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Preparation method of meclofenoxate hydrochloride freeze-dried powder injection

A technology of meclofenxetil hydrochloride and freeze-dried powder injection is applied in the field of cerebral function rehabilitation drugs, which can solve the problems of drug stability destruction, poor moisture resistance, etc., achieve stable drug effect, reduce hygroscopicity or deliquescence, improve The effect of anti-moisture effect

Pending 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

[0003] The application provides a preparation method of meclofenoxate hydrochloride freeze-dried powder injection, which is used to solve the technical problems that the existing meclofenoxate hydrochloride injection preparations have poor moisture resistance and drug stability is easily destroyed

Method used

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  • Preparation method of meclofenoxate hydrochloride freeze-dried powder injection
  • Preparation method of meclofenoxate hydrochloride freeze-dried powder injection

Examples

Experimental program
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Effect test

Embodiment 1

[0030] For ease of understanding, see figure 1 The present application provides an embodiment of a method for preparing a hydrochloride ester frozen, including the following steps:

[0031] Step 1, the preparation: The drug prescription includes 2-4 parts by weight of hydrochloride, 0.01-0.5 parts by weight of polyethylene glycol, 4-14 parts by weight of excipients, including a prescription amount 45% -70% mannitol at the hydrochloride of methoxyl hydrochloride;

[0032] Step 2, mixed dissolution: mix hydrochloride, polyethylene glycol, and excipients to dissolve, during dissolution, water can be added to the drug to dissolve or rate the acid, and stirred for 10-30 minutes after dissolving for 10-30 minutes. 3.0-5.5 mixture;

[0033] Step 3, activated carbon adsorption: Adding a mixture obtained by activated carbon to step 2, stirring adsorption of 10-30 minutes after detonating carbon, preparing a carbon filtrate;

[0034] Step 4, fine filtration and sterilization: The anti-carbo...

Embodiment 2

[0040]As a further improvement of Example 1, the present application provides an embodiment of a method for preparing a hydrochloride ester freeze-dry powder injection, optionally, polyethylene glycol selects PEG-4000. Alternatively, polyethylene glycol is selected from PEG-6000. Alternatively, the addition of activated carbon is from 0.05% to 0.15% by the weight of the mixed liquid. Alternatively, in step 4, a microporous filtrate was sequentially filtered and sterilized. Alternatively, in step 4, a cylindrical microporous filter with a 0.22 μm filter element is sequentially employed is filtered and sterilized. Alternatively, the freeze drying in step 5 includes the following steps: pre-freeze: the filling of the pressed half-plus is placed in a freeze-dried machine having a temperature of -35 ° C to -25 ° C, frozen 4-4.5 hours. Solid-state drug; sublimation: at a constant temperature rise to -15 ° C, the vacuum treatment of the pre-free solid drug is carried out, so that the moi...

Embodiment 3

[0045] In order to facilitate understanding of the above embodiments, the present application provides a test description, and the control agent uses two hydrochloride-free frozen powder injections on the market, and labeled a control agent 1 and 2, respectively. In one embodiment, the lyophilized powder needle experimental agent A and B, which can be prepared according to the drug prescription and the present application, and two experimental agents include: 3 parts by weight of hydrochloride, 10 The weight of the excipient, wherein the excipient comprises mannitol, malic acid and trehalose, step 2 (mixed dissolved), the pH of the mixed liquid obtained is 4.3, and the addition of activated carbon is mixed with the mixture. The weight of 0.10% in turn, a microporous filter film having a filtration aperture of 0.45 μm, 0.22 μm is used in two copies, and the freeze drying includes the following steps:

[0046] Pre-ferrite: The filling of the pressed half-plus is placed in a lyophili...

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Abstract

The invention discloses a preparation method of a meclofenoxate hydrochloride freeze-dried powder injection. The preparation method comprises the following six steps: preparing materials, mixing and dissolving, adsorbing with activated carbon, finely filtering and sterilizing, detecting and freeze-drying, and packaging to obtain a finished product. A used prescription comprises the following components in parts by weight: 2 to 4 parts of meclofenoxate hydrochloride, 0.01 to 0.5 part of polyethylene glycol and 4 to 14 parts of excipient. The excipient comprises mannitol, and the prescription dosage of the mannitol is 45% to 70% of the prescription dosage of the meclofenoxate hydrochloride. According to the preparation method provided by the invention, the prepared meclofenoxate hydrochloride freeze-dried powder injection is good in moisture-resistant effect and good in medicine stability, and the technical problems that an existing meclofenoxate hydrochloride injection preparation is poor in moisture resistance, and the medicine stability is prone to being damaged are solved.

Description

Technical field [0001] The present application relates to the field of brain function rehabilitation drugs, and more particularly to a method of preparation of hydrochloride ester frozen. Background technique [0002] Hydrochloride hydrochloride, mainly in the cerebral cortex, can promote the redox reduction of brain cells, regulate the metabolism of neuronal cells, and excite the inhibitory central nervous; clinically used for traumatic coma, children's enuresis, awareness Brain function rehabilitation links such as obstacles, senile nature and alcoholism. However, the moisture absorption of hydrochloride itself is large, and it is prone to hydrolysis or ankle disquestation, and the stability of the drug component is prone to, and therefore, for those skilled in the art, it provides a hydrochloride capable hydrochloride that can effectively moistive moisture. The preparation process or prescription of the ester injection preparation is necessary; and the applicant shall have a m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/10A61K47/26A61K47/12A61K31/216A61P25/00
CPCA61K9/19A61K9/0019A61K47/10A61K47/26A61K47/12A61K31/216A61P25/00
Inventor 章世舜李文强黄浪莹李富志王珉陈春喜
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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