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Norethindrone composition freeze-dried tablets and preparation method thereof

A technology of norethindrone and its composition, applied in the field of norethindrone composition freeze-dried tablets and its preparation, to achieve the effects of large dissolution rate, improved bioavailability, and high bioavailability

Inactive Publication Date: 2015-05-06
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] 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 norethindrone freeze-dried tablets by freeze-drying process

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[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 6.5, 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, 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 0.625 g of norethindrone, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.

[0032] E. After measuring the content of norethindrone in the medicinal solu...

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 4-5, then heat to 72°C and keep for 120 minutes to make 13% (W / V) cornstarch solution.

[0037] 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.

[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 norethindrone 0.625 gram (calculated by 1000), add 1L corn-sucrose solution, stir 30 minutes.

[0040] E. After measuring the content of norethindrone in the m...

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Abstract

The invention provides norethindrone composition freeze-dried tablets and a preparation method thereof, and relates to the technical fields of medicines and medicine production. The norethindrone composition freeze-dried tablets contain norethindrone, starch and cane sugar, wherein starch and cane sugar are used as auxiliary materials; common corn starch is subjected to a heating process treatment, so that the adhesion and disintegration functions of starch in the tablets can be improved, and the formability of the tablets can be improved, and the norethindrone composition freeze-dried tablets only need the two auxiliary materials, namely starch and cane sugar. The norethindrone composition freeze-dried tablets adopt a freeze-drying process of cooling twice and heating twice, the formability of the tablets can be better because of cooling twice and heating twice, and the dissolution rate of the tablets is increased, thus improving the bioavailability of the tablets; the tablets overcome the defects of common norethindrone tablets, reduce the types and the dosages of the auxiliary materials in the norethindrone tablets, have a high dissolution rate and a high bioavailability, and ensure the curative effect and the safety of clinical medication.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine production, in particular to a norethindrone composition freeze-dried tablet and a preparation method thereof. Background technique [0002] This product is white or off-white crystalline powder; odorless, slightly bitter taste. This product is dissolved in chloroform, slightly soluble in ethanol, slightly soluble in acetone, insoluble in water. [0003] Molecular formula C20H26O2 [0004] Molecular weight 298.43 [0005] Taking birth control pills for contraception is a relatively safe and effective method of contraception that can greatly reduce the possibility of pregnancy. For use in all normal healthy females, except those who are breastfeeding. The advantage of contraceptives is that the success rate is relatively high, and if you insist on using it, the contraceptive rate can reach 99%. The second is that it is reversible, and can become pregnant again after stopping th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/567A61K47/36A61K47/26A61P15/18
Inventor 程姣姣李彪石金友汪金灿郝结兵
Owner HAINAN WEI KANG PHARMA QIANSHAN