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Butylphthalide nasal drop and preparation method thereof

A technology of butylphthalide and nasal drops, applied in the field of medicine, can solve problems such as undisclosed technical solutions of butylphthalide nasal drops, and achieve the effects of small size, fast onset of action and simple preparation process

Active Publication Date: 2014-01-15
SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] In summary, the research on butylphthalide preparations in the prior art still cannot meet the needs of clinical use, and there is an urgent need for a pharmaceutical preparation that is quick onset, small in size, easy to use, and simple in preparation process and is suitable for clinical first aid. The prior art also does not disclose the technical scheme for preparing nasal drops from butylphthalide

Method used

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  • Butylphthalide nasal drop and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Prescription composition:

[0045] components Dosage ( g ) Weight percentage (%) rac-Butylphthalide 1.5 7.89 medium chain glycerides 1.5 7.89 Water for Injection 10.0 52.63 Polyoxyethylene 40 Hydrogenated Castor Oil 3.0 15.79 Vitamin E 1.0 5.26 Mannitol 1.0 5.26 citric acid 1.0 5.26

[0046] Preparation:

[0047] (1) Prepare the oil phase: weigh 1.5 g of butylphthalide and 1.5 g of medium-chain glyceride, mix well, and preheat in a 60°C water bath;

[0048] (2) Prepare the water phase: weigh 1.0g of mannitol\3.0g of polyoxyethylene 40 hydrogenated castor oil, 1.0g of vitamin E and 1.0 of mannitol in 10.0g of water for injection, and preheat in a water bath at 60°C;

[0049] (3) Preparation of colostrum: Slowly pour the oil phase obtained in step (1) into the water phase obtained in step (2), and disperse with a high-speed shear dispersing emulsifier for 5 minutes at 10,000 rpm. Colostrum is prepared by ...

Embodiment 2

[0054] prescription composition

[0055] components Dosage ( g ) Weight percentage (%) rac-Butylphthalide 3.0 16.67 Water for Injection 10.0 55.56 Polysorbate 80 1.5 8.33 Oleic acid 1.5 8.33 Sodium chloride 1.5 8.33 citric acid 0.5 2.78

[0056] Preparation:

[0057] (1) Prepare the oil phase: weigh 3.0 g of butylphthalide and preheat in a water bath at 60°C;

[0058] (2) Prepare the water phase: weigh 1.5g of polysorbate 80, 1.5g of sodium chloride and oleic acid in 10.0g of 15g of water for injection, and preheat in a water bath at 60°C;

[0059] (3) Preparation of colostrum: Slowly pour the oil phase obtained in step (1) into the water phase obtained in step (2), and disperse with a high-speed shear dispersing emulsifier for 5 minutes at 10,000 rpm. Colostrum is prepared by ultrasonic method or high-speed shear Method (FA25 laboratory high-shear dispersing emulsifier, Shanghai Fluke Electromechanical Equipment Co...

Embodiment 3

[0064] Prescription composition:

[0065] components Dosage ( g ) Weight percentage (%) rac-Butylphthalide 4.5 25.00 Water for Injection 10.0 55.56 Polyoxyethylene 35 castor oil 1.5 8.33 Mannitol 1.0 5.56 citric acid 1.0 5.56

[0066] Preparation:

[0067] (1) Prepare the oil phase: weigh 4.5 g of butylphthalide, and preheat it in a water bath at 60°C;

[0068] (2) Prepare the water phase: weigh 1.5g of polyoxyethylene 35 castor oil and 1.0g of mannitol into 10.0g of water for injection, and preheat in a 60°C water bath;

[0069] (3) Preparation of colostrum: Slowly pour the oil phase obtained in step (1) into the water phase obtained in step (2), and disperse with a high-speed shear dispersing emulsifier for 5 minutes at 10,000 rpm. Colostrum is prepared by ultrasonic method or high-speed shear Method (FA25 laboratory high-shear dispersing emulsifier, Shanghai Fluke Electromechanical Equipment Co., Ltd.);

[0070] (4) Ho...

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Abstract

The invention relates to a butylphthalide nasal drop and a preparation method thereof. The butylphthalide nasal drop prepared by adopting the method has the advantages of good stability, quick effect, small size and simple preparation process, and is convenient to use, suitable for clinical first aid and suitable for industrialized production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a medicinal nasal drop and a preparation method thereof, in particular to a butylphthalide nasal drop and a preparation method thereof. Background technique [0002] Butylphthalide (3-n-butylpthhalide, NBP for short), full name 3-butyl-1(H)-isobenzofuranone, also known as apigenin A, is a racemate extracted from celery seed , can also be artificially synthesized. Butylphthalide is an oily liquid that is insoluble in water and has a strong celery smell. The molecule contains a chiral carbon atom, so it exists in two optical isomers, namely, L-butylphthalide (l-3-n- butylphthalide) and d-3-n-butylphthalide. Butylphthalide can reduce the infarction after focal cerebral ischemia, increase the cerebral blood flow in the ischemic area and improve the microcirculation in the cerebral ischemic area, protect the mitochondrial function, reduce the degree of neurological damage, and improv...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/365A61P9/10A61P7/02A61P25/28
Inventor 牛锋郭海波李影刘晓辉李品颖
Owner SHIJIAZHUANG PHARMA GRP NBP PHARMA CO LTD
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