CN110967430A - Method for measuring dissolution curve of coenzyme Q10 capsule - Google Patents
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Abstract
The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining a dissolution curve of a coenzyme Q10 capsule. According to the method, the dissolution rates of the coenzyme Q10 capsule at different time points are measured by adopting a paddle method, and then a dissolution curve is drawn, wherein a dissolution medium is a mixed solution containing triton and polysorbate. The method solves the technical problem that the conventional dissolution determination method in the prior art cannot accurately measure the dissolution behavior of the coenzyme Q10 capsule, can better reflect the quality of the coenzyme Q10 capsule, enables the dissolution determination result to be closer to the in-vivo dissolution effect, and has practical reference significance.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining a dissolution curve of a coenzyme Q10 capsule.
Background
In order to comprehensively improve the quality of the domestic imitation drugs and reach the level consistent with the internal and external quality and curative effect of the original preparation, a scientific and reasonable solid preparation dissolution curve is formulated, which is an important step for improving the success rate of in vivo bioequivalence tests, and provides a basis for listing the characteristic dissolution curve of the drugs into the corresponding quality standard, thereby providing guarantee for the consistency of the quality among drug batches and the consistency of the drug quality before and after process change. At present, at the domestic synthesis and process level, impurity control is more than adequate, but in order to achieve in vivo bioequivalence, certain difficulty is still existed, in order to make prejudgment on in vivo bioequivalence tests and improve the success rate of bioequivalence tests, the establishment of an in vitro dissolution detection method with strong discrimination becomes the key and difficult point of the consistency evaluation work of solid oral preparations.
Coenzyme Q10(Coenzyme Q10, structure is as following formula 1) is also called ubiquinone, is a Coenzyme loosely combined with protein in respiratory chain, is a fat-soluble quinone compound widely existing in organism, and plays an important role in proton displacement and electron transfer in human respiratory chain.
Coenzyme Q10 is used as cell metabolism and cell respiration activator, is also an important antioxidant and nonspecific immunopotentiator, can inhibit mitochondrial peroxidation, and has effects of promoting oxidative phosphorylation reaction and protecting structural integrity of biological membrane. In addition, coenzyme Q10 has an enhancing effect on immune non-specificity, and can enhance the antibody production ability and improve T cell function. Coenzyme Q10 is essentially a metabolic activator, which can activate cellular respiration, accelerate the production of Adenosine Triphosphate (ATP) and perform the function of detoxification and emergency treatment; it can also change the anoxia state of cell and tissue, and has good protecting and improving effects on liver, brain, heart and nervous system, and can enhance in vivo nonspecific immune response. Proved by verification, the traditional Chinese medicine composition can be used for the adjuvant treatment of cardiovascular diseases (such as viral myocarditis and chronic cardiac insufficiency), hepatitis (such as viral hepatitis, subacute hepatic necrosis and chronic active hepatitis), and the comprehensive treatment of cancers (can relieve certain adverse reactions caused by radiotherapy, chemotherapy and the like).
Regarding the stability and solubility of coenzyme Q10, the solubility and stability of Q10 are reported by chengpojie et al in the document "solubility determination and stability investigation of coenzyme Q10", coenzyme Q10 is soluble in chloroform, benzene, acetone, ether or petroleum ether, is very slightly soluble in ethanol, and is insoluble in water; is easy to be damaged under alkaline and illumination conditions.
At present, the quality standard of the coenzyme Q10 capsules collected in pharmacopoeia of various countries does not stipulate the check of dissolution rate; the dissolution test method specified in the USP40 standard is limited to water-soluble coenzyme Q10, which is performed by paddle method at a rotation speed of 75 per minute, using 500ml of water as dissolution medium, and sampling at 60 minutes, with the limit being 75% of the indicated amount. However, the capsule is almost insoluble in water, and the difference of in vitro dissolution behavior between the capsule and the original preparation cannot be evaluated, so that the in vivo bioequivalence test is predicted.
Disclosure of Invention
The invention aims to overcome the defects of the existing standard, provides an evaluation method of a coenzyme Q10 capsule dissolution curve, has the characteristics of science, durability, reproducibility and the like, can be used for quality consistency (similarity) evaluation work of a simulated medicine and an original medicine, and can also provide guarantee for quality consistency among medicine batches.
In order to achieve the above object, the present invention provides the following technical solutions:
a method for measuring a dissolution curve of a coenzyme Q10 capsule comprises the steps of measuring the dissolution rates of the coenzyme Q10 capsule at different time points by adopting a paddle method, and then drawing the dissolution curve, wherein a dissolution medium is a mixed solution containing triton and polysorbate.
In the establishment process of the technical scheme of the invention, the influence of different dissolution methods on the dissolution behavior of the product is examined. At present, the standard of dissolution measurement is operated by a paddle method, and the coenzyme Q10 capsules float in a dissolution medium, so that the dissolution is preferably carried out by a paddle method with a settling basket, namely, the coenzyme Q10 capsules are filled into the settling basket and then dissolved by the paddle method.
The difficulty in the dissolution determination of coenzyme Q10 capsules lies in the screening of the dissolution medium. The inventor examines the influence of different dissolution media on the dissolution behavior of the coenzyme Q10 capsule. When water, a 5% polysorbate 80 solution, a 5% sodium lauryl sulfate solution, an isopropanol-1% polysorbate 80 solution (25:75), and a 5% triton x-100 solution were used as dissolution media, the coenzyme Q10 capsules were poorly soluble in the polysorbate 80 and sodium lauryl sulfate aqueous solutions, and were almost insoluble. For the medium of isopropanol and polysorbate 80, complete dissolution still cannot be achieved after 6 hours of dissolution, and isopropanol is an organic solvent and is not recommended to be used as a dissolution medium. Therefore, conventional surfactants and organic solvents are not suitable for the dissolution rate investigation of the product. In a 5% triton x-100 solution, coenzyme Q10 was eluted to some extent but not completely.
However, further experiments show that when the mixed solution containing the triton and the polysorbate is used as a dissolution medium, the coenzyme Q10 can be completely dissolved, and the coenzyme Q10 capsule has better distinguishing force for different processes and formulas.
Preferably, when the concentration of triton is 2 to 10 wt%, the effect of discrimination of the dissolution curve is further greatly improved as compared with other values within the concentration range defined in the present invention, and when the concentration is out of this range (particularly, when the concentration is more than 10%), the effect of discrimination is reduced.
Preferably, the polysorbate is polysorbate 80 at a concentration of 0.1 to 2 wt%.
In the establishment process of the technical scheme, the influence of different rotating speeds on the dissolution behavior of the product is examined. The product has poor solubility, and when the rotating speed is 50 revolutions per minute and 75 revolutions per minute, the product is slow in dissolution and is not suitable for comparison of similarity of dissolution behaviors, so the rotating speed is set as 100 revolutions per minute.
In the invention, the method for detecting the dissolution rate of the coenzyme Q10 capsule by adopting the paddle method comprises the following steps: according to 0931 dissolution determination method of four general rules of the Chinese pharmacopoeia 2015 edition, 1000mL of mixed solution containing triton and polysorbate is used as dissolution medium, the rotating speed is 100 revolutions per minute, the solution is taken at different time points, filtered and used as test solution, according to 0512 high performance liquid chromatography of four general rules of the Chinese pharmacopoeia 2015 edition, 275nm is used as detection wavelength, and the dissolution amount of the coenzyme Q10 capsule is determined and calculated.
In terms of setting of the sampling time, it is preferable to set 3 to 5 time points for sampling as a sample solution between 0 and 60min of the dissolution time and 2 to 3 time points for sampling as a sample solution after 60 min.
Further, samples were taken as test solutions at the dissolution times of 10, 15, 30, 45, 60, 90, and 120min, respectively.
When the method is adopted for determination, the dissolution rate of the coenzyme Q10 capsule at 120min is more than 90%.
The invention further discovers that the following factors also have certain influence on the detection effect of the determination method among the influencing factors of the determination method, and further optimize the detection effect, so that the distinguishing effect of the whole technical scheme is further improved.
Preferably, the dissolution medium is degassed.
Preferably, the sampling is carried out, then the filtration is carried out, and the subsequent filtrate is taken for detection; filtration with a 0.22 μm filter is preferred.
Preferably, the dissolution rate is detected by high performance liquid chromatography, wherein the high performance liquid chromatography has the following chromatographic conditions:
a chromatographic column: using a Waters MicroBondapak C18 chromatographic column
Mobile phase: methanol: absolute ethanol 65:35
Flow rate: 1.0ml/min
Sample introduction volume: 20 μ l.
Further, the elution procedure is isocratic elution.
The invention also provides a method for evaluating the similarity of the dissolution curves of the coenzyme Q10 capsules, wherein a similarity factor method is adopted, the average dissolution rate data of a reference preparation and a test preparation at different time points are utilized to calculate a similarity factor f2, and the similarity factor f2 is used for evaluating the similarity between the reference preparation and the test preparation.
Compared with the prior art, the invention has the following beneficial effects:
(1) the method solves the technical problem that the conventional dissolution determination method in the prior art cannot accurately measure the dissolution behavior of the coenzyme Q10 capsule, can better reflect the quality of the coenzyme Q10 capsule, enables the dissolution determination result to be closer to the in-vivo dissolution effect, and has practical reference significance.
(2) The method has the characteristics of science, durability, reproducibility and the like, can effectively distinguish the influence of different prescriptions and process variables on the in-vitro release of the coenzyme Q10, can be used for evaluating the quality consistency of the imitation drugs and the original drugs, and can also provide guarantee for the quality consistency among drug batches, so that the quality of the drugs is guaranteed, and the consistency of the quality and the curative effect is achieved.
Drawings
FIG. 1 is the dissolution curves of three homemade samples and one original ground sample measured by the measuring method of the present invention
FIG. 2 is a graph showing the dissolution curves of six primary ground samples measured by the measuring method of the present invention
FIG. 3 is a dissolution curve of a home-made sample measured in triplicate by the assay method of the present invention.
Detailed Description
The method of the present invention is described below with reference to specific examples to make it easier to understand and understand the technical solution of the present invention, but the present invention is not limited thereto. The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials are commercially available, unless otherwise specified.
Study of dissolution methodology
1 selection of dissolution Medium
1.1 preparation of dissolution media
Weighing appropriate amount of Triton x-100 and polysorbate 80, adding water to dissolve, diluting to 1000mL, and shaking.
1.2 chromatographic conditions:
a chromatographic column: a Waters MicroBondapak C18(4.6 mm. times.150 mm, 10 μm) column was used
Mobile phase: methanol: anhydrous ethanol 65:35
Detection wavelength: 275nm
Flow rate: 1.0ml/min
Sample introduction volume: 20 mu L of the solution;
column temperature: 30 ℃;
isocratic elution.
1.3 dissolution Curve measuring method
After coenzyme Q10 capsules were filled in a sediment basket, mixed solutions A (5 wt% Triton, water), B (5 wt% Triton +0.1 wt% polysorbate 80 aqueous solution), C (5 wt% Triton +0.2 wt% polysorbate 80 aqueous solution), D (5 wt% Triton +0.5 wt% polysorbate 80 aqueous solution), E (5 wt% Triton +1 wt% polysorbate 80 aqueous solution) and F (5 wt% Triton +2 wt% polysorbate 80 aqueous solution) were used as dissolution media, and the rotation speed was 100 rpm, and 2mL of the solution was filtered at 10 min, 15 min, 30 min, 45 min, 60min, 90 min and 120min, respectively, and the solution was used as a test solution, and the dissolution media at the same temperature and the same volume were immediately supplemented; the cumulative dissolution rate (%) of coenzyme Q10 capsules was determined and calculated by taking the solutions at each time point according to the chinese pharmacopoeia 2015 edition of general rules 0512 high performance liquid chromatography, and the results are shown in table 1 below.
TABLE 1 cumulative dissolution Rate results of coenzyme Q10 capsules in different dissolution media
As can be seen from the data in table 1: when the triton solution is used as a dissolution medium, the accumulative dissolution rate of the coenzyme Q10 capsule is less than 65% in 120min, and when the mixed solution containing the triton and polysorbate 80 is used as the dissolution medium, the accumulative dissolution rate of the coenzyme Q10 capsule is more than 90% in 120 min. The dissolution behavior of the mixed solution E was further examined as follows.
Example 1
A method for measuring a dissolution curve of a coenzyme Q10 capsule specifically comprises the following steps:
dissolution medium: solution E (5 wt% triton +1 wt% polysorbate 80 aqueous solution) was mixed.
The dissolution curve of three batches of self-made samples and original ground samples of different prescriptions (table 2) is determined by adopting the dissolution determination method of 1.3, the difference of dissolution behaviors among different prescriptions is obvious, which shows that the method has stronger distinguishing effect and is suitable for determining the dissolution curve of the capsule, the specific determination result is shown in the following table 3, and the dissolution curve is shown in the attached figure 1.
TABLE 2 sample information
| Batch number | |
| Self-made sample 1 | Q-20190601 |
| Self-made sample 2 | Q-20190703 |
| Self-made sample 3 | Q-20190905 |
| Original preparation | 85A77S |
TABLE 3 measurement results of dissolution Profile of coenzyme Q10 Capsule
When the dissolution curve of a batch of original ground samples is measured by adopting the method, the relative standard deviation of the cumulative dissolution rate of six samples at different time points is better (less than 10 percent), which shows that the uniformity of the method is good, and the method is suitable for measuring the dissolution curve of the capsule, and the specific measurement results are shown in the following table 4, and the dissolution curve is shown in the attached figure 2.
TABLE 4 dissolution Curve measurements of six parallel particles of the same batch of the original sample
| Original research | 0min | 10min | 15min | 30min | 45min | 60min | 90min | 120min |
| 1 | 0 | 24.75 | 42.92 | 61.66 | 75.80 | 84.78 | 91.44 | 95.47 |
| 2 | 0 | 25.96 | 43.89 | 65.37 | 73.48 | 92.47 | 94.47 | 93.52 |
| 3 | 0 | 28.14 | 45.55 | 65.83 | 77.15 | 90.65 | 96.14 | 96.54 |
| 4 | 0 | 22.62 | 42.51 | 63.16 | 75.58 | 85.47 | 91.84 | 95.44 |
| 5 | 0 | 24.14 | 43.90 | 64.38 | 71.05 | 90.82 | 91.46 | 93.52 |
| 6 | 0 | 25.19 | 41.20 | 62.83 | 77.50 | 90.27 | 95.49 | 94.42 |
| |
0 | 25.13 | 43.33 | 63.87 | 75.09 | 89.08 | 93.47 | 94.82 |
| RSD％ | / | 7.37 | 3.41 | 2.51 | 3.25 | 3.55 | 2.29 | 1.27 |
The method is adopted to repeatedly measure the same batch of self-made samples for three times, the three measurement results have no obvious difference, the repeatability of the method is good, the method is suitable for measuring the dissolution curve of the capsule, the measurement results are shown in the following table 5, and the dissolution curve is shown in the attached figure 3.
TABLE 5 dissolution Curve measurements of the same batch of samples repeated three times
| Self- |
0min | 10min | 15min | 30min | 45min | 60min | 90min | 120min |
| For the |
0 | 26.35 | 38.28 | 58.65 | 72.06 | 79.51 | 94.37 | 97.03 |
| For the |
0 | 23.62 | 35.61 | 57.49 | 70.56 | 78.89 | 92.84 | 95.09 |
| The |
0 | 27.80 | 39.34 | 60.67 | 72.96 | 82.54 | 93.65 | 96.86 |
The method has strong distinguishing capability by combining the results, can distinguish the difference between different prescriptions, has the uniformity and the repeatability meeting the requirements, and is suitable for evaluating the difference between batches of the capsules, and can evaluate the difference of in-vitro dissolution behavior between the capsules and the original preparation, thereby making a prediction for in-vivo bioequivalence tests and improving the success rate of bioequivalence tests.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (9)
1. A method for measuring the dissolution curve of a coenzyme Q10 capsule comprises the steps of measuring the dissolution rates of the coenzyme Q10 capsule at different time points by adopting a paddle method, and then drawing the dissolution curve.
2. The method of determining the dissolution profile of coenzyme Q10 capsules according to claim 1, wherein the concentration of triton is 2 to 10 wt%.
3. The method for determining the dissolution profile of coenzyme Q10 capsule according to claim 1, wherein the polysorbate is present at a concentration of 0.1 to 2 wt%.
4. The method for determining the dissolution curve of the coenzyme Q10 capsule according to any one of claims 1 to 3, wherein the paddle method is used for detecting the dissolution of the coenzyme Q10 capsule: according to 0931 dissolution determination method of four general rules of the Chinese pharmacopoeia 2015 edition, 1000mL of mixed solution containing triton and polysorbate is used as dissolution medium, the rotating speed is 100 revolutions per minute, the solution is taken at different time points, filtered and used as test solution, according to 0512 high performance liquid chromatography of four general rules of the Chinese pharmacopoeia 2015 edition, 275nm is used as detection wavelength, and the dissolution amount of the coenzyme Q10 capsule is determined and calculated.
5. The method of claim 4, wherein the sample solutions are obtained at 10, 15, 30, 45, 60, 90 and 120min from the dissolution time of the coenzyme Q10 capsule.
6. The method for determining the dissolution curve of the coenzyme Q10 capsule, which is claimed in claim 5, wherein the dissolution rate of the coenzyme Q10 capsule at 120min is more than 90%.
7. The method for determining the dissolution curve of the coenzyme Q10 capsule according to claim 4, wherein the chromatographic conditions of high performance liquid chromatography are as follows:
a chromatographic column: using a Waters MicroBondapak C18 chromatographic column
Mobile phase: methanol: absolute ethanol 65: 35;
flow rate: 1.0ml/min
Sample introduction volume: 20 μ L.
8. The method of claim 4, wherein the elution profile of the coenzyme Q10 capsule is measured by the paddle method after the coenzyme Q10 capsule is placed in a basket.
9. The method for evaluating the similarity of the dissolution curves of the coenzyme Q10 capsules is characterized in that a similarity factor method is adopted, and the similarity factor f2 is calculated by using the average dissolution data of a reference preparation and a test preparation measured at different time points, wherein the similarity factor f2 is used for evaluating the similarity between the reference preparation and the test preparation.
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|---|---|---|---|---|
| CN111579672A (en) * | 2020-05-27 | 2020-08-25 | 北京康立生医药技术开发有限公司 | Coenzyme Q10 direct-pressure controlled release agent and analysis method |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981750A (en) * | 2005-12-16 | 2007-06-20 | 沈阳市万嘉生物技术研究所 | Soluble A-SH CoA-SH Q10 composition and its production |
| CN102293753A (en) * | 2010-06-25 | 2011-12-28 | 沈阳药科大学 | Coenzyme Q10 nanosuspension freeze-dried composition and preparation method and application thereof |
| WO2012040352A2 (en) * | 2010-09-21 | 2012-03-29 | The Cleveland Clinic Foundation | Methods for predicting and treating myocardial damage |
| CN103536574A (en) * | 2013-09-29 | 2014-01-29 | 邵爱霞 | Coenzyme Q10 soft capsule and preparation method thereof |
-
2019
- 2019-12-25 CN CN201911354365.3A patent/CN110967430B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1981750A (en) * | 2005-12-16 | 2007-06-20 | 沈阳市万嘉生物技术研究所 | Soluble A-SH CoA-SH Q10 composition and its production |
| CN102293753A (en) * | 2010-06-25 | 2011-12-28 | 沈阳药科大学 | Coenzyme Q10 nanosuspension freeze-dried composition and preparation method and application thereof |
| WO2012040352A2 (en) * | 2010-09-21 | 2012-03-29 | The Cleveland Clinic Foundation | Methods for predicting and treating myocardial damage |
| CN103536574A (en) * | 2013-09-29 | 2014-01-29 | 邵爱霞 | Coenzyme Q10 soft capsule and preparation method thereof |
Non-Patent Citations (5)
| Title |
|---|
| SHUQIN XIA 等: "Improved assay of coenzyme Q10 from liposomes by Tween 80 solubilisation and UV spectrophotometry", 《JOURNAL OF THE SCIENCE OF FOOD AND GRICULTURE》 * |
| 杨建龙 等: "茴拉西坦胶囊质量标准的改进", 《海峡药学》 * |
| 林宏琳 等: "HPLC法快速测定辅酶Q10 维生素E软胶囊中2种功效成分含量", 《药物分析杂志》 * |
| 梁翠荣 等: "辅酶Q10片与辅酶Q10胶囊溶出度试验方法的探讨", 《中国药事》 * |
| 秋翠: "难溶性药物的溶出试验中使用表面活性剂时注意事项", 《HTTPS://WWW.XIANJICHINA.COM/SPECIAL/DETAIL_395328.HTML》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111579672A (en) * | 2020-05-27 | 2020-08-25 | 北京康立生医药技术开发有限公司 | Coenzyme Q10 direct-pressure controlled release agent and analysis method |
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