Alprazolam composition lyophilized tablet and preparation method thereof
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A technology of alprazolam and its composition, which is applied in the field of alprazolam composition freeze-dried tablets and its preparation, to achieve the effects of improving bioavailability, improving formability, and large dissolution rate
Inactive Publication Date: 2015-05-20
HAINAN WEI KANG PHARMA QIANSHAN
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[0007] Starch is the basic excipient of oral solid preparations. It is formed by the polymerization of glucose molecules. It is often used as a binder, diluent and disintegrating agent in tablets. It is cheap and easy to obtain, and is safe for the human body. However, starch is used alone as an excipient There is no report on the production of gliclazide freeze-dried tablets by freeze-drying process
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Embodiment 1
[0026]
[0027]
[0028] A. Weigh 100g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 6.0±0.1, then heat to 72°C and keep for 120 minutes to make 9% (W / V) cornstarch solution.
[0029] B. Measure 45ml of purified water, boil it, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.
[0030] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.
[0031] D. Weigh 80 g of alprazolam, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0032] E. After measuring the content of alprazolam in the medi...
Embodiment 2
[0035]
[0036] A. Weigh 130g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 6.0±0.1, then heat to 72°C and keep for 120 minutes to make 13% (W / V ) of cornstarch solution.
[0037] B. Measure 45ml of purified water, boil it, add 85g of sucrose, stir, after dissolving, continue heating to 100°C, filter with refined cotton, wash the filter with an appropriate amount of hot distilled water, combine the lotion and filtrate, let cool, add Add appropriate amount of distilled water to make the whole volume into 100mL, stir well to obtain B solution.
[0038] C. Mix the solution obtained in step A with the solution obtained in step B, fully stir for 30 minutes, and then lower the solution to normal temperature to obtain a corn-sucrose solution.
[0039] D, take by weighing 80 grams of alprazolam (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0040] E. After measuring the content ...
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Abstract
The invention provides an alprazolam composition lyophilized tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The tablet is prepared from alprazolam, starch and cane sugar, wherein starch and cane sugar are used as auxiliaries, common corn starch is subjected to heating treatment to improve the adhering and disintegrating effects of the starch in the tablet, so that the moldability of the tablet can be improved. The alprazolam composition lyophilized tablet only needs two auxiliaries of starch and cane sugar. According to the preparation method, a twice-cooling twice-heating lyophilizing process is adopted for the alprazolam composition lyophilized tablet, the moldability of the tablet can be better by means of twice cooling and twice heating, the solubility of the tablet can be improved, and the bioavailability of the tablet can be improved; the tablet is capable of overcoming the defect of conventional alprazolam tablets and reducing the types and usage of auxiliaries in the alprazolam tablets, is high in solubility and high in bioavailability, and can be used for guaranteeing the curative effect and safety of clinical administration.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of alprazolam composition and a preparation method thereof. Background technique [0002] This product is a benzodiazepine hypnotic sedative and anxiolytic. The drug acts on the benzodiazepine receptor (BZR) of the central nervous system, strengthens the binding of the central inhibitory neurotransmitter γ-aminobutyric acid (GABA) to the GABA receptor, promotes the opening of chloride channels, and hyperpolarizes cells , enhance the synaptic inhibition mediated by GABAergic neurons, and reduce the excitability of neurons. BZR is divided into type I and type II. It is believed that the stimulation of type I receptors can explain the anxiolytic effects of BZ drugs, while type II receptors are related to the sedative and skeletal muscle relaxation effects of these drugs. [0003] Molecular formula C 17 h 13 ClN 4 , molecular weig...
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