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L-arginine compound crystal and preparation method thereof

An arginine and compound technology, applied in the field of medicine, can solve problems such as no solution, and achieve the effects of low bulk density, low hygroscopicity and simple process

Active Publication Date: 2013-07-03
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, for L-arginine, in addition to the problem of bulk density, it also has hygroscopicity, which makes storage a certain problem
However, the prior art does not propose a corresponding solution

Method used

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  • L-arginine compound crystal and preparation method thereof
  • L-arginine compound crystal and preparation method thereof
  • L-arginine compound crystal and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] [Example 1] Preparation of L-arginine crystals

[0037] 1) Prepare A solution: Sterile filter 600L of a mixed solvent of absolute ethanol and acetone (the volume ratio of absolute ethanol to acetone is 5:1) into a crystallization tank, and cool down to 12°C for use, which is A solution;

[0038] 2) Preparation of solution B: Add 60kg of water for injection into the dissolving tank, control the temperature at 70°C, add 30kg of crude L-arginine, add 0.45kg of activated carbon after dissolving, stir for 30min to decolorize, filter aseptically, and use 10kg of water for injection Washing, collecting filtrate and washing liquid, obtains B solution;

[0039] 3) Add solution B to solution A, lower the temperature to 15°C, precipitate crystals, grow crystals for 2 hours, filter, wash, and vacuum dry at 45°C until the water content is less than 0.5%.

[0040] The bulk density of the obtained L-arginine compound crystal is 0.36g / cm 3 , the X-ray powder diffraction of the cryst...

Embodiment 2-9

[0041] [Example 2-9] Preparation of L-arginine crystals according to the parameters shown in Table 1

[0042] Below is embodiment 2-9, and operating procedure is with embodiment 1, and concrete process parameter is shown in table 1:

[0043] Table 1, Embodiment 2-9

[0044]

[0045] The X-ray powder diffraction patterns obtained by measuring the L-arginine compound crystals obtained in Examples 2-9 using Cu-Kα rays are similar to those in Example 1.

Embodiment 10

[0046] [Example 10] Refining L-arginine according to the method of prior art

[0047] According to "Crystalization Process of Low Bulk Density Arginine as Cephradine Co-solvent for Injection" [Liang Baochen, Chen Hui, Dong Ying. Crystallization Process of Low Bulk Density Arginine as Cephradine Co-solvent for Injection [J]. Chinese Journal of Antibiotics, 2005, 30(11):693-694], the specific steps are as follows:

[0048] 1) Add 100ml of deionized water and 50g of crude L-arginine into a 250ml three-neck flask, heat the water bath to 55°C, and stir until dissolved;

[0049] 2) Put 0.50g of activated carbon into the bottle, stir for 10min, filter with suction, and transfer the filtrate to a 500ml three-necked bottle;

[0050] 3) Adjust the stirring speed (250-400r / min), and add 95% ethanol that has been pre-cooled to 5-10°C into the arginine solution;

[0051] 4) Suction filter the crystallization feed liquid, wash, and vacuum dry at 80°C until the water content is lower than ...

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Abstract

The invention relates to an L-arginine compound crystal and a preparation method thereof. The L-arginine compound crystal has an X-ray powder diffractogram disclosed as Figure 1. Compared with the L-arginine compound prepared by the refinement method in the prior art, the L-arginine compound crystal provided by the invention has a different X-ray powder diffractogram, and is a new crystal form different from that in the prior art. The hygroscopicity test detects that the L-arginine compound crystal provided by the invention has lower hygroscopicity than that in the prior art. The invention also provides a preparation method of the L-arginine compound crystal. The method is simple and feasible. The L-arginine compound crystal prepared by the method is a new crystal form different from thatin the prior art, and has lower hygroscopicity.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an L-arginine compound crystal and a preparation method. Background technique [0002] L-Arginine (L-Arginine) is a basic amino acid, and its active conformation in the body is L-form, that is, L-Arginine. The chemical name of L-arginine is α-amino-δ-guanidinovaleric acid and the molecular formula is C 6 h 14 N 4 o 2 , the relative molecular mass is 174.4, and the structural formula is as follows: [0003] [0004] L-arginine participates in the ornithine cycle in the human body, promotes the formation of urea, makes the ammonia produced in the human body turn into non-toxic urea through the ornithine cycle, and excretes it through urine, thereby reducing the blood ammonia concentration. This product has a higher concentration of hydrogen ions, which helps to correct the acid-base balance in hepatic encephalopathy. [0005] As an important co-solvent, L-argi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C279/14C07C277/08
Inventor 刘明霞刘新泉李晓峰王平
Owner SHANDONG LUOXIN PHARMA GRP CO LTD