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Method for preparing bee venom injection

A technology of injection and bee venom, which is applied in the fields of pharmaceutical formulation, drug delivery, medical raw materials derived from arthropods, etc., can solve the problems of difficult control of product quality and instability of bee venom, and achieve the purpose of inhibiting oxidative deterioration, improving stability, The effect of improving purity

Inactive Publication Date: 2012-04-11
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 5g of bee venom, dissolve it with 100ml of water for injection, add it into a 500ml separating funnel, extract twice with 35ml of n-octanol, and release the water layer. Use a Sephadex column to separate, collect the bee venom liquid at a wavelength of 280nm, and place it at -10 to -15°C for 2 hours before use; then prepare 0.2mol / L KH with water for injection below 30°C 2 PO 4 The buffer solution is 200ml, and the pH value is controlled at 4.5-5.5. Then dissolve the frozen bee venom solution with prepared buffer solution, add water for injection to about 20000ml, ultrafilter with 5000 molecular weight ultrafiltration equipment, add 10g glycine to the filtrate, add 20g activated carbon, remove the heat source, fully stir and then coarsely filter , after passing the inspection, the feed liquid is sterilized and filtered through a 0.2um filter membrane, and then packaged.

[0019] The production process of batching and sub-packaging is required to be carried out i...

Embodiment 2

[0022] Weigh 5g of bee venom, dissolve it with 200ml of water for injection, add it into a 500ml separating funnel, extract twice with 25ml of isooctyl alcohol, and release the water layer. Separate 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), the bee venom liquid was collected at a wavelength of 280nm, and placed in a freezer at -15°C for 1 hour for later use; then 0.2mol / L KH was prepared with water for injection below 30°C 2 PO 4 The buffer solution is 200ml, and the pH value is controlled at 5.2. Then dissolve the frozen bee venom solution with prepared buffer solution, add water for injection to about 20,000ml, ultrafilter with 10,000 molecular weight ultrafiltration equipment, add 20g of glycine to the filtrate, add 40g of activated carbon, remove heat source, fully stir and then coarsely filter , after passing the inspection, the feed liquid is sterilized and filtered thro...

Embodiment 3

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

[0025] (1) Dissolving: Take 5 g of bee venom, add 100 ml of water for injection to dissolve, 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 repeatedly with water for injection 3 times, put it into a chromatographic column, connect the water supply system, and rinse it with water for injection for 2 hours. .

[0027] (3) Adding the medicinal solution into the Sephadex gel, allowing the medicinal solution to be separated and extracted in the Sephadex column. The liquid outlet is monitored and collected by an ultraviolet monitoring recorder (control flow rate is 5ml per minute), and there is an absorbing component at a wavelength of 280nm, which is collected into a glass bottle until the protei...

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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 pharmaceutical preparations, in particular to a preparation method of bee venom injection. Background technique: [0002] Bee venom is a transparent liquid with a special aromatic smell, bitter taste, and acidic. The pH is 5.0-5.5. The specific gravity is 1.313. Bee venom has anti-inflammatory and analgesic effects, and can be used to treat rheumatoid arthritis, rheumatoid arthritis, peripheral neuritis and neuralgia and other diseases. The bee venom preparation currently used clinically is mainly bee venom injection. Because the bee venom solution is unstable, it is easy to contaminate miscellaneous bacteria and deteriorate, and it can usually only be stored for a few days at room temperature. However, heat sterilization of bee venom can completely lose its efficacy. Therefore, how to prepare a bee venom injection with stable and reliable quality has always been a focus of medical researchers. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K35/64
Inventor 梁凤林
Owner NORTH CHINA PHARMA COMPANY