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Application of butylphthalide composition in preparation of medicine for preventing or treating nephropathy

A composition and technology of butylphthalide, applied in the fields of chemistry and medicine, can solve problems such as treatment and prevention of nephropathy patients without butylphthalide, and achieve the effect of good therapeutic effect

Pending Publication Date: 2022-03-22
CHENGDU SHIBEIKANG BIOLOGICAL MEDICINE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] After a lot of experiments, the applicant accidentally found that butylphthalide has a protective effect on the kidney; there are no reports on the use of butylphthalide in the treatment and prevention of patients with kidney disease, especially those with renal insufficiency

Method used

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  • Application of butylphthalide composition in preparation of medicine for preventing or treating nephropathy
  • Application of butylphthalide composition in preparation of medicine for preventing or treating nephropathy
  • Application of butylphthalide composition in preparation of medicine for preventing or treating nephropathy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: the preparation of pharmaceutical composition 1, its formulation prescription (prescription quantity 100) is:

[0029]

[0030]

[0031] Preparation method: Take the prescribed amount of purified water, boil and cool to 80°C. Weigh 50 g sodium sulfobutylbeta cyclodextrin (substitution degree 6.2-6.9, average substitution degree 6.4, molecular weight 2145.2 g / mol), 90 g sodium chloride, add to 8 L 80 ° C purified water, stir to dissolve completely. Weigh 2.5 g of butylphthalide, add it to the sodium sulfobutylbeta cyclodextrin solution, stir in an oil bath at 80°C for 90 minutes to dissolve completely. Allow to cool to room temperature, add 0.2M hydrochloric acid solution to adjust the pH value to 4.5, and add purified water to 10L. Filter through a 0.45 μm filter membrane with a circulating water-type multi-purpose vacuum pump. Fill the prepared solution in 100ml / bottle. After filling, it was sterilized at 121° C. for 15 minutes at high temperatur...

Embodiment 2

[0032] Embodiment 2: the preparation of pharmaceutical composition 2, its formulation prescription (prescription quantity 100) is:

[0033]

[0034] Preparation method: Take the prescribed amount of purified water, boil and cool to 80°C. Weigh 60g sodium sulfobutylbeta cyclodextrin (degree of substitution 6.2-6.9, average degree of substitution 6.4, molecular weight 2145.2g / mol), 90g sodium chloride, add to 8L 80°C purified water, stir to dissolve completely. Weigh 2.5 g of butylphthalide, add it to the sodium sulfobutylbeta cyclodextrin solution, stir in an oil bath at 80°C for 90 minutes to dissolve completely. Allow to cool to room temperature, add 0.2M hydrochloric acid solution to adjust the pH value to 4.5, and add purified water to 10L. Filter through a 0.45 μm filter membrane with a circulating water-type multi-purpose vacuum pump. Fill the prepared solution in 100ml / bottle. After filling, it was sterilized at 121° C. for 15 minutes at high temperature to obtain ...

Embodiment 3

[0035] Embodiment 3: the preparation of (5mL: 25mg, 5mg / ml) of medicinal composition 3, preparation prescription (prescription quantity 100) is:

[0036]

[0037] Preparation method: Take the prescribed amount of purified water, boil and cool to 80°C. Weigh 60 g of sodium sulfobutylbeta cyclodextrin (degree of substitution 6.2-6.9, average degree of substitution 6.4, molecular weight 2145.2 g / mol), add it to 400 mL of purified water at 80°C, and stir to dissolve completely. Weigh 2.5 g of butylphthalide, add it to the sodium sulfobutylbeta cyclodextrin solution, stir in an oil bath at 80°C for 120 min to dissolve completely. Allow to cool to room temperature, add 0.2M hydrochloric acid solution to adjust the pH value to 4.5, and add purified water to 500mL. Filter through a 0.45 μm filter membrane with a circulating water-type multi-purpose vacuum pump. Fill the prepared solution at 5mL / bottle. After filling, it was sterilized at 121°C for 15 minutes at high temperature ...

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Abstract

The invention discloses application of a butylphthalide composition in preparation of a medicine for preventing or treating nephropathy, and relates to the field of chemistry and medicine. According to the application of the composition in preparation of the medicine for preventing or treating the nephropathy, the composition comprises butylphthalide with an effective dose or pharmaceutically acceptable salt of butylphthalide, and further comprises a pharmaceutically acceptable carrier sulfobutyl beta-cyclodextrin sodium. The composition disclosed by the invention has a kidney protection effect on both acute kidney injury and chronic kidney injury. The composition not only can be used for treating acute or chronic renal insufficiency nephropathy, but also can be used for treating cerebral apoplexy complicated nephropathy.

Description

technical field [0001] The present invention relates to the field of chemistry and medicine, specifically, the present invention relates to the new application of the composition containing butylphthalide or its salt, more specifically relates to the preparation of the composition containing butylphthalide or its salt in the medicine for preventing or treating nephropathy Applications. Background technique [0002] The incidence rate of chronic kidney disease (CKD) in my country is about 10.8%. Chronic kidney disease has become a public health problem. Studies have shown (Wang Hailong et al. Meta-analysis of the relationship between chronic kidney disease and stroke [J]. Chinese General Medicine, 2012, v.15; No.321(05):485-489): Chronic kidney disease can increase the risk of stroke is a risk factor for stroke. The probability of stroke in CKD patients is 1.31 times that of normal people; in addition, the probability of ischemic stroke in CKD patients is higher than that o...

Claims

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Application Information

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IPC IPC(8): A61K31/365A61K47/40A61P13/12A61P9/10
CPCA61K31/365A61K47/40A61P13/12A61P9/10
Inventor 牟霞聂昱曾燕群
Owner CHENGDU SHIBEIKANG BIOLOGICAL MEDICINE TECH CO LTD
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