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Novel cryoprotectants prescription for treatment of botulinum toxin a freeze-dried powder and injection preparation

A technology of freeze-drying protective agent and botulinum toxin, which is applied in the direction of freeze-drying transportation, pharmaceutical formulations, medical preparations of non-active ingredients, etc., which can solve problems such as virus contamination, achieve less side effects, high safety, and convenient use Effect

Active Publication Date: 2008-06-25
BEIJING MINHAI BIOTECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Gelatin is used as a protective agent for active substances in the existing A-type BoNT freeze-dried preparations for injection in my country (Yang Zhong 1997), but gelatin is mainly derived from cattle, which is a heterologous substance for humans, and there are also With the risk of virus contamination (such as mad cow disease), Japan and some European and American countries have banned the import of such products

Method used

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  • Novel cryoprotectants prescription for treatment of botulinum toxin a freeze-dried powder and injection preparation
  • Novel cryoprotectants prescription for treatment of botulinum toxin a freeze-dried powder and injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] The A-type BoNT of the present invention can specifically be prepared by the following method:

[0057] I. Components of toxin-producing medium

[0058] Enzyme Hydrolyzed Casein 1%~10%

[0059] Yeast extract powder 1%~10%

[0060] Sodium Thioglycolate 0.01%~0.05%

[0061] Cysteine ​​hydrochloride 0.01%~0.1%

[0062] Glucose 1%~2%

[0063] the rest is water

[0064] II. Formation of toxin-producing medium

[0065] (1) Dissolve casein hydrolyzate, yeast extract powder, sodium thiothioglycolate, and cysteine ​​hydrochloride in distilled water, adjust the pH to 7.2-7.3, and sterilize at 121°C for 30 minutes for later use.

[0066] (2) Another 20% glucose solution was sterilized at 112°C for 30 minutes, and added in proportion before inoculation.

[0067] III. Toxigenic culture

[0068] Inoculate the Clostridium botulinum type A after adaptation in the toxin-producing medium, and culture at 37°C for 4 days.

[0069] IV. Exquisite purification of toxins

[0070] (1)...

Embodiment 2

[0081] (1) Freeze-dried protective solution ingredients:

[0082] 20% Human Serum Albumin 125ml

[0083] Sucrose 25g

[0084] Water for injection Add water to 875ml

[0085] (2) Configuration method:

[0086] a) Measure human serum albumin according to the prepared amount;

[0087] b) Weigh the sucrose according to the prepared amount, add water for injection to dissolve, adjust the pH to 6.8, and sterilize under high pressure at 121° C. for 20 minutes.

[0088] a) After mixing the solutions of a and b, add a certain amount of A-type BoNT diluent, filter with a 0.22 microporous membrane, and pack in 0.5ml / cartridges into vials.

[0089] b) Freeze-drying the protein product according to the freeze-drying curve, the freeze-dried finished product is sterile and qualified, and the moisture content is not more than 3%.

Embodiment 3

[0091] (1) Freeze-dried protective solution composition:

[0092] 20% Human Serum Albumin 125ml

[0093] Lactose 25g

[0094] Add water for injection to 875ml

[0095] (2) Configuration method

[0096] a) Measure human serum albumin according to the prepared amount;

[0097] b) Weigh the lactose according to the prepared amount, add water for injection to dissolve, adjust the pH to 6.8, sterilize under high pressure at 121°C for 20 minutes;

[0098] c) Mix a and b solutions evenly, then add a certain amount of Type A BoNT diluent, filter with a 0.22 microporous membrane, and pack in 0.5ml / cartridges into vials;

[0099] d) Freeze-drying the protein product according to the freeze-drying curve, the freeze-dried product is sterile, and the moisture content is not more than 3%.

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Abstract

The invention relates to a medicine preparation of botulinus toxin A, which can be stored for 12 months under room temperature, and for 36 months under 4 DEG. C in the solid form of lyophiled powder injection when a preferable lyopilization protecting agent is added. The lyopilization protecting agent is prepared by mixing human serum albumin, sucrose or human serum albumin, lactose, with water in a certain ratio. The medicine preparation of botulinus toxin A is applied to diseases such as heterotropia, blepharospasm, mimic convulsion and spastic strabismus. Compared with former formulation, the botulinus toxin A of the invention has good quality and high stability.

Description

technical field [0001] The present invention relates to a pharmaceutical preparation of botulinum toxin type A, which can be stored stably for at least 12 months at room temperature and can be stored stably for 36 months at 4°C in the solid form of freeze-dried powder injection by adding a preferred lyoprotectant . Background technique: [0002] Botulinum neurotoxin (BoNT), also known as botulinum toxin (botulinumtoxin), is a polypeptide neurotoxin secreted by Clostridium botulinum under anaerobic conditions. Neurotoxins affect the transmission of nerve impulses by inhibiting the release of the neurotransmitter acetylcholine at the neuromuscular junction, leading to muscle flaccid paralysis. [0003] Type A BoNT is one of the most toxic substances known at present, but in recent years, it has been applied to the treatment of strabismus, blepharospasm, hemifacial spasm and spastic strabismus, and achieved satisfactory results. In 1989, Type A BoNT was approved by the US Foo...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/16A61K47/42A61K47/26A61P21/02
Inventor 刘建凯王景林郑海发张小伶高姗
Owner BEIJING MINHAI BIOTECH