Butyphthalide injection and preparation method thereof
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A technology of butylphthalide and injection, applied in the field of medicine, can solve the problems of unstable quality, inability to meet clinical drug requirements, difficult operation and the like
Active Publication Date: 2018-05-01
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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Problems solved by technology
This dosage form needs to be compatible with glucose injection or sodium chloride injection when used, it is difficult to operate when diluted in clinical application, and it is still intravenous injection or infusion
[0007] To sum up, the butylphthalide dosage forms disclosed in the prior art have complex processes, unstable quality, and still cannot well meet the needs of clinical medication.
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Embodiment 1
[0113] Embodiment 1 Butylphthalide injection (water injection): contains butylphthalide, soybean lecithin, and water for injection, and the prescription dosage of the three is shown in the following table:
[0114] Based on 100mL:
[0115] Material name
[0116] Preparation process: Dissolve soybean lecithin in about 90ml of water for injection at 40-60°C, slowly add butylphthalide dropwise, stir well, break up with a high-pressure homogenizer, control the particle size to be less than 50 nanometers, obtain a clear liquid, replenish water To 100ml, add 0.1% activated carbon and stir for 30 minutes, filter to remove charcoal, sterilize, pack in 10ml each, and sterilize.
Embodiment 2
[0117] Embodiment 2 Butylphthalide injection (water injection): contains butylphthalide, polyethylene glycol-12 hydroxystearate and water for injection, and the prescription dosage of the three is shown in the following table:
[0118] Material name
[0119] Preparation process: Dissolve polyethylene glycol-12 hydroxystearate in about 90ml of water for injection at 20-30°C, slowly add butylphthalide dropwise, stir well, no oil droplets appear on the liquid surface, and obtain a clear liquid, replenish water To 100ml, add 0.2% activated carbon and stir for 30 minutes, filter to remove charcoal, sterilize, pack in 10ml each, and sterilize.
Embodiment 3
[0120] Example 3 Butylphthalide injection (freeze-dried powder injection): contains butylphthalide, polyethylene glycol-12 hydroxystearate and water for injection, and the prescription dosage of the three is shown in the following table:
[0121] Material name
[0122] Preparation process: Dissolve polyethylene glycol-12 hydroxystearate in about 90ml of water for injection at 20-30°C, slowly add butylphthalide dropwise, stir well, until no oil drops appear on the liquid surface, add mannitol and glucose to dissolve , to obtain a clear liquid, add water to 100ml, add 0.1% activated carbon and stir for 30 minutes, filter to remove carbon, sterilize, subpackage, each 5ml, freeze-dried.
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Abstract
The invention relates to a butyphthalide injection and a preparation method of the butyphthalide injection. The butyphthalide injection disclosed by the invention contains butyphthalide or a derivative of butyphthalide, a surfactant and water for injection, wherein the surfactant is selected from one or more of phospholipid, polyethylene glycol-12-hydroxy stearate, polyethylene glycol-VE carbonate, polyethylene glycol-VE succinate, polyethylene glycol- distearoyl phosphatidyl ethanolamine, polyethylene glycol-cholesteryl succinate, polyethylene glycol-cholesterol methyl ester, polyethylene glycol- cholesterol sulfate, polyoxyethylene sorbitan fatty acid ester, and poloxamer. The butyphthalide injection disclosed by the invention can effectively mask the special fragrance of butyphthalide,the quality is stable, the content of butyphthalide is high, the butyphthalide injection can be sub-packaged into a preparation with small volume, can be used for intravenous injection, and also can be used for intramuscular injection, so that the requirements of clinical administration are met; a preparation process is simple, the operability is strong, and the industrialization is facilitated.
Description
[0001] This application is a divisional application of an invention patent application with the application number CN201210214131.0, the application date is June 27, 2012, and the invention title is "a butylphthalide injection and its preparation method". technical field [0002] The invention belongs to the technical field of medicine and relates to a drug injection and a preparation method thereof, in particular to a butylphthalide injection and a preparation method thereof. Background technique [0003] Butylphthalide (3-n-butylphthalide, 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 and D-butylphthalide. Butylphthalide can reduce the infarction after focal cereb...
Claims
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