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Spirolactone composition freeze-dried tablets and preparation method thereof

A technology of spironolactone and its composition, which is applied in the field of spironolactone composition freeze-dried tablets and its preparation, to achieve the effects of good formability, improved dissolution rate, and improved adhesion

Inactive Publication Date: 2015-04-08
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[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 spironolactone freeze-dried tablets by freeze-drying process

Method used

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  • Spirolactone composition freeze-dried tablets and preparation method thereof
  • Spirolactone composition freeze-dried tablets and preparation method thereof
  • Spirolactone composition freeze-dried tablets and preparation method thereof

Examples

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Effect test

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 5.5-7.0, 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 12 g of spironolactone, add it into 1L corn-sucrose solution, and stir for 30 minutes.

[0031] E. After measuring the spironolactone content of the medicinal solution...

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 5.5-7.0, 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 12 grams of spironolactone (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.

[0039] E. After measuring the spironolact...

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Abstract

The invention provides spirolactone composition freeze-dried tablets and a preparation method thereof, and relates to the technical field of medicine and medicine production. The spirolactone composition freeze-dried tablets comprise spirolactone, starch and sucrose; the starch and sucrose are used as accessories, common corn starch is processed by a heating process, the bonding and disintegration effects of the starch in the tablets can be improved, the formability of the tablets is increased, and only two accessories, namely starch and sucrose, are needed in the spirolactone composition freeze-dried tablets. A freeze-drying process of two-time reduction and two-time increase is adopted for the spirolactone composition freeze-dried tablets, the formability of the tablets is better through two-time reduction and two-time increase of temperature, and the dissolubility of the tablets is improved so as to improve the bioavailability of the tablets; the tablets overcome the shortcomings of common spirolactone tablets, and the types and amount of accessories in the spirolactone tablets are reduced; and moreover, the dissolubility and bioavailability of the tablets are high, and the curative effect and safety of clinical medication are guaranteed.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a freeze-dried spironolactone composition tablet and a preparation method thereof. Background technique [0002] Spironolactone is an aldosterone antagonist diuretic. Its main function is to produce diuresis by inhibiting potassium excretion and sodium reabsorption, and it is used for adjuvant treatment of hypertension. [0003] Structural formula: Molecular weight: 416.57 [0004] Ordinary spironolactone tablets contain many types and quantities of excipients. Generally, fillers, lubricants, disintegrants, binders, flavoring agents, etc. are used. , the dissolution rate of spironolactone tablets reaches more than 75% in 60 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 and the main drug, and the impurities in the excipients will affe...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/585A61K47/36A61K47/26A61P7/10A61P9/12
Inventor 汪余胜汪宁卿李珠珠饶经纬李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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