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Method for preparing bee venom injection

A technology of injection and bee venom, which is applied in the fields of medical formula, drug delivery, bone diseases, etc. It can solve the problems of unstable bee venom and difficulty in product quality control, and achieve the effects of inhibiting oxidative deterioration, improving purity, and reducing costs

Inactive Publication Date: 2011-05-04
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] This method ignores the unstable nature of bee venom, so its product quality is difficult to control

Method used

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  • Method for preparing bee venom injection
  • Method for preparing bee venom injection
  • Method for preparing bee venom injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Weigh 5 g of bee venom, dissolve it with 100 ml of water for injection, add it to a 500 ml separatory funnel, extract twice with 35 ml of n-octanol, and release the aqueous layer. Separation with Sephadex column, collect bee venom liquid at wavelength 280nm, place it at -10~-15℃ and freeze for 2 hours for later use; then prepare 0.2mol / L KH with water for injection below 30℃ 2 PO 4 Buffer 200ml, pH value controlled at 4.5-5.5. Then use the prepared buffer to dissolve the frozen bee venom solution, add water for injection to about 20000ml, use 5000 molecular weight ultrafiltration equipment for ultrafiltration, add 10g glycine to the filtrate, add 20g activated carbon, remove the heat source, stir well and then coarsely filter , After passing the inspection, the feed liquid is sterilized and filtered by a 0.2um filter membrane and then packaged.

[0019] The production process of batching and sub-packaging is required to be carried out in a clean environment of class 1...

Embodiment 2

[0022] Weigh 5 g of bee venom, dissolve it with 200 ml of water for injection, add it to a 500 ml separatory funnel, extract twice with 25 ml of isooctanol, and release the aqueous layer. Separation was carried out with Sephadex column ( Sephadex G-10 (40~120m), mobile phase A 0.1mol / L phosphate buffer (pH7.0), mobile phase B water, flow rate 1.5ml / min), collect the bee venom liquid at a wavelength of 280 nm, and place it at -15 °C for 1 hour for later use; then use water for injection below 30 °C to prepare 0.2mol / L KH 2 PO 4 Buffer 200ml, pH value controlled at 5.2. Then use the prepared buffer to dissolve the frozen bee venom solution, add water for injection to about 20,000ml, use 10,000 molecular weight ultrafiltration equipment for ultrafiltration, add 20g of glycine to the filtrate, add 40g of activated carbon, remove the heat source, fully stir and then coarsely filter , After passing the inspection, the feed liquid is sterilized and filtered by a 0.2um filter membr...

Embodiment 3

[0024] Embodiment 3 (prepared according to the preparation method of bee venom injection disclosed by CN101259144)

[0025] (1) Dissolution: take 5g of bee venom, add 100ml of water to dissolve in water for injection, add 50% (V / V) ether to degrease twice, heat, evaporate residual ether, filter to remove insoluble impurities.

[0026] (2) Separation and extraction: After soaking Sephadex G-50 in water for injection for 12 hours, wash it with water for injection 3 times, put it into a chromatography column, connect the water supply system, and rinse it with water for injection for 2 hours. .

[0027] (3) Adding the medicinal solution to Sephadex, and separating and extracting the medicinal solution in a Sephadex column. The liquid outlet is monitored and collected by an ultraviolet monitoring recorder (the flow rate is controlled at 5ml per minute), and there is an absorption component at a wavelength of 280nm, that is, it is collected into a glass bottle until the protein pea...

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Abstract

The invention discloses a method for preparing a bee venom injection, which comprises the following steps of: (a) weighing bee venom, water for injection and octanol in a mass-to-volume ratio of 1:(20-30):(5-7); (b) dissolving the bee venom in the water for injection and then adding the octanol for extraction; separating extract liquor by using a sephadex column; and (c) freezing the bee venom for 1-2h at the temperature ranging from -10 DEG C to -15 DEG C; diluting the frozen bee venom solution to an specific amount with a prepared buffer solution; carrying out ultrafiltration by using ultrafiltration equipment, adding 0.05-0.1% of glycine, stirring, carrying out rough filtration and fine filtration and finally packaging. The bee venom injection prepared by the method has the advantage of stable quantity and high percent of pass.

Description

Technical field: [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of a bee venom injection. Background technique: [0002] Bee venom is a transparent liquid with a special aromatic odor, bitter and acidic. The pH is 5.0-5.5. The specific gravity is 1.313. Bee venom has anti-inflammatory and analgesic properties and can be used to treat rheumatoid arthritis, rheumatoid arthritis, peripheral neuritis and neuralgia. The most commonly used bee venom preparations are bee venom injections. Because the bee venom solution is unstable, it is easy to contaminate bacteria and deteriorate, and it can usually only be stored for a few days at room temperature. And heat sterilization of bee venom, its efficacy can be completely lost. Therefore, how to prepare bee venom injection with stable and reliable quality has always been the focus of medical researchers. [0003] CN101259144 discloses a preparation metho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/64A61K9/08A61P29/00A61P19/02A61P19/04A61P25/02A61P25/04
Inventor 梁凤林
Owner NORTH CHINA PHARMA COMPANY
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