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A kind of polydatin pharmaceutical composition without organic solvent and preparation method thereof

A technology of organic solvent and polydipside, applied in the field of medicine, can solve problems such as deepening and color of bubble head solution, and achieve the effect of increasing solubility, ensuring product quality, and meeting the needs of clinical medication.

Active Publication Date: 2020-10-02
SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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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 pharmaceutical composition of high-concentration polydatin that does not contain ethanol and other organic solvents. The problem of bubble head generated during the sealing process and the color deepening of the solution that is prone to occur during the high temperature sterilization process have the effect of stabilizing the active ingredient, and are suitable for scale-up production and clinical direct injection administration

Method used

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  • A kind of polydatin pharmaceutical composition without organic solvent and preparation method thereof
  • A kind of polydatin pharmaceutical composition without organic solvent and preparation method thereof
  • A kind of polydatin pharmaceutical composition without organic solvent and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0029]

[0030] Preparation process: prepare sodium carbonate-sodium bicarbonate buffer solution for later use; weigh the prescribed amount of polyethylene glycol lauryl hydroxystearate and polydatin and add part of the prescribed amount to the sodium carbonate-sodium bicarbonate buffer solution. Stir to dissolve it completely, add sodium carbonate-sodium bicarbonate buffer solution to the full amount; remove the pyrogen by ultrafiltration; take the liquid medicine after ultrafiltration to check the content, pH value, bacterial endotoxin and other items; 0.22 μm sterilizing filter membrane for sterilizing filtration; potting; sterilizing; lamp inspection to obtain polydatin injection.

Embodiment 2

[0032]

[0033] Preparation process: prepare sodium carbonate-sodium bicarbonate buffer solution for later use; weigh the prescribed amount of polyethylene glycol lauryl hydroxystearate and polydatin and add part of the prescribed amount to the sodium carbonate-sodium bicarbonate buffer solution. Stir to dissolve it completely, add sodium carbonate-sodium bicarbonate buffer solution to the full amount; remove the pyrogen by ultrafiltration; take the liquid medicine after ultrafiltration to check the content, pH value, bacterial endotoxin and other items; 0.22 μm sterilizing filter membrane for sterilizing filtration; potting; sterilizing; lamp inspection to obtain polydatin injection.

Embodiment 3

[0035]

[0036] Preparation process: prepare sodium carbonate-sodium bicarbonate buffer solution for later use; weigh the prescribed amount of polyethylene glycol lauryl hydroxystearate and polydatin and add part of the prescribed amount to the sodium carbonate-sodium bicarbonate buffer solution. Stir to dissolve it completely, add sodium carbonate-sodium bicarbonate buffer solution to the full amount; remove the pyrogen by ultrafiltration; take the liquid medicine after ultrafiltration to check the content, pH value, bacterial endotoxin and other items; 0.22 μm sterile filter membrane for sterile filtration; filling and freeze-drying to obtain polydatin freeze-dried powder injection.

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Abstract

The invention relates to the field of pharmaceutical preparations, and in particular, relates to a polydatin pharmaceutical composition containing no organic solvent and a preparation method thereof.The polydatin pharmaceutical composition comprises polydatin, a solubilizing agent and a solvent. The solubilizing agent is polyethylene glycol dodecyl hydroxy stearate, and the solvent is water for injection or a pH buffer solution or a sodium chloride solution or a glucose solution. According to the polydatin pharmaceutical composition containing no organic solvent, the dosage form is a pharmaceutically acceptable conventional dosage form such as water for injection or pre-serviced water or an aqueous solution freeze-dried product prepared from normal saline. The preparation method of the polydatin pharmaceutical composition mainly comprises the steps of dissolution, filtration, sealed potting, sterilization, lamp examination and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a polydatin pharmaceutical composition free of organic solvents and a preparation method thereof. Background technique [0002] Polydatin (PD) is a monomer extracted from the dried rhizome of Polygonum Cuspidatum Sieb. et Zucc, which can be called resveratrol glycoside. PD is widely distributed in plants with high content and strong biological activity. Modern pharmacological studies have shown that PD has significant effects on cardiomyocytes, vascular smooth muscle cells, anti-platelet aggregation, and improvement of microcirculation. In addition, it can also reduce tissue and organ damage caused by various factors, and has the functions of protecting liver cells, anti-oxidation, and lowering blood lipids. and anti-lipid peroxidation. [0003] The chemical structure of polydatin is 3,4',5-trihydroxystilbene-3-β-D-glucoside (3,4',5-trihydroxy-trans stilbene-3-β-D-...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/7034A61K47/14A61P9/00A61P7/02A61P1/16A61P39/06A61P3/06
CPCA61K9/0019A61K9/08A61K9/19A61K31/7034A61K47/14A61P1/16A61P3/06A61P7/02A61P9/00A61P39/06
Inventor 崔婧王志国王丽丽杨经安
Owner SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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