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Freeze dried powder injection of coenzyme Q10 and its preparation process

A technology of freeze-dried powder injection and Q10, which is applied in the field of freeze-dried powder injection containing coenzyme Q10 and its preparation, and can solve problems such as hidden dangers in clinical application, low bioavailability, and poor stability

Active Publication Date: 2005-03-16
HAINAN PULIN PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets and capsules have low bioavailability due to the first-pass effect after oral administration
Among them, the small water injection that has been on the market uses Tween-80 as a surfactant to solubilize, but due to coenzyme Q 10 It is a fat-soluble drug, and coenzyme Q 10 There is a quinone group in the structure, which is quite sensitive to light and oxygen, so its stability is not very good. The small water needle will become turbid or even precipitate if left for a long time, and coenzyme Q in the aqueous solution state 10 It is more easily degraded by light and oxygen, which affects the quality of the product and brings certain hidden dangers to clinical application
As disclosed in Chinese patent CN 1226823, "containing coenzyme Q 10 The pharmaceutical composition "provides a coenzyme Q-containing 10 A pharmaceutical composition as an active ingredient that promotes coenzyme Q after oral administration 10 Absorption; Japanese Patent JP59148718 disclosed "coenzyme Q 10 Ingredient” In order to obtain good oral absorption and effect, it is made into microparticles by freeze-drying method, but the first-pass effect after oral administration cannot be avoided

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: Mix 25 mg of polyoxyl stearate and 25 mg of Tween-80, melt in a water bath at 70° C. to 80° C., and stir to form a homogeneous state. Continue to bathe in warm water at 70°C to 80°C, avoid light (the following entire operation process needs to be protected from light), add 5mg of coenzyme Q 10 Mix well, then add 2ml of water for injection, stir to dissolve, the solution is clear, filter with a 0.22 μm microporous membrane, and then place it in a freeze dryer for freeze drying. The freeze-drying conditions in the freeze dryer are controlled as follows: pre-freeze the solution at -30°C for 4 hours; then sublimate and dry at -10°C for 25 hours; then raise the temperature to 10°C for re-drying for 20 hours, and finally sealed to get orange-yellow coenzyme Q 10 Freeze-dried powder injection.

Embodiment 2

[0021] Example 2: Mix 30 mg of polyoxyl stearate and 15 mg of Tween-80, melt in a water bath at 50° C. to 100° C., and stir to form a homogeneous state. Continue to bathe in warm water at 50°C to 100°C, avoid light (the following entire operation process needs to be protected from light), add 5 mg of coenzyme Q 10 , mix well, then add 2ml of water for injection, stir to dissolve, the solution is clear, finally add 50mg of mannitol, stir to dissolve, the solution is clear, filter it with a 0.22 μm microporous membrane, and then place it in a freeze dryer for freeze drying. The freeze-drying conditions in the freeze dryer are controlled as follows: pre-freeze the solution at -40°C for 5 hours; then sublime and dry at -15°C for 30 hours; hours, and finally sealed to get orange-yellow coenzyme Q 10 Freeze-dried powder injection.

experiment example 1

[0022] Experimental Example 1: Coenzyme Q 10 Stability of lyophilized powder for injection.

[0023] Coenzyme Q made to embodiment 1 10 The stability of freeze-dried powder injection and conventional small water injection was investigated. The influencing factors were placed under 4500LX light for 10 days, filled with oxygen, and placed at 30°C for 10 days. Samples were taken and measured on the fifth and tenth days respectively. The results are shown in the table 1.

[0024]

[0025] Above result shows: coenzyme Q of the present invention 10 The lyophilized powder can be quickly reconstituted after adding water to obtain a clear and transparent injection. Under the same experimental conditions, the quality stability of the powder injection was significantly better than that of the small water injection. This kind of good solubility and quality stability not only ensures the safety of medication, but also prolongs the life of coenzyme Q. 10 validity period.

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PUM

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Abstract

The invention discloses a freeze dried injection containing coenzyme Q#-[10], which comprises coenzyme Q#[10] and surface active agent, wherein the surface-active agent is the mixture of Twain and polyoxyl stearate, the medicinal active component being coenzyme Q#-[10], the weight ratio of coenzyme Q#[10] and Twain is 1:1-1:50, the weight ratio of coenzyme Q#[10] and pollyoxyl stearate is 1:1-1:50.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an injection containing coenzyme Q 10 Freeze-dried powder injection and preparation method thereof. Background technique [0002] coenzyme Q 10 (molecular formula is C 59 h 90 o 4 ) is a class of fat-soluble quinone compounds that share common characteristics with vitamins. coenzyme Q 10 It plays the role of transferring hydrogen in the respiratory chain and activates many enzymes. coenzyme Q 10 The total content in the human body is 0.5mg-1.5mg, and the level in the heart, liver and pancreas is relatively high, and the distribution in the cell is the most in the mitochondria (45%-50%), and the least in the cytoplasm (5 %-10%). [0003] endogenous coenzyme Q 10 It has the function of binding protein source, and three kinds of coenzyme Q have been found 10 Binding proteins: QPs, QPc and QPn. In the cellular respiratory chain, it has the function of dire...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/122A61P9/04A61P9/06A61P9/10
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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