Compound diol plastid, preparation method and application thereof

Abstract

The present invention provides a compound diol plastid, a preparation method and application thereof. The compound diol plastid comprises a scutellaria baicalensis extract, a phellodendron amurense extract, an auxiliary material and a solvent, wherein the solvent comprises alcohol and water, the alcohol comprises ethanol and propylene glycol, the auxiliary material comprises lecithin and / or cholesterol, wherein the volume ratio of the auxiliary material to the solvent is (9.5-11.6):1, the volume ratio of the alcohol to the solvent is (0.38-0.63):1, and the volume ratio of the ethanol to the alcohol is (0.38-0.63):1. The above-mentioned compound diol plastid provided in the present application can improve the encapsulation rate of the drug component, and has a small particle size and high stability, and achieves the effect of promoting the transdermal absorption of the active ingredient, thereby achieving the purpose of improving the bioavailability of the drug and enhancing the therapeutic effect.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine preparations, and in particular to a compound diol plastid, a preparation method and application thereof. Background Art

[0002] Qinbai ointment is a commonly used external preparation, the main ingredients of which are scutellaria baicalensis and phellodendron chinense. It has the effects of clearing away heat and dampness, reducing swelling and relieving pain. It is mainly used to treat heat-toxic sores and furuncles, and is now mostly used to treat psoriasis, folliculitis, dermatitis, eczema, etc. The commonly used Qinbai ointment formula is prepared by grinding the medicinal materials into powder and then mixing them with vaseline. However, since the diseased skin it targets is mostly epidermal hyperplasia with obvious inflammatory infiltration, showing redness, swelling, heat, and pain, the original ointment is made by directly adding the medicinal materials into the vaseline matrix after crushing the medicinal materials, and the active ingredients are difficult to absorb, and a long time and large dosage are required to achieve a certain therapeutic effect.

[0003] In view of the existence of the above problems, in order to improve the clinical efficacy of Qinbai Paste, it is necessary to provide a dosage form with a higher absorption rate, which is of great significance for the absorption of active ingredients and shortening the efficacy time. Summary of the invention

[0004] The main purpose of the present invention is to provide a compound diol plastid, a preparation method and application thereof, so as to solve the problem that the active ingredients in the existing Qinbai paste are difficult to absorb and require a long time and a large amount of medicine to achieve a certain therapeutic effect.

[0005] In order to achieve the above-mentioned purpose, the present invention provides a compound diol plastid on the one hand, which comprises a scutellaria baicalensis extract, a phellodendron amurense extract, an auxiliary material and a solvent, wherein the solvent comprises alcohol and water, the alcohol comprises ethanol and propylene glycol, the auxiliary material comprises lecithin and / or cholesterol, wherein the volume ratio of the auxiliary material to the solvent is (9.5-11.6):1, the volume ratio of the alcohol to the solvent is (0.38-0.63):1, and the volume ratio of ethanol to alcohol is (0.38-0.63):1.

[0006] Furthermore, the weight percentage of lecithin accounts for 75-100wt% of the auxiliary material; preferably, the auxiliary material also includes an auxiliary surfactant, and the auxiliary surfactant is preferably selected from one or more of Tween, Poloxamer and Span; the volume ratio of the auxiliary material to the solvent is preferably (9.5-10.5):1; the volume ratio of the alcohol to the solvent is preferably (0.38-0.42):1; the volume ratio of ethanol to alcohol is preferably (0.57-0.63):1.

[0007] In order to achieve the above-mentioned object, another aspect of the present invention further provides a preparation, which comprises the above-mentioned composite diol plastid provided in the present application.

[0008] Further, the preparation is selected from ointment, cream, gel, film, lotion, tincture or liniment.

[0009] Another aspect of the present invention provides a method for preparing the above-mentioned compound diol plastid provided in the present application, and the method for preparing the compound diol plastid comprises: preparing the compound diol plastid using Scutellaria baicalensis extract, Phellodendron amurense extract, auxiliary materials and solvent as raw materials, and during the preparation process, intermittently turning on an ultrasonic device in the presence of an ice water bath.

[0010] Furthermore, the preparation process of the compound diol plastid includes: mixing the scutellaria baicalensis extract, the phellodendron amurense extract and the auxiliary materials to form a precursor solution; and adding a solvent to the precursor solution, intermittently turning on the ultrasonic device in the presence of an ice water bath, filtering, and forming the compound diol plastid; preferably, 50-70% ethanol is used to extract scutellaria baicalensis to obtain the scutellaria baicalensis extract; preferably, 50-70% ethanol is used to extract phellodendron amurense to obtain the phellodendron amurense extract; more preferably, the preparation time of the compound diol plastid is 5-10 minutes, and the time of a single ultrasonic action is 5-15 seconds, and the time interval between two adjacent ultrasonic actions is 5-10 seconds; more preferably, the ultrasonic power is 5-20kHz, and further preferably 9.5-10.5kHz; more preferably, the temperature of the preparation process is 30-40°C; more preferably, the water addition rate is 1-2mL / min.

[0011] Furthermore, the weight percentage of lecithin accounts for 77.9-86.1wt% of the auxiliary materials.

[0012] Furthermore, the preparation steps of the Scutellaria baicalensis extract include: heating and refluxing Scutellaria baicalensis and a first organic solvent to obtain a first extract; and subjecting the first extract to a first spray drying to obtain the Scutellaria baicalensis extract; preferably, the temperature of the first spray drying process is 150 to 200°C; preferably, the liquid inlet rate of the first spray drying process is 15 to 25 mL / min.

[0013] Furthermore, the preparation steps of the Phellodendron chinense extract include: heating and refluxing Phellodendron chinense and a second organic solvent to obtain a second extract; and subjecting the second extract to a second spray drying to obtain the Phellodendron chinense extract; preferably, the temperature of the second spray drying process is 150 to 200°C; preferably, the liquid inlet rate of the second spray drying process is 15 to 30 mL / min; more preferably, the first organic solvent and the second organic solvent are 50 to 70% ethanol.

[0014] Another aspect of the present invention provides an application of the above-mentioned compound diol protoplast provided by the present application, or the above-mentioned preparation provided by the present application, or the preparation method of the above-mentioned compound diol protoplast provided by the present application in the preparation of a drug for treating psoriasis, folliculitis, dermatitis or eczema.

[0015] Another aspect of the present invention provides an application of the above-mentioned compound diol plasmid provided by the present application, or the above-mentioned preparation provided by the present application, or the preparation method of the above-mentioned compound diol plasmid provided by the present application in the treatment or prevention of psoriasis, folliculitis, dermatitis or eczema.

[0016] By applying the technical solution of the present invention, the above-mentioned compound diol plasmid provided in the present application can improve the encapsulation rate of drug ingredients, have a smaller particle size and higher stability, and achieve the effect of promoting the transdermal absorption of active ingredients, thereby achieving the purpose of improving the bioavailability of drugs and enhancing the therapeutic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0018] Figure 1 The electron microscope image of the composite diol plastid prepared according to Example 28 of the present invention is shown;

[0019] Figure 2 The graph shows the relationship between the in vitro cumulative transdermal absorption amount Q of baicalin in the Qinbaifang extract and the compound diol plastid and time during the in vitro transdermal absorption study of the compound diol plastid;

[0020] Figure 3 The graph shows the relationship between the in vitro cumulative transdermal absorption amount Q of the Qinbaifang extract and the berberine in the compound diol plastid and time during the in vitro transdermal absorption study of the compound diol plastid;

[0021] Figure 4 A bar graph showing the intradermal retention of baicalin and berberine in the Qinbaifang extract and the compound diol plastids during the in vitro transdermal absorption study of the compound diol plastids. DETAILED DESCRIPTION

[0022] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below in conjunction with the embodiments.

[0023] As described in the background art, the active ingredients in the existing Qinbai ointment are difficult to absorb, and a long time and a large amount of medicine are required to achieve a certain therapeutic effect. In order to solve the above technical problems, the first aspect of the present application provides a compound diol plasmid, which includes a scutellaria baicalensis extract, a phellodendron chinense extract, an auxiliary material and a solvent, wherein the solvent includes alcohol and water, the alcohol includes ethanol and propylene glycol, and the auxiliary material includes lecithin and / or cholesterol, wherein the volume ratio of the auxiliary material to the solvent is (9.5-11.6):1, the volume ratio of the alcohol to the solvent is (0.38-0.63):1, and the volume ratio of ethanol to alcohol is (0.38-0.63):1.

[0024] Ethanol can dissolve lipids and drugs well, but it is easy to volatilize and easily lead to instability of ethosomes. However, the combination of ethanol and a solvent that is not easy to volatilize and can strengthen the stability of ethosomes can dissolve lipids and drugs while ensuring the stability of ethosomes.

[0025] The above-mentioned compound diol plasmid provided in the present application can improve the encapsulation rate of drug ingredients, has a smaller particle size and higher stability, and can achieve the effect of promoting the transdermal absorption of active ingredients, thereby achieving the purpose of improving the bioavailability of drugs and enhancing the therapeutic effect.

[0026] In order to improve the stability of the ethosomes and reduce the particle size of the ethosomes, in a preferred embodiment, the weight percentage of lecithin accounts for 75-100wt% of the auxiliary material. Preferably, the weight percentage of lecithin accounts for about 82% of the auxiliary material.

[0027] It should be noted that the term "about" or "approximately" in this application with respect to a numerical value means ±5% of the numerical value, but explicitly includes the exact numerical value. For example, "approximately" 82% weight percentage refers to a weight percentage from 77.9% to 86.1%, but also explicitly includes a weight percentage of exactly 82%.

[0028] In order to improve the solubility of each component, preferably, the auxiliary material also includes a co-surfactant. In order to further improve the solubility of each component, preferably the co-surfactant includes but is not limited to one or more of Tween, Poloxamer and Span.

[0029] In a preferred embodiment, the volume ratio of the excipient to the solvent is (9.5-10.5): 1. The volume ratio of the excipient to the solvent includes but is not limited to the above range, and limiting it within the above range is beneficial to improving the stability of the alcohol body and inhibiting the aggregation and fusion of the alcohol body. Preferably, the volume ratio of the excipient to the solvent is 10: 1.

[0030] In a preferred embodiment, the volume ratio of alcohol to solvent is (0.38-0.42):1. The volume ratio of alcohol to solvent includes but is not limited to the above range, and limiting it within the above range is beneficial to further improve the stability of ethosomes and further reduce the particle size of ethosomes, thereby facilitating better dissolution of lipids and making aggregation and fusion more difficult. Preferably, the volume ratio of alcohol to solvent is about 0.4:1.

[0031] It should be noted that a volume ratio of “about” 0.4:1 refers to a volume ratio of from 0.38:1 to 0.42:1, but also explicitly includes a volume ratio of exactly 0.4:1.

[0032] In a preferred embodiment, the volume ratio of ethanol to alcohol is (0.57-0.63): 1. The volume ratio of ethanol to alcohol includes but is not limited to the above range, and limiting it within the above range is beneficial to further improve the stability of the alcohol body and further reduce the particle size of the alcohol body. Preferably, the volume ratio of ethanol to alcohol is about 0.6: 1.

[0033] It should be noted that a volume ratio of “about” 0.6:1 refers to a volume ratio of from 0.57:1 to 0.63:1, but also explicitly includes a volume ratio of exactly 0.6:1.

[0034] The second aspect of the present application also provides a preparation, which comprises the above-mentioned compound diol plastid provided in the present application. The above-mentioned compound diol plastid provided in the present application can improve the encapsulation rate of the drug components, has a smaller particle size and higher stability, and can achieve the effect of promoting the transdermal absorption of the active ingredients, thereby achieving the purpose of improving the bioavailability of the drug and enhancing the therapeutic effect. Therefore, the above-mentioned preparation provided in the present application has a higher absorption rate and a shorter therapeutic effect time.

[0035] In a preferred embodiment, the preparation includes, but is not limited to, an ointment, a cream, a gel, a paint, a lotion, a tincture or a liniment.

[0036] The third aspect of the present application also provides a method for preparing the above-mentioned compound diol plasmid provided by the present application, and the method for preparing the compound diol plasmid comprises: preparing the compound diol plasmid using Scutellaria baicalensis extract, Phellodendron amurense extract, auxiliary materials and solvents as raw materials, and during the preparation process, intermittently turning on an ultrasonic device in the presence of an ice water bath.

[0037] In the above preparation method, the effective ingredients in the medicinal materials of Scutellaria baicalensis and Phellodendron chinense are first extracted, and then the extract is dried into powder; under the conditions of ice-water bath and specific ultrasonic action, the above powder is subjected to alcohol body inclusion with auxiliary materials and solvent to prepare a compound diol body. The alcohol body has a phospholipid bilayer structure similar to that of a cell membrane, and is easy to penetrate and fuse with the cell membrane. At the same time, under the above-mentioned specific raw material ratio, ultrasonic conditions and ice-water bath, the prepared compound diol body has a small particle size and a high drug encapsulation rate; based on the above two factors, the compound diol body prepared by the above preparation method can improve the encapsulation rate of the drug components and achieve the effect of promoting the transdermal absorption of the effective ingredients, thereby achieving the purpose of improving the bioavailability of the drug and enhancing the efficacy. At the same time, the above preparation method also has the advantages of simple operation, low cost and short preparation cycle.

[0038] In a preferred embodiment, the preparation process of the compound diol plastid comprises: mixing the scutellaria baicalensis extract, the phellodendron amurense extract and the auxiliary materials to form a precursor solution; and adding the solvent to the precursor solution, intermittently turning on the ultrasonic device in the presence of an ice water bath, filtering, and forming the compound diol plastid.

[0039] In order to improve the yield of the scutellaria baicalensis extract, preferably, 50-70% ethanol is used to extract the scutellaria baicalensis to obtain the scutellaria baicalensis extract.

[0040] In order to improve the yield of the Phellodendron amurense extract, preferably, 50-70% ethanol is used to extract the Phellodendron amurense to obtain the Phellodendron amurense extract.

[0041] In order to ensure the dispersibility of the alcohol body and further improve the stability of the alcohol body, more preferably, the preparation time of the compound diol body is 5 to 10 minutes, the single ultrasonic action time is 5 to 15 seconds, and the time interval between two adjacent ultrasonic actions is 5 to 10 seconds.

[0042] In order to further reduce the particle size of the ethosome while ensuring the stability of the ethosome, more preferably, the ultrasonic power is 5 to 20 kHz, and more preferably 9.5 to 10.5 kHz. Preferably, the ultrasonic power is about 10 kHz.

[0043] It should be noted that the ultrasonic power of “about” 10 kHz refers to the ultrasonic power from 9.5 kHz to 10.5 kHz, but also explicitly includes the ultrasonic power of just 10 kHz.

[0044] In a preferred embodiment, the temperature of the preparation process is 30-40°C.

[0045] In a preferred embodiment, the water addition rate is 1-2 mL / min.

[0046] In order to improve the stability of the ethosomes and reduce the particle size of the ethosomes, in a preferred embodiment, the weight percentage of lecithin accounts for 77.9-86.1wt% of the auxiliary material.

[0047] In a preferred embodiment, the preparation steps of the Scutellaria baicalensis extract include: heating and refluxing Scutellaria baicalensis and a first organic solvent to obtain a first extract; and subjecting the first extract to a first spray drying to obtain the Scutellaria baicalensis extract; preferably, the temperature of the first spray drying process is 150 to 200°C; preferably, the liquid inlet rate of the first spray drying process is 15 to 25 mL / min.

[0048] In the present invention, heating scutellaria baicalensis and the first organic solvent for reflux can effectively extract the effective components in scutellaria baicalensis to obtain the first extract; and spray drying the first extract is beneficial to improving the encapsulation rate of baicalin in the ethosome.

[0049] In a preferred embodiment, the preparation steps of the Phellodendron chinense extract include: heating and refluxing Phellodendron chinense and a second organic solvent to obtain a second extract; and subjecting the second extract to a second spray drying to obtain the Phellodendron chinense extract; preferably, the temperature of the second spray drying process is 150 to 200°C; preferably, the liquid inlet rate of the second spray drying process is 15 to 30 mL / min; more preferably, the first organic solvent and the second organic solvent are 50 to 70% ethanol.

[0050] Heating and refluxing Phellodendron chinense and the second organic solvent can effectively extract the active ingredients in Phellodendron chinense to obtain the second extract. Spray drying the second extract is beneficial to controlling the entrapment rate of berberine in the ethosome.

[0051] The first organic solvent and the second organic solvent can be selected from commonly used types in the art. In order to further improve the extraction rate of the effective components, preferably, the first organic solvent and the second organic solvent are 40-60% ethanol.

[0052] The fourth aspect of the present application also provides an application of the above-mentioned compound diol protoplast provided by the present application, or the above-mentioned preparation provided by the present application, or the preparation method of the above-mentioned compound diol protoplast provided by the present application in the preparation of a drug for treating psoriasis, folliculitis, dermatitis or eczema.

[0053] The compound diol plastid prepared by the above preparation method can improve the encapsulation rate of the drug components and achieve the effect of promoting the transdermal absorption of the active ingredients, thereby achieving the purpose of improving the bioavailability of the drug and enhancing the therapeutic effect. At the same time, the above preparation method also has the advantages of simple operation, low cost and short preparation cycle. At the same time, the above preparation method also has the advantages of simple operation, low cost and short preparation cycle. When the above preparation method is used to prepare drugs for treating psoriasis, psoriasis, folliculitis, dermatitis or eczema, the transdermal absorption rate and efficacy of the drug can be improved.

[0054] The present application is further described in detail below in conjunction with specific embodiments. These embodiments should not be construed as limiting the scope of protection claimed in the present application.

[0055] Preparation of Scutellaria baicalensis and Phellodendron amurense extracts

[0056] Weigh 500g of Phellodendron chinense (batch number 16050702, Beijing Xinglin Pharmaceutical Co., Ltd.), add 10 times the amount of 60% ethanol and reflux extract 3 times, the time is 1h, 1h, 0.5h respectively, combine the filtrate, filter, recover the ethanol and concentrate to an appropriate amount. Set the spray drying temperature to 180℃, the liquid feeding speed to 25mL / min, collect the powder, weigh and record 33g, and the paste rate is 6.6%. Calculation shows that 0.39g of Scutellaria baicalensis powder is equivalent to 1g of crude drug.

[0057] Weigh 500g of Scutellaria baicalensis (batch number 16102503, Beijing Xinglin Pharmaceutical Co., Ltd.), add 10 times the amount of 60% ethanol and reflux extract 3 times, the time is 1h, 1h, 0.5h respectively, combine the filtrate, filter, recover the ethanol and concentrate to an appropriate amount. Set the spray drying temperature to 180℃, the liquid feeding speed to 18mL / min, collect the powder, weigh and record 118g, and the paste yield is 23.6%. Calculation shows that 0.11g of Phellodendron chinense powder is equivalent to 1g of crude drug.

[0058] Determination of the content of main components in the extract of Qinbai

[0059] (1) Solution preparation

[0060] Preparation of baicalin reference solution: Take an appropriate amount of baicalin reference, weigh accurately, add methanol to make a solution containing 0.875 mg of baicalin per 1 mL.

[0061] Preparation of berberine reference solution: Take an appropriate amount of berberine reference solution, accurately weigh it, add methanol to make a solution containing 0.0862 mg of berberine per 1 mL.

[0062] Preparation of the test solution of Scutellaria baicalensis extract: take about 0.1 g of Scutellaria baicalensis extract, add 20 mL of methanol, weigh the weight, ultrasonicate for 30 min, cool, weigh again, make up the lost weight with methanol, shake well, filter with a microporous filter membrane, and take the filtrate as the test solution of Scutellaria baicalensis extract.

[0063] Preparation of Phellodendron chinense test solution: Take about 0.1 g of Phellodendron chinense extract, add 20 mL of methanol, weigh the weight, ultrasonicate for 30 min, cool, weigh again, make up the lost weight with methanol, shake well, filter with a microporous filter membrane, and take the filtrate as the test solution of Phellodendron chinense extract.

[0064] (2) Content determination

[0065] The chromatographic conditions were as follows:

[0066] Instrument: Waters Acquity H-class; Chromatographic column: Kromasil100-5PHENY (4.6mm×50mm, 5μm)

[0067] The mobile phase was acetonitrile and 0.3% formic acid water, the flow rate was 0.8 mL / min, and the column temperature was 40° C. The injection volume was 10 μl, and gradient elution was performed. The elution conditions are shown in Table 1.

[0068] Table 1

[0069] Time (min) Acetonitrile (vol%) 0.3% formic acid aqueous solution (vol%) 0 25 75 11.5 39 61

[0070] The external standard method was used to test the content of baicalin in the test solution of Scutellaria baicalensis extract, and the results are shown in Table 2; the external standard method was used to test the content of berberine in the test solution of Phellodendron amurense, and the test results are shown in Table 3.

[0071] Table 2

[0072] sample Baicalin content (%) 1 10.3888 2 10.3877 3 10.6347 Mean / % 10.4704 RSD / % 1.36

[0073] Table 3

[0074] sample Berberine content (%) 1 3.7632 2 3.7886 3 3.8861 Mean / % 3.8127 RSD / % 1.7

[0075] As shown in Tables 2 and 3, the average content of baicalin in the Scutellaria baicalensis extract is 10.4704%, and the average content of berberine in the Phellodendron amurense extract is 3.8127%.

[0076] Preparation of compound diol plasmids

[0077] (1) Lecithin and solvent usage ratio

[0078] Examples 1 to 5

[0079] 7.8 mg of Scutellaria baicalensis extract, 2.2 mg of Phellodendron amurense extract, and 100 mg of lecithin were accurately weighed and placed in a first conical flask, which was sealed with a turn-down stopper to prepare raw material solution 1. Raw material solutions 2 to 5 were prepared in the same manner.

[0080] Add 4 mL, 3.6 mL, 3.2 mL, 2.8 mL, and 2.4 mL of alcohol solvent (the volume ratio of anhydrous ethanol to propylene glycol is 6:4) to the above raw material solutions 1 to 5, and place them on a magnetic stirrer respectively, and stir them at a constant temperature at 37°C and 450 r / min until they are fully dissolved. Use a syringe to absorb the corresponding volume (mL) of purified water as shown in the table below (wherein the volume ratio of alcohol solvent to water is 2:3, for example: when the total volume of solvent (alcohol + water) is 10 mL, the purified water is 6 mL), add the liquid in the syringe to the above conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above conical flask in an ice water bath for ultrasonication (total working time is 10 minutes, ultrasonic power is 10kHz, ultrasonic operation and stop are performed alternately, ultrasonic operation time is 15 seconds, and ultrasonic stop time is 5 seconds). The above was taken out and cooled to room temperature, filtered through a 0.22 μm microporous filter membrane, and sealed and stored at room temperature to obtain the desired compound diol protists 1 to 5.

[0081] The particle size of the compound diol was tested using a Malvern laser particle size analyzer. The results are shown in Table 4.

[0082] Table 4

[0083]

[0084] It can be seen from Table 4 that the smaller the volume of solvent (alcohol solvent + water), the smaller the particle size of the ethosome. However, below 8 mL, a small amount of particles larger than 1000 nm begin to appear. The large particles are the aggregation and fusion of small particles, indicating that the ethosomes are oversaturated and prone to aggregation and fusion, making the solution unstable. The particle size distribution of the ethosomes prepared from 10 mL and 9 mL solutions is uniform. For the convenience of calculation, the ratio of the mass (mg) of lecithin to the volume (mL) of (alcohol solvent + water) is determined to be 10: (0.9-1).

[0085] (2) Effect of alcohol content

[0086] Examples 6 to 10

[0087] Accurately weigh 7.8 mg of Scutellaria baicalensis extract, 2.2 mg of Phellodendron chinense extract, and 100 mg of lecithin, put them into the first conical flask, and plug them with a turn-over stopper to ensure sealing conditions, as raw material liquid 6. Prepare raw material liquids 1, 7 to 10 in the same way. Add anhydrous ethanol and propylene glycol (the volume ratio of anhydrous ethanol to propylene glycol is 6:4) to the above conical flasks respectively, the corresponding volumes are shown in Table 5, and placed on a magnetic stirrer, at 37°C and 450r / min, constant temperature stirring until fully dissolved. Use a syringe to absorb the corresponding volume of purified water as shown in Table 5 (for example, when the alcohol content is 10%, the purified water is 9mL), and add the liquid in the syringe to each conical flask at a flow rate of 2mL / min. After the addition is completed, continue stirring for 30min. Place the above conical flask in an ice water bath for ultrasound (total working time is 10min, ultrasonic power is 10kHz, ultrasonic work and stop are alternated, ultrasonic working time is 15s, and ultrasonic stop time is 5s). The above was taken out and cooled to room temperature, filtered with a 0.22 μm microporous filter membrane, and sealed and stored at room temperature. The particle size of the compound diol plastid was tested using a Malvern laser particle size analyzer, and the results are shown in Table 5.

[0088] Table 5

[0089]

[0090] As shown in Table 5, if the alcohol content is too low, lipids cannot be completely dissolved and it is difficult to obtain alcohol bodies. If the alcohol content is too high, it is easy to volatilize, the alcohol bodies are unstable and easy to aggregate and fuse. Therefore, the optimal alcohol content (alcohol content = alcohol solvent volume / (alcohol solvent volume + water volume) × 100%) is 40%.

[0091] (3) Ratio of ethanol to propylene glycol in alcohol solvent

[0092] Examples 11 to 14

[0093] Accurately weigh 7.8 mg of Scutellaria baicalensis extract, 2.2 mg of Phellodendron chinense extract, and 100 mg of lecithin, put them into the first conical flask, and plug them with a turn-over stopper to ensure sealing conditions, as raw material solution 11. Prepare raw material solutions 12 to 14 in the same way. Add a mixed solution of anhydrous ethanol and propylene glycol to each of the above conical flasks (see Table 6 for the specific volume and volume ratio), place it on a magnetic stirrer, and stir it at a constant temperature at 37°C and 450r / min until it is fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to each conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above conical flask in an ice water bath and ultrasonicate (total working time is 10 min, ultrasonic power is 10 kHz, ultrasonic work and stop are alternated, ultrasonic work time is 15 s, and ultrasonic stop time is 5 s). Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature. The particle size of the compound diol was tested using a Malvern laser particle size analyzer. The results are shown in Table 6.

[0094] Table 6

[0095] Anhydrous ethanol (mL) Propylene glycol (mL) Volume ratio Particle size (nm) Embodiment 11 3.2 0.8 4∶1 Emulsion Example 12 2.4 1.6 3∶2 150 Example 13 1.6 2.4 2∶3 160 Embodiment 14 0.8 3.2 1∶4 Emulsion

[0096] As shown in Table 6, when the volume ratio of anhydrous ethanol to propylene glycol is 4:1 or 1:4, the results are both milky liquids, indicating that the preparation of the ethosome has failed; and when the volume ratio of anhydrous ethanol to propylene glycol is 3:2, the particle size of the ethosome is the smallest, which is a more preferred condition.

[0097] (4) Screening of ultrasonic process conditions

[0098] Examples 15 to 18

[0099] Weigh 7.8 mg of Scutellaria baicalensis extract, 2.2 mg of Phellodendron chinense extract, and 100 mg of lecithin in a conical flask, and plug it with a turn-over stopper to ensure sealing conditions, as raw material solution 15; prepare raw material solutions 16 to 18 in the same way. Add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the above-mentioned conical flask, place it on a magnetic stirrer, and stir it at a constant temperature at 37°C and 450 r / min until it is fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to the above-mentioned conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above-mentioned conical flask in an ice water bath for ultrasound (total working time is 10 minutes, ultrasonic power is 10kHz, ultrasonic work and stop are alternated, ultrasonic work time is 15 seconds, and ultrasonic stop time is 5 seconds). Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature. Each embodiment is measured in parallel 4 times. The ultrasonic power and the particle size of the compound diol solid obtained by Malvern laser particle size analyzer are shown in Table 7.

[0100] Table 7

[0101]

[0102] It can be seen from Table 7 that when the power is 10 kHz (50% of the rated power), the particle size of the alcohol body is the smallest.

[0103] (5) Lecithin to Cholesterol Ratio

[0104] Examples 19 to 24

[0105] Accurately weigh 7.8 mg of Scutellaria baicalensis extract, 2.2 mg of Phellodendron chinense extract, lecithin and cholesterol (the amount of lecithin and cholesterol added is shown in Table 8), put them into the first conical flask, and plug them with a turn-over stopper to ensure the sealing condition, as raw material solution 19. Prepare raw material solutions 20 to 24 in the same way. Add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the above conical flasks respectively, place them on a magnetic stirrer, and stir them at a constant temperature at 37°C and 450 r / min until they are fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to each conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above conical flask in an ice water bath for ultrasound (total working time is 10 min, ultrasonic power is 10 kHz, ultrasonic work and stop are alternated, ultrasonic work time is 15 s, and ultrasonic stop time is 5 s). Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature. The particle size of the compound diol was tested using a Malvern laser particle size analyzer. The results are shown in Table 8.

[0106] Table 8

[0107] Lecithin (mg) Cholesterol (mg) Particle size (nm) Zeta potential (mV) Embodiment 19 90 10 51.82 -1.24 Embodiment 20 88 12 50.27 -4.87 Embodiment 21 86 14 52.37 -4.49 Embodiment 22 84 16 53.57 -5.33 Embodiment 23 82 18 51.25 -8.9 Embodiment 24 80 20 87.99 -9.07

[0108] It can be seen from Table 8 that with the increase in the amount of cholesterol used, the absolute value of Zeta potential also increases, and the absolute value of Zeta potential is between 0 and 30 mV. The larger the value, the more stable the system. The absolute value of Zeta potential of the sample in Example 24 is slightly increased compared with the absolute value of Zeta potential of the sample in Example 23, but the particle size increases significantly. Therefore, the ratio of lecithin to cholesterol in the sample in Example 23 is the optimal ratio.

[0109] Establishment of the determination method for baicalin and berberine and its methodological investigation

[0110] (1) Linear relationship investigation

[0111] The results of the investigation using conventional methods in the field show that:

[0112] Baicalin has a good linear relationship within the range of 0.000625 μg to 1 μg, as shown in the figure, and the equation is: y = 4994311X-31168 (R = 0.9996);

[0113] Berberine has a good linear relationship within the range of 0.006 μg to 0.32 μg. The curve is shown in the figure, and the equation is: y=4994311X-31168 (R=0.9998).

[0114] (2) Precision test

[0115] The conventional method in the art was used to perform precision testing, and the test results showed that the content of baicalin RSD = 0.075% (n = 6) and the content of berberine RSD = 0.284% (n = 6), indicating that the UPLC equipment has good precision.

[0116] (3) Repeatability experiment

[0117] The test was repeated six times, and the average content of baicalin was calculated to be 0.172 mg / mL, RSD=1.045% (n=6), and the average content of berberine was 0.0152 mg / mL, RSD=0.982% (n=6), indicating that the optimized test sample preparation method has good reproducibility.

[0118] (4) Stability test

[0119] The above compound diol protease was sampled at 0, 1, 2, 4, 8, 16, and 24 hours of standing, and chromatographic analysis was performed. The results showed that the peak area RSD% of baicalin was 0.279 (n=6), and the peak area RSD% of berberine was 0.460 (n=6), indicating that the sample was stable within 24 hours.

[0120] (5) Sample recovery experiment

[0121] Accurately pipette 9 portions of compound diol protists with known content, 0.5 mL each, into 2 mL volumetric flask A, add 0.1 mg / mL baicalin reference methanol solution and 0.08 mg / mL berberine reference methanol solution to three portions, as low-concentration samples; add 0.2 mg / mL baicalin reference methanol solution and 0.16 mg / mL berberine reference methanol solution to three portions, as medium-concentration samples; add 0.4 mg / mL baicalin reference methanol solution and 0.32 mg / mL berberine reference methanol solution to three portions, as high-concentration samples. The mixture was fixed to volume with methanol, ultrasonically demulsified for 30 minutes, cooled to room temperature, 1 mL of methanol demulsified solution in volumetric flask A was accurately pipetted into 5 mL volumetric flask B, 50% methanol water (volume ratio) was diluted to the scale, filtered through a 0.22 μm filter membrane, and chromatographic analysis was performed. The experimental results of the recovery rate of baicalin added to the compound diol plastid are shown in Table 9, and the experimental results of the recovery rate of berberine added to the compound diol plastid are shown in Table 10.

[0122] Table 9

[0123]

[0124] Table 10

[0125]

[0126] Optimal drug-lipid ratio was selected based on encapsulation efficiency

[0127] The dialysis method was used to measure the encapsulation efficiency of the compound diol plastid. The dialysis bag was a ready-to-use dialysis bag with 18-10000 DRC membrane, which can pass compounds with a molecular weight of less than 10000 Daltons, with a pore size of about 5nm and a diameter of 1cm.

[0128] Accurately weigh the scutellaria extract, phellodendron extract, 82 mg lecithin and 18 mg cholesterol (see Table 11 for the amount of scutellaria extract and phellodendron extract added), put them into a conical flask, and plug them with a turn-over stopper to ensure sealing conditions as the raw material solution. Add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the above conical flask, place it on a magnetic stirrer, and stir at a constant temperature at 37°C and 450 r / min until it is fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to each conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is complete. Place the above conical flask in an ice water bath for ultrasound (total working time is 10 min, ultrasonic power is 10 kHz, ultrasonic working time is 15 s, and ultrasonic stop time is 5 s). Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature.

[0129] Take a dialysis bag with an effective length of 4 cm, accurately add 1 mL of the above compound diol plasmid (drug-to-lipid ratio see Table 11), clamp both ends and place in a 250 mL beaker. Add 200 g of purified water to the beaker as the dialysis receiving solution, and dialyze for 24 hours at 37 ° C and a stirring rate of 300 r / min. After the dialysis is completed, draw 100 mL of the dialysis receiving solution, evaporate to dryness in a water bath, add 2 mL of 50% methanol aqueous solution to the residue to dissolve, make up to volume, filter with a 0.22 μm microporous filter membrane, and determine the content of free drug MY by UPLC. Accurately draw 1 mL of the compound diol plasmid into a 2 mL volumetric flask A, make up to volume with methanol and ultrasonically demulsify for 30 minutes, cool to room temperature, accurately draw 1 mL of the methanol demulsification solution in volumetric flask A into a 5 mL volumetric flask B, dilute to scale with 50% methanol water (volume ratio), pass through a 0.22 μm filter membrane, and determine the total drug content MZ by UPLC. Calculate the encapsulation efficiency: Encapsulation efficiency % = (MZ-MY) / MZ×100%, the results are shown in Table 11.

[0130] Table 11

[0131]

[0132] As can be seen from Table 11, compared with the ethosomes with a drug-to-lipid ratio of 1:10, the drug content of the ethosomes with a drug-to-lipid ratio of 1:5 increased by 50%, the baicalin encapsulation rate decreased by 0.5 percentage points, and the berberine encapsulation rate decreased by 1.2 percentage points. The actual increase in the drug content in the ethosomes is relatively high, so the preferred drug-to-lipid ratio is 1:5.

[0133] Performance verification of the best formula:

[0134] The preparation method is as follows:

[0135] Weigh 15.6 mg of Scutellaria baicalensis extract, 4.4 mg of Phellodendron chinense extract, 82 mg of lecithin, and 18 mg of cholesterol in a conical flask, and plug it with a turn-over stopper to ensure sealing conditions, as raw material solution 28. Prepare raw material solutions 29 to 30 in the same way. Add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the above-mentioned conical flask, place it on a magnetic stirrer, and stir it at a constant temperature at 37°C and 450 r / min until it is fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to the above-mentioned conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above-mentioned conical flask in an ice water bath for ultrasound (total working time is 10 minutes, the ultrasound working time is 15 seconds, and the ultrasound stop time is 5 seconds). Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature. Each embodiment is measured in parallel 4 times. The particle size and Zeta potential of the compound diol protons obtained by Malvern laser particle size analyzer are shown in Table 12.

[0136] The appearance of the compound diol matrix was observed under an electron microscope, and the particle size and Zeta potential were measured. The feasibility, stability and repeatability of the process were verified. The transmission electron microscope image of the compound diol matrix prepared in Example 28 is shown in FIG. Figure 1 .

[0137] Table 12

[0138] Embodiment 28 Embodiment 29 Embodiment 30 Particle size (nm) 51.25 52.37 52.01 Zeta Potential -8.9 -8.6 -8.8 Baicalin encapsulation rate (%) 97.8 97.7 98.1 Berberine encapsulation rate (%) 33.3 35.1 33.9

[0139] It can be seen from Table 12 that the compound diol matrix prepared by the above formula has a smaller particle size, higher stability and higher encapsulation efficiency.

[0140] Study on the Transdermal Absorption of Compound Diols in Vitro

[0141] Comparative study on the in vitro transdermal permeability of Qinbaifang extract and Qinbaifang extract alcoholsomes. Compare the drug-containing alcoholsomes with the drug-containing alcohol solution with the same drug content and alcohol content.

[0142] Qinbaifang diol plastid: Weigh 15.6 mg of Scutellaria baicalensis extract, 4.4 mg of Phellodendron chinense extract, 82 mg of lecithin, and 18 mg of cholesterol in a conical flask, and plug it with a turn-over stopper to ensure sealing conditions, as raw material solution 28. Prepare raw material solutions 29 to 30 in the same way. Add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the above conical flask, place it on a magnetic stirrer, and stir it at a constant temperature at 37°C and 450 r / min until it is fully dissolved. Use a syringe to draw 6 mL of purified water, add the liquid in the syringe to the above conical flask at a flow rate of 2 mL / min, and continue stirring for 30 minutes after the addition is completed. Place the above conical flask in an ice water bath for ultrasonication (total working time is 10 minutes, the ultrasonic working time is 15 seconds, and the ultrasonic stop time is 5 seconds. Take out the above and cool it to room temperature, filter it with a 0.22 μm microporous filter membrane, and seal it for storage at room temperature.

[0143] Drug-containing alcohol solution: Weigh 15.6 mg of Scutellaria baicalensis extract and 4.4 mg of Phellodendron amurense extract into a conical flask, add 2.4 mL of anhydrous ethanol and 1.6 mL of propylene glycol to the conical flask, place on a magnetic stirrer, and stir at 37°C and 450 r / min until fully dissolved. Use a syringe to draw 6 mL of purified water, add it to the conical flask, and stir evenly.

[0144] Compound diol plasmids were prepared by modified Franz diffusion cell method. Fresh Balb / C mouse hairless skin was fixed between the supply chamber and the receiving chamber of the Franz diffusion cell, with the stratum corneum facing up. A 30% ethanol aqueous solution was added to the receiving chamber as the receiving solution. The bubbles between the receiving solution and the skin were removed. 2 mL of drug-containing alcohol plasmids or drug-containing alcohol solution was added to the supply chamber and sealed. The device was placed in a transdermal diffusion experimenter, the water bath temperature was about 37 ° C, and the magnetic rotor speed was 300 rpm. 3 mL of receiving solution was taken out at 2.4.8.12.16.20.24 h, and fresh receiving solution of the same volume and temperature was immediately added. The target components baicalin and berberine were determined by UPLC in the receiving solution. The cumulative transdermal absorption and intradermal retention of Qinbaifang extract and compound diol plasmids were compared in vitro.

[0145] (1) Cumulative transdermal absorption

[0146] The cumulative release per unit area Q (μg·cm) at each time point was calculated according to the following formula -2 ),

[0147]

[0148] Where V is the volume of the receiving liquid in the receiving chamber (6.6 mL), Xn is the component content measured at the nth sampling point (μg), Xi is the component content measured at the ith sampling point (μg), and S is the release area (2.0096 cm2 ), R is the sample injection volume (10 μL), and 3 represents 3 mL of receiving solution absorbed each time. The in vitro cumulative transdermal absorption of baicalin Q versus time t is plotted, as shown in Figure 2 The results of in vitro 24h transdermal release of baicalin from compound diol plasmids and drug-containing alcohol solution (n=6) are shown in Table 13.

[0149] Table 13

[0150] t(h)h <![CDATA[Drug-loaded ethosomes (μg·cm -2 )]]> <![CDATA[Drug-containing alcohol solution (μg·cm -2 )]]> 2 0.136 0.063 4 0.673 0.307 6 1.211 0.683 8 1.728 0.925 10 2.092 1.026 12 2.423 1.249 24 4.491 2.094

[0151] The relationship curve between the in vitro cumulative transdermal absorption of berberine in the extract of Qinbaifang and the compound diol plastid and time is shown in Figure 3 The results of 24h transdermal release of berberine in compound diol plasmids and drug-containing alcohol solution in vitro (n=6) are shown in Table 14.

[0152] Table 14

[0153]

[0154]

[0155] It can be seen from Tables 13 and 14 that ethosomes can increase the transdermal rate and cumulative release of baicalin and berberine in the Qinbai recipe.

[0156] (2) Determination of intradermal retention

[0157] After 24 hours, the skin was removed, the medication site was cut off, and the skin surface was wiped dry with an ethanol cotton ball. The skin was cut into pieces and placed in a 2mL EP tube. 0.5mL of 50% methanol water (volume ratio) solution was added. The mixture was homogenized by a homogenizer for 90 seconds, centrifuged at 12000r / min for 10min, and the supernatant was aspirated. The residue was rinsed twice with 50% methanol water (volume ratio), 0.5mL each time. The three solutions were combined and filtered through a 0.22μm microporous membrane. The intradermal retention per unit area was calculated by UPLC. The MG bar graph of the intradermal retention of baicalin and berberine in the Qinbaifang extract (containing the alcohol solution) and the compound diol plastid is shown in Figure 4 The skin retention of the compound diol plasmid and the drug-containing alcohol solution was compared (n=4). The comparison results are shown in Table 15.

[0158] Table 15

[0159] Baicalin (μg) Berberine (μg) Drug-containing ethosomes 11.406 7.852 Alcoholic solution containing medicine 10.035 4.821

[0160] In summary, compared with the drug-containing alcohol solution with the same alcohol content, the compound diol plasmid can significantly increase the intradermal retention and cumulative transdermal absorption of the drug, that is, it has a promoting effect on the transdermal absorption of the drug.

[0161] From the above description, it can be seen that the above embodiments of the present invention achieve the following technical effects: the compound diol plasmid significantly increases the intradermal retention and 24-hour cumulative transdermal absorption of the representative ingredients of baicalin and berberine in Qinbai Fang. It has a significant promoting effect on the transdermal absorption of drugs. Qinbai Fang diol plasmid, as a preparation intermediate, can be prepared into gels, creams, etc., which can be selected for different treatment diseases.

[0162] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the terms used in this way can be interchangeable where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those described herein, for example.

[0163] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A compound diol matrix, characterized in that: The compound diol plastid comprises scutellaria baicalensis extract, phellodendron amurense extract, auxiliary materials and solvent, wherein the solvent comprises alcohol and water, the alcohol comprises ethanol and propylene glycol, the auxiliary material is lecithin, wherein the volume ratio of the auxiliary material to the solvent is 10:(0.9-1), the volume ratio of the alcohol to the solvent is (0.4-0.5):1, and the volume ratio of the ethanol to the alcohol is (0.4-0.6):1; scutellaria baicalensis is extracted with 50-70% ethanol to obtain the scutellaria baicalensis extract; phellodendron amurense is extracted with 50-70% ethanol to obtain the phellodendron amurense extract.

2. A compound diol matrix, characterized in that: The compound diol plastid comprises scutellaria baicalensis extract, phellodendron amurense extract, auxiliary materials and solvent, wherein the solvent comprises alcohol and water, the alcohol comprises ethanol and propylene glycol, the auxiliary materials comprise lecithin and cholesterol, wherein the volume ratio of the auxiliary materials to the solvent is 10:1, the volume ratio of the alcohol to the solvent is 0.4:1, the volume ratio of the ethanol to the alcohol is 0.6:1, and the weight percentage of the lecithin accounts for 80-90wt% of the auxiliary materials; 50-70% ethanol is used to extract scutellaria baicalensis to obtain the scutellaria baicalensis extract; 50-70% ethanol is used to extract phellodendron amurense to obtain the phellodendron amurense extract.

3. The compound diol matrix according to claim 1 or 2, characterized in that: The auxiliary material further comprises an auxiliary surfactant, and the auxiliary surfactant is selected from one or more of Tween, Poloxamer and Span.

4. The compound diol matrix according to claim 2, characterized in that: The drug-to-lipid ratio is 1:

5.

5. The compound diol matrix according to claim 1, characterized in that: The volume ratio of the alcohol to the solvent is 0.4:

1.

6. The compound diol matrix according to claim 1, characterized in that: The volume ratio of the ethanol to the alcohol is 0.4:1 or 0.6:

1.

7. A preparation, characterized in that The preparation comprises the compound diol plastid according to claim 1 or 2.

8. The preparation according to claim 7, characterized in that The preparation is selected from ointments, creams, gels, paints, lotions, tinctures or liniments.

9. A method for preparing the composite diol matrix according to claim 1 or 2, characterized in that: The preparation method of the compound diol plastid comprises: The compound diol plastid is prepared using scutellaria baicalensis extract, phellodendron amurense extract, auxiliary materials and solvent as raw materials, and during the preparation process, an ultrasonic device is intermittently turned on in the presence of an ice water bath; The scutellaria baicalensis root is extracted with 50-70% ethanol to obtain the scutellaria baicalensis root extract; and the phellodendron amurense root is extracted with 50-70% ethanol to obtain the phellodendron amurense root extract.

10. The method for preparing the compound diol matrix according to claim 9, characterized in that: The preparation process of the compound diol plastid comprises: Mixing the scutellaria baicalensis extract, the phellodendron amurense extract and the auxiliary materials to form a precursor solution; and The solvent is added to the precursor solution, and in the presence of the ice-water bath, an ultrasonic device is intermittently turned on to filter and form the composite diol plastid.

11. The method for preparing the compound diol matrix according to claim 10, characterized in that: The preparation time of the compound diol protist is 5 to 10 minutes, the single ultrasonic action time is 5 to 15 seconds, and the time interval between two adjacent ultrasonic actions is 5 to 10 seconds.

12. The method for preparing the compound diol matrix according to claim 10, characterized in that: The ultrasonic power is 5 to 20 kHz.

13. The method for preparing the compound diol matrix according to claim 12, characterized in that: The ultrasonic power is 9.5-10.5 kHz.

14. The method for preparing the compound diol matrix according to claim 12, characterized in that: The ultrasonic power is 10 kHz.

15. The method for preparing the compound diol matrix according to claim 10, characterized in that: The temperature of the preparation process is 30-40°C.

16. The method for preparing a compound diol matrix according to claim 10, characterized in that: The water is added at a rate of 1 to 2 mL / min.

17. The method for preparing a compound diol matrix according to claim 10, characterized in that: The weight percentage of the lecithin accounts for 80-86.1wt% of the auxiliary material.

18. The method for preparing a compound diol matrix according to claim 9, characterized in that: The preparation steps of the scutellaria baicalensis extract include: heating the scutellaria baicalensis root and 50-70% ethanol under reflux to obtain a first extract; and The first extract is subjected to a first spray drying to obtain the Scutellaria baicalensis extract.

19. The method for preparing a compound diol matrix according to claim 18, characterized in that: The temperature of the first spray drying process is 150-200°C.

20. The method for preparing a compound diol matrix according to claim 18, characterized in that: The liquid feeding rate in the first spray drying process is 15-25 mL / min.

21. The method for preparing a compound diol matrix according to claim 9, characterized in that: The preparation steps of the Phellodendron chinense extract include: heating the Phellodendron chinense and 50-70% ethanol under reflux to obtain a second extract; and The second extract is subjected to a second spray drying to obtain the Phellodendron chinense extract.

22. The method for preparing a compound diol matrix according to claim 21, characterized in that: The temperature of the second spray drying process is 150-200°C.

23. The method for preparing a compound diol matrix according to claim 21, characterized in that: The liquid feeding rate of the second spray drying process is 15-30 mL / min.

24. Use of the compound diol plastid according to claim 1 or 2 or the preparation according to claim 7 or 8 in the preparation of a drug for treating psoriasis or folliculitis.

25. Use of the compound diol plastid according to claim 1 or 2 or the preparation according to claim 7 or 8 in the preparation of a drug for treating dermatitis.

26. Use of the compound diol plastid according to claim 1 or 2 or the preparation according to claim 7 or 8 in the preparation of a drug for treating eczema.

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