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A kind of freeze-dried preparation of coenzyme A and preparation method thereof

A technology of freeze-dried preparations and coenzyme, which is applied in the direction of freeze-dried transportation, medical preparations containing active ingredients, anti-toxins, etc., which can solve the problems of unstable product quality, reduced potency content, high drying weight loss, etc., and achieve the appearance of finished products Good, stable finished product quality, simple prescription effect

Inactive Publication Date: 2017-02-15
武陟维尔康生化制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of the above method: during preparation, coenzyme A needs to be added to the solution of mannitol, lactose, cysteine ​​hydrochloride or mannitol, calcium gluconate, cysteine ​​hydrochloride, so that coenzyme A is always in a non-dry state, The product is easy to degrade and the potency content is reduced
It is still in a non-drying state during the freeze-drying process, and the weight loss on drying after freeze-drying is high, which makes it easy to degrade during storage, and the titer content decreases, which ultimately makes the product quality unstable.

Method used

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  • A kind of freeze-dried preparation of coenzyme A and preparation method thereof
  • A kind of freeze-dried preparation of coenzyme A and preparation method thereof
  • A kind of freeze-dried preparation of coenzyme A and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation

[0028] (1) Take by weighing the stabilizer gelatin, lactose, and coenzyme A of the prescribed amount, first add the stabilizer to prepare water for injection with 50% volume, stir and heat to 40°C for dissolution, add medicinal charcoal with a volume of 0.1% (g / ml), Stir and adsorb for 25 minutes, filter and decarbonize, add sodium hydroxide to adjust the pH value to 5.8-6.8, cool to room temperature, then add weighed coenzyme A to disperse it, and stir to form a stable solution.

[0029] (2) Take by weighing the skeleton agent mannitol and the reducing agent cysteine ​​hydrochloride of the prescription amount, add 30% water for injection of the preparation volume, stir to make it dissolve completely, add medicinal charcoal with a volume of 0.1% (g / ml), stir Adsorbed for 20 minutes, decarbonized by filtration, adjusted the pH value to 5.8-6.8 by adding sodium hydroxide, and cooled to room temperature.

[0030] (3) Combine the above two liquids...

Embodiment 2

[0036]

[0037] Preparation

[0038] (1) Take by weighing the stabilizer gelatin, lactose, and coenzyme A of the prescribed amount, first add the stabilizer to prepare water for injection with 50% volume, stir and heat to 40°C for dissolution, add medicinal charcoal with a volume of 0.5% (g / ml), Stir and adsorb for 30 minutes, filter and decarbonize, add sodium hydroxide to adjust the pH value to 5.8-6.8, cool to room temperature, then add weighed coenzyme A to disperse it, and stir to form a stable solution.

[0039] (2) take by weighing the skeleton agent mannitol of recipe quantity, reducing agent cysteine ​​hydrochloride, then add preparation volume 30% water for injection, stir and make it dissolve completely, add the medicinal charcoal of volume 0.5% (g / ml), Stir and adsorb for 30 minutes, filter to remove carbon, add sodium hydroxide to adjust the pH value to 5.8-6.8, and cool to room temperature.

[0040] (3) Combine the above two liquids, add water for injection t...

Embodiment 3

[0046]

[0047]

[0048] Preparation

[0049] (1) Take by weighing the stabilizer gelatin, lactose, and coenzyme A of the prescribed amount, first add the stabilizer to prepare water for injection with 50% volume, stir and heat to 40°C for dissolution, add medicinal charcoal with a volume of 0.1% (g / ml), Stir and adsorb for 25 minutes, filter and decarbonize, add sodium hydroxide to adjust the pH value to 5.8-6.8, cool to room temperature, then add weighed coenzyme A to disperse it, and stir to form a stable solution.

[0050] (2) Take by weighing the skeleton agent mannitol and the reducing agent cysteine ​​hydrochloride of the prescription amount, add 30% water for injection of the preparation volume, stir to make it dissolve completely, add medicinal charcoal with a volume of 0.1% (g / ml), stir Adsorbed for 25 minutes, filtered to remove carbon, added sodium hydroxide to adjust the pH value to 5.8-6.8, and cooled to room temperature.

[0051] (3) Combine the above two...

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Abstract

The invention discloses a coenzyme A freeze drying agent and a preparation method thereof, which comprise product prescription, stable liquid preparation, injection preparation, aseptic filtration, filling, freeze drying, capping, leakage detecting and lamp detection packing, and uses coenzyme A as main effective components, and uses optimized skeleton agent mannitol, reductant cysteine hydrochloride, stabilizer gelatin and lactose and the like as pharmaceutic adjuvants to improve stability of drugs. The coenzyme A freeze drying agent and the preparation method thereof reduce water content of finished products below 0.6% by optimizing freeze drying process, and enables coenzyme A for injection to be steadier. The coenzyme A freeze drying agent and the preparation method thereof solve the stability problem of the coenzyme A, improve product yield of the coenzyme A, and have the advantage of simple process, steady quality and high product yield compared with existing freeze drying agents.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a freeze-dried preparation of coenzyme A and a preparation method thereof. Background technique [0002] Coenzyme A is composed of pantothenic acid, cysteine, adenosine triphosphate in Mg 2+ Synthesized by a series of enzyme-catalyzed reactions with the participation of coenzyme A, the active group in the coenzyme A molecule is a sulfhydryl group, which can form a sulfur enzyme with an acid group. The degradation process of coenzyme A in the body is basically opposite to the synthesis process. The degradation products pantethein and pantothenic acid can enter the synthesis pathway of coenzyme A and be converted into coenzyme A to maintain a relatively constant level of coenzyme A in the body. [0003] Coenzyme A deficiency in humans can cause depression, anxiety, irritability, loss of appetite, fatigue, recurrent respiratory infections, numbness, muscle wea...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/42A61K47/18A61K47/26A61P7/00A61P7/04A61P43/00A61P1/16A61P31/14A61P31/20A61P9/10A61P9/14A61P13/00A61P13/12A61P3/06A61P39/00
Inventor 刘盛儒王增鑫隗青孙岩王基伟
Owner 武陟维尔康生化制药有限公司
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