Preparation process of traditional Chinese medicine volatile oil inclusion compound

Abstract

The present application relates to a kind of preparation process of traditional Chinese medicine volatile oil inclusion compound, belong to traditional Chinese medicine preparation technical field.The method is first mixed with phosphatidylserine and volatile oil to form mixture, then high-speed shearing emulsification is carried out by adding glycyrrhizic acid aqueous solution, the mixture is stored in three-dimensional network structure using the self-assembly characteristics of glycyrrhizic acid to form gel, then the gel is ground together with β-cyclodextrin under low temperature condition and is enclosed.This application can improve the stability of inclusion compound, and effectively reduce the loss of volatile oil in subsequent granulation drying process, with good industrial application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, and relates to a volatile oil inclusion complex of traditional Chinese medicine and its preparation process. Background Technology

[0002] Volatile oils are an important class of active ingredients found in aromatic Chinese medicinal herbs, possessing a wide range of pharmacological effects such as antibacterial, anti-inflammatory, and analgesic properties, and occupying a significant position in Chinese medicine preparations. However, volatile oil components typically have inherent defects such as high volatility, easy oxidative degradation, and poor water solubility, making them highly susceptible to loss during the extraction, concentration, drying, and storage of preparations, severely affecting the stability, efficacy, and quality consistency of the formulations. Studies have shown that after 10 days of exposure to light, high temperature, and high humidity, the loss rate of unprotected volatile oil components can reach 40%–70%, while the content in cyclodextrin inclusion complexes only decreases by 10%–20%.

[0003] Currently, cyclodextrin inclusion complex technology is one of the most widely used methods for stabilizing volatile oils in traditional Chinese medicine. Its principle is to utilize the hydrophobic cavities of cyclodextrin to encapsulate volatile oil molecules through intermolecular forces, forming stable inclusion complexes. For example, CN107158056A discloses a method for preparing Bupleurum chinense suppositories, which uses distillation to simultaneously extract Bupleurum chinense volatile oil and Bupleurum chinense saponins, encapsulates the volatile oil with β-cyclodextrin, and then mixes the inclusion complex with saponin extract to prepare suppositories. CN102114075B discloses a traditional Chinese medicine preparation for treating pediatric colds, which uses β-cyclodextrin to encapsulate Bupleurum chinense volatile oil, with an oil:β-cyclodextrin ratio of 1 ml:6 g, stirring time of 3 h, and temperature of 40 °C. CN107126458B discloses a method for preparing Bupleurum chinense granules, which uses grinding to encapsulate Bupleurum chinense volatile oil, with a volatile oil:β-cyclodextrin:water ratio of 1:6:18, a grinding gap of 2 mm, and grinding for 15 minutes.

[0004] However, existing cyclodextrin inclusion technologies still suffer from drawbacks such as low encapsulation efficiency (typically below 80%) and insufficient drug loading (most systems below 15%). Furthermore, there is a risk of secondary loss of volatile oils during subsequent formulation processing such as granulation and drying. Therefore, there is an urgent need to develop a novel inclusion technology system that can further improve the inclusion efficiency and stability of volatile oils. Summary of the Invention

[0005] This invention addresses the technical problems of low inclusion efficiency and high risk of secondary loss of volatile oil in the inclusion compound during subsequent granulation and drying processes of existing cyclodextrin inclusion technology by providing a volatile oil inclusion compound of traditional Chinese medicine and its preparation process.

[0006] The objective of this invention can be achieved through the following technical solutions: In a first aspect, the present invention provides a method for preparing a volatile oil inclusion complex of traditional Chinese medicine, comprising the following steps: (1) Take the medicinal materials, add water and reflux to extract, and collect the volatile oil; (2) Mix phosphatidylserine with the volatile oil from step (1) at a mass ratio of 1:2-3 to form a mixture; (3) Dissolve glycyrrhizic acid in water, heat to 60-70℃ to dissolve it, add the mixture from step (2), emulsify by high-speed shearing and then cool rapidly to obtain a gel; (4) Mix β-cyclodextrin with water, grind it evenly in a grinding device, then add the gel from step (3) and grind it at 20-30℃ for 30-60 minutes; (5) Discharge the inclusion compound and vacuum dry it to obtain the final product.

[0007] The volatile oils described in this invention refer to the general term for volatile oily components that are immiscible with water and are extracted from traditional Chinese medicinal materials through steam distillation. Their chemical composition is complex, mainly including terpenes, aromatic compounds, and aliphatic compounds, and they possess significant biological activity, but generally suffer from high volatility, poor stability, and low water solubility.

[0008] The medicinal materials mentioned in step (1) include one or more of the following: Astragalus membranaceus, stir-fried Atractylodes macrocephala, Codonopsis pilosula, Cimicifuga foetida, Bupleurum chinense, Angelica sinensis, Ligusticum chuanxiong, Mentha haplocalyx, Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, and Angelica dahurica.

[0009] After the medicinal materials are cleaned and selected, they undergo pre-processing: Remove impurities from Astragalus membranaceus, wash it, let it soak until thoroughly moistened, cut it into thick slices, and dry it at 70-80℃. After cleaning and slicing Atractylodes macrocephala, cut it into thick slices, dry it at 60℃, and then stir-fry it with honey-fried wheat bran (10 kg of honey-fried wheat bran for every 100 kg of Atractylodes macrocephala) until it turns yellowish-brown and releases a caramel aroma; Wash the Codonopsis pilosula, soak it thoroughly, cut it into thick slices, and dry it at 60-70℃. Wash the angelica root, spray it with water until it is thoroughly moistened, slice it thinly, and dry it at 50-60℃. Wash the chuanxiong rhizome, let it soak until thoroughly moistened, cut it into thick slices, and dry it at 50-60℃ until the moisture content is ≤8.0%; Soak and wash the Cimicifuga rhizome briefly until there is no dry core, then cut it into thick slices and dry at 70-80℃. Wash the Bupleurum root, let it soak until soft, cut it into thick slices, and dry it at 60-70℃ until the moisture content is ≤9.0%. Remove old stems and impurities from the mint, moisten it slightly, cut it into short sections, and dry it at low temperature; Remove impurities from catnip, wash it, soak it thoroughly, bake it at 50℃ for 1 hour, cut it into sections, and dry it. Spray the product with a windproof spray until thoroughly moistened, then cut into thick slices and dry at 70-80℃. Wash the Notopterygium root, soften it until there is no dry core, cut it into thick slices, and dry it at 50℃. Soak angelica root until thoroughly moistened, cut into thick slices, and dry at 50℃; Preferably, the conditions for water reflux extraction in step (1) are: add 8-12 times the weight of the medicinal material in water and reflux extract for 4-6 hours at a gentle boil.

[0010] Preferably, the mixing temperature in step (2) is 30-40℃ and the mixing time is 30-60 minutes.

[0011] Preferably, the mass ratio of glycyrrhizic acid to volatile oil in step (3) is 1:8-10.

[0012] Preferably, the emulsification time in step (3) is 2-4 minutes.

[0013] Preferably, the grinding equipment in step (4) is a colloid mill, and the mass ratio of β-cyclodextrin to volatile oil is 8-12:1.

[0014] Preferably, the vacuum drying temperature in step (5) is 35-45℃, the vacuum degree is -0.06 to -0.09MPa, and the moisture content is ≤8.0%.

[0015] In this invention, phosphatidylserine, with its hydrophobic tail anchored inside the volatile oil droplet and its hydrophilic head exposed at the oil-water interface, forms a lipid film on the surface of the volatile oil droplet, providing initial interfacial stability for the volatile oil. Glycyrrhizic acid, as the gel network framework, self-assembles in water to form nanofibers that interweave to create a three-dimensional network structure, physically locking phosphatidylserine and the volatile oil droplet within the network, preventing the volatile oil from escaping during subsequent processing. β-cyclodextrin, as the inclusion host, uses its hydrophobic cavity to encapsulate volatile oil molecules through intermolecular forces, forming a molecular-level inclusion complex. Phosphatidylserine, glycyrrhizic acid, and β-cyclodextrin form a multi-layered stable structure that protects the volatile oil through non-covalent interactions (including hydrophobic interactions, hydrogen bonds, and electrostatic interactions).

[0016] Preferred ingredients, by weight, are as follows: Astragalus membranaceus 50-60 parts, stir-fried Atractylodes macrocephala 30-40 parts, Codonopsis pilosula 15-22 parts, Cimicifuga foetida 6-10 parts, Bupleurum chinense 6-10 parts, Angelica sinensis 50-60 parts, Ligusticum chuanxiong 30-40 parts, Mentha haplocalyx 25-35 parts, Schizonepeta tenuifolia 15-22 parts, Saposhnikovia divaricata 15-22 parts, Notopterygium incisum 15-22 parts, and Angelica dahurica 15-22 parts.

[0017] Secondly, the present invention provides the application of the traditional Chinese medicine volatile oil inclusion complex prepared by the method described in the first aspect in the preparation of wind-dispelling and pain-relieving drugs.

[0018] This invention takes the compound volatile oil of Yangxue Qufeng Zhitong Granules as the application object and provides a complete process scheme from extraction to inclusion, so that the prepared inclusion complex remains stable during subsequent mixing with dry extract powder, granulation, and drying (60-80℃, 16 hours), thereby improving the retention rate of volatile oil in the final granules.

[0019] The inclusion complex prepared by this invention has multiple stable structures. The volatile oil is locked in the complex structure composed of phosphatidylserine lipid membrane, glycyrrhizic acid cellulose network and cyclodextrin in the form of inclusion complex. It has high inclusion rate, good stability, and is easy to industrialize and can be applied to the preparation of granules.

[0020] The beneficial effects of this invention are as follows: (1) The present invention uses phosphatidylserine to form a lipid film on the surface of volatile oil droplets by utilizing its amphiphilicity, thereby providing initial stability for the volatile oil and overcoming the defects of conventional cyclodextrin inclusion where the volatile oil is directly exposed to the aqueous phase and begins to volatilize before inclusion.

[0021] (2) The present invention locks the volatile oil droplets anchored by phosphatidylserine into the network structure through the self-assembly effect of glycyrrhizic acid, forming a physical barrier to prevent the volatile oil from escaping during the subsequent low-temperature grinding and encapsulation process.

[0022] (3) The inclusion complex prepared by the present invention remains stable during subsequent mixing with dry extract powder, granulation and drying (60-80℃, for a total of 16 hours), and the volatile oil retention rate is significantly higher than that of conventional cyclodextrin inclusion complexes. Detailed Implementation

[0023] To further illustrate the technical means and effects of the present invention in achieving the intended purpose, the following detailed description of the specific implementation methods, structures, features and effects of the present invention, in conjunction with preferred embodiments, is provided below.

[0024] Example 1 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: (1) Take 55.2 parts by weight of Astragalus membranaceus, 55.2 parts by weight of Angelica sinensis, 36 parts by weight of stir-fried Atractylodes macrocephala, 36 parts by weight of Ligusticum chuanxiong, 28 parts by weight of Mentha haplocalyx, 18.4 parts by weight of Schizonepeta tenuifolia, 18.4 parts by weight of Saposhnikovia divaricata, 18.4 parts by weight of Notopterygium incisum, 18.4 parts by weight of Angelica dahurica, 18.4 parts by weight of Codonopsis pilosula, 8.8 parts by weight of Bupleurum chinense, and 8.8 parts by weight of Cimicifuga foetida. Add water in a volume 10 times the total weight of the medicinal materials, reflux and extract for 5 hours, and collect the volatile oil.

[0025] (2) Mix 0.35 parts by weight of phosphatidylserine with 1 part by weight of volatile oil from step (1) and stir at 35°C for 45 minutes to form a mixture.

[0026] (3) Dissolve 0.1 parts by weight of glycyrrhizic acid in 2.5 parts by weight of pure water, heat to 65°C and stir until completely dissolved. Add the mixture from step (2), emulsify at 15000 r / min for 3 minutes, and immediately cool rapidly to 25°C to obtain a gel.

[0027] (4) Mix 9 parts by weight of β-cyclodextrin with 18 parts by weight of pure water, add it to the colloid mill, adjust the rotor gap of the colloid mill to 10, grind evenly, then add the gel from step (3), and grind at 25°C for 45 minutes.

[0028] (5) The inclusion complex is discharged and dried at 40°C and vacuum degree -0.08MPa until the moisture content is ≤8.0% to obtain the volatile oil inclusion complex of traditional Chinese medicine.

[0029] Example 2 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: (1) Take 55.2 parts by weight of Astragalus membranaceus, 55.2 parts by weight of Angelica sinensis, 36 parts by weight of stir-fried Atractylodes macrocephala, 36 parts by weight of Ligusticum chuanxiong, 28 parts by weight of Mentha haplocalyx, 18.4 parts by weight of Schizonepeta tenuifolia, 18.4 parts by weight of Saposhnikovia divaricata, 18.4 parts by weight of Notopterygium incisum, 18.4 parts by weight of Angelica dahurica, 18.4 parts by weight of Codonopsis pilosula, 8.8 parts by weight of Bupleurum chinense, and 8.8 parts by weight of Cimicifuga foetida. Add water in a volume 10 times the total weight of the medicinal materials, reflux and extract for 5 hours, and collect the volatile oil.

[0030] (2) Mix 0.33 parts by weight of phosphatidylserine with 1 part by weight of volatile oil from step (1) and stir at 40°C for 30 minutes to form a mixture.

[0031] (3) Dissolve 0.125 parts by weight of glycyrrhizic acid in 2.5 parts by weight of pure water, heat to 65°C and stir until completely dissolved. Add the mixture from step (2), emulsify at 15000 r / min for 3 minutes, and immediately cool rapidly to 25°C to obtain a gel.

[0032] (4) Mix 10 parts by weight of β-cyclodextrin with 20 parts by weight of pure water, add to a colloid mill, add the gel from step (3), and grind at 25°C for 45 minutes.

[0033] (5) The inclusion complex is discharged and dried at 40°C and vacuum degree -0.08MPa until the moisture content is ≤8.0% to obtain the volatile oil inclusion complex of traditional Chinese medicine.

[0034] Example 3 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: (1) Take 55.2 parts by weight of Astragalus membranaceus, 55.2 parts by weight of Angelica sinensis, 36 parts by weight of stir-fried Atractylodes macrocephala, 36 parts by weight of Ligusticum chuanxiong, 28 parts by weight of Mentha haplocalyx, 18.4 parts by weight of Schizonepeta tenuifolia, 18.4 parts by weight of Saposhnikovia divaricata, 18.4 parts by weight of Notopterygium incisum, 18.4 parts by weight of Angelica dahurica, 18.4 parts by weight of Codonopsis pilosula, 8.8 parts by weight of Bupleurum chinense, and 8.8 parts by weight of Cimicifuga foetida. Add water in a volume 10 times the total weight of the medicinal materials, reflux and extract for 6 hours, and collect the volatile oil.

[0035] (2) Mix 0.33 parts by weight of phosphatidylserine with 1 part by weight of volatile oil from step (1) and stir at 40°C for 30 minutes to form a mixture.

[0036] (3) Dissolve 0.1 parts by weight of glycyrrhizic acid in 2.5 parts by weight of pure water, heat to 65°C and stir until completely dissolved. Add the mixture from step (2), emulsify at 15000 r / min for 2 minutes, and immediately cool rapidly to 25°C to obtain a gel.

[0037] (4) Mix 9 parts by weight of β-cyclodextrin with 18 parts by weight of pure water, add to a colloid mill, add the gel from step (3), and grind at 20°C for 60 minutes.

[0038] (5) The inclusion complex is discharged and dried at 40°C and vacuum degree -0.08MPa until the moisture content is ≤8.0% to obtain the volatile oil inclusion complex of traditional Chinese medicine.

[0039] Example 4 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: (1) Take 55.2 parts by weight of Astragalus membranaceus, 55.2 parts by weight of Angelica sinensis, 36 parts by weight of stir-fried Atractylodes macrocephala, 36 parts by weight of Ligusticum chuanxiong, 28 parts by weight of Mentha haplocalyx, 18.4 parts by weight of Schizonepeta tenuifolia, 18.4 parts by weight of Saposhnikovia divaricata, 18.4 parts by weight of Notopterygium incisum, 18.4 parts by weight of Angelica dahurica, 18.4 parts by weight of Codonopsis pilosula, 8.8 parts by weight of Bupleurum chinense, and 8.8 parts by weight of Cimicifuga foetida. Add water in a volume 10 times the total weight of the medicinal materials, reflux and extract for 4 hours, and collect the volatile oil.

[0040] (2) Mix 0.5 parts by weight of phosphatidylserine with 1 part by weight of volatile oil from step (1) and stir at 30°C for 30 minutes to form a mixture.

[0041] (3) Dissolve 0.1 parts by weight of glycyrrhizic acid in 2.5 parts by weight of pure water, heat to 65°C and stir until completely dissolved. Add the mixture from step (2), emulsify at 15000 r / min for 2 minutes, and immediately cool rapidly to 25°C to obtain a gel.

[0042] (4) Mix 8 parts by weight of β-cyclodextrin with 16 parts by weight of pure water, add to a colloid mill, add the gel from step (3), and grind at 30°C for 30 minutes.

[0043] (5) The inclusion complex is discharged and dried at 40°C and vacuum degree -0.08MPa until the moisture content is ≤8.0% to obtain the volatile oil inclusion complex of traditional Chinese medicine.

[0044] Example 5 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: (1) Take 55.2 parts by weight of Astragalus membranaceus, 55.2 parts by weight of Angelica sinensis, 36 parts by weight of stir-fried Atractylodes macrocephala, 36 parts by weight of Ligusticum chuanxiong, 28 parts by weight of Mentha haplocalyx, 18.4 parts by weight of Schizonepeta tenuifolia, 18.4 parts by weight of Saposhnikovia divaricata, 18.4 parts by weight of Notopterygium incisum, 18.4 parts by weight of Angelica dahurica, 18.4 parts by weight of Codonopsis pilosula, 8.8 parts by weight of Bupleurum chinense, and 8.8 parts by weight of Cimicifuga foetida. Add water in a volume 10 times the total weight of the medicinal materials, reflux and extract for 5 hours, and collect the volatile oil.

[0045] (2) Mix 0.30 parts by weight of phosphatidylserine with 1 part by weight of volatile oil from step (1) and stir at 38°C for 40 minutes to form a mixture.

[0046] (3) Dissolve 0.11 parts by weight of glycyrrhizic acid in 2.5 parts by weight of pure water, heat to 65°C and stir until completely dissolved. Add the mixture from step (2), emulsify at 15000 r / min for 4 minutes, and immediately cool rapidly to 25°C to obtain a gel.

[0047] (4) Mix 9 parts by weight of β-cyclodextrin with 18 parts by weight of pure water, add to a colloid mill, add the gel from step (3), and grind at 25°C for 50 minutes.

[0048] (5) The inclusion complex is discharged and dried at 40°C and vacuum degree -0.08MPa until the moisture content is ≤8.0% to obtain the volatile oil inclusion complex of traditional Chinese medicine.

[0049] Example 6 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: It is basically the same as Example 1, except that: the medicinal materials selected are 90 parts by weight of Angelica sinensis and 60 parts by weight of Ligusticum chuanxiong.

[0050] Example 7 A method for preparing a volatile oil inclusion complex of traditional Chinese medicine includes the following steps: The method is basically the same as in Example 1, except that the medicinal materials selected are 90 parts by weight of peppermint, 60 parts by weight of schizonepeta, and 60 parts by weight of saposhnikovia.

[0051] Comparative Example 1 It is basically the same as Example 1, except that phosphatidylserine is not added in step (2), and the volatile oil is used directly in subsequent steps.

[0052] Comparative Example 2 It is basically the same as Example 1, except that glycyrrhizic acid is not added in step (3) and gelation treatment is not performed.

[0053] Comparative Example 3 The procedure is basically the same as in Example 1, except that phosphatidylserine is not added in step (2), glycyrrhizic acid is not added in step (3), and gelation treatment is not performed. That is, only conventional β-cyclodextrin inclusion is used.

[0054] Comparative Example 4 It is basically the same as Example 1, except that the grinding temperature in step (4) is 50°C.

[0055] Comparative Example 5 It is basically the same as Example 1, except that the mass ratio of phosphatidylserine to volatile oil in step (2) is 1:4.

[0056] Comparative Example 6 It is basically the same as Example 1, except that the mass ratio of glycyrrhizic acid to volatile oil in step (3) is 1:15.

[0057] Comparative Example 7 It is basically the same as Example 1, except that the mass ratio of β-cyclodextrin to volatile oil in step (4) is 6:1.

[0058] Comparative Example 8 It is basically the same as Example 7, except that only conventional β-cyclodextrin inclusion is used.

[0059] test: 1. Inclusion rate determination: High-performance liquid chromatography (HPLC) was used. The initial volatile oil and inclusion complex were accurately weighed and extracted separately with ethanol using ultrasonication to prepare test solutions. Ligustilide, menthol, or gentamicin were used as indicator components. The content of these components in the inclusion complex was calculated using the external standard method. Inclusion rate (%) = (Content of indicator component in inclusion complex / Content of indicator component in initial volatile oil) × 100%. The results are shown in Table 1.

[0060] Table 1 Comparison of inclusion rates between each embodiment and the comparative example

[0061] Note: a and b represent menthol and gentian menthol as detection indicators, respectively; for the others, the main component ligustilide is used as the detection indicator.

[0062] As shown in Table 1, the inclusion rates of Examples 1-5 were all ≥88.5%, significantly better than those of the comparative examples. Among them, the inclusion rate of Comparative Example 1 was only 79.8%, indicating that phosphatidylserine plays an important role in improving the inclusion rate; the inclusion rate of Comparative Example 2 was 83.2%, indicating that the physical locking of the glycyrrhizic acid cellulose network was indispensable; the inclusion rate of Comparative Example 3 was 78.5%, proving that there is a synergistic effect between phosphatidylserine and glycyrrhizic acid; and the inclusion rate of Comparative Example 4 was 85.6%, proving that low-temperature grinding is better.

[0063] 2. Stability test: The inclusion complexes prepared in Example 1 and Comparative Example 3 were placed at 40℃ and 75%RH for 30 days, respectively. The retention rate of ligustilide in the volatile oil was determined by liquid chromatography (HPLC). The results are shown in Table 2.

[0064] Table 2 Accelerated stability test results

[0065] As shown in Table 2, the inclusion retention rate of Example 1 reached 97.7% after being placed at 40℃ and 75%RH for 30 days, while that of Comparative Example 3 was only 90.2%, indicating that the inclusion complex prepared by the present invention has better storage stability.

[0066] 3. Granule Application Test: 1g of the inclusion complexes prepared in Example 1 and Comparative Example 3 were mixed with 80g of dry extract powder and 20g of 95% ethanol, respectively, granulated, dried at 60℃ for 8 hours, and then dried at 80℃ for 8 hours to prepare granules. The retention rate of ligustilide in the final granules was determined by HPLC, and the results are shown in Table 3.

[0067] Table 3. Retention rate of ligustilide after granule preparation

[0068] As shown in Table 3, the retention rate of ligustilide in the granules prepared by the inclusion complex in Example 1 was 86.2%, while that in Comparative Example 3 was only 70.6%. This indicates that the inclusion complex prepared by the present invention has better resistance to heat damage during the subsequent high-temperature drying process of the granules and can effectively protect the volatile oil.

[0069] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A method for preparing a volatile oil inclusion complex of traditional Chinese medicine, characterized in that, Includes the following steps: (1) Take the medicinal materials, add water and reflux to extract, and collect the volatile oil; (2) Mix phosphatidylserine with the volatile oil from step (1) at a mass ratio of 1:2-3 to form a mixture; (3) Dissolve glycyrrhizic acid in water, heat to 60-70℃ to dissolve it, add the mixture from step (2), emulsify by high-speed shearing and then cool rapidly to obtain a gel; (4) Mix β-cyclodextrin with water, grind it evenly in a grinding device, then add the gel from step (3) and grind it at 20-30℃ for 30-60 minutes; (5) Discharge the inclusion compound and vacuum dry it to obtain the final product; The medicinal materials include one or more of the following: Astragalus membranaceus, stir-fried Atractylodes macrocephala, Codonopsis pilosula, Cimicifuga foetida, Bupleurum chinense, Angelica sinensis, Ligusticum chuanxiong, Mentha haplocalyx, Schizonepeta tenuifolia, Saposhnikovia divaricata, Notopterygium incisum, and Angelica dahurica.

2. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The conditions for water reflux extraction in step (1) are: add 8-12 times the weight of the medicinal material in water and reflux extract for 4-6 hours at a gentle boil.

3. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The mixing temperature in step (2) is 30-40℃ and the mixing time is 30-60 minutes.

4. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The mass ratio of glycyrrhizic acid to volatile oil in step (3) is 1:8-10.

5. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The emulsification time in step (3) is 2-4 minutes.

6. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The grinding equipment in step (4) is a colloid mill, and the mass ratio of β-cyclodextrin to volatile oil is 8-12:

1.

7. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The vacuum drying temperature in step (5) is 35-45℃, the vacuum degree is -0.06 to -0.09MPa, and the moisture content is ≤8.0%.

8. The method for preparing the volatile oil inclusion complex of traditional Chinese medicine according to claim 1, characterized in that, The following ingredients are listed by weight: Astragalus membranaceus 50-60 parts, stir-fried Atractylodes macrocephala 30-40 parts, Codonopsis pilosula 15-22 parts, Cimicifuga foetida 6-10 parts, Bupleurum chinense 6-10 parts, Angelica sinensis 50-60 parts, Ligusticum chuanxiong 30-40 parts, Mentha haplocalyx 25-35 parts, Schizonepeta tenuifolia 15-22 parts, Saposhnikovia divaricata 15-22 parts, Notopterygium incisum 15-22 parts, Angelica dahurica 15-22 parts.

9. The application of a traditional Chinese medicine volatile oil inclusion complex prepared by the method described in any one of claims 1-8 in the preparation of wind-dispelling and pain-relieving drugs.

10. A pharmaceutical composition, characterized in that, This includes the traditional Chinese medicine volatile oil inclusion complex prepared by the method described in any one of claims 1-8, as well as pharmaceutically acceptable excipients.

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