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Diazepam composition freeze-dried tablet and preparation method thereof
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A composition and freeze-dried tablet technology, applied in the field of diazepam composition freeze-dried tablet and its preparation, to achieve the effects of good formability, improved dissolution and improved adhesion
Inactive Publication Date: 2015-05-06
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 diazepam 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 2.5 g of diazepam, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0031] E. After measuring the content of diazepam in the medicinal solution, di...
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) 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 2.5 grams of diazepam (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0039] E. After measuring the content of diaze...
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Abstract
The invention provides a diazepam composition freeze-dried tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The diazepam composition freeze-dried tablet comprises diazepam, starch and canesugar; the starch and the canesugar are used as auxiliary materials, and common corn starch is heated, so that the adhesion and disintegration functions of the starch in the tablet can be improved, the formability of the tablet is improved; the diazepam composition freeze-dried tablet only needs two auxiliary materials: the starch and the canesugar. The diazepam composition freeze-dried tablet adopts a freeze-drying process of cooling for twice and heating for twice, the formability of the tablet is better, the dissolution rate of the tablet is improved and the bioavailability of the tablet is improved; the tablet has the advantages of overcoming the defects of the common diazepam tablet and decreasing the kinds and dosage of the auxiliary materials in the diazepam tablet, is large in dissolution rate and high in bioavailability and ensures the curative effect and safety of clinic medication.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried tablet of a diazepam composition and a preparation method thereof. Background technique [0002] Diazepam is a benzodiazepinedrug, a central depressant, with good anxiolytic, sedative, hypnotic, anticonvulsant and muscle relaxant effects. Its stability, muscle relaxation and anticonvulsant effects are stronger than chlordiazepoxide, and can indirectly expand arterioles and veins, reduce peripheralvascular resistance, increase coronary blood flow, decrease left ventricular end-diastolic pressure, and reduce oxygen consumption. [0003] [0004] Ordinary diazepam tablets contain many types and quantities of excipients. Generally, fillers, lubricants, disintegrants, binders, flavoring agents, etc. are used. According to the second part of the Chinese Pharmacopoeia (2010 edition), diazepam According to the quality standard of Panpan Table...
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