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Clindamycin palmitate hydrochloride particle and preparation method thereof

A technology of clindamycin hydrochloride and palmitate, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as inapplicability to children

Inactive Publication Date: 2018-01-19
GUANGZHOU DAGUANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that the currently disclosed sustained-release oral solid preparations of clindamycin are mostly tablets or capsules, which are not suitable for children to take.

Method used

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  • Clindamycin palmitate hydrochloride particle and preparation method thereof
  • Clindamycin palmitate hydrochloride particle and preparation method thereof
  • Clindamycin palmitate hydrochloride particle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: Preparation of Clindamycin Hydrochloride Palmitate Granules

[0040] The present embodiment provides the preparation method of clindamycin palmitate hydrochloride granules, specifically as follows:

[0041] (1) Preparation of drug ball core:

[0042] Ball core prescription 1:

[0043]

[0044] Ball core prescription 2 (porogen content):

[0045]

[0046] Ball core prescription 3 (carrier material content):

[0047]

[0048] The drug pellet core of the above prescription is prepared by wet soft material / extrusion spheronization process, and the specific operation is as follows:

[0049] Dissolve clindamycin palmitate hydrochloride, ethyl cellulose and poloxamer 188 in 50% ethanol solution as a binder solution; glyceryl behenate, magnesium carbonate and microcrystalline cellulose Mesh sieve, pour it into the wet granulator, stir and shear for 10 minutes to make it fully mixed; at a stirring speed of 10r / min and a shear speed of 20r / min, spray th...

Embodiment 2

[0060] Example 2: Research on release rate of clindamycin hydrochloride palmitate in vitro

[0061] Make 5 kinds of clindamycin hydrochloride palmitate granule preparations by embodiment 1, specifically as follows:

[0062] WX1: pill core prescription 1, uncoated

[0063] WX2: pill core prescription 2, uncoated

[0064] WX3: pellet core prescription 3, uncoated

[0065] MP1: pill core prescription 1, coating solution prescription 1

[0066] Determination of in vitro release: Refer to "Chinese Pharmacopoeia" 2015 Edition Four Other General Rules 0931 Second Method Determination, take artificial gastric juice (0.1mol / L dilute hydrochloric acid solution) 500ml dissolution medium into the dissolution cup, preheat to 37±0.5℃, Adjust the rotation speed to 50r / min, add 1 unit of granule, and operate according to the law. After 0.5h and 1.5h, take 10ml of the solution, filter it, take the subsequent filtrate as the test solution, and make up in time (the supplement solution is arti...

Embodiment 3

[0070] Example 3: Stability of granules in water

[0071] WX1 and MP1 in Example 2 were placed in 100ml of purified water, after fully shaking, 5ml of the solution was taken, filtered, and the subsequent filtrate was taken as the test solution. After making up 5ml of purified water, let it stand for 15min, fully shake, take 5ml of the solution, filter, and take the continued filtrate as the test solution. Another 10 mg of clindamycin palmitate hydrochloride reference substance was taken, accurately weighed, dissolved in purified water and diluted to a solution containing 100 μg per 1 ml as the reference substance solution. Take the above-mentioned test solution and reference solution, and measure according to the chromatographic conditions under the content determination of clindamycin hydrochloride palmitate in the second part of the Chinese Pharmacopoeia 2015 edition, and calculate the dissolution amount of clindamycin hydrochloride palmitate.

[0072] preparation ...

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Abstract

The invention provides a clindamycin palmitate hydrochloride particle and a preparation method thereof. The clindamycin palmitate hydrochloride particle provided by the invention consists of a drug pill core and a coating layer covering the outside of the drug pill core, wherein the drug pill core comprises clindamycin palmitate hydrochloride, a carrier and a water-soluble pore-forming agent; andthe coating layer comprises a pH-dependent coating material. According to the clindamycin palmitate hydrochloride particle provided by the invention, a soft material is prepared by virtue of a wet process / the drug pill core is prepared by virtue of an extrusion-spheronisation process firstly, and then the soft material or the drug pill core is coated by coating liquid by virtue of a spray coatingprocess. The clindamycin palmitate hydrochloride particle provided by the invention is applicable to children; the integrity of the particle can be kept before the particle is taken, and the particle,after entering human bodies, can be slowly released, so that a stable and lasting blood concentration can be provided, and clinical demands of reducing the times of administration, reducing dose-related toxicity and improving patient compliance can be satisfied; and meanwhile, the bad taste of the medicine (the particle) can be masked without adding a great amount of flavoring agents.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to clindamycin hydrochloride palmitate granules which are stable in drug release, less in frequency of taking medicine, less in adverse reactions, less in addition of flavoring agents, suitable for children, and a method for preparing the preparation . Background technique [0002] Clindamycin belongs to the lincosamide class of antibiotics, another member of which is lincomycin. Although lincosamide antibiotics are a small category of antibacterial drugs, they have good market prospects both at home and abroad. Market reports in recent years show that the United States and Japan are the largest lincomycin markets in the world, with sales It accounts for about three-quarters of the world market, and the sales of lincosamide antibiotics in hospitals in major cities in China rank third with penicillins, accounting for 17% of the total sales of antibacterial drug...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/50A61K31/7056A61K47/32A61K47/38A61P31/04
Inventor 陈伟翰黄伟静曾雪芳
Owner GUANGZHOU DAGUANG PHARMA
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