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A kind of preparation method of doxycycline hydrochloride freeze-dried powder injection for injection

A technology of doxycycline hydrochloride and freeze-dried powder for injection is applied in the field of preparation of doxycycline hydrochloride freeze-dried powder for injection, and can solve the problems of increasing working hours, energy consumption, reducing production efficiency, prolonging freeze-drying cycle, etc. , to reduce energy consumption, improve freeze-drying efficiency, and achieve the effect of no shrinkage

Active Publication Date: 2017-10-20
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the increase in the amount of solvent, the freeze-drying cycle is prolonged, the working hours and energy consumption are increased, and the production efficiency is reduced.
Simultaneously, due to the increase of solvent amount, must use the larger container (vial) of volume, cause the finished product number of freeze-drying under the unit volume to be few, be unfavorable for actual production

Method used

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  • A kind of preparation method of doxycycline hydrochloride freeze-dried powder injection for injection
  • A kind of preparation method of doxycycline hydrochloride freeze-dried powder injection for injection
  • A kind of preparation method of doxycycline hydrochloride freeze-dried powder injection for injection

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Effect test

Embodiment 1

[0031] A preparation method of doxycycline hydrochloride freeze-dried powder injection for injection, comprising the following steps:

[0032] (1) Dissolve 5g of doxycycline hydrochloride, 24.8g of vitamin C, and 20g of mannitol in 50g of water for injection, then add 0.2g of medicinal activated carbon, then fully stir for 15 minutes, let stand for 15 minutes to decolorize, and pass through 0.45μm micro After decarburization and sterilizing by pore filter membrane, the content of the intermediate is detected, and the dose containing 0.1 g of doxycycline is divided into 10 ml vials of doxycycline.

[0033] (2) Freeze-drying, including three stages of pre-freezing, primary sublimation and re-drying, the operation steps of each stage are as follows:

[0034] Pre-freezing: first quickly drop the temperature of the material to -20°C and keep it for 30 minutes, then lower the temperature of the material to -30°C at a constant speed at a rate of 1°C every 5 minutes, until the materia...

Embodiment 2

[0039] A preparation method of doxycycline hydrochloride freeze-dried powder injection for injection, comprising the following steps:

[0040] (1) Dissolve 3g of doxycycline hydrochloride, 20g of vitamin C, and 25g of mannitol in 51.9g of water for injection, then add 0.1g of medicinal activated carbon for decolorization, decarbonize through microporous membrane filtration, and after sterilization and filtration, detect The content of intermediates is divided into 10ml vials according to the dosage of 0.1g doxycycline in each tube.

[0041] (2) Freeze-drying, including three stages of pre-freezing, primary sublimation and re-drying, the operation steps of each stage are as follows:

[0042] Pre-freezing: First, quickly drop the temperature of the material to -18°C and keep it for 60 minutes, then lower the temperature of the material to -28°C at a constant speed at a rate of 1°C every 3 minutes, until the material is completely frozen, and then quickly drop the temperature of ...

Embodiment 3

[0047] A preparation method of doxycycline hydrochloride freeze-dried powder injection for injection, comprising the following steps:

[0048] (1) Dissolve 8g of doxycycline hydrochloride, 30g of vitamin C, and 15g of mannitol in 46.5g of water for injection, then add 0.5g of medicinal activated carbon for decolorization, decarbonize through microporous membrane filtration, and after sterilization and filtration, detect The content of intermediates is divided into 10ml vials according to the dosage of 0.1g doxycycline in each tube.

[0049] (2) Freeze-drying, including three stages of pre-freezing, primary sublimation and re-drying, the operation steps of each stage are as follows:

[0050] Pre-freezing: First, quickly drop the temperature of the material to -22°C and keep it for 20 minutes, then lower the temperature of the material to -35°C at a constant speed at a rate of 1°C every 6 minutes, until the material is completely frozen, and then quickly drop the temperature of ...

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Abstract

The invention discloses a preparation method of doxycycline hydrochloride freeze-dried powder injection for injection, which includes the steps of batching, freeze-drying, etc., wherein the pre-freezing process is carried out in three steps, that is, firstly, the temperature of the material is rapidly reduced to -20°C or so, and then lowered to around -20°C at a uniform speed, and finally dropped to -40°C to keep warm. Raise the temperature of the material to about -5°C and keep it warm for 1-3 hours. By adopting a special freeze-drying process, the present invention solves the technical problem that high-concentration doxycycline hydrochloride medicine solution is difficult to freeze-dry, and the solid content of the medicine solution can reach more than 50%, thereby improving the freeze-drying efficiency and shortening the freeze-drying time. Drying cycle, the appearance of the prepared product is full, without shrinkage, collapse, faults, etc., and the resolubility and quality stability are good.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation method of doxycycline hydrochloride freeze-dried powder for injection. Background technique [0002] Doxycycline hydrochloride, chemical name is 6-methyl-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-1,11-dioxo-1,4,4a,5 , 5a, 6, 11, 12a-octahydro-2-tetracenecarboxamide hydrochloride, pale yellow or yellow crystalline powder; smelly, bitter. Soluble in water or methanol, slightly soluble in ethanol or acetone, insoluble in chloroform. Its structural formula is as follows: [0003] [0004] The doxycycline hydrochloride preparation is used for treating asthma, and has certain curative effect on respiratory tract, urinary tract bacterial and mycoplasma infection. Compared with tetracycline, it has the advantages of strong antibacterial effect, less drug-resistant strains, long half-life and less adverse reactions. [0005] The form...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/65A61P11/06A61P31/04A61P13/02
Inventor 舒志元余修祥金涛王志涛方征远江强
Owner HAINAN GENERAL & KANGLI PHARMA
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