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Polydatin medicinal composition containing polyvinyl pyrrolidone

A polyvinylpyrrolidone and composition technology, which is applied in the field of high-concentration polyvinylidene pharmaceutical compositions, can solve the problems of difficulty in storing drugs, difficulty in obtaining a clinical preparation scheme for polyvinylpyrrolidone injection, and unsuitable preparation of synthetic drug preparations.

Active Publication Date: 2010-09-29
SHENZHEN NEPTUNUS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, polydatin has a solubility of 3 mg / ml in pure water above pH 12, while the pH value of injections is generally specified in the range of 4.0 to 9.0; the method of heating and dissolving is not suitable for the preparation of synthetic pharmaceutical preparations; adding surfactants ( Tween 80) to prepare a solution of polydatin injection with a higher concentration, which makes it difficult to store the drug because it cannot be refrigerated
As stated in Chinese patent application CN 1709269A, within the scope allowed by clinical preparations, it is difficult to obtain an ideal clinical formulation of polydatin injection by adjusting the pH value and adding Tween-like surfactants and other conventional preparation methods

Method used

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  • Polydatin medicinal composition containing polyvinyl pyrrolidone
  • Polydatin medicinal composition containing polyvinyl pyrrolidone
  • Polydatin medicinal composition containing polyvinyl pyrrolidone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1. Prescription

[0030] raw material

Dosage

PVP K15

30mg, 93mg, 158mg, 333mg, 529.4mg

pure water

3ml

[0031] Second, the method

[0032]Weigh 30mg, 93mg, 158mg, 333mg and 529.4mg of PVP K15 and add 3ml of pure water to make 10mg / ml, 31mg / ml, 52.7mg / ml, 111mg / ml and 176.5mg / ml PVP K15 aqueous solutions respectively. First, add polydatin to the prepared 5 reagent bottles to supersaturation, prepare another bottle of 31mg / ml PVP K15 solution, add 0.80mg polydatin, and prepare polydatin PVP with a known concentration of 0.267mg / ml K15 solution. After sonication at 40°C for 30 minutes, place at room temperature for 3 hours, then filter through a 0.45 μm microporous membrane, and dilute 300 times with pure water. Detected by HPLC, according to the peak area of ​​31 mg / ml PVP K15 polydatin aqueous solution of known concentration, calculate the saturation concentration of polydatin under different PVP K15 aqueous solution concentrat...

Embodiment 2

[0034] 1. Prescription

[0035] raw material

Dosage

PVP K30

33.7mg, 103.3mg, 176.3mg, 333mg

pure water

3ml

[0036] Second, the method

[0037] Weigh 33.7mg, 103.3mg, 176.3mg and 333mg of PVP K30 and add 3ml of pure water to make PVP K30 aqueous solutions of 11.2mg / ml, 34.4mg / ml, 58.8mg / ml and 111mg / ml respectively. First, add polydatin to the prepared 4 reagent bottles to supersaturation, prepare another bottle of 34.4mg / ml PVP K30 solution, add 0.80mg polydatin, and prepare polydatin with a known concentration of 0.267mg / ml PVP K30 solution. After sonication at 40°C for 30 minutes, place at room temperature for 3 hours, then filter through a 0.45 μm microporous membrane, and dilute 300 times with pure water. Detect with HPLC, calculate the saturation concentration of polydatin under different PVP K30 aqueous solution concentration according to the peak area of ​​known concentration 34.4mg / ml PVP K30 polydatin aqueous solution.

Embodiment 3

[0039] 1. Prescription

[0040] raw material

Dosage

PVP K60

30mg, 61.2mg, 93mg, 125mg, 158mg, 225.8mg, 333mg

pure water

3ml

[0041] Second, the method

[0042] Weigh 30mg, 61.2mg, 93mg, 125mg, 158mg, 225.8mg and 333mg of PVP K60 and add 3ml of pure water to make 10mg / ml, 20.4mg / ml, 31mg / ml, 41.7mg / ml, 52.7mg / ml respectively , 75.3mg / ml and 111mg / ml PVP K30 aqueous solution. First, add polydatin to the prepared 7 reagent bottles to supersaturation, prepare another bottle of 34.4mg / ml PVP K60 solution, add 0.80mg polydatin, and prepare polydatin with a known concentration of 0.267mg / ml PVP K60 solution. After sonication at 40°C for 30 minutes, place at room temperature for 3 hours, then filter through a 0.45 μm microporous membrane, and dilute 200 times with pure water. Detect with HPLC, calculate the saturation concentration of polydatin under different PVP K60 aqueous solution concentration according to the peak area of ​​known con...

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PUM

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Abstract

The invention relates to a high-concentration polydatin drug composition containing polyvinylpyrrolidone, and contains polydatin and solubilizer polyvinylpyrrolidone; the polyvinylpyrrolidone is PVP K15 or PVP K30, the polydatin is in the water solution or physiological saline of polyvinylpyrrolidone (PVP) K15 or K30, and the solubility can achieve the specification of the conventional injection preparation.

Description

technical field [0001] The invention relates to a high-concentration polydatin pharmaceutical composition containing polyvinylpyrrolidone, and also relates to an injection preparation containing the pharmaceutical composition. Background technique [0002] In 1963, Nomura Susumu isolated and obtained polydatin from the plant Polygonum cuspidatum Sieb.et Zucc. Later, he found that polydatin also exists in spruce, grapes, peanuts and other plants. The chemical name of polydatin is 3,4',5-trihydroxystilbene-3-β-D-glucoside (C 20 h 22 o 8 ), which is a trans-stilbene compound, its structure is shown below. [0003] [0004] Basic pharmacological studies have shown that polydatin, as a medicinal ingredient, has physiological activities such as improving microcirculation, lowering blood fat, and anti-tumor, but the solubility of polydatin in pure water or saline solution is limited. The saturation concentration in normal saline is about 0.25mg / ml, and according to the Chine...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7034A61K47/32A61K9/08A61P9/00A61P3/06A61P35/00A61K36/704
Inventor 肖波赵金华曲伟张丽娟于琳
Owner SHENZHEN NEPTUNUS PHARM CO LTD