Composition containing coenzyme Q10, preparation method and application
By combining coenzyme Q10, olive oil, stabilizers, solubilizers, and cyclodextrin derivatives, along with high-speed shear homogenization and vacuum degassing processes, the problems of low solubility and insufficient stability of coenzyme Q10 have been solved, achieving high solubility and long-term stability, making it suitable for the health supplement industry.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- GUANGDONG RUNHE BIOTECHNOLOGY CO LTD
- Filing Date
- 2026-02-26
- Publication Date
- 2026-05-08
AI Technical Summary
Coenzyme Q10 has a large molecular weight, strong lipid solubility, and extremely poor water solubility, resulting in very low dissolution. Existing technologies have insufficient product stability when trying to improve solubility.
A coenzyme Q10-containing composition was prepared by combining coenzyme Q10, olive oil, stabilizers, solubilizers, carriers, and cyclodextrin derivatives with high-speed shear homogenization, vacuum degassing, and raw material pretreatment processes. This improved the composition's dispersibility and solubility. Furthermore, the synergistic effect of the stabilizer system and pretreatment process ensured the stability of the composition during storage.
The prepared composition has an in vitro dissolution rate of over 88%, and the coenzyme Q10 retention rate is stable at over 97% for 6 months under conditions of 25℃ and 60% relative humidity. It does not change color, separate into layers, or precipitate during long-term storage. It is easy to operate and suitable for large-scale industrial production.
Abstract
Description
Technical Field
[0001] This invention relates to the field of health product technology, and in particular to a composition containing coenzyme Q10, its preparation method, and its uses. Background Technology
[0002] Coenzyme Q10 is a core component of the mitochondrial respiratory chain in human cells. It has physiological activities such as antioxidation, enhancing cellular energy metabolism, and protecting myocardial function, and is widely used in the health product industry.
[0003] However, Coenzyme Q10 has a large molecular weight, strong lipid solubility, and extremely poor water solubility, resulting in very low dissolution rate, which severely restricts its full efficacy. Current technologies often improve Coenzyme Q10 solubility by adding oil carriers such as olive oil, while some methods optimize dissolution performance by adding surfactants. However, this easily leads to insufficient product stability and problems such as stratification and precipitation during storage.
[0004] Therefore, developing a coenzyme Q10 composition that simultaneously improves dissolution and stability and can be industrially produced has become an urgent need in the current health supplement industry. Summary of the Invention
[0005] To address the aforementioned problems, this invention provides a composition containing coenzyme Q10, a preparation method, and its uses. The technical solution adopted by this invention is as follows: The present invention provides a composition containing coenzyme Q10, comprising the following components in parts by weight: 10-20 parts coenzyme Q10, 30-40 parts olive oil, 3-5 parts stabilizer, 5-10 parts solubilizer, 6-10 parts carrier, and 5-6 parts cyclodextrin derivative; The stabilizer is selected from vitamin E and ascorbyl palmitate; the solubilizer is selected from polyethylene glycol 400 and Tween 80; the carrier is selected from steviol glycoside and maltodextrin; the cyclodextrin derivative is hydroxypropyl-β-cyclodextrin; The olive oil mentioned is olive oil that has undergone degumming and deacidification pretreatment. The pretreated olive oil has an acid value ≤0.5mgKOH / g and a moisture content ≤0.1wt%.
[0006] Furthermore, the weight ratio of vitamin E and ascorbate palmitate in the stabilizer is (2-3):1.
[0007] Furthermore, the weight ratio of polyethylene glycol 400 and Tween 80 in the cosolvent is (2-4):(1-2).
[0008] Furthermore, the weight ratio of the steviol glycoside and the maltodextrin in the carrier is (1-2):1.
[0009] In another aspect, the present invention provides a method for preparing the coenzyme Q10-containing composition, comprising the following steps: (1) The raw olive oil was subjected to degumming and deacidification treatment in sequence. The degumming treatment was carried out by hydration and stirring combined with centrifugation to remove the gum. The deacidification treatment was carried out by alkali refining reaction under vacuum and soap residue separation. After washing and dehydration, the olive oil was pretreated with an acid value ≤0.5mg KOH / g and a moisture content ≤0.1wt%. (2) Heat the pretreated olive oil in step (1) to 35-45℃, then add coenzyme Q10 and stabilizer, stir at 500-800r / min for 15-25min until the raw materials are completely dissolved and a uniform oil phase is formed; (3) Add cosolvent, carrier and hydroxypropyl-β-cyclodextrin to the obtained oil phase, heat to 45-55℃, homogenize using a high-speed shear disperser at 10000-12000r / min for 15-20min, then degas under vacuum conditions of -0.08~-0.09MPa for 5-8min, then cool to 25-30℃ and stir for 10-15min to form a composition containing coenzyme Q10.
[0010] Further, in step (1), the specific method of degumming is as follows: heat the olive oil to 60-75℃, add hot water at 70-85℃ which is 1-3% of the weight of the olive oil, mix at a stirring speed of 100-300 rpm for 20-40 minutes, and then remove the gum by centrifugation and collect the upper degummed olive oil.
[0011] Further, in step (1), the specific method for deacidification is as follows: the degummed olive oil is heated to 70-85°C under vacuum conditions of -0.05 ~ -0.07 MPa, and a NaOH alkaline solution with a concentration of 2-8 wt% is added. The mixture is stirred at a speed of 300-600 rpm for 10-30 minutes to form soapstock. Then, the soapstock is separated by centrifugation at 85-95°C. The separated oil is then washed with water until the washing wastewater is neutral. Finally, it is dehydrated and dried to obtain pretreated olive oil.
[0012] In another aspect, the present invention provides the use of the coenzyme Q10-containing composition in the preparation of health products with antioxidant or immune-enhancing effects.
[0013] In another aspect, the present invention provides a health product containing coenzyme Q10, comprising the aforementioned coenzyme Q10-containing composition and pharmaceutically acceptable excipients; The excipients are selected from one or more of magnesium stearate, micronized silica gel, sodium carboxymethyl cellulose, and erythritol.
[0014] Furthermore, the amount of the excipient added is 2-8% of the weight of the composition containing coenzyme Q10.
[0015] Furthermore, the dosage forms of the health products containing coenzyme Q10 include capsules, granules, and tablets.
[0016] Furthermore, in preparing the capsule dosage form, the coenzyme Q10-containing composition is filled into empty capsules to obtain the finished product, wherein the content of the coenzyme Q10-containing composition is 0.3-0.5g / capsule.
[0017] The beneficial effects of this invention are: This invention combines the synergistic effects of multiple components in the formulation system with high-speed shear homogenization, vacuum degassing, and raw material pretreatment processes. Through the synergistic effects of stabilizers, cosolvents, carriers, and cyclodextrin derivatives, and using degummed and deacidified olive oil as the oil phase matrix, the dispersibility and solubility of coenzyme Q10 are improved. The resulting composition achieves an in vitro dissolution rate of over 88%. Simultaneously, through the synergistic effect of the stabilizer system and the pretreatment and degassing processes, the prepared composition can be stably stored for 6 months at 25°C and 60% relative humidity, with a coenzyme Q10 retention rate of over 97%. Long-term storage shows no discoloration, stratification, or precipitation, and exhibits excellent homogeneity. Furthermore, this method is simple to operate, meets the needs of large-scale industrial production, and has high practical application value and promising prospects for promotion. Detailed Implementation
[0018] The present invention will be further illustrated below with reference to specific embodiments. Unless otherwise specified, the raw materials, reagents, or apparatus used in the following embodiments can be obtained from conventional commercial sources or by existing known methods.
[0019] Example 1:
[0020] A composition containing coenzyme Q10, comprising the following components in parts by weight: 20 servings of Coenzyme Q10; 40 servings of olive oil; Stabilizer 3 parts: 2 parts vitamin E, 1 part ascorbyl palmitate (weight ratio of the two is 2:1); 10 parts cosolvent: 6 parts polyethylene glycol 400, 4 parts Tween 80 (weight ratio of the two is 2:1). Carrier 6 parts: 4 parts steviol glycosides, 2 parts maltodextrin (weight ratio of the two is 2:1); Cyclodextrin derivatives: 6 parts hydroxypropyl-β-cyclodextrin.
[0021] The method for preparing the composition containing coenzyme Q10 includes the following steps: (1) The olive oil is subjected to degumming and deacidification processes in sequence. The specific steps are as follows: ① The raw olive oil was degummed sequentially using a water-based method. The equipment was a constant temperature stirred reactor. First, the olive oil was added to the constant temperature stirred reactor and heated to 60°C. Then, 3% of its weight of deionized water at 70°C was added to the olive oil. The stirring speed was 300 r / min, and the mixture was kept at the temperature and stirred for 30 min. After standing and separating into layers for 2 h, the lower layer of colloidal phospholipid complex was removed by centrifugation, and the upper layer of degummed olive oil was collected. ② The olive oil was deacidified using the alkali refining method. The degummed olive oil was heated to 85°C under a vacuum of -0.06 MPa. An 8 wt% sodium hydroxide solution was slowly added to the degummed olive oil (the amount added was 1.2 times the theoretical alkali amount, which was calculated based on the initial acid value of olive oil of 1.8 mg KOH / g, i.e., the mass of sodium hydroxide added in this example was 1.54 mg / g of degummed olive oil, corresponding to a KOH equivalent of 2.16 mg / g of degummed olive oil). The stirring speed was 400 r / min, and the mixture was stirred for 25 min to form soap stock. The mixture was allowed to stand and separate into layers for 4 h, and the lower layer of soap stock was removed by centrifugation at 85°C. ③ Refining process: The deacidified olive oil was washed with deionized water until the pH reached 6.8-7.2, then transferred to a vacuum dryer and dried at -0.09 MPa and 70℃ for 1.5 hours to complete the pretreatment of the olive oil, obtaining pretreated olive oil for later use. The acid value of the pretreated olive oil was determined by titration according to the standard "Determination of Acid Value and Acidity of Animal and Vegetable Oils" (GB / T 5530-2022); the moisture content of the pretreated olive oil was determined by oven drying according to the standard "Determination of Moisture and Volatile Matter Content of Animal and Vegetable Oils" (GB / T 5528-2021). The results showed that the acid value of the pretreated olive oil was 0.3 mg KOH / g, and the moisture content was 0.08 wt%. (2) By weight, heat the pretreated olive oil to 40°C, add coenzyme Q10, vitamin E and ascorbyl palmitate, stir at 600 r / min, keep warm and stir for 20 min, the material is evenly dispersed to form a uniform oil phase; (3) Add polyethylene glycol 400, Tween 80, steviol glycosides, maltodextrin and hydroxypropyl-β-cyclodextrin to the oil phase obtained in step (2), heat to 50°C, homogenize at 11000 r / min for 18 min using a high-speed shear disperser, then degas under vacuum at -0.085 MPa for 6 min, then cool to 28°C and stir for 12 min to form the composition Z1 containing coenzyme Q10.
[0022] Example 2: A composition containing coenzyme Q10, comprising the following components in parts by weight: 10 servings of Coenzyme Q10; 30 servings of olive oil; Stabilizer 5 parts: 3.75 parts vitamin E, 1.25 parts ascorbyl palmitate (weight ratio of the two is 3:1); Cosolvent 5 parts: 4 parts polyethylene glycol 400, 1 part Tween 80 (weight ratio of the two is 4:1). Carrier 10 parts: 5 parts steviol glycosides, 5 parts maltodextrin (weight ratio of the two is 1:1); Cyclodextrin derivatives: 5 parts hydroxypropyl-β-cyclodextrin; The preparation steps of the composition containing coenzyme Q10 are the same as in Example 1, and composition Z2 containing coenzyme Q10 is obtained.
[0023] Comparative Example 1: Compared to Example 1, the amount of coenzyme Q10 used in this comparative example was increased to 25 parts. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D1 containing coenzyme Q10.
[0024] Comparative Example 2 Compared to Example 1, the amount of coenzyme Q10 used in this comparative example was reduced to 15 parts. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D2 containing coenzyme Q10.
[0025] Comparative Example 3: Compared to Example 1, the amount of olive oil used in this comparative example was increased to 45 parts. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D3 containing coenzyme Q10.
[0026] Comparative Example 4: Compared to Example 1, the amount of olive oil used in this comparative example was reduced to 15 parts, while the remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D4 containing coenzyme Q10.
[0027] Comparative Example 5: Compared with Example 1, the amount of stabilizer used in this comparative example was increased to 6 parts, including 4 parts of vitamin E and 2 parts of ascorbate palmitate. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D5 containing coenzyme Q10.
[0028] Comparative Example 6: Compared to Example 1, the amount of stabilizer used in this comparative example is reduced, and the amount of stabilizer added is 2 parts, including 1 part vitamin E and 1 part ascorbate palmitate. The remaining process parameters and raw material amounts are the same as in Example 1, resulting in composition D6 containing coenzyme Q10.
[0029] Comparative Example 7: Compared to Example 1, the amount of cosolvent used in this comparative example is increased to 11 parts, including 7 parts of polyethylene glycol 400 and 4 parts of Tween 80. The remaining process parameters and raw material amounts are the same as in Example 1, resulting in composition D7 containing coenzyme Q10.
[0030] Comparative Example 8: Compared with Example 1, the amount of cosolvent used in this comparative example was reduced, and the amount of cosolvent added was 4 parts, including 3 parts of polyethylene glycol 400 and 1 part of Tween 80. The remaining process parameters and raw material amounts were the same as in Example 1, and composition D8 containing coenzyme Q10 was obtained.
[0031] Comparative Example 9: Compared to Example 1, the amount of carrier used in this comparative example is increased to 11 parts, including 6 parts of steviol glycosides and 5 parts of maltodextrin. The remaining process parameters and raw material amounts are the same as in Example 1, resulting in composition D9 containing coenzyme Q10.
[0032] Comparative Example 10: Compared to Example 1, the amount of carrier used in this comparative example is reduced to 5 parts, including 3 parts of steviol glycoside and 2 parts of maltodextrin. The remaining process parameters and raw material amounts are the same as in Example 1, resulting in composition D10 containing coenzyme Q10.
[0033] Comparative Example 11: Compared with Example 1, in this comparative example, the stabilizer is only vitamin E (3 parts), and the other process parameters and raw material amounts are the same as in Example 1, resulting in composition D11 containing coenzyme Q10.
[0034] Comparative Example 12: Compared with Example 1, in this comparative example, the stabilizer is only ascorbate palmitate (3 parts), and the other process parameters and raw material amounts are the same as in Example 1, resulting in composition D12 containing coenzyme Q10.
[0035] Comparative Example 13: Compared with Example 1, in this comparative example, the stabilizer vitamin E was replaced. The stabilizer included 2 parts of rosemary extract and 1 part of ascorbyl palmitate. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D13 containing coenzyme Q10.
[0036] Comparative Example 14: Compared with Example 1, the stabilizer ascorbate palmitate was replaced in this comparative example. The stabilizer included 2 parts vitamin E and 1 part propyl gallate. The remaining process parameters and raw material amounts were the same as in Example 1, and composition D14 containing coenzyme Q10 was obtained.
[0037] Comparative Example 15: Compared with Example 1, in this comparative example, the co-solvent was only polyethylene glycol 400 (10 parts), and the other process parameters and raw material amounts were the same as in Example 1, resulting in composition D15 containing coenzyme Q10.
[0038] Comparative Example 16: Compared with Example 1, in this comparative example, the co-solvent is only Tween 80 (10 parts), and the other process parameters and raw material amounts are the same as in Example 1, resulting in composition D16 containing coenzyme Q10.
[0039] Comparative Example 17: Compared with Example 1, in this comparative example, the cosolvent Tween 80 was replaced. The cosolvent included 6 parts of polyethylene glycol 400 and 4 parts of Span 80. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D17 containing coenzyme Q10.
[0040] Comparative Example 18: Component Substitution Compared with Example 1, in this comparative example, the cosolvent polyethylene glycol 400 was replaced, and the cosolvents were 6 parts propylene glycol and 4 parts Tween 80. The remaining process parameters and raw material amounts were the same as in Example 1, and composition D18 containing coenzyme Q10 was obtained.
[0041] Comparative Example 19: Compared with Example 1, in this comparative example, the carrier is only maltodextrin (6 parts), and the other process parameters and raw material amounts are the same as in Example 1, resulting in composition D19 containing coenzyme Q10.
[0042] Comparative Example 20: Compared with Example 1, in this comparative example, the carrier is only steviol glycoside (6 parts), and the other process parameters and raw material amounts are the same as in Example 1, resulting in composition D20 containing coenzyme Q10.
[0043] Comparative Example 21: Compared with Example 1, in this comparative example, the carrier maltodextrin was replaced. The carrier included 4 parts steviol glycosides and 2 parts mannitol. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D21 containing coenzyme Q10.
[0044] Comparative Example 22: Compared with Example 1, in this comparative example, the carrier steviol glycoside was replaced. The carrier included 4 parts erythritol and 2 parts maltodextrin. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D22 containing coenzyme Q10.
[0045] Comparative Example 23: Compared with Example 1, no cyclodextrin derivative was added in this comparative example, and the remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D23 containing coenzyme Q10.
[0046] Comparative Example 24: Compared with Example 1, the amount of cyclodextrin derivative used in this comparative example was increased by adding 7 parts of hydroxypropyl-β-cyclodextrin. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D24 containing coenzyme Q10.
[0047] Comparative Example 25: Compared with Example 1, the amount of cyclodextrin derivative used in this comparative example was reduced, and 4 parts of hydroxypropyl-β-cyclodextrin were added. The remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D25 containing coenzyme Q10.
[0048] Comparative Example 26: Compared with Example 1, in step (1) of this comparative example, there is no degumming step of olive oil. Only deacidification pretreatment is performed on the olive oil. The remaining process parameters and raw material dosage are the same as in Example 1. The composition D26 containing coenzyme Q10 is obtained. The acid value of the pretreated olive oil is 0.3 mg KOH / g and the moisture content is 0.09 wt%.
[0049] Comparative Example 27: Compared with Example 1, in step (1) of this comparative example, there is no deacidification step of olive oil. Only degumming pretreatment is performed on the olive oil. The remaining process parameters and raw material dosage are the same as in Example 1. The composition D27 containing coenzyme Q10 is obtained. The acid value of the pretreated olive oil is 1.7 mg KOH / g and the moisture content is 0.08 wt%.
[0050] Comparative Example 28: Compared with Example 1, in this comparative example, the olive oil after degumming and deacidification pretreatment had an acid value of 0.6 mgKOH / g and a moisture content of 0.2 wt%; the remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D28 containing coenzyme Q10.
[0051] The specific process parameters for the olive oil pretreatment process (step (1)) in this comparison are adjusted as follows: ① Degumming process: The stirring rate was 200 r / min, the heat preservation stirring time was 20 min, and the other degumming conditions were the same as in Example 1, which resulted in incomplete removal of the adhesive and indirectly affected the subsequent deacidification effect; ② Deacidification process: The amount of sodium hydroxide solution added was 1.1 times the theoretical amount of alkali, and the other deacidification conditions were the same as in Example 1, which resulted in incomplete neutralization of free fatty acids and a high acid value; ③ Refining and drying process: The vacuum drying vacuum degree is -0.07MPa, the drying temperature is 65℃, and the drying time is 1h. The remaining refining conditions are the same as in Example 1, which leads to insufficient removal of moisture and high moisture content.
[0052] Comparative Example 29: Compared with Example 1, in step (3) of this comparative example, the high-speed shearing homogenization process was replaced by stirring at 500 r / min for 20 min, and the remaining process parameters and raw material amounts were the same as in Example 1, resulting in composition D29 containing coenzyme Q10.
[0053] Comparative Example 30: Compared with Example 1, in step (3) of this comparative example, there is no vacuum degassing step. After high-speed shearing homogenization, the temperature is directly reduced and kept warm while stirring. The remaining process parameters and raw material amounts are the same as in Example 1, and the composition D30 containing coenzyme Q10 is obtained.
[0054] The coenzyme Q10-containing compositions prepared in Examples 1-2 and Comparative Examples 1-30 were subjected to performance tests. The test methods and results are as follows: 1. In vitro dissolution test of the composition (1) Test samples: Compositions containing coenzyme Q10 Z1-Z2 of Examples 1-2, and Compositions containing coenzyme Q10 D1-D30 of Comparative Examples 1-30.
[0055] (2) Test method: Refer to the dissolution test method (paddle method) of Part IV of the 2020 edition of the Pharmacopoeia of the People's Republic of China. 900 mL of 0.5% sodium dodecyl sulfate solution was used as the dissolution medium, the temperature was 37℃±0.5℃, and the rotation speed was 50 r / min.
[0056] (3) Sampling and detection: 5 mL samples were taken at sampling time points of 5 min, 15 min, 30 min, 45 min and 60 min respectively. The samples were filtered through a 0.45 μm filter membrane and the filtrate was used as the test solution. The coenzyme Q10 content was determined by HPLC (chromatographic column: C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: methanol-ethanol (volume ratio 80:20); flow rate: 1.0 mL / min; detection wavelength: 275 nm; column temperature: 30 ℃; injection volume: 20 μL). The cumulative dissolution rate was calculated and the cumulative dissolution rate at 60 min was used as the evaluation index.
[0057] (4) Test results: The results are shown in Table 1: Table 1. In vitro dissolution results of coenzyme Q10-containing compositions in Examples 1-2 and Comparative Examples 1-30 Sample number Cumulative dissolution rate (%) over 60 minutes Dissolution curve fitting R² Z1 89.5 0.994 Z2 88.6 0.992 D1 85.0 0.990 D2 80.8 0.986 D3 80.4 0.985 D4 76.8 0.972 D5 74.5 0.968 D6 72.3 0.965 D7 79.1 0.986 D8 71.8 0.962 D9 78.5 0.983 D10 70.9 0.959 D11 84.2 0.989 D12 83.7 0.988 D13 82.5 0.987 D14 81.9 0.986 D15 80.2 0.984 D16 79.6 0.982 D17 78.9 0.981 D18 78.3 0.980 D19 80.5 0.985 D20 79.8 0.983 D21 78.7 0.981 D22 78.1 0.980 D23 82.1 0.987 D24 81.5 0.986 D25 80.7 0.984 D26 76.3 0.971 D27 75.8 0.970 D28 77.2 0.973 D29 70.5 0.958 D30 78.6 0.983 As shown in Table 1, the in vitro dissolution rates of the compositions in Examples 1-2 were all higher than 88%, and the goodness of fit of the dissolution curves R was [missing information]. 2 All values are greater than 0.99, indicating that the composition prepared by this invention has excellent and stable dissolution properties; Comparative Examples 1-4 are comparative examples for adjusting the amount of active ingredient and oil phase. Among them, D1 (excessive Coenzyme Q10) had a dissolution rate of 85.0%, D2 (small amount of Coenzyme Q10) had a dissolution rate of 80.8%, D3 (excessive olive oil) had a dissolution rate of 80.4%, and D4 (small amount of olive oil) had a dissolution rate of 76.8%, all of which were lower than those of Examples 1-2. This indicates that the amount of Coenzyme Q10 and olive oil must be controlled within the range specified in this invention to ensure good dissolution effect. Too high or too low a amount will lead to a decrease in dissolution rate. When Coenzyme Q10 is in excess, its fat-soluble characteristics mean that the excess part cannot be fully dispersed by olive oil and excipients, and it is easy to form an aggregate, which hinders its dissolution and release in the dissolution medium. When the amount of olive oil deviates from the optimal range, too much will dilute the effective concentration of the cosolvent and carrier, while too little will not be able to fully encapsulate Coenzyme Q10, both of which will disrupt the dispersion balance of the system and reduce the dissolution efficiency.
[0058] Comparative Examples 5-6, 8, and 10 were comparative examples for adjusting the amount of excipients. The dissolution rate of D5 (excess stabilizer) was 74.5%, D6 (small amount stabilizer) was 72.3%, D8 (small amount of cosolvent) was 71.8%, and D10 (small amount of carrier) was 70.9%, all significantly lower than that of Examples 1-2. This indicates that the amount of stabilizer, cosolvent, and carrier is not necessarily better the more or the less. The dosage range defined in this invention is an optimized range that can achieve the optimal balance between excipients, active ingredients, and the oil phase. The optimal synergistic dissolution effect was observed. However, excessive stabilizer can disrupt system compatibility, while insufficient stabilizer cannot effectively assist in the stable dispersion of active ingredients. Insufficient solubilizer is inadequate to improve the water solubility of coenzyme Q10, and insufficient carrier cannot effectively carry and disperse the active ingredients. The dissolution rates of D7 (excessive solubilizer) and D9 (excessive carrier) were 79.1% and 78.5%, respectively, which are also lower than those of Examples 1-2. This further demonstrates the importance of controlling the amount of excipients. Excessive solubilizer and carrier will dilute the concentration of effective components in the system, disrupt the dispersion balance, and reduce the dissolution efficiency. Comparative Examples 11-14 are stabilizer-related comparative examples. The dissolution rates of D11 (vitamin E only) and D12 (ascorbyl palmitate only) were 84.2% and 83.7%, respectively, both lower than that of Example 1. This demonstrates that the stabilizer combination scheme (vitamin E and ascorbyl palmitate) can more effectively promote the dispersion and release of active ingredients compared to a single component, reflecting the synergistic effect of the excipient combination. It also shows that the combination of the two can take into account both oil phase compatibility and antioxidant properties. The dissolution rates of D13 (vitamin E replaced with rosemary extract) and D14 (ascorbyl palmitate replaced with propyl gallate) were 82.5% and 81.9%, respectively, both lower than that of Example 1. This indicates that the stabilizer combination selected in this invention cannot be obtained by conventional substitution. Its combination has specific synergistic advantages. The replaced excipients have poor compatibility with the system and cannot form an effective dispersion effect. Comparative Examples 15-18 are comparative examples related to co-solvents. D15 (polyethylene glycol 400 only) had a dissolution rate of 80.2%, and D16 (Tween 80 only) had a dissolution rate of 79.6%, which is lower than that of Example 1, demonstrating the synergistic effect of the co-solvent compound scheme, promoting the dispersion of coenzyme Q10 from the oil phase to the dissolution medium. D17 (Tween 80 replaced with Span 80) had a dissolution rate of 78.9%. The emulsifying and dispersing ability of Span 80 is insufficient, and it cannot effectively disperse coenzyme Q10 into the water-soluble dissolution medium. D18 (polyethylene glycol 400 replaced with propylene glycol) had a dissolution rate of 78.3%. The synergistic effect of propylene glycol and Tween 80 is weaker than that of polyethylene glycol 400, making it difficult to improve the water solubility of coenzyme Q10. The dispersion efficiency and affinity of both are not as good as the combination selected in this invention, resulting in a decline in dissolution performance, which is lower than that of Example 1. This demonstrates the specificity of the co-solvent combination of this invention. Replacing it with other co-solvents will lead to a decrease in dissolution performance. Comparative Examples 19-22 are carrier-related comparative examples. D19 (maltodextrin only) had a dissolution rate of 80.5%, and D20 (stevioside only) had a dissolution rate of 79.8%, both lower than Example 1. The combination of steviol and maltodextrin can adsorb and encapsulate coenzyme Q10 microparticles, reducing their aggregation. The adsorption and encapsulation capacity of a single component is limited, thus proving that the carrier combination in this invention has a synergistic effect. D21 (maltodextrin replaced with mannitol) had a dissolution rate of 78.7%, and D22 (stevioside replaced with erythritol) had a dissolution rate of 78.1%, both lower than Example 1. This illustrates the specificity and synergistic advantages of the carrier combination in this invention. The replaced carrier components cannot synergize with the cosolvent and oil phase, making it difficult to stably disperse the active ingredients, thus reducing the dissolution rate. Comparative Examples 23-25 are comparative examples related to cyclodextrin derivatives. The dissolution rate of D23 (without added cyclodextrin derivative) was 82.1%, D24 (excess cyclodextrin) was 81.5%, and D25 (small amount of cyclodextrin) was 80.7%, all lower than that of Example 1. This proves that the addition and dosage control of cyclodextrin derivatives are crucial to improving dissolution. Hydroxypropyl-β-cyclodextrin can form an inclusion complex with coenzyme Q10, reducing its lipid-soluble aggregation tendency and improving its antioxidant stability. At the same time, hydroxypropyl-β-cyclodextrin helps maintain the homogeneity of the system. Hydroxypropyl-β-cyclodextrin works synergistically with the components of the original formulation to further optimize dissolution performance. However, the addition and dosage control must comply with the scope defined in this invention; otherwise, the synergistic stabilizing effect cannot be fully utilized.
[0059] Comparative Examples 26-28 are comparative examples related to olive oil pretreatment. The dissolution rate of D26 (deacidification only, no degumming) was 76.3%, and the dissolution rate of D27 (degumming only, no deacidification) was 75.8%. The dissolution rate dropped significantly, indicating that the pretreatment steps of degumming and deacidification of olive oil (step (1)) are crucial to improving the dissolution performance of the product. The absence of any step in the pretreatment steps will result in the residue of gum or free fatty acids, which will hinder the dissolution of active ingredients. The dissolution rate of D28 (pretreatment not up to standard, acid value 0.6 mg KOH / g, moisture 0.2 wt%) was 77.2%, which was lower than that of Example 1. This indicates that the acid value and moisture content of the olive oil after pretreatment need to be controlled within the range specified in this invention in order to ensure a good dissolution effect. Comparative Examples 29-30 are comparative examples related to the preparation process. D29 (without high-speed shear homogenization) had a dissolution rate of 70.5%, the lowest among all comparative examples. This indicates that high-speed shear homogenization is crucial for dispersing the oil phase, breaking the initial aggregation state of the active ingredient coenzyme Q10, and promoting dissolution. High-speed shear homogenization can achieve sufficient dispersion of each component, ensuring that the carrier and cyclodextrin derivative can effectively contact the dispersed coenzyme Q10, thereby exerting the synergistic effect of molecular-level inclusion and particle-level encapsulation, consolidating the dispersion effect, and improving the dissolution efficiency. D30 (without vacuum degassing) had a dissolution rate of 78.6%, lower than that of Example 1. This indicates that vacuum degassing has a positive impact on removing bubbles in the system and improving the homogeneity of the composition. The absence of this step will lead to a certain degree of decrease in dissolution performance.
[0060] 2. Stability determination of the composition (1) Test samples: Compositions containing coenzyme Q10 Z1-Z2 of Examples 1-2, and Compositions containing coenzyme Q10 D1-D30 of Comparative Examples 1-30.
[0061] (2) Test method: Long-term stability test was adopted. The long-term stability test conditions were 25℃ and 60% relative humidity. After the composition was sealed and packaged, it was placed for 6 months. Samples were taken at 0, 1, 3 and 6 months to determine the coenzyme Q10 content and calculate the retention rate [Retention rate = (coenzyme Q10 content at a certain time point / coenzyme Q10 content at time 0) × 100%]; at the same time, the appearance and uniformity of the sample were observed.
[0062] (3) Detection method: Accurately weigh approximately 0.1 g of each composition sample and place it in a 25 mL volumetric flask. Dissolve the sample in anhydrous ethanol and dilute to the mark. Shake well. Filter the solution through a 0.45 μm organic phase microporous membrane and use the filtrate as the test solution. The content is determined by HPLC. The chromatographic column is a C18 column (4.6 mm × 250 mm, 5 μm); the mobile phase is methanol-ethanol (volume ratio 80:20); the flow rate is 1.0 mL / min; the detection wavelength is 275 nm; the column temperature is 30 ℃; and the injection volume is 20 μL.
[0063] (4) The test results are shown in Table 2.
[0064] Table 2. Stability test results of the compositions of Examples 1-2 and Comparative Examples 1-30. Sample number Coenzyme Q10 retention rate (%) after 6 months Appearance changes (after 6 months) Uniformity (after 6 months) Z1 97.9 Pale yellow, uniform, oily consistency, without discoloration. No stratification, no sedimentation, good homogeneity Z2 97.2 Pale yellow, uniform, oily consistency, without discoloration. No stratification, no sedimentation, good homogeneity D1 82.3 Yellowish and oily, with a distinct yellowish tinge. There are obvious layers, with a gelatinous sediment at the bottom. D2 87.7 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D3 86.6 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D4 85.7 Yellowish and oily, with a distinct yellowish tinge. Slight stratification, with a small amount of sediment at the bottom. D5 78.9 Deep yellow, oily, and severely yellowed. There is obvious stratification, with flocculent precipitate in the middle. D6 75.3 Yellowish and oily, with a distinct yellowish tinge. Severe stratification, with a large amount of gelatinous sediment at the bottom. D7 84.5 Pale yellow oily texture, slightly yellowish No stratification, with a very small amount of fine sediment at the bottom. D8 76.1 Yellowish and oily, with a noticeably yellowish edge. There are obvious layers, with sediment accumulation at the bottom. D9 83.8 Pale yellow oily, with no obvious discoloration. No layering, with a small amount of fine sediment at the bottom. D10 77.5 Yellow oily, slightly discolored Slight stratification, with a small amount of sediment at the bottom. D11 88.2 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D12 87.9 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D13 86.7 Pale yellow oily, with no obvious discoloration. No stratification, no sedimentation, good homogeneity D14 85.9 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D15 85.3 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D16 84.8 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D17 83.5 Pale yellow oily, with no obvious discoloration. No stratification, with very little sediment at the bottom. D18 82.9 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D19 85.6 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D20 84.7 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D21 83.2 Pale yellow oily, with no obvious discoloration. No stratification, with very little sediment at the bottom. D22 82.6 Pale yellow oily texture, slightly yellowish No layering, with a small amount of fine sediment at the bottom. D23 88.5 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D24 87.8 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D25 86.9 Pale yellow oily texture, slightly yellowish No stratification, no sedimentation, good homogeneity D26 80.2 Yellow oily, slightly browned Slight stratification, with a small amount of gelatinous sediment at the bottom. D27 79.5 Yellow oily, with obvious browning. There is obvious stratification, with a large amount of gelatinous sediment at the bottom. D28 81.3 Yellow oily, slightly browned Slight stratification, with a small amount of sediment at the bottom. D29 72.8 Dark yellow oily, severely browned Severe layering, obvious color difference between upper and lower layers, and a large amount of sediment at the bottom. D30 83.9 Pale yellow oily texture, slightly yellowish No stratification, with a very small amount of fine sediment at the bottom. As shown in Table 2, the stability test results indicate that the compositions Z1 and Z2 prepared in Examples 1-2 exhibit excellent stability. After 6 months, the coenzyme Q10 retention rates reached 97.9% and 97.2%, respectively. Moreover, after 6 months, they remained as a uniform pale yellow oil without discoloration, layering, or precipitation, demonstrating good uniformity. This fully proves the rationality of the formulation component matching, raw material pretreatment, and preparation process of the present invention, achieving long-term stable storage of the compositions.
[0065] The stability of Comparative Examples 1-4 was significantly lower than that of Examples 1-2: D1 (excessive Coenzyme Q10) had a retention rate of only 82.3%, the sample was noticeably yellow, layered, and had a gelatinous precipitate at the bottom. This was because the amount of Coenzyme Q10 exceeded the optimal range and could not be fully dispersed and coated by the oil phase and excipients, making it prone to oxidative degradation and phase separation. D2 (small amount of Coenzyme Q10) and D3 (excessive olive oil) had retention rates of 87.7% and 86.6%, respectively. Although the retention rates were better than D1, a small amount of fine precipitate appeared at the bottom of both, indicating that insufficient Coenzyme Q10 or excessive olive oil would disrupt the homogeneity of the system and easily lead to component precipitation during long-term storage. D4 (small amount of olive oil) had a retention rate of 85.7%, the sample edge was slightly brown and slightly layered. This was because insufficient olive oil could not provide a stable oil phase environment for Coenzyme Q10, leading to oxidative discoloration of the composition. At the same time, the system's dispersibility decreased, causing layering.
[0066] When the amounts of excipients in Comparative Examples 5-10 deviated from the limits specified in this invention, the stability decreased significantly. Specifically, D5 (excess stabilizer) had a retention rate of 78.9%, with localized brown spots and obvious stratification. This is because excessive stabilizer easily produces synergistic antagonistic effects, failing to improve the antioxidant effect and damaging system compatibility, leading to component analysis. D6 (small amount of stabilizer) had a retention rate of only 75.3%, the lowest among all comparative examples. The sample showed a deep yellow discoloration and severe stratification, indicating that insufficient stabilizer could not effectively inhibit the oxidative degradation of coenzyme Q10 and could not maintain system stability. D8 (small amount of cosolvent)... The retention rates of D10 (with a small amount of carrier) were 76.1% and 77.5%, respectively, both showing obvious stratification, precipitation, and yellowing. Due to insufficient amounts of cosolvent and carrier, uniform dispersion of the components could not be achieved, and phase separation was likely to occur during long-term storage, while also exacerbating the oxidation of coenzyme Q10. The retention rates of D7 (with excessive cosolvent) and D9 (with excessive carrier) were 84.5% and 83.8%, respectively. Although their stability was better than that of the comparative examples with deviations in the amount of other excipients, it was still lower than that of the examples. A very small amount of precipitation appeared at the bottom, proving that more excipients are not necessarily better. The dosage range limited by this invention can achieve the best synergistic stabilization effect between the excipients and each component.
[0067] The results of Comparative Examples 11-14 further validate the synergistic advantages of the stabilizer compound scheme of the present invention; the retention rates of D11 (vitamin E only) and D12 (ascorbyl palmitate only) were 88.2% and 87.9%, respectively, with no stratification precipitation but slight yellowing, indicating that the antioxidant effect of a single stabilizer is limited and cannot achieve the long-term stabilizing effect of the compound system; the retention rates of D13 (vitamin E replaced with rosemary extract) and D14 (ascorbyl palmitate replaced with propyl gallate) were 86.7% and 85.9%, respectively. Compared with Examples 1-2, their stability further decreased, proving that the combination of vitamin E and ascorbyl palmitate selected in the present invention has a specific synergistic effect, and the use of other stabilizers cannot achieve the same stabilizing effect. The choice of compound ratio and type is crucial to the stability of the composition.
[0068] Comparative Examples 15-18 demonstrate the importance of the co-solvent formulation. D15 (polyethylene glycol 400 only) and D16 (Tween 80 only) showed retention rates of 85.3% and 84.8%, respectively, with a small amount of fine sediment at the bottom. This is because the dispersing ability of a single co-solvent is limited, failing to achieve uniform compatibility of the components, and long-term storage easily leads to sedimentation. D17 (Tween 80 replaced with Span 80) and D18 (polyethylene glycol 400 replaced with propylene glycol) showed retention rates of 83.5% and 82.9%, respectively, with further reduced stability. This indicates that the polyethylene glycol 400 and Tween 80 formulation used in this invention can specifically improve the dispersion stability of coenzyme Q10. Using other co-solvents would disrupt the system's compatibility, making it impossible to maintain system homogeneity in the long term, leading to a decrease in the stability of the composition.
[0069] The results of Comparative Examples 19-22 demonstrate the synergistic stabilizing effect of the carrier combination. The retention rates of D19 (maltodextrin only) and D20 (stevioside only) were 85.6% and 84.7%, respectively. Because a single carrier cannot simultaneously address both dispersibility and stability, both D19 and D20 exhibited slight yellowing and a small amount of precipitation, making them prone to component separation during long-term storage. The retention rates of D21 (maltodextrin replaced with mannitol) and D22 (stevioside replaced with erythritol) were 83.2% and 82.6%, respectively, with further decreased stability. Mannitol cannot effectively encapsulate coenzyme Q10 for an extended period, easily leading to its oxidative aggregation and precipitation. Erythritol has poor compatibility with other components and cannot synergistically maintain system homogeneity; replacing other carriers weakens this synergistic effect, thus reducing stability. The above demonstrates that the combination of steviol and maltodextrin selected in this invention can synergistically work with the oil phase and cosolvent to maintain long-term homogeneity and stability of the system, and replacing other carriers weakens this synergistic effect.
[0070] The results of Comparative Examples 23-25 demonstrate the stability-enhancing effect of cyclodextrin derivatives. The retention rate of D23 (without added cyclodextrin derivatives) was 88.5%, that of D24 (excess cyclodextrin) was 87.8%, and that of D25 (small amount of cyclodextrin) was 86.9%. Although no stratification or precipitation was observed, a slight yellowing was present, and the retention rates were all lower than those of Examples 1 and 2. This proves that cyclodextrin derivatives can form inclusion complexes with coenzyme Q10, enhancing its antioxidant stability and helping to maintain the homogeneity of the system. The addition and dosage control must comply with the limitations of this invention; otherwise, the synergistic stabilizing effect cannot be fully realized. The cyclodextrin derivative encapsulates coenzyme Q10 at the molecular level and isolates it from oxidizing media, while the carrier immobilizes the inclusion complex at the particle level and prevents migration and aggregation. This dual protection significantly improves stability. Therefore, in Comparative Example 23, using only the carrier would result in decreased stability due to the inability to simultaneously achieve molecular-level protection and particle-level immobilization, failing to achieve the long-term stability effect of the examples. However, Examples 1-2, with the dual encapsulation of cyclodextrin derivatives, can significantly reduce the contact between coenzyme Q10 and air and oxidizing media, greatly improving the retention rate.
[0071] Comparative Examples 26-28 demonstrate the importance of the pretreatment steps and standards for olive oil. D26 (deacidification only, no degumming) and D27 (degumming only, no deacidification) had retention rates of 80.2% and 79.5%, respectively, both exhibiting browning, stratification, and gelatinous precipitation. The absence of the degumming step leads to residual gum in the olive oil, disrupting the system's homogeneity. The absence of the deacidification step also results in residual free fatty acids, accelerating the oxidative degradation of coenzyme Q10. D28 (pretreatment substandard, acid value 0.6 mg KOH / g, moisture 0.2 wt%) had a retention rate of 81.3%, exhibiting slight browning and stratification. This indicates that the acid value and moisture content of the pretreated olive oil must be strictly controlled within the limits specified in this invention; otherwise, residual free fatty acids and moisture will act as catalysts for coenzyme Q10 oxidation, simultaneously compromising system stability.
[0072] Comparative Examples 29 and 30 are related to the preparation process, verifying the decisive role of key process steps in stability. D29 (without high-speed shear homogenization) had a retention rate of only 72.8%, the lowest among all comparative examples. The sample showed severe browning, stratification, and a large amount of sediment at the bottom. High-speed shear homogenization can achieve sufficient dispersion of each component, breaking the aggregation state of coenzyme Q10. Its absence leads to uneven component dispersion, making severe phase separation likely during long-term storage. Simultaneously, the increased surface area of coenzyme Q10 exposed to air accelerates oxidative degradation. D30 (without vacuum degassing) had a retention rate of 83.9%, with slight yellowing and a very small amount of sediment. Vacuum degassing effectively removes air bubbles from the system, avoiding component oxidation and phase separation caused by air bubbles. Its absence causes residual air bubbles in the system to become carriers of oxidation reactions, while also affecting the uniformity of component dispersion, leading to decreased stability.
[0073] In summary, by reasonably limiting the amount and type of each component, adopting a double pretreatment process for olive oil, and optimizing the key steps of high-speed shear homogenization and vacuum degassing, this invention achieves excellent stability of the composition. Its coenzyme Q10 retention rate is ≥97% after 6 months, and it does not change color, separate into layers, or precipitate during long-term storage, which is significantly better than the comparative examples, further proving the advantages of the formulation and process of this invention.
[0074] Example 3: The health supplement containing coenzyme Q10 in this embodiment is composed of the following components: Take 100 parts of the coenzyme Q10-containing composition Z2 prepared in Example 1, add 1.5 parts magnesium stearate and 0.5 parts micronized silica gel (the total amount of excipients added is 2.0% of the weight of the composition), stir at 300 r / min for 5 min, after the materials are mixed evenly, fill into empty capsules using a fully automatic capsule filling machine, with a filling amount of 0.3 g per capsule (coenzyme Q10 content is 15.6 mg), to obtain the finished soft capsule S1 containing coenzyme Q10.
[0075] The above-mentioned soft capsule product S1 was tested for its antioxidant and immune-enhancing properties: One hundred and twenty SPF-grade Kunming mice, weighing 20±2g, half male and half female, were selected and acclimatized for one week. They were then randomly divided into two groups of 30 mice each: a blank control group and a S1 group. The S1 group was administered the corresponding sample S1 by gavage daily at a dose of 2 mg / kg body weight (calculated as coenzyme Q10). The blank control group was given an equal volume of physiological saline. The gavage was continued for 30 days, and samples were collected 24 hours after the last administration for analysis.
[0076] (1) Antioxidant efficacy test: Mouse liver tissue was taken and tissue homogenate was prepared. The activities of superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and malondialdehyde (MDA) were determined by the kit method. The operation was performed according to the kit instructions.
[0077] The reagent kits used are as follows: SOD activity assay kit (Nanjing Jiancheng Bioengineering Institute, catalog number: A001-1-1); GSH-Px activity assay kit (Nanjing Jiancheng Bioengineering Institute, catalog number: A005-1-1); MDA content assay kit (Nanjing Jiancheng Bioengineering Institute, catalog number: A003-1-1). (2) Detection of immune enhancement efficacy: The carbon clearance index (K value) and phagocytic index (α value) of mice were measured, and the spleen index and thymus index (organ weight / body weight × 100%) were calculated; the proliferation capacity of mouse spleen lymphocytes was measured by the MTT assay and expressed as the stimulation index (SI). The MTT reagent was purchased from Beijing Solarbio Science & Technology Co., Ltd. (product number: M8180).
[0078] The test results are shown in Table 3.
[0079] Table 3. Results of antioxidant and immune-enhancing effects in Group S1 and the blank control group. detection indicators Blank control group Group S1 SOD activity (U / mg prot) 128.5±10.3 203.7±16.8** GSH-Px activity (U / mg prot) 86.3±7.2 145.8±12.7** MDA content (nmol / mg prot) 5.8±0.6 2.8±0.3** Carbon Coverage Index K 0.018±0.002 0.036±0.004** Phagocytosis Index α 0.152±0.014 0.258±0.023** Spleen index (%) 0.28±0.03 0.46±0.05** Thymus index (%) 0.16±0.02 0.27±0.03** Splenic lymphocyte stimulation index (SI) 1.00±0.08 2.08±0.17** Note: Compared with the blank control group, **P<0.01 (extremely significant difference).
[0080] As shown in Table 3, compared with the blank control group, the SOD and GSH-Px activities in the liver tissue of mice in the S1 group were significantly increased, and the MDA content was significantly decreased, indicating that the soft capsules prepared in Example 3 have excellent antioxidant effects. At the same time, the carbon clearance index, phagocytic index, spleen index, thymus index and spleen lymphocyte stimulation index of mice in the S1 group were all significantly higher than those in the blank control group (P<0.01), indicating that the soft capsules prepared in this scheme can effectively enhance the non-specific and specific immune functions of mice.
[0081] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.
Claims
1. A composition containing coenzyme Q10, characterized in that, The components include the following parts by weight: Coenzyme Q10 10-20 parts, olive oil 30-40 parts, stabilizer 3-5 parts, solubilizer 5-10 parts, carrier 6-10 parts, cyclodextrin derivative 5-6 parts; The stabilizer is selected from vitamin E and ascorbyl palmitate; the solubilizer is selected from polyethylene glycol 400 and Tween 80; the carrier is selected from steviol glycoside and maltodextrin; the cyclodextrin derivative is hydroxypropyl-β-cyclodextrin; The olive oil is olive oil that has undergone degumming and deacidification pretreatment.
2. The composition containing coenzyme Q10 according to claim 1, characterized in that, The weight ratio of vitamin E to ascorbate palmitate in the stabilizer is (2-3):
1.
3. The composition containing coenzyme Q10 according to claim 1, characterized in that, The weight ratio of polyethylene glycol 400 to Tween 80 in the cosolvent is (2-4):(1-2).
4. The composition containing coenzyme Q10 according to claim 1, characterized in that, The weight ratio of the steviol glycosides and the maltodextrin in the carrier is (1-2):
1.
5. The method for preparing the composition containing coenzyme Q10 according to claim 1, characterized in that, Includes the following steps: (1) The raw olive oil was subjected to degumming and deacidification treatment in sequence. The degumming treatment was carried out by hydration and stirring combined with centrifugation to remove the gum. The deacidification treatment was carried out by alkali refining reaction under vacuum and soap residue separation. After washing and dehydration, the olive oil was pretreated with an acid value ≤0.5mg KOH / g and a moisture content ≤0.1wt%. (2) Heat the pretreated olive oil in step (1) to 35-45℃, then add coenzyme Q10 and stabilizer, stir at 500-800r / min for 15-25min to form a uniform oil phase; (3) Add a cosolvent, a carrier and a cyclodextrin derivative to the obtained oil phase, heat to 45-55℃, homogenize using a high-speed shear disperser at a speed of 10000-12000 r / min for 15-20 min, then degas under vacuum conditions of -0.08~-0.09 MPa for 5-8 min, then cool to 25-30℃ and stir for 10-15 min to form a composition containing coenzyme Q10.
6. The preparation method according to claim 5, characterized in that, In step (1), the specific method of degumming is as follows: heat the olive oil to 60-75℃, add hot water at 1-3% of the weight of the olive oil, mix at a stirring speed of 100-300 rpm for 20-40 minutes, and then remove the gum by centrifugation and collect the upper degummed olive oil.
7. The preparation method according to claim 5, characterized in that, In step (1), the specific method for deacidification is as follows: the degummed olive oil is heated to 70-85℃ under vacuum conditions of -0.05 ~ -0.07 MPa, and a NaOH alkaline solution with a concentration of 2-8 wt% is added. The mixture is stirred at a speed of 300-600 rpm for 10-30 minutes to form soapstock. Then, the soapstock is separated by centrifugation at 85-95℃. The separated olive oil is then washed with water until the washing wastewater is neutral. Finally, it is dehydrated and dried to obtain pretreated olive oil.
8. The use of the coenzyme Q10-containing composition according to claim 1 in the preparation of health products with antioxidant or immune-enhancing effects.
9. A health product containing coenzyme Q10, characterized in that, The composition comprising the coenzyme Q10-containing composition of claim 1, and pharmaceutically acceptable excipients; The excipients are selected from one or more of magnesium stearate, micronized silica gel, sodium carboxymethyl cellulose, and erythritol.
10. The health product according to claim 9, characterized in that, The dosage forms of the health products containing coenzyme Q10 include capsules, granules, and tablets.