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A kind of production technology for controlling the density of chondroitin sulfate sodium

A kind of chondroitin sulfate sodium and production process technology, which is applied in the field of medicine, can solve the problems affecting the molding of tablets or capsules, waste of production resources, etc., and achieve the effects of easy control, saving production costs, and improving yield

Active Publication Date: 2019-06-28
RIZHAO LANSHAN BIOCHEM PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The density of chondroitin sulfate sodium raw material plays a decisive role in the formulation process of tablets or capsules when it is made into dosage forms. Too large or too small density will affect the molding of dosage forms such as tablets or capsules. Therefore, the control of sulfuric acid The density of chondroitin sodium API is a key part of the preparation process, and there is no relevant technology to solve this problem
[0006] Chinese patent CN 105399864A discloses a "preparation process of high-purity and low molecular weight uranium chondroitin sulfate", Chinese patent CN103214595B discloses a "preparation method of sodium chondroitin sulfate", and Chinese patent CN103601815B discloses a "alkali hydrolysis- Enzymatic hydrolysis combined with flocculation and precipitation method to extract sodium chondroitin sulfate", the preparation process of the above patents does not involve the control of the density of sodium chondroitin sulfate
[0007] In view of the above, at present, what is urgently needed in the market is a method that can overcome the above-mentioned defects and meet the needs of different dosage forms for different densities of chondroitin sulfate sodium raw materials, so as to avoid excessive or too small densities affecting the molding of dosage forms, resulting in the production of enterprises. waste of resources

Method used

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  • A kind of production technology for controlling the density of chondroitin sulfate sodium
  • A kind of production technology for controlling the density of chondroitin sulfate sodium
  • A kind of production technology for controlling the density of chondroitin sulfate sodium

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Experimental program
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Effect test

Embodiment 1

[0058] A production process for controlling the density of chondroitin sulfate sodium, comprising:

[0059] T1. Take 12 kg of chondroitin sulfate sodium sample and dissolve it in water at a ratio of 1:10, stir evenly, and make a mother liquor, which is recorded as group A, and divided into 12 parts by volume, respectively recorded as A11, A12, A13, A21, A22 , A23, A31, A32, A33, A41, A42, A43, adjust each solution to be 20°C;

[0060] T2, above-mentioned each solution selects ethanol to add the precipitation mode of mother liquor, the ethanol concentration after the precipitation of adjustment A11 is 68%, the ethanol concentration after the precipitation of A12 is 70%, the ethanol concentration after the precipitation of A13 is 72%, the ethanol concentration after the precipitation of A21 The ethanol concentration after the precipitation of A22 is 80%, the ethanol concentration after the precipitation of A23 is 82%, the ethanol concentration after the precipitation of A31 is 7...

Embodiment 2

[0067] A production process for controlling the density of chondroitin sulfate sodium, comprising:

[0068] S1. Take 60 kg of chondroitin sulfate sodium sample and dissolve it in water at a ratio of 1:10, stir evenly, and make mother liquor, which is recorded as group B, and divided into 12 parts by volume, respectively recorded as B11, B12, B13, B21, B22 , B23, B31, B32, B33, B41, B42, B43, adjust each solution to be 20°C;

[0069] S2, above-mentioned each solution selects mother liquor to add the precipitation mode of ethanol, the ethanol concentration after the precipitation of adjustment B11 is 68%, the ethanol concentration after the precipitation of B12 is 70%, the ethanol concentration after the precipitation of B13 is 72%, the ethanol concentration after the precipitation of B21 The concentration of ethanol after precipitation of B22 is 80%, the concentration of ethanol after precipitation of B23 is 82%, the concentration of ethanol after precipitation of B31 is 70%, t...

Embodiment 3

[0076] A customer needs 100kg of chondroitin sulfate sodium raw materials with a density of 0.60±0.05g / ml and 0.80±0.05g / ml respectively for the preparation of capsules and tablets. The process for producing chondroitin sulfate sodium according to the customer’s requirements is as follows:

[0077] 1. Dissolve 250kg of sodium chondroitin sulfate sample in 2500L of water and stir evenly;

[0078] 2. Use a pump to transfer 1250L of mother liquor to the precipitating tank A filled with ethanol, adjust the ethanol concentration to 80%, and the precipitation temperature to 20°C;

[0079] 3. Transfer the remaining 1250L mother liquor to another precipitation tank B, add ethanol and adjust the ethanol concentration to 75%, and the precipitation temperature to 20°C.

[0080] 4. Suction filtration, dehydration, and drying of the materials in the two sedimentation tanks A and B to obtain the bulk drug of chondroitin sulfate sodium; wherein the weight of product A is 121kg, and the weigh...

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Abstract

The invention belongs to the field of medicine and particularly discloses a production technology capable of controlling the density of chondroitin sulfate sodium. The technology comprises the steps as follows: mother liquor is prepared and divided into A1, A2, B1 and B2 with equal volumes, and the temperatures of the solutions are adjusted to be 20 DEG C; the A1 and the A2 are precipitated by adding ethanol to the mother liquor, and the concentration of ethanol is adjusted to 68%-82% after precipitation of the A1; the precipitation temperature of the A2 is adjusted to the room temperature of 38-42 DEGC, and the concentration of ethanol is adjusted to 70%-80% after precipitation of A2; the B1 and the B2 are precipitated by adding ethanol to the mother liquor, and the concentration of ethanol is adjusted to 68%-82% after precipitation of the B1; the precipitation temperature of the B2 is adjusted to the room temperature of 38-42 DEGC, and the concentration of ethanol is adjusted to 70%-80% after precipitation of B2; the precipitated solutions are dehydrated, dried, crushed and sieved, and chondroitin sulfate sodium raw materials with different densities are obtained. The technology is reasonable in design, simple and convenient, the densities of the raw materials are easy to control, the cost is low, the yield rate in product preparation production is increased, and the technology is applicable to large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a production process for controlling the density of chondroitin sulfate sodium. Background technique [0002] Chondroitin sulfate (CS) is a class of glycosaminoglycans covalently attached to proteins to form proteoglycans. Chondroitin sulfate is widely distributed in the extracellular matrix and cell surface of animal tissues. The sugar chain is composed of alternating glucuronic acid and N-acetylgalactosamine (also known as N-acetylgalactosamine) disaccharide units. The linking region is linked to a serine residue of the core protein. CS is a natural acidic mucopolysaccharide, which is a biological polymer compound. CS has three isomers of A, C and D, all of which are composed of D-glucuronic acid and N-acetyl-D-galactosamine sulfate It is composed of units, but the position of the sulfuric acid group is different. CS widely exists in cartilage tissues of humans and some a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/08
CPCC08B37/0003C08B37/0069
Inventor 尤加宇张新庆申加秋赵贵吉刘英豪马锡峰赵梦喆
Owner RIZHAO LANSHAN BIOCHEM PROD
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