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Preparation method of doxycycline hyclate freeze-dried powder injection

A technology of doxycycline hydrochloride and freeze-dried powder injection, which is applied in the field of preparation of doxycycline hydrochloride freeze-dried powder injection for injection, and can solve problems such as increased working hours, energy consumption, unfavorable actual production, and extended freeze-drying cycle , to achieve the effect of reducing energy consumption, no shrinkage, and full appearance

Active Publication Date: 2015-11-25
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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  • Preparation method of doxycycline hyclate freeze-dried powder injection
  • Preparation method of doxycycline hyclate freeze-dried powder injection
  • Preparation method of doxycycline hyclate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
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 intermediate Body content, divided into 10ml vials containing 0.1g of doxycycline.

[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 the material To -38 ℃, kee...

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 intermediate Body content, divided into 10ml vials containing 0.1g of doxycycline.

[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 the material To -45 ℃, kee...

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Abstract

The invention discloses a preparation method of doxycycline hyclate freeze-dried powder injection. The method includes steps of material preparing, freeze drying and the like, wherein pre-freezing is performed in three steps, the temperature of materials is fast decreased to about minus 20 DEG C, then the temperature of the materials is decreased to about minus 30 DEG C at a constant speed, and the temperature of the materials is finally fast decreased to about minus 40 DEG C and the temperature is kept; sublimation is performed in two steps, the temperature of the materials is increased to about minus 20 DEG C and the temperature is kept for 5-10 hours, and then the temperature of the materials is increased to about minus 5 DEG C and the temperature is kept for 1-3 hours. The method has the advantages that the special freeze drying process is used to solve the technical problem that the doxycycline hyclate liquid is difficult in freeze drying, doxycycline hyclate liquid solid content can reach above 50%, freeze drying efficiency is increased, freeze drying cycle is shortened, and products are full in appearance, free of atrophy, collapse, fracture and the like, and good in re-dissolving performance and mass stability.

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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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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