Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof

A technology for cyproheptadine hydrochloride and pharmaceutical preparations, which is applied in the field of rapid-release pharmaceutical preparations and preparations of cyproheptadine hydrochloride, which can solve the problems of poor drug absorption and achieve high blood drug concentration, high solubility, and easy absorption

Active Publication Date: 2020-12-04
SHANGHAI HUA SURNAME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the above defects or improvement needs of the prior art, the present invention provides a rapid-release pharmaceutical preparation of cyproheptadine hydrochloride and a preparation method thereof, in which a corresponding design is made in combination with the solubility curve of cyproheptadine hydrochloride itself and its sink characteristics. A kind of cyproheptadine hydrochloride fast-release pharmaceutical preparation, and its preparation structure such as the outer pH control layer and its specific components are studied and designed, and a corresponding inner layer is an active layer with cyproheptadine hydrochloride as the active ingredient , the outer layer is a pH control layer that can quickly form a microenvironment with a pH of 3 to 6 when it meets water. This pharmaceutical preparation structure can effectively solve the technical problem of poor drug absorption caused by patients failing to take cyproheptadine hydrochloride after meals

Method used

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  • Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof
  • Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof
  • Cyproheptadine hydrochloride quick-release pharmaceutical preparation and preparation method thereof

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preparation example Construction

[0042] The present invention also provides a kind of preparation method of cyproheptadine hydrochloride fast-release pharmaceutical preparation, comprising the steps of:

[0043] (1) Drying each component of the pH control layer and then granulating and mixing uniformly;

[0044] (2) Mix the components of the active layer after sieving, dry and mix uniformly after wet granulation;

[0045] (3) The pH control layer and the active layer obtained in step (1) and step (2) are jointly compressed into a preparation structure in which the inner layer is an active layer with cyproheptadine hydrochloride as an active ingredient and the outer layer is a pH control layer, That is, the rapid release pharmaceutical preparation of cyproheptadine hydrochloride is obtained.

[0046] In some embodiments, step (1) specifically includes the following steps: first, each component of the control layer is dried under suitable temperature conditions, for example, mannitol, disodium hydrogen phospha...

specific Embodiment

[0052] The rapid-release pharmaceutical preparation of cyproheptadine hydrochloride provided in this example comprises an inner active layer with cyproheptadine hydrochloride as the main active ingredient and an outer pH control layer. Wherein the outer pH control layer (also known as the effervescent layer) and the active layer mainly include ingredients and content as shown in Table 1:

[0053] Table 1 Example 1 to Example 3 Cyproheptadine hydrochloride quick-release pharmaceutical preparations, its inner layer active layer and outer layer pH control layer components and the corresponding prescription quantity of 10000 tablets of this preparation

[0054]

[0055]

[0056] The pharmaceutical preparation is an effervescent tablet, and the pH control layer granules of the effervescent tablet are prepared according to the following preparation method:

[0057] (1-1) Mannitol, NaH 2 PO 4 12H 2 O, citric acid, anhydrous sodium carbonate, sodium bicarbonate were dried at ...

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Abstract

The invention belongs to the field of pharmaceutical dosage forms, and particularly relates to a cyproheptadine hydrochloride quick-release pharmaceutical preparation and a preparation method thereof.The pharmaceutical preparation comprises an inner active layer taking cyproheptadine hydrochloride as an active component and an outer pH control layer, wherein the pH control layer is a quick-release layer, and furthermore, the pH control layer can be dissolved in water to generate a microenvironment with the pH value of 3-6, so that the cyproheptadine hydrochloride has higher solubility and iseasily absorbed by a human body no matter the medicine is taken before or after meals.

Description

technical field [0001] The invention belongs to the field of pharmaceutical dosage forms, and more specifically relates to a fast-release pharmaceutical preparation of cyproheptadine hydrochloride and a preparation method thereof. Background technique [0002] Cyproheptadine hydrochloride, its CAS: 41354-29-4, molecular formula is C 21 h 21 N·HCl. It is a drug used in the treatment of urticaria, allergic and contact dermatitis, and allergic asthma. [0003] Cyproheptadine hydrochloride is a pH-dependent drug. The solubility curve of cyproheptadine hydrochloride is included in the Japanese Orange Book, which records that when the pH is 1.2, its solubility is 0.72 mg / mL; when the pH is 4.0, its solubility is 4.39 mg / mL; when the pH is 6.8, its solubility is 0.89mg / mL; its solubility in water is 4.23mg / mL. Cyproheptadine hydrochloride is a pH-dependent substance, and its solubility is relatively high between pH 3 and 6, and its solubility is small at both pH values, but it ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K9/20A61K47/02A61K47/12A61K47/36A61K31/4418A61P17/00A61P37/08A61P11/06
CPCA61K9/0007A61K9/2086A61K9/2095A61K31/4418A61P17/00A61P37/08A61P11/06
Inventor 毕德忠吴卫雯
Owner SHANGHAI HUA SURNAME PHARMA
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