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Injection containing meclofenoxate hydrochloride and its preparing method

A technology of meclofenoxate hydrochloride and injection, which is applied in the fields of pharmaceutical formulations, organic non-active ingredients, nervous system diseases, etc., and can solve problems such as long production cycle, impact on product stability, and low single-batch output

Inactive Publication Date: 2007-07-18
ZHENDI MEDICINE CONSULTATION NANJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because meclofenoxate hydrochloride is extremely unstable in aqueous solution, the dosage forms for intravenous administration on the market at home and abroad are only freeze-dried preparations and aseptic subpackaged preparations. The prescription and process of clofenac lyophilized preparations, and lyophilization cannot avoid the use of water as a solvent, which affects the stability of the product. At the same time, compared with injections, lyophilized The production cycle is long, the cost is high, and the output of a single batch is small, which limits the wide application of this product in clinical practice.

Method used

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preparation example Construction

[0022] The preparation process of the aseptic filtration method mainly comprises the following steps: prepare the meclofenoxate hydrochloride solution of 125mg / ml, add activated carbon and stir evenly, decarbonize, aseptically filter, the medicinal liquid is divided into sterilized vials, stoppered, Just roll the lid and serve. The stability results of the meclofenoxate hydrochloride injection prepared by filtration sterilization are shown in Table 2:

[0023] The stability of the meclofenoxate hydrochloride injection prepared by the sterile filtration method of table 2

[0024] solvent

time (month)

PH value

relative substance(%)

Content (%)

ethanol

0

12

3.67

3.70

0.34

0.39

100.2

99.4

Propylene Glycol

0

12

3.69

3.66

0.36

0.45

99.5

98.7

polyethylene glycol 400

0

12

3....

Embodiment 1

[0036] Prescription composition:

[0037] (a) Meclofenoxate hydrochloride 250mg

[0038] (b) Propylene glycol up to 2ml

[0039] Preparation Process:

[0040] (1) Take by weighing 250mg of meclofenoxate hydrochloride and dissolve in 80% of the prescription amount of propylene glycol.

[0041] (2) Add propylene glycol to 2ml.

[0042] (3) Add 0.01% activated carbon for needles to the above solution, and stir evenly.

[0043] (4) The liquid medicine is decarburized to clarification by a 5um titanium rod, and after the intermediate content is qualified, the liquid medicine is pre-filtered by a 0.45um microporous membrane.

[0044] (5) According to the requirements of aseptic operation, filter the medicinal solution through a 0.22um microporous membrane to obtain a sterile solution.

[0045] (6) The liquid medicine is filled in aseptic vials, about 2 ml per bottle, corked and capped to obtain the meclofenoxate hydrochloride injection.

Embodiment 2

[0047] Prescription composition:

[0048] (a) Meclofenoxate hydrochloride 250mg

[0049] (b) Add absolute ethanol to 2ml

[0050] Preparation Process:

[0051] (1) Take by weighing 250 mg of meclofenoxate hydrochloride, and dissolve it in the dehydrated alcohol of 80% recipe quantity.

[0052] (2) Add absolute ethanol to 2ml.

[0053] (3) Add 0.01% activated carbon for needles to the above solution, and stir evenly.

[0054] (4) The liquid medicine is decarburized to clarification by a 5um titanium rod, and after the intermediate content is qualified, the liquid medicine is pre-filtered by a 0.45um microporous membrane.

[0055] (5) According to the requirements of aseptic operation, filter the medicinal solution through a 0.22um microporous membrane to obtain a sterile solution.

[0056] (6) The liquid medicine is filled in aseptic vials, about 2 ml per bottle, corked and capped to obtain the meclofenoxate hydrochloride injection.

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Abstract

An injection of meclofenoxate hydrochloride and its preparing process which features use of non-water solvent chosen from alcohol, propanediol, glycerin, polyethanediol-300 and polyethanediol-400, and use of filter sterilizing method or wet-heat sterilizing method for high stability are disclosed.

Description

technical field [0001] The invention relates to a preparation of meclofenoxate hydrochloride injection and a preparation method thereof. Background technique [0002] Meclofenoxate Hydrochloride was artificially synthesized by French scientist Professor Thuillier in 1957. Its chemical name is p-chlorophenoxyacetic acid dimethylaminoacetate. It is a central stimulant drug that has been used for many years, mainly for traumatic brain injury coma , neonatal hypoxia, nervous disorders, and can control children's enuresis caused by deep sleep and low awakening alert point. In 1996, it was discovered that it can remove lipofuscin and free radicals in nerve cells, promote body metabolism, protect cell membranes, enhance memory and improve intelligence. It is called an activator of brain cell metabolism, which can promote the utilization of carbohydrates by brain cells. Increase the intake of oxygen to the brain, promote the oxidation-reduction process, increase the blood flow of t...

Claims

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Application Information

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IPC IPC(8): A61K31/221A61K9/08A61K47/34A61K47/08A61P25/00A61K47/10
Inventor 穆加兵
Owner ZHENDI MEDICINE CONSULTATION NANJING
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