CN107929246B - Antioxidant coenzyme Q10 freeze-dried powder and production process thereof - Google Patents
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Abstract
The invention discloses an antioxidant coenzyme Q10 freeze-dried powder and a production process thereof, and the types and the use amounts of auxiliary materials such as an emulsifier, a stabilizer and the like are screened; dispersing the material particle size to nanometer level by high pressure micro jet homogenization, and uniformly distributing the particle size after homogenization; the antioxidant coenzyme Q10 freeze-dried powder has the advantages of small particle size, uniform distribution, stable process conditions, good repeatability and convenient operation. The production process comprises the following steps: s1, stirring coenzyme Q10, a cold drying protective agent, polyethylene glycol, glycerol, sodium oleate and water for 5-15 minutes to obtain a mixed solution; s2, homogenizing by a high-pressure homogenizer; s3, filtering by a microporous filter; and S4, vacuum freeze drying.
Description
Technical Field
The invention relates to coenzyme Q10 freeze-dried powder, in particular to antioxidant coenzyme Q10 freeze-dried powder and a production process thereof.
Background
Coenzyme Q (ubiquinone), a fat-soluble quinone compound, is also an important electron transporter on the inner membrane of mitochondria. The head of the coenzyme Q molecule is a benzene ring structure, and the chemical structure is that 2, 3-dimethoxy-5 benzoquinone is used as a core and is connected with a plurality of isoprene side chains. The number of isoprene side chains attached to different organisms is different, 10 in human body, so that the isoprene side chains are called coenzyme Q10, and the structure of the coenzyme Q10 is similar to that of vitamin K, so that the coenzyme Q is also called vitamin Q. Coenzyme Q10 is also known as decene quinone, abbreviated CoQ 10; the molecular formula is: c59H90O4Relative molecular mass: 863.36.
coenzyme Q10 is a lipid-soluble retinoid. It is widely existed in human body and other organism cells, and has important physiological function activity. Coenzyme Q10 is an essential component of energy metabolism, and its main function is to transfer protons and electron carriers during cellular respiration, and to generate a potential difference that can pass through biological membranes, thereby driving the transfer of electrons and protons.
Coenzyme Q10 is an rare compound integrating medical use and nutrition and health care, and the value and potential of the coenzyme Q10 in the fields of medicine, food, cosmetics and the like are continuously paid attention to and developed and are also widely applied.
The coenzyme Q10 is an immunologic function regulating medicine, can be used for treating chronic hepatitis and subacute hepatic necrosis, and has certain curative effect on other liver diseases; the coenzyme can be used for treating cardiovascular diseases, such as congestive heart failure, arrhythmia angina, rheumatic heart disease, hypertension and the like, and has an auxiliary treatment function; can be used as antitumor drug, and has certain therapeutic effect on breast cancer, prostatic cancer, rectal cancer, etc.; there are also many related research reports on the aspect of treating nervous system diseases, such as adjuvant therapy of Parkinson's disease, by using coenzyme Q10. In addition, coenzyme Q10 has significant effects in relieving necrotizing periodontitis, treating duodenal ulcer and gastric ulcer, and promoting pancreatic function and secretion.
Disclosure of Invention
The invention provides antioxidant coenzyme Q10 freeze-dried powder and a production process thereof, and the antioxidant coenzyme Q10 freeze-dried powder can be used as a hypodermic injection.
The technical scheme is as follows:
a production process of antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring coenzyme Q10, a cold drying protective agent, polyethylene glycol, glycerol, sodium oleate and water for 5-15 minutes to obtain a mixed solution;
s2, homogenizing by a high-pressure homogenizer;
s3, filtering by a microporous filter;
and S4, vacuum freeze drying.
A production process of antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 20-30 parts by weight of coenzyme Q10, 4-8 parts by weight of cold dry protective agent, 5-15 parts by weight of polyethylene glycol, 10-20 parts by weight of glycerol, 0.1-0.5 part by weight of sodium oleate and 55-65 parts by weight of water at the rotation speed of 400-600 revolutions per minute for 5-15 minutes to obtain a mixed solution;
s2, adding the mixed solution into a high-pressure homogenizer, and homogenizing for 1-2 hours under the pressure of 100-150MPa to obtain a homogeneous solution;
s3, filtering the homogeneous liquid by using a microporous filter to obtain a filtrate;
s4, carrying out vacuum freeze drying on the filtrate to obtain the product.
Further, the production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 20-30 parts by weight of coenzyme Q10, 4-8 parts by weight of cold dry protective agent, 5-15 parts by weight of polyethylene glycol, 10-20 parts by weight of glycerol, 0.1-0.5 part by weight of sodium oleate and 55-65 parts by weight of water at the rotation speed of 400-600 revolutions per minute for 5-15 minutes to obtain a mixed solution;
s2, adding the mixed solution into a high-pressure micro-jet homogenizer, and homogenizing for 30-50 minutes under the pressure of 100-150MPa to obtain a homogeneous solution;
s3, filtering the homogeneous liquid by using a microporous filter to obtain a filtrate;
s4, carrying out vacuum freeze drying on the filtrate to obtain the product.
Further, the production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 20-30 parts by weight of coenzyme Q10, 4-8 parts by weight of cold dry protective agent, 5-15 parts by weight of polyethylene glycol, 10-20 parts by weight of glycerol, 0.1-0.5 part by weight of sodium oleate and 55-65 parts by weight of water at the rotation speed of 400-600 revolutions per minute for 5-15 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution for 8-12 minutes under the conditions that the ultrasonic power is 200-;
s3, filtering the homogeneous liquid by using a microporous filter to obtain a filtrate;
s4, carrying out vacuum freeze drying on the filtrate to obtain the product.
The freeze-drying protective agent is trehalose and/or mannitol. In one embodiment of the present invention, the lyoprotectant consists of 85-95 wt% trehalose and 5-15 wt% mannitol.
The filter core material of the microporous filter is polypropylene, and the filtering precision is 0.2-0.5 μm.
The vacuum freeze drying condition is that the thickness of the material is controlled to be 4-9mm, the pre-freezing temperature is set to be-20 to-30 ℃, the sample is kept for 1.5-2.5 hours after the temperature is reduced to the set temperature, the sublimation temperature is set to be 5-15 ℃, the analysis temperature is 30-40 ℃, the vacuum degree is 10-30pa, and the drying time is 20-28 hours.
An antioxidant coenzyme Q10 lyophilized powder is prepared by the above production process. Every antioxidant coenzyme Q10 freeze-dried powder containing 30mg of reduced coenzyme Q10 is added with 2ml of normal saline when in use to form subcutaneous injection taking prototype coenzyme Q10 for intramuscular injection as a main material.
The technical effects are as follows:
the production process of the antioxidant coenzyme Q10 freeze-dried powder screens the types and the dosage of auxiliary materials such as an emulsifier, a stabilizer and the like; dispersing the material particle size to nanometer level by high pressure micro jet homogenization, and uniformly distributing the particle size after homogenization; the antioxidant coenzyme Q10 freeze-dried powder has the advantages of small particle size, uniform distribution, stable process conditions, good repeatability and convenient operation.
Detailed Description
Placing the antioxidant coenzyme Q10 lyophilized powder in an environment with the temperature of 25 + -1 deg.C and the relative humidity of 60 + -5%, and sealing and storing for 6 months.
The oxidation resistance was measured by DPPH method. DPPH is accurately weighed to prepare a solution with the concentration of 0.2mmol/LDPPH, and the solution is stored in a brown bottle in a dark place at low temperature. The sample to be tested was diluted to 0.5mg/mL with deionized water. Taking 2mL and 0.5mg/mL sample liquid in a test tube, adding 2mL and 0.2mmol/LDPPH solution, mixing uniformly, standing in the dark at room temperature for 30min, measuring the absorbance value at 517nm by using an ultraviolet spectrophotometer UV-2000 (Enicoco (Shanghai) Limited instruments company) and measuring the absorbance value at 517nm by using Ai, simultaneously measuring the absorbance value at 2mL and 0.5mg/mL sample liquid by using 2mL absolute ethyl alcohol, standing in the dark at room temperature for 30min, measuring the absorbance value at 517nm by using an ultraviolet spectrophotometer UV-2000 (Enicoco (Shanghai) Limited instruments company) and measuring the absorbance value at 517nm by using 2mL and 0.2mmol/LDPPH solution and adding 2mL distilled water and standing, and measuring the absorbance value at 517nm by using an ultraviolet spectrophotometer UV-2000 (Enicoco (Shanghai) Limited instruments company and measuring Ac. The DPPH radical clearance rate of the sample is calculated according to the following formula: the clearance is [1- (Ai-Aj)/Ac ] × 100%.
In the examples, the coenzyme Q10 was supplied from Xinchang pharmaceutical factory, Zhejiang pharmaceutical products, Ltd, and the content was 99.6 wt%.
In the examples, the polyethylene glycol is Japanese lapacho medicine USP grade polyethylene glycol 1000.
In the examples, glycerin was supplied from Jiangxi Yipu drug industry Co., Ltd for injection.
Sodium oleate is supplied by Lipoid, germany, in the examples.
In examples trehalose (CAS number: 99-20-7) was supplied by Shanghai-sourced Biotech, Inc.
In the examples, mannitol (CAS number: 87-78-5) is pharmaceutical-grade mannitol provided by Qingdao Mingyue algae group, Inc.
In the examples, an ultrasonic cleaning apparatus of model VGT-2013QT, which is available from Guangdong ultrasound corporation, was used as the ultrasonic cleaning apparatus.
In the examples, the high-pressure homogenizer was a high-pressure homogenizer model scientz-150 available from Dedu precision instruments, Inc., Changzhou.
The high-pressure microfluidizer of the examples was obtained from DeBEE, Dobuit, USA, and is of MiniDB type.
In the embodiment, the microporous filter is a WK-500 microporous filter provided by Wenzhou Furikang mechanical science and technology, the filter element is made of polypropylene, and the filtering precision is 0.45 mu m.
Example 1
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 6 parts by weight of trehalose, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, adding the mixed solution into a high-pressure homogenizer, and homogenizing for 90 minutes under the pressure of 120MPa to obtain a homogenized solution;
s3, filtering the homogeneous liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
Example 2
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 6 parts by weight of trehalose, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, adding the mixed solution into a high-pressure micro-jet homogenizer, and homogenizing for 40 minutes under the pressure of 120MPa to obtain a homogenized solution;
s3, filtering the homogeneous liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
Example 3
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 6 parts by weight of trehalose, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution in an ultrasonic instrument at the ultrasonic power of 300W and the ultrasonic frequency of 40kHz for 10 minutes, and then adding the mixed solution into a high-pressure micro-jet homogenizer to homogenize the mixed solution under the pressure of 120MPa for 30 minutes to obtain a homogenized solution;
s3, filtering the homogeneous liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
Comparative example 1
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 6 parts by weight of trehalose, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution in an ultrasonic instrument for 40 minutes under the conditions that the ultrasonic power is 300W and the ultrasonic frequency is 40kHz to obtain ultrasonic treatment solution;
s3, filtering the ultrasonic treatment liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
Example 4
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 6 parts by weight of mannitol, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution in an ultrasonic instrument at the ultrasonic power of 300W and the ultrasonic frequency of 40kHz for 10 minutes, and then adding the mixed solution into a high-pressure micro-jet homogenizer to homogenize the mixed solution under the pressure of 120MPa for 30 minutes to obtain a homogenized solution;
s3, filtering the homogeneous liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
Example 5
The production process of the antioxidant coenzyme Q10 freeze-dried powder comprises the following steps:
s1, stirring 25 parts by weight of coenzyme Q10, 5.4 parts by weight of trehalose, 0.6 part by weight of mannitol, 10 parts by weight of polyethylene glycol, 15 parts by weight of glycerol, 0.25 part by weight of sodium oleate and 60 parts by weight of deionized water at the rotating speed of 500 revolutions per minute for 10 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution in an ultrasonic instrument at the ultrasonic power of 300W and the ultrasonic frequency of 40kHz for 10 minutes, and then adding the mixed solution into a high-pressure micro-jet homogenizer to homogenize the mixed solution under the pressure of 120MPa for 30 minutes to obtain a homogenized solution;
s3, filtering the homogeneous liquid by using a microporous filter, wherein the filter element of the microporous filter is made of polypropylene, and the filtering precision is 0.45 mu m, so as to obtain filtrate;
s4, carrying out vacuum freeze drying on the filtrate, wherein the vacuum freeze drying condition is to control the thickness of the material to be 7mm, set the pre-freezing temperature to be-25 ℃, keep the sample for 2 hours after the temperature is reduced to the set temperature, set the sublimation temperature to be 10 ℃, the analysis temperature to be 35 ℃, the vacuum degree to be 20pa, and dry the sample for 24 hours to obtain the antioxidant coenzyme Q10 freeze-dried powder.
The antioxidant coenzyme Q10 freeze-dried powder is placed in an environment with the temperature of 25 +/-1 ℃ and the relative humidity of 60 +/-5% for sealed storage for 6 months, and then the test is carried out, and the result is that: the DPPH radical clearance rate is 69%.
Test example 1
The lyophilized powders of antioxidant coenzyme Q10 of examples 1 to 4 and comparative example 1 were stored in a sealed condition at a temperature of 25. + -. 1 ℃ and a relative humidity of 60. + -. 5% for 6 months, and then tested. The specific test results are shown in table 1.
Table 1: test result table
| DPPH radical scavenging ratio (%) | |
| Example 1 | 58 |
| Example 2 | 61 |
| Example 3 | 65 |
| Example 4 | 63 |
| Comparative example 1 | 55 |
Test example 2
The lyophilized powders of antioxidant coenzyme Q10 of examples 1 to 5 and comparative example 1 were subjected to fatigue resistance test.
The inspection basis is as follows: inspection and evaluation of health food (2003 edition)
Test animals: BALB/CICRC57 clean grade, 240 male adult mice weighing 18. + -.1 g, supplied by Shanghai Sphere-BikeKa laboratory animals Co., Ltd (approval: SCXK < Shanghai > 2008-0016).
Adding 2ml of normal saline into each 30mg of antioxidant coenzyme Q10 freeze-dried powder of reduced coenzyme Q10, and uniformly mixing to obtain a sample solution. In the experiment, a blank control group, a normal saline control group and 6 experimental groups are arranged to form seven groups, 30 mice in each group are used, the intragastric administration amount is 33.4mL/kg · bw every day (namely, 33.4mL of sample solution is intragastric administered to each kilogram of body weight of the mice), and the seven groups are continuously used for 30 days.
The placebo group was gavaged without the use of the sample.
The control group of saline was intragastrically infused with saline.
30min after the last gavage, the tail root was loaded with 5% weight of zinc particles, the mice were placed in a swimming box (water depth 40cm, water temperature 30 ℃. + -. 1 ℃), and the time from swimming to death of the mice was recorded. During the trial, each group of mice had free access to food and water. The test results are shown in Table 2.
After the comparison of the experimental groups, the statistical analysis is carried out, and the result shows that P is less than 0.05, and the difference has statistical significance. The comparison result of the control group and the experimental group shows that P is less than 0.05, and the difference has statistical significance.
Table 2: weight swimming time result table
| Time, min | |
| Example 1 | 42.8 |
| Example 2 | 44.1 |
| Example 3 | 46.5 |
| Example 4 | 47.1 |
| Example 5 | 50.9 |
| Comparative example 1 | 41.6 |
| Blank control group | 28.3 |
| Physiological saline control group | 28.2 |
As shown in the table, compared with the example 1, the high-pressure micro-jet homogenization treatment adopted in the example 2 of the invention greatly improves the DPPH free radical clearance rate and the mouse weight-bearing swimming time. The reason for this may be that the high pressure microjet can disperse the particle size of the material to the nanometer level, and the particle size distribution is uniform after homogenization, which is more beneficial to absorption and utilization.
Claims (5)
1. The preparation method of the antioxidant coenzyme Q10 freeze-dried powder is characterized by comprising the following steps:
s1, stirring 20-30 parts by weight of coenzyme Q10, 4-8 parts by weight of freeze-drying protective agent, 5-15 parts by weight of polyethylene glycol, 10-20 parts by weight of glycerol, 0.1-0.5 part by weight of sodium oleate and 55-65 parts by weight of water at the rotation speed of 400-600 revolutions per minute for 5-15 minutes to obtain a mixed solution;
s2, carrying out ultrasonic treatment on the mixed solution for 8-12 minutes under the conditions that the ultrasonic power is 200-;
s3, filtering the homogeneous liquid by using a microporous filter to obtain a filtrate;
s4, carrying out vacuum freeze drying on the filtrate to obtain the product.
2. The method for preparing the antioxidant coenzyme Q10 freeze-dried powder according to claim 1, which is characterized in that: the freeze-drying protective agent consists of 85-95 wt% of trehalose and 5-15 wt% of mannitol.
3. The method for preparing the antioxidant coenzyme Q10 freeze-dried powder according to claim 1, which is characterized in that: the filter core material of the microporous filter is polypropylene, and the filtering precision is 0.2-0.5 μm.
4. The method for preparing the antioxidant coenzyme Q10 freeze-dried powder according to claim 1, which is characterized in that: the vacuum freeze drying condition is that the thickness of the material is controlled to be 4-9mm, the pre-freezing temperature is set to be-20 to-30 ℃, the sample is kept for 1.5-2.5 hours after the temperature is reduced to the set temperature, the sublimation temperature is set to be 5-15 ℃, the analysis temperature is 30-40 ℃, the vacuum degree is 10-30pa, and the drying time is 20-28 hours.
5. An antioxidant coenzyme Q10 lyophilized powder prepared by the preparation method of any one of claims 1 to 4.
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