Production formula and technology of high-treatment-effect cyproheptadine hydrochloride tablets

A technology of cyproheptadine hydrochloride tablets and cyproheptadine hydrochloride, which is applied in the medical field, can solve problems such as adverse reactions, user poisoning, and excessive blood drug concentration, and achieve the effects of simplifying the production process, ensuring safety, and improving product quality

Pending Publication Date: 2020-09-11
上海复旦复华药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Under normal circumstances, the release rate of the main drug in the human body is too fast, which will cause the blood drug concentration in the human body to exceed the upper limit of the therapeutic window, resulting in user poisoning and a large number of adverse reactions. Therefore, it is necessary to strictly control the drug in the human body. Release degree and exposure, namely Cmax and AUC
At present, the quality and curative effect of Cyproheptadine Hydrochloride Tablets produced by using the published production prescription and technology cannot reach the foreign advanced level

Method used

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  • Production formula and technology of high-treatment-effect cyproheptadine hydrochloride tablets

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Effect test

Embodiment

[0038] Embodiment: According to relevant bioequivalence test regulations, carry out human body bioavailability and bioequivalence under fasting and postprandial state with the cyproheptadine hydrochloride tablet produced by Nichi-Iko Pharmaceutical Co., Ltd. Sexual test, while observing the safety of the test preparation and reference preparation in healthy subjects, so as to prove that its quality and curative effect have reached the advanced level abroad. The test results show that: the pharmacokinetic parameters AUC and Cmax are analyzed by the mixed effect model of double crossover design after logarithmic transformation, and double one-sided test (TOST), the geometric mean ratio of test preparation and reference preparation AUC If the 90% confidence interval falls within the range of 80.00% to 125.00%, and the 90% confidence interval of the Cmax geometric mean ratio falls within the range of 80.00% to 125.00%, the test preparation and the reference preparation are bioequiv...

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Abstract

The invention belongs to the field of medicines, and particularly discloses a production formula and technology of high-treatment-effect cyproheptadine hydrochloride tablets. The formula comprises thefollowing components in compounding ratio of 2g of cyproheptadine hydrochloride, 50-60g of lactose, 18-22g of starch, 2-2.5g of cellulose and 0.9-1.1g of magnesium stearate. The technology comprisesthe specific steps of S1, adding the cyproheptadine hydrochloride raw material in a micronizing machine set, performing micronizing, and crushing lactose; S2, performing mixing: mixing the obtained cyproheptadine hydrochloride with the lactose and the starch to obtain a mixture, and adding the mixture in a boiling pelletizer; S3, preparing an adhesive; S4, performing granulation; S5, shaping granules; S6, performing total mixing; and S7, performing tabletting and bottling. Production is performed based on a boiling-over granulation making technology, through disintegration characteristics of different auxiliary materials, the disintegration speed of medicines in different environment of bodies is controlled, blood medicine level in human bodies when the medicines are released in the humanbodies is consistent with that of original medicines, the production flow is simplified, besides, the product quality is improved, the release speed of main medicines is controlled, and the medicationsafety is guaranteed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a production prescription and process of cyproheptadine hydrochloride tablets with high curative effect. Background technique [0002] Cyproheptadine Hydrochloride Tablets can compete with the histamine released from tissues for the H1 receptors on effector cells, thereby preventing the onset of allergic reactions and relieving the convulsive and congestive effects of histamine. It is used for allergic diseases, such as urticaria, Papular urticaria, eczema, itchy skin. Under normal circumstances, the release rate of the main drug in the human body is too fast, which will cause the blood drug concentration in the human body to exceed the upper limit of the therapeutic window, resulting in user poisoning and a large number of adverse reactions. Therefore, it is necessary to strictly control the drug in the human body. The degree of release and exposure, namely Cmax and AUC. At present, th...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K47/26A61K47/12A61K31/4418A61P37/08A61P17/00A61P17/04
CPCA61K9/2013A61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/4418A61P17/00A61P17/04A61P37/08
Inventor 于嘉薛伟祥程梅霞万叶青朱泽龙
Owner 上海复旦复华药业有限公司
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