solute, and taking 95% ethanol aqueous solution as a solvent to prepare a 2% hydroxypropyl methylcellulose solution by mass percent of hydroxypropyl methylcellulose;

[0050] Mix 940 g of acetyl-L-carnitine arginine dihydrochloride prepared in Example 1 with 60 g of hydroxypropyl methylcellulose ethanol solution in a wet mixing granulator for 15 minutes until uniform;

[0051] Discharge the mixture in the wet mixing granulator, install the 20-mesh screen on the oscillating granulator, start the machine to make granules, dry in an explosion-proof oven at 40-50°C for 3-4 hours, and then sieve the granulator to 18 mesh Net whole grain. Acetyl-L-carnitine arginine dihydrochloride granules are obtained.

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Abstract

The invention discloses a preparation method of acetyl-L-carnitine arginine dihydrochloride moisture-proof particles. The method comprises the following steps: adding 1-3% of hydroxypropyl methyl cellulose and 80-98% of an ethanol solution with the mass percent into acetyl L-carnitine arginine dihydrochloride, uniformly mixing the materials, preparing granules by adopting conventional operation, and thereby obtaining the acetyl L-carnitine arginine dihydrochloride moisture-proof particles. The moisture absorption of the particles obtained by the method is obviously reduced, and the stability is improved.

Description

technical field [0001] The invention relates to the technical field of acetyl-L-carnitine preparation, in particular to a method for preparing acetyl-L-carnitine arginine dihydrochloride moisture-proof granules. Background technique [0002] Acetyl-L-carnitine is a natural substance present in the body, especially abundant in muscle, brain and sperm. It participates in a series of important metabolic processes in the human body. It takes away acetyl groups from cells and assists in energy transfer. Acetyl-L-carnitine plays an important role in the central nervous system and male reproduction. It can improve memory and is mainly used to treat senile dementia. [0003] Arginine is an α-amino acid and one of the 20 common natural amino acids. In mammals, arginine is classified as a semi-essential or conditionally essential amino acid. [0004] In order to be able to supplement acetyl-L-carnitine and arginine at the same time, the prior art compounded acetyl-L-carnitine hydroc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/221A61K31/198A61K47/38A61P25/28
CPCA61K9/1652A61K31/198A61K31/221A61P25/28A61K2300/00
Inventor 卿笃清周伟梅国庆关秋张炳辉
Owner リャオニンコンセプヌトラシーオーエルティーディー
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