CN110585137B - Preparation method of solid dispersion of magnolia officinalis alcohol extract - Google Patents
Preparation method of solid dispersion of magnolia officinalis alcohol extract Download PDFInfo
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Abstract
The invention provides a preparation method of solid dispersion of magnolia officinalis alcohol extract, which comprises the following steps: dissolving Magnolia officinalis ethanol extract lyophilized powder and carrier in ethanol solution, rotary evaporating to remove ethanol solution, drying, and pulverizing; the carrier consists of polyethylene glycol and poloxamer. The preparation method of the solid dispersion of the magnolia officinalis alcohol extract can prepare the solid dispersion of the magnolia officinalis alcohol extract with extremely high dissolution rate, is favorable for improving the total dissolution rate of magnolol and honokiol which are main effective ingredients of magnolia officinalis, improves the water solubility of the magnolia officinalis, improves the utilization rate of the magnolia officinalis, is convenient for further refining related preparations of the magnolia officinalis, and expands the clinical application.
Description
Technical Field
The invention relates to a preparation method of solid dispersion of magnolia officinalis alcohol extract.
Background
The cortex Magnolia officinalis is dry bark, root bark and branch bark of Magnolia officinalis of Magnoliaceae, Magnolia officinalis of Rhd. Hou Po is bitter and pungent in flavor and warm in nature. It enters spleen, stomach, lung and large intestine meridians. It can dry dampness, resolve phlegm, descend qi and remove fullness. Can be used for treating damp stagnation, abdominal distention, vomiting, diarrhea, food stagnation, qi stagnation, abdominal distention, constipation, phlegm retention, asthma, and cough. The main active ingredients in the magnolia officinalis, such as magnolol, honokiol and the like, are difficult to dissolve in water, the oral bioavailability is still low, the development of related product preparations is limited, and the clinical application is influenced. At present, the dissolution rate of the traditional Chinese medicine is improved from monomer components, and the characteristic of the overall action of multiple components of the traditional Chinese medicine is ignored.
Disclosure of Invention
In order to solve the problems, the invention provides a preparation method of solid dispersion of magnolia officinalis alcohol extract.
The invention provides a preparation method of solid dispersion of magnolia officinalis alcohol extract, which comprises the following steps:
dissolving Magnolia officinalis ethanol extract lyophilized powder and carrier in ethanol solution, rotary evaporating to remove ethanol solution, drying, and pulverizing;
the carrier consists of polyethylene glycol and poloxamer.
Further, the polyethylene glycol is polyethylene glycol 6000; the poloxamer is poloxamer 188.
Further, the mass ratio of the magnolia officinalis alcohol extract freeze-dried powder to the carrier is 1: 3-1: 9; the mass ratio of the polyethylene glycol to the poloxamer in the carrier is 1: 3-3: 1.
Further, the mass ratio of the magnolia alcohol extract freeze-dried powder to the carrier is 1: 5.4; the mass ratio of the polyethylene glycol to the poloxamer in the carrier is 0.9: 1.
Further, the ethanol solution is 80-95% ethanol solution; and/or the volume of the ethanol solution is 8-12 times (v/w) of the total mass of the magnolia officinalis alcohol extract freeze-dried powder and the carrier; preferably, the ethanol solution is 90% ethanol solution; and/or the volume of the ethanol solution is 10 times (v/w) of the total mass of the magnolia officinalis alcohol extract freeze-dried powder and the carrier.
Further, stirring the mixture when the mixture is dissolved in the ethanol solution, wherein the stirring time is 60-120 min; preferably, the stirring time is 115 min.
Further, the rotary evaporation condition is 70 ℃ water bath heating; and/or the drying is drying for 24 hours in a vacuum drying oven at 45 ℃; and/or, sieving the crushed materials by a 40-mesh sieve.
Further, the preparation method of the magnolia alcohol extract freeze-dried powder comprises the following steps:
taking mangnolia officinalis decoction pieces, crushing, carrying out hot reflux extraction on the mangnolia officinalis decoction pieces for 1-3 times by using 70-80% ethanol, filtering, combining filtrates, concentrating under reduced pressure, freeze-drying, and crushing to obtain the mangnolia officinalis decoction pieces; adding 6-10 times (v/w) of ethanol into the reflux extraction every time; the reflux extraction is carried out for 1-3 h each time.
Further, the preparation method of the magnolia alcohol extract freeze-dried powder comprises the following steps:
pulverizing cortex Magnolia officinalis decoction pieces, extracting with 70% ethanol under reflux for 2 times, filtering, mixing filtrates, concentrating under reduced pressure, freeze drying, and pulverizing; adding 8 times (v/w) of ethanol into the reflux extraction every time; the reflux extraction is carried out for 1.5h each time.
Further, the concentration under reduced pressure is carried out at 50 ℃ to recover the solvent until no alcohol smell exists.
In the invention, v/w is a volume-to-mass ratio and has a unit of mL/g.
The preparation method of the solid dispersion of the magnolia officinalis alcohol extract can prepare the solid dispersion of the magnolia officinalis alcohol extract with extremely high dissolution rate, is favorable for improving the total dissolution rate of magnolol and honokiol which are main effective ingredients of magnolia officinalis, improves the water solubility of the magnolia officinalis, improves the utilization rate of the magnolia officinalis, is convenient for further refining related preparations of the magnolia officinalis, and expands the clinical application.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Drawings
FIG. 1 shows the dissolution rates of solid dispersion of Magnolia officinalis alcohol extract prepared by different preparation methods.
FIG. 2 shows the dissolution rate of solid dispersion of Magnolia officinalis alcohol extract prepared with different carrier types.
FIG. 3 shows the dissolution rates of solid dispersion of Magnolia officinalis alcohol extract in different dissolution media.
Detailed Description
The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products. Wherein the decoction pieces of cortex Magnolia officinalis are collected from Shangjiang Honghua of Sichuan province, and identified as Magnoliaceae cortex Magnolia officinalis of fiscilalis Rehd.et Wils; magnolol (Dalian Meiren Biotechnology Co., Ltd., batch No. A0316AS, purity > 98%); honokiol reference (Dalian Meiren Biotechnology Co., Ltd., batch No. S0318AS, purity > 98%); polyethylene glycol 6000(PEG 6000); poloxamer 188 (F68).
Example 1 preparation method of solid dispersion of Magnolia officinalis alcohol extract of the present invention
1. Preparation of magnolia officinalis alcohol extract freeze-dried powder
Pulverizing cortex Magnolia officinalis decoction pieces to obtain coarse powder, weighing 1kg, extracting with 70% ethanol under reflux for 2 times, adding 8 times (v/w) of 70% ethanol each time, extracting for 1.5 hr, and filtering. Mixing the filtrates, concentrating under reduced pressure at 50 deg.C to recover solvent until no alcohol smell exists, freeze drying the extractive solution, and pulverizing to obtain Magnolia officinalis ethanol extract lyophilized powder (MOE).
2. Preparation of solid dispersion of magnolia officinalis alcohol extract
The solid dispersion of the magnolia officinalis alcohol extract is prepared by a solvent method. The specific method comprises the following steps:
weighing the Magnolia officinalis alcohol extract freeze-dried powder and a carrier according to the mass ratio of 1:5.4, wherein the carrier consists of polyethylene glycol 6000 and poloxamer 188 according to the mass ratio of 0.9: 1. Adding 10 times (v/w) of 90% ethanol into the lyophilized powder and vehicle, stirring with magnetic stirrer for 115min for dissolving, and mixing. Heating in 70 deg.C water bath, rotary evaporating to remove 90% ethanol, drying in vacuum drying oven at 45 deg.C for 24 hr, pulverizing, and sieving with 40 mesh sieve to obtain solid dispersion (MOE-SD) of cortex Magnolia officinalis ethanol extract.
The advantageous effects of the present invention are demonstrated by specific test examples below.
Experimental example 1 research on preparation of solid dispersion of alcoholic extract of Magnolia officinalis by different preparation methods
1. Test method
Different methods (solvent method, melting method, solvent-melting method and grinding method) are adopted to prepare the solid dispersion of the magnolia officinalis alcohol extract, and the optimal method for preparing the solid dispersion of the magnolia officinalis alcohol extract is researched.
A solvent method: the MOE prepared in example 1 and a carrier are weighed according to the mass ratio of 1:5, wherein the carrier is poloxamer 188. Adding 10 times (v/w) of 90% ethanol into the lyophilized powder and vehicle, stirring with magnetic stirrer for 115min for dissolving, and mixing. Heating in 70 deg.C water bath, rotary evaporating to remove 90% ethanol, drying in vacuum drying oven at 45 deg.C for 24 hr, pulverizing, and sieving with 40 mesh sieve to obtain solid dispersion (MOE-SD) of cortex Magnolia officinalis ethanol extract.
A melting method: the MOE prepared in example 1 and a carrier are weighed according to the mass ratio of 1:5, wherein the carrier is poloxamer 188. Putting the carrier in a crucible in water bath at 70 ℃ to reach a molten state, adding the weighed MOE, stirring for dissolving, uniformly mixing, quickly coating on the surface of a cooled steel plate, taking out after becoming brittle, putting in a vacuum drying oven, drying at 45 ℃ for 24h, drying, crushing, and sieving with a 40-mesh sieve to obtain the Magnolia officinalis alcohol extract solid dispersion (MOE-SD).
Solvent-melt method: the MOE prepared in example 1 and a carrier are weighed according to the mass ratio of 1:5, wherein the carrier is poloxamer 188. Putting the carrier in a crucible, heating in water bath at 70 ℃ to a molten state, adding 10 times (v/w) of MOE dissolved in 90% ethanol, stirring and mixing uniformly, removing the solvent in the solution by rotary evaporation, quickly coating on the surface of a cooled steel plate, taking out after becoming crisp, putting in a vacuum drying oven, drying at 45 ℃ for 24h, drying, crushing, and sieving with a 40-mesh sieve to obtain the magnolia officinalis alcohol extract solid dispersion (MOE-SD).
Grinding method: the MOE prepared in example 1 and a carrier are weighed according to the mass ratio of 1:5, wherein the carrier is poloxamer 188. And (3) placing the MOE and the carrier in a mortar, vigorously grinding, and sieving by a 40-mesh sieve to obtain the solid dispersion (MOE-SD) of the magnolia officinalis alcohol extract.
And (3) detecting the dissolution rate of the solid dispersion of the magnolia officinalis alcohol extract prepared by the 4 different methods. The specific detection method comprises the following steps: taking the solid dispersion (MOE-SD) of the magnolia officinalis alcohol extract containing 1g of MOE in each group, and directly putting the solid dispersion into a dissolving cup. According to the second method (Paddle method) of dissolution determination method [ pharmacopoeia of the people's republic of China 2015 edition of general rules of four departments 0931]900mL of artificial intestinal juice is used as a dissolution medium, and the rotating speed is 50 r.min-1The temperature of the dissolution liquid was (37. + -. 0.5) ℃ according to the method. Taking 5mL of solution after 5, 10, 15, 20, 30, 45, 60 and 120min respectively, adding the same volume of dissolution medium at the same temperature, taking out the solution, adding the same volume of methanol, filtering with 0.45 μm microporous membrane, and taking the subsequent filtrate as the sample solution. Taking the subsequent filtrate for sample chromatographic analysis. And calculating the accumulated total dissolution rate of the magnolol and the honokiol at different time points, and drawing a dissolution curve.
2. Test results
The test results are shown in FIG. 1.
As can be seen from fig. 1: the cumulative dissolution rate at 120min is solvent method > melting method > solvent-melting method > grinding method, so the solid dispersion of the magnolia officinalis alcohol extract prepared by the solvent method selected in the experiment effectively improves the total dissolution rate of magnolol and honokiol.
Experimental example 2 study on solid dispersion of Magnolia officinalis alcohol extract prepared by different types of carriers
1. Test method
The MOE prepared in example 1 is taken, the mass ratio of the MOE to the carrier is 1:5, and PEG6000, F68, hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP K30) and PEG600: F68 (mass ratio is 1:1) are respectively selected as the carrier. When the solid dispersion of the magnolia officinalis alcohol extract is prepared, only the types of the carriers are changed, and the rest parameters and the preparation method are the same as the example 1.
Detecting the dissolution rate of the solid dispersion of the magnolia officinalis alcohol extract prepared by the different carriers. The specific detection method was the same as in test example 1.
2. Test results
The test results are shown in FIG. 2.
As can be seen from fig. 2: the cumulative dissolution at 120min was PEG 6000: f68 is more than PEG6000 and more than F68 is more than PVP K30 and more than HPMC, and the combined carrier can improve the total dissolution rate of magnolol and honokiol. In order to avoid the aging problem caused by a single carrier, PEG6000-F68 is combined with the carrier to prepare the solid dispersion of the magnolia officinalis alcohol extract in the research.
Experimental example 3 dissolution rates of solid dispersion of Magnolia officinalis alcohol extract in different dissolution media
1. Test method
The solid dispersion of the magnolia bark alcohol extract prepared in example 1 is taken. The dissolution rates of the compound in artificial gastric juice, artificial intestinal juice and pure water are respectively considered.
About 1g of MOE-SD was directly charged into a dissolution cup. According to the second method (Paddle method) of dissolution determination method [ pharmacopoeia of the people's republic of China 2015 edition of general rules of four departments 0931]900mL of artificial gastric juice, artificial intestinal juice and pure water are taken as dissolution media and the rotating speed is 50 r.min-1The temperature of the dissolution liquid was (37. + -. 0.5) ℃ according to the method. Taking 5mL of solution after 5, 10, 15, 20, 30, 45, 60 and 120min respectively, adding the same volume of dissolution medium at the same temperature, taking out the solution, adding the same volume of methanol, filtering with 0.45 μm microporous membrane, and taking the subsequent filtrate as the sample solution. Taking the subsequent filtrate for sample chromatographic analysis. And calculating the accumulated total dissolution rate of the magnolol and the honokiol at different time points, and drawing a dissolution curve.
2. Test results
The test results are shown in FIG. 3.
As can be seen from fig. 3: the cumulative dissolution rate at 120min is pure water > artificial gastric juice > artificial intestinal juice. The total dissolution rate of magnolol and honokiol in pure water and artificial gastric juice of the solid dispersion of the magnolia alcohol extract is obviously superior to that in artificial intestinal juice.
Experimental example 4 Effect of other parameters on solid Dispersion of Magnolia bark alcohol extract of the present invention
1. Test method
The influence of the carrier ratio (the mass ratio of the polyethylene glycol 6000 to the poloxamer 188), the drug loading ratio (the mass ratio of the magnolia officinalis alcohol extract freeze-dried powder to the carrier) and the stirring time on the total dissolution rate of magnolol and honokiol of the solid dispersion of the magnolia officinalis alcohol extract in 60min is researched. The preparation method of the solid dispersion of each group of the magnolia officinalis alcohol extracts only changes the carrier ratio, the drug loading ratio, the concentration of the solvent ethanol and the stirring time according to the table 1, and the other parameters and the preparation method are completely the same as the example 1.
2. Test results
The dissolution rate of the solid dispersion of the magnolia officinalis alcohol extract in each group is detected according to the method described in the experimental example 1. The dissolution rate results of the solid dispersion of the magnolia officinalis alcohol extract prepared by the preparation methods are shown in table 1.
TABLE 1 dissolution of solid dispersion of alcoholic extract of Magnolia officinalis of the present invention under different parameters
The test result shows that: when the solid dispersion of the magnolia officinalis alcohol extract is prepared, when the mass ratio of the polyethylene glycol 6000 to the poloxamer 188 is 0.9:1, the mass ratio of the magnolia officinalis alcohol extract freeze-dried powder to the carrier is 1:5.4, the stirring time is 115min, and the rest parameters and the preparation method are completely the same as those in example 1, the obtained solid dispersion of the magnolia officinalis alcohol extract has the largest dissolution rate, and the obtained solid dispersion of the magnolia officinalis alcohol extract is optimal.
In conclusion, the preparation method of the solid dispersion of the magnolia officinalis alcohol extract can prepare the solid dispersion of the magnolia officinalis alcohol extract with extremely high dissolution rate, is favorable for improving the total dissolution rate of magnolol and honokiol which are main effective ingredients of magnolia officinalis, improves the water solubility of the magnolia officinalis, improves the utilization rate of the magnolia officinalis, is convenient for further refining related preparations of the magnolia officinalis, and expands the clinical application.
Claims (7)
1. A preparation method of solid dispersion of magnolia officinalis alcohol extract is characterized in that: it comprises the following steps:
dissolving Magnolia officinalis ethanol extract lyophilized powder and carrier in ethanol solution, rotary evaporating to remove ethanol solution, drying, and pulverizing;
the carrier consists of polyethylene glycol and poloxamer;
the polyethylene glycol is polyethylene glycol 6000; the poloxamer is poloxamer 188;
the mass ratio of the magnolia officinalis alcohol extract freeze-dried powder to the carrier is 1: 5.4; the mass ratio of the polyethylene glycol to the poloxamer in the carrier is 0.9: 1;
and stirring while dissolving in the ethanol solution, wherein the stirring time is 115 min.
2. The method of claim 1, wherein: the ethanol solution is 80-95% ethanol solution; and/or the volume of the ethanol solution is 8-12 times (v/w) of the total mass of the magnolia officinalis alcohol extract freeze-dried powder and the carrier.
3. The method of claim 2, wherein: the ethanol solution is 90% ethanol solution; and/or the volume of the ethanol solution is 10 times (v/w) of the total mass of the magnolia officinalis alcohol extract freeze-dried powder and the carrier.
4. The method of claim 1, wherein: the rotary evaporation condition is 70 ℃ water bath heating; and/or the drying is drying for 24 hours in a vacuum drying oven at 45 ℃; and/or, sieving the crushed materials by a 40-mesh sieve.
5. The method of claim 1, wherein: the preparation method of the magnolia officinalis alcohol extract freeze-dried powder comprises the following steps:
taking mangnolia officinalis decoction pieces, crushing, carrying out hot reflux extraction on the mangnolia officinalis decoction pieces for 1-3 times by using 70-80% ethanol, filtering, combining filtrates, concentrating under reduced pressure, freeze-drying, and crushing to obtain the mangnolia officinalis decoction pieces; adding 6-10 times (v/w) of ethanol into the reflux extraction every time; the reflux extraction is carried out for 1-3 h each time.
6. The method of claim 5, wherein: the preparation method of the magnolia officinalis alcohol extract freeze-dried powder comprises the following steps:
pulverizing cortex Magnolia officinalis decoction pieces, extracting with 70% ethanol under reflux for 2 times, filtering, mixing filtrates, concentrating under reduced pressure, freeze drying, and pulverizing; adding 8 times (v/w) of ethanol into the reflux extraction every time; the reflux extraction is carried out for 1.5h each time.
7. The method of claim 5, wherein: the reduced pressure concentration is carried out at 50 ℃, and the solvent is recovered by reduced pressure concentration until no alcohol smell exists.
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| CN105012242A (en) * | 2015-07-21 | 2015-11-04 | 南京中医药大学 | Solid dispersion prepared from magnolol, honokiol or mixture of magnolol and honokiol and preparation method of solid dispersion by hot-melt extrusion |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105012242A (en) * | 2015-07-21 | 2015-11-04 | 南京中医药大学 | Solid dispersion prepared from magnolol, honokiol or mixture of magnolol and honokiol and preparation method of solid dispersion by hot-melt extrusion |
Non-Patent Citations (2)
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| 厚朴总酚固体分散体不同制备方法的比较研究;李杰，等;《中国中药杂志》;20151130;第40卷(第22期);4400-4405 * |
| 厚朴酚-交联羧甲基纤维素钠固体分散体的制备及体外溶出研究;唐岚，等;《中国中药杂志》;20160229;第41卷(第3期);433-437 * |
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