Amoxicillin capsule and preparation method thereof

An amoxicillin capsule and amoxicillin technology, applied in the field of capsule preparation, can solve the problems of large relative particle size of amoxicillin heavy powder, poor stability of amoxicillin capsules, poor dissolution rate of amoxicillin capsules, etc. The effect of amoxicillin light powder flying, shortening mixing time and improving drug dissolution

Inactive Publication Date: 2021-07-20
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in order to ensure the stability of the drug, this technical solution uses amoxicillin heavy powder to prepare capsules, but due to the relatively large particle size of amoxicillin heavy powder, there is a phenomenon of uneven mixing, and this technical solution lacks disintegrants, etc. Excipients, resulting in poor dissolution rate of prepared amoxicillin capsules
[0005] A Chinese invention patent application with publication number CN109172539 A discloses a kind of amoxicillin capsule and its production method and application. In order to improve the dissolution rate of amoxicillin, the technical scheme adjusts the ratio of amoxicillin heavy powder and light powder , increased the amount of light powder, but clearly restricted the amount of light powder and the minimum particle size. It is difficult to mix, and the increase in the amount of light powder will make it more difficult to mix light powder and heavy powder. The light powder aggregates, and the specific surface area of ​​the aggregated part of the light powder is large, and the increase i

Method used

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  • Amoxicillin capsule and preparation method thereof
  • Amoxicillin capsule and preparation method thereof
  • Amoxicillin capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0031] Embodiment 1 A kind of preparation method of amoxicillin capsule

[0032] The present embodiment is a preparation method of amoxicillin capsules, and the specific preparation process includes the following steps performed in sequence:

[0033] 1) Set the equipment parameters of the dry granulator: the stirring speed is 17 rpm, the screw feeding speed is 56 rpm, the pressure of the pressing roller is 6.8 MPa, the rotational speed of the pressing roller is 13 rpm, the temperature of the pressing roller is 25 ℃, the granulating speed is 130 rpm, and the granulating speed is 130 rpm. The aperture of the particle screen is 0.84mm, and the mesh number of the rotary vibrating screen is 20 mesh, 30 mesh and 80 mesh.

[0034] Under the conditions of a temperature of 25°C and a humidity of 52%, the amoxicillin crude drug was dried in nitrogen at 25°C for 30s, then added to the hopper of a dry granulator for granulation, and collected through a 20-mesh sieve and failed to pass. A...

Example

[0040] Embodiment 2~6 The preparation method of amoxicillin capsule

[0041] Embodiments 2 to 6 are respectively a preparation method of amoxicillin capsules, and their steps are basically the same as those of embodiment 1, and the difference is only in the amount of raw materials and process parameters. For details, see Table 1:

[0042] List of various process parameters in Table 1 Examples 2 to 6

[0043]

[0044]

[0045] The contents of other parts of Examples 2 to 6 are the same as those of Example 1.

[0046] The amoxicillin capsules prepared in Examples 1-6 have good stability and high dissolution rate.

Example Embodiment

[0047] Experimental Example 1 Dissolution Determination of Amoxicillin Capsules

[0048] Comparative Examples 1 to 10 are comparative tests of the preparation process of amoxicillin capsules in Example 1, and the differences are only:

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Abstract

The invention provides an amoxicillin capsule and a preparation method thereof, and belongs to the technical field of medicine preparation. 10 to 35 wt% of amoxicillin calomel with the particle size being smaller than 0.180 mm, 10 to 40 wt% of amoxicillin heavy powder with the particle size being 0.600 to 0.850 mm and the balance of amoxicillin heavy powder with the particle size being 0.180 to 0.600 mm are taken and subjected to heavy powder mixing, then the mixture and magnesium stearate are alternately fed and mixed, then filling and polishing are conducted, and the amoxicillin capsule is obtained. The amoxicillin capsule with high stability and good dissolution rate is obtained by adjusting the particle size ratio of the amoxicillin powder and increasing the dosage of the amoxicillin calomel without limiting the minimum particle size of the calomel, but limiting the maximum particle size of the heavy powder.

Description

technical field [0001] The invention relates to the preparation of capsules, in particular to an amoxicillin capsule and a preparation method thereof. Background technique [0002] Amoxicillin, also known as amoxycillin or amoxycillin, is the most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotics, clinically used to treat tonsillitis, laryngitis, pneumonia, chronic bronchitis, urinary Systemic infection, skin and soft tissue infection, suppurative pleurisy, hepatobiliary system infection, sepsis, typhoid fever, dysentery, etc. At present, oral dosage forms of amoxicillin mainly include tablets, capsules, granules, etc., and amoxicillin capsules are mainly used clinically as a therapeutic drug. [0003] Due to the poor solubility of amoxicillin, which is slightly soluble in water and insoluble in ethanol, the amoxicillin capsules made have the problem of poor dissolution. The poor dissolution rate further limits the in vivo absorption of amoxicilli...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/43A61K47/12A61P1/00A61P11/00A61P11/02A61P11/04A61P13/00A61P27/16A61P31/04
CPCA61K9/4858A61K9/4808A61K9/4883A61K31/43A61P31/04A61P27/16A61P11/02A61P11/04A61P11/00A61P13/00A61P1/00Y02A50/30
Inventor 陈海刚王玉娟陈晞刘超罗秀莲高嘉璐
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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