Nilestriol composition freeze-dried tablets and preparation method thereof
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A technology of nilestriol and its composition, which is applied in the field of freeze-dried tablets of nilestriol composition and its preparation, to achieve the effects of improving bioavailability, improving adhesion, and high dissolution rate
Inactive Publication Date: 2015-05-06
HAINAN WEI KANG PHARMA QIANSHAN
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[0008] 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 nylestriol freeze-dried tablets by freeze-drying process
Method used
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Embodiment 1
[0027]
[0028]
[0029] A. Weigh 100g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5-7.5, then heat to 72°C and keep for 120 minutes to make 9% (W / V) cornstarch solution.
[0030] 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.
[0031] 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.
[0032] D. Weigh 1 g of nylestriol, add it into 1 L of corn-sucrose solution, and stir for 30 minutes.
[0033] E. After measuring the content of nylestriol in the medicinal ...
Embodiment 2
[0036]
[0037] A. Weigh 130g of cornstarch, add 900ml of purified water and stir, use a pH regulator to control the pH of the solution at 5-7.5, then heat to 72°C and keep for 120 minutes to make 13% (W / V) cornstarch solution.
[0038] B. Measure 45ml of purified water, boil it, 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.
[0039] 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.
[0040] D. Weigh 1 gram of nylestriol (calculated as 1000 tablets), add 1L corn-sucrose solution, and stir for 30 minutes.
[0041] E. After measuring the content of nylestriol in th...
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Abstract
The invention provides nilestriol composition freeze-dried tablets and a preparation method thereof, and relates to the technical fields of medicines and medicine production. The nilestriol composition freeze-dried tablets contain nilestriol, 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 nilestriol composition freeze-dried tablets only need the two auxiliary materials, namely starch and cane sugar. The nilestriol 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 nilestriol tablets, reduce the types and the dosages of the auxiliary materials in the nilestriol 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 freeze-dried tablet of a nilestriol composition and a preparation method thereof. Background technique [0002] Nylestriol is a derivative of estriol. Estriol is a metabolite of estradiol. Its pharmacological action is similar to that of estradiol, but its biological activity is low, so it has a weak effect on endometrial hyperplasia. It is suitable for estrogen replacement therapy in perimenopausal women. Because of the increased lipophilicity after the introduction of cyclopentyl ether at the 3-position, it is beneficial for intestinal absorption and storage in adipose tissue, and then slowly released to play a long-term effect. Its 17-position introduces ethynyl to enhance estrogenic activity. [0003] [0004] Molecular weight: 380.53 [0005] Ordinary nylestriol tablets contain many types and quantities of excipients, generally fillers, lubri...
Claims
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