Lorazepam composition freeze-dried tablet and preparation method thereof
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A technology of lorazepam and composition, which is applied in the field of lorazepam composition freeze-dried tablet and preparation thereof, and achieves the effects of large dissolution rate, high bioavailability, and reduction of types and dosages of auxiliary materials
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 lorazepam 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 ) of 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 0.5 g of lorazepam, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0031] E. After measuring the content of lorazepam in the medicinal soluti...
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 0.5 gram of lorazepam (calculated by 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0039] E. After measuring the content of loraz...
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Abstract
The invention provides a lorazepam composition freeze-dried tablet and a preparation method thereof, and relates to the technical field of medicines and medicine production. The lorazepam composition freeze-dried tablet is prepared from lorazepam, starch and cane sugar, and prepared by the following steps: using starch and cane sugar as auxiliary materials, performing heating process treatment on the ordinary corn starch to improve the bonding and disintegration functions of starch in the tablet and the formability of the tablet, wherein the lorazepam composition freeze-dried tablet only needs the two auxiliary materials including starch and cane sugar. The lorazepam composition freeze-dried tablet is prepared by the two-temperature-rising two-temperature-decrease freeze-drying technology; the two-temperature-rising process and the two-temperature-decrease process can facilitate better formability and improve the dissolution rate of the tablet, so as to improve the bioavailability of the tablet; the tablet overcomes the defect of the common lorazepam, is high in dissolution rate and high in bioavailability, and ensures the curative effect and the safety of the clinical medication; the preparation method can reduce the varieties and the dosage of the auxiliary materials in lorazepam.
Description
technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a lorazepam composition freeze-dried tablet and a preparation method thereof. Background technique [0002] Lorazepam is a short-acting benzodiazepine, which has similar pharmacological effects to diazepam, but stronger. In addition to anxiolytic and sedative effects, it also has strong anticonvulsant effects. [0003] [0004] Ordinary lorazepam tablets contain many types and quantities of excipients. Generally, fillers, lubricants, disintegrants, binders, flavoring agents, etc. are used. According to the second labor of the Chinese Pharmacopoeia (2010 edition), According to the quality standard of larazepam tablets, the dissolution rate of lorazepam tablets reaches more than 70% in 30 minutes, which is qualified, and more and more studies have shown that the toxic and side effects of the excipients themselves, the incompatibility of the excipients a...
Claims
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