Clonazepam composition freeze-dried tablet and preparation method thereof
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The technology of clonazepam and composition is applied in the field of clonazepam composition freeze-dried tablet and preparation thereof, and achieves the effects of good formability, high bioavailability and high dissolution rate
Inactive Publication Date: 2015-04-29
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 clonazepam freeze-dried tablets by freeze-drying process
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Embodiment 1
[0026]
[0027] A. Weigh 100g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5.5-7.5, then heat to 72°C and keep for 120 minutes to make 9% (W / V) cornstarch solution.
[0028] B. Measure 45ml of purified water, boil, 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.
[0029] 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.
[0030] D. Weigh 0.25 g of clonazepam, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0031] E. After measuring the content of clonazepam in the medicinal solutio...
Embodiment 2
[0034]
[0035] A. Weigh 130g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5.5-7.5, then heat to 72°C and keep for 120 minutes to make 13% (W / V ) of cornstarch solution.
[0036] B. Measure 45ml of purified water, boil, 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.
[0037] 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.
[0038] D, take by weighing 0.25 grams of clonazepam (calculated by 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0039] E. After measuring the content o...
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Abstract
The invention provides a clonazepam composition freeze-dried tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The clonazepam composition freeze-dried tablet is prepared from clonazepam, starch and cane sugar, starch and cane sugar are used as auxiliary materials, and heating process treatment is performed on the ordinary corn starch, so that the bonding and disintegration functions of starch in the tablet are improved, the formability of the tablet is improved, and the clonazepam composition freeze-dried tablet only needs the two auxiliary materials namely starch and cane sugar. The clonazepam composition freeze-dried tablet is prepared by the freeze-drying process that the temperature is increased and decreased for two times; the process that the temperature is increased and decreased for two times enables the formability of the tablet to be better and increases the dissolution rate of the tablet, so as to improve the bioavailability of the tablet; the tablet overcomes the defect of the common clonazepam, is high in dissolution rate and high in bioavailability, and ensures the curative effect and the safety of the clinical medication; the varieties and the dosage of the auxiliary materials in clonazepam are reduced.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of clonazepam composition and a preparation method thereof. Background technique [0002] Clonazepam is a benzodiazepine antiepileptic and anticonvulsant drug. The drug has antagonism effect on various animal epilepsy models, especially the antagonism effect on the clonic convulsion model caused by pentylenetetrazol, and has strong effect on maximal electroshock convulsion, strychnine and picrotoxin convulsion, etc. antagonistic effect. It has inhibitory effect on various types of epilepsy. Clonazepam inhibits both the ictal discharges of epileptic lesions and the spread of discharges to surrounding tissues. 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 GABAA receptor, promotes the opening of chl...
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