Traditional Chinese medicine volatile oil, preparation method and application thereof, and traditional Chinese medicine granules

Abstract

The invention relates to traditional Chinese medicine volatile oil, a preparation method and application thereof and traditional Chinese medicine granules, and relates to the technical field of traditional Chinese medicine, the preparation method comprises the following steps: adding raw materials of a Linggui curcuma zedoary and licorice decoction prescription into water, and then carrying out ultrasonic synergistic pulsed electric field pretreatment to obtain a mixture; decocting the mixture, and collecting a medicine steam condensate to obtain the medicine steam condensate and a decoction; extracting the medicine steam condensate by a volatile oil extractor, and collecting volatile oil to obtain the traditional Chinese medicine volatile oil. Aiming at the classic famous prescription of the Linggui curcuma zedoary decoction, ultrasonic and pulsed electric field pretreatment is introduced on the basis of the prior art, and a composite field formed by the cavitation effect of ultrasonic waves and the electroporation effect of a pulsed electric field is utilized to promote dissolution of functional components of a medicine, so that the utilization rate of the medicine and the working efficiency are improved; meanwhile, it is found that the obtained extract has good anti-osteoporosis activity, and the discovery opens up a new clinical application field for the classic prescription of the Linggui curcuma zedoary and liquorice decoction.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine volatile oil, a preparation method and application thereof, and traditional Chinese medicine granules. Background Art

[0002] Ling Gui Zhu Gan Tang, as a treasure among traditional Chinese medicine prescriptions, originated from Treatise on Febrile and Miscellaneous Diseases. Its original prescription precisely matched four liang of Poria cocos, three liang of cinnamon twig and white atractylodes, and two liang of licorice. Through the delicate decoction process - six liters of water, boil three liters, remove the dregs and take it warm in three portions, it shows the excellent effects of warming yang, transforming phlegm, strengthening spleen and removing dampness. This prescription is mainly for phlegm and fluid caused by insufficient middle yang. Patients often show symptoms of chest and flank fullness, dizziness, palpitations, shortness of breath and cough, white and slippery tongue coating, and stringy or deep and tight pulse. In modern medicine, Ling Gui Zhu Gan Tang is widely used in the treatment of chronic bronchitis, bronchial asthma, cardiogenic edema, chronic glomerulonephritis edema, Meniere's disease and other diseases, and has a wide range of uses.

[0003] However, although the traditional decoction form is convenient for clinical diagnosis and treatment of TCM and flexible addition and subtraction, it also has limitations that cannot be ignored: poor taste, inconvenience in carrying, and potential loss of active ingredients (such as volatile oils) during decoction, these factors often reduce patient acceptance and the convenience of treatment. In response to this challenge, a number of technological innovations have emerged in recent years, such as patents such as CN 108653387A, CN 112294869A, CN 112263609A and CN 114632099A, which attempt to transform Ling Gui Shu Gan Tang into granules in order to overcome the inherent defects of decoctions. Although these efforts have improved the convenience of medication to a certain extent, there are still problems such as time-consuming preparation process and the need to further improve drug utilization, which limits its wider application and promotion. Summary of the invention

[0004] In order to solve the above problems, the present invention provides a Chinese medicine volatile oil and a preparation method and application thereof, and Chinese medicine granules.

[0005] In a first aspect, the present invention provides a method for preparing a volatile oil of traditional Chinese medicine, the preparation method comprising the following steps:

[0006] The raw materials of Ling Gui Zhu Gan Tang are added into water, and then pre-treated by ultrasound-assisted pulse electric field to obtain a mixture;

[0007] The mixed material is boiled and the drug vapor condensate is collected to obtain the drug vapor condensate and the boiled liquid;

[0008] The drug vapor condensate is extracted through a volatile oil extractor and volatile oil is collected to obtain the traditional Chinese medicine volatile oil.

[0009] Furthermore, the ultrasound-assisted pulsed electric field pretreatment step includes the following process:

[0010] The electrodes of the pulse electric field device are placed in water, and the distance between the electrodes is set to 20-30 mm, the constant voltage of the pulse power supply is set to 5-10 V, and the pulse period is set to 1-5 ms;

[0011] Insert the ultrasonic probe of the ultrasonic equipment into the water and set the ultrasonic power to 200-450W;

[0012] The pulse electric field device and the ultrasonic device are turned on simultaneously to perform the ultrasonic coordinated pulse electric field pretreatment for 10 to 20 minutes.

[0013] Furthermore, the distance between the electrodes is 25 mm, the constant voltage of the pulse power supply is 7 V, the pulse period is 2 ms, and the ultrasonic power is 350 W.

[0014] Furthermore, the raw materials of the Ling Gui Shu Gan Tang prescription are composed of Poria cocos, cinnamon twig, Atractylodes macrocephala and licorice in a weight ratio of 4:3:3:2, and the weight ratio of the raw materials of the Ling Gui Shu Gan Tang prescription and the water is 1:(5-10).

[0015] In a second aspect, the present invention provides a volatile oil of traditional Chinese medicine, which is prepared by the preparation method described in any one of the first aspects.

[0016] In a third aspect, the present invention provides use of the Chinese herbal volatile oil or Ling Gui Zhu Gan Tang described in any one of the first aspect and the second aspect in the preparation of a drug for treating osteoporosis.

[0017] In a fourth aspect, the present invention provides a Chinese medicine granule, wherein the Chinese medicine granule comprises the Chinese medicine volatile oil described in any one of the first aspect and the second aspect.

[0018] Furthermore, the preparation method of the Chinese medicine granules comprises the following process:

[0019] The volatile oil, β-cyclodextrin compound and water are mixed, and then ground and dried to obtain an inclusion compound;

[0020] The decoction is concentrated and dried to obtain an extract;

[0021] The inclusion compound, the extract and maltodextrin are mixed and then granulated to obtain the traditional Chinese medicine granules.

[0022] Furthermore, the weight ratio of the volatile oil, the β-cyclodextrin compound and the water is 1:(10-20):(30-60), the β-cyclodextrin compound includes at least one of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, dimethyl-β-cyclodextrin, carboxymethyl-β-cyclodextrin and p-toluenesulfonyl-β-cyclodextrin; the weight ratio of the inclusion compound, the extract and the maltodextrin is (0.3-0.6):10:(0-2.0).

[0023] Furthermore, the types of diseases treated by the Chinese medicine granules include osteoporosis.

[0024] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art:

[0025] The embodiments of the present invention provide a Chinese medicine volatile oil, a preparation method and application thereof, and Chinese medicine granules. For the classic prescription Ling Gui Shu Gan Tang, the present invention introduces ultrasound synergistic pulse electric field pretreatment on the basis of the existing technology, and utilizes the composite field formed by the cavitation effect of ultrasound and the electroporation effect of the pulse electric field to promote the dissolution of the effective ingredients of the medicine and shorten the decoction time, thereby improving the drug utilization rate and work efficiency; at the same time, the present invention finds that the obtained extract has good anti-osteoporosis activity, and this discovery has opened up a new clinical application field for the classic prescription Ling Gui Shu Gan Tang. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0027] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0028] Figure 1 The present invention provides a schematic flow chart of a method for preparing a volatile oil of traditional Chinese medicine.

[0029] Figure 2 It is a schematic diagram of the formation of a stable inclusion complex between the enaldehyde group in the cinnamaldehyde contained in the volatile oil of the present invention and the -OH bond of the β-cyclodextrin compound.

[0030] Figure 3 The infrared spectra are of the stable inclusion complex formed by the enaldehyde group in the cinnamaldehyde contained in the volatile oil of the present invention and the -OH bond of the β-cyclodextrin compound, cinnamaldehyde and the physical mixture of the two. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0033] In a first aspect, the present invention provides a method for preparing a volatile oil of a traditional Chinese medicine, such as Figure 1 As shown, the preparation method comprises the following steps:

[0034] The raw materials of Ling Gui Zhu Gan Tang are added into water, and then pre-treated by ultrasound-assisted pulse electric field to obtain a mixture;

[0035] The mixed material is boiled and the drug vapor condensate is collected to obtain the drug vapor condensate and the boiled liquid;

[0036] The drug vapor condensate is extracted through a volatile oil extractor and volatile oil is collected to obtain the traditional Chinese medicine volatile oil.

[0037] The embodiment of the present invention provides a method for preparing volatile oil of traditional Chinese medicine. For the classic prescription Ling Gui Shu Gan Tang, the present invention introduces ultrasound synergistic pulse electric field pretreatment on the basis of the existing technology, and utilizes the composite field formed by the cavitation effect of ultrasound and the electroporation effect of the pulse electric field to promote the dissolution of the effective ingredients of the medicine and shorten the decoction time, thereby improving the utilization rate of the medicine and the work efficiency; at the same time, the present invention finds that the obtained extract has good anti-osteoporosis activity, and this discovery has opened up a new clinical application field for the classic prescription Ling Gui Shu Gan Tang.

[0038] In the present invention, the medicinal vapor condensate refers to the process in which the water vapor evaporates and rises as the water is heated and boiled during the decoction of the traditional Chinese medicine. When the water vapor encounters a relatively cold pot cover or other condensation surface, it condenses into water droplets. However, these water droplets are not pure distilled water, because they contain various volatile components and other medicinal ingredients released during the decoction of the traditional Chinese medicine. These water droplets containing medicinal ingredients are the "medicinal vapor condensate".

[0039] In some specific embodiments, the ultrasound-assisted pulsed electric field pretreatment step includes the following process:

[0040] The electrodes of the pulse electric field device are placed in water, and the distance between the electrodes is set to 20-30 mm, the constant voltage of the pulse power supply is set to 5-10 V, and the pulse period is set to 1-5 ms;

[0041] Insert the ultrasonic probe of the ultrasonic equipment into the water and set the ultrasonic power to 200-450W;

[0042] The pulse electric field device and the ultrasonic device are turned on simultaneously to perform the ultrasonic coordinated pulse electric field pretreatment for 10 to 20 minutes.

[0043] In some specific embodiments, the distance between the electrodes is 25 mm, the constant voltage of the pulse power supply is 7 V, the pulse period is 2 ms; and the ultrasonic power is 350 W.

[0044] In some specific embodiments, the raw materials of the Ling Gui Shu Gan Tang prescription are composed of Poria cocos, cinnamon twig, Atractylodes macrocephala and licorice in a weight ratio of 4:3:3:2, and the weight ratio of the raw materials of the Ling Gui Shu Gan Tang prescription and the water is 1:(5-10).

[0045] In a second aspect, based on the same inventive concept, the present invention provides a Chinese herbal volatile oil, which is prepared by the preparation method described in any one of the first aspects.

[0046] In the third aspect, based on the same inventive concept, the present invention provides the use of the Chinese medicine volatile oil or Ling Gui Zhu Gan Tang described in any one of the first aspect and the second aspect in the preparation of a drug for treating osteoporosis.

[0047] Through experimental verification, the present invention found that the traditional Chinese medicine granules prepared from the obtained Ling Gui Zhu Gan Tang extract exhibited good anti-osteoporosis activity. This discovery has opened up a new clinical application field for the classic prescription of Ling Gui Zhu Gan Tang, and especially provided a new choice of traditional Chinese medicine for the prevention and treatment of type I osteoporosis.

[0048] In a fourth aspect, based on the same inventive concept, the present invention provides a Chinese medicine granule, wherein the Chinese medicine granule comprises the Chinese medicine volatile oil described in any one of the first aspect and the second aspect.

[0049] In some specific embodiments, the method for preparing the Chinese medicine granules comprises the following process:

[0050] The volatile oil, β-cyclodextrin compound and water are mixed, and then ground and dried to obtain an inclusion compound;

[0051] The decoction is concentrated and dried to obtain an extract;

[0052] The inclusion compound, the extract and maltodextrin are mixed and then granulated to obtain the traditional Chinese medicine granules.

[0053] In the present invention, the volatile oil and the β-cyclodextrin compound are ground in advance, so that the effective components such as cinnamaldehyde in the volatile oil and the β-cyclodextrin compound can form a more stable inclusion compound through hydrogen bonding. Figure 2 and Figure 3 shown.

[0054] In some specific embodiments, the weight ratio of the volatile oil, the β-cyclodextrin compound and the water is 1:(10-20):(30-60), preferably 1:15:48; the β-cyclodextrin compound includes at least one of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, dimethyl-β-cyclodextrin, carboxymethyl-β-cyclodextrin and p-toluenesulfonyl-β-cyclodextrin, preferably hydroxypropyl-β-cyclodextrin; the weight ratio of the inclusion compound, the extract and the maltodextrin is (0.3-0.6):10:(0-2.0), preferably 0.5:10:1.7.

[0055] In some specific embodiments, the diseases treated by the Chinese medicine particles include osteoporosis.

[0056] It should be noted that, unless otherwise specified or described, the components and raw materials involved in the Chinese medicine volatile oil and its preparation method and application, and Chinese medicine granules provided in the embodiments of the present invention can be directly made from commercially available products or made in-house according to the processes disclosed in the prior art. At the same time, unless otherwise specified or described, the steps involved can be carried out according to the steps and parameters disclosed in the prior art such as CN108653387A, CN 112294869A, CN 112263609A, and CN 114632099A, or using existing equipment, and the present invention document will not repeat them one by one.

[0057] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0058] Example 1

[0059] This example provides a Chinese medicine volatile oil, and the preparation method of the Chinese medicine volatile oil comprises the following steps:

[0060] Step (1): adding raw materials of Ling Gui Shu Gan Tang prescription consisting of Poria cocos, cinnamon twig, Atractylodes macrocephala and liquorice in a weight ratio of 4:3:3:2 to water, wherein the weight ratio of the raw materials of Ling Gui Shu Gan Tang prescription to the water is 1:7, and then placing electrodes of a pulsed electric field device and an ultrasonic probe of an ultrasonic device in the water, setting parameters of the pulsed electric field device: the distance between electrodes is 25 mm, the constant voltage of the pulse power supply is 7 V and the pulse period is 2 ms, setting parameters of the ultrasonic device: the ultrasonic power is 350 W, and simultaneously turning on the pulsed electric field device and the ultrasonic device to perform the ultrasonic synergistic pulsed electric field pretreatment for 15 minutes to obtain a mixture;

[0061] Step (2): boiling the mixture obtained in step (1) for 60 minutes, and collecting the drug vapor condensate to obtain the drug vapor condensate and the decoction liquid;

[0062] Step (3): extracting and collecting volatile oil from the medicinal vapor condensate obtained in step (2) through a volatile oil extractor to obtain the traditional Chinese medicine volatile oil.

[0063] Example 2

[0064] This example provides a Chinese medicine volatile oil, and the preparation method of the Chinese medicine volatile oil comprises the following steps:

[0065] Step (1): adding raw materials of Ling Gui Shu Gan Tang prescription consisting of Poria cocos, cinnamon twig, Atractylodes macrocephala and liquorice in a weight ratio of 4:3:3:2 to water, wherein the weight ratio of the raw materials of Ling Gui Shu Gan Tang prescription to the water is 1:5, and then placing electrodes of a pulsed electric field device and an ultrasonic probe of an ultrasonic device in the water, setting parameters of the pulsed electric field device: the distance between electrodes is 20 mm, the constant voltage of the pulse power supply is 5 V and the pulse period is 1 ms, setting parameters of the ultrasonic device: the ultrasonic power is 200 W, and simultaneously turning on the pulsed electric field device and the ultrasonic device to perform the ultrasonic synergistic pulsed electric field pretreatment for 20 minutes to obtain a mixture;

[0066] Step (2): boiling the mixture obtained in step (1) for 60 minutes, and collecting the drug vapor condensate to obtain the drug vapor condensate and the decoction liquid;

[0067] Step (3): extracting and collecting volatile oil from the medicinal vapor condensate obtained in step (2) through a volatile oil extractor to obtain the traditional Chinese medicine volatile oil.

[0068] Example 3

[0069] This example provides a Chinese medicine volatile oil, and the preparation method of the Chinese medicine volatile oil comprises the following steps:

[0070] Step (1): adding raw materials of Ling Gui Shu Gan Tang prescription consisting of Poria cocos, cinnamon twig, Atractylodes macrocephala and liquorice in a weight ratio of 4:3:3:2 to water, wherein the weight ratio of the raw materials of Ling Gui Shu Gan Tang prescription to the water is 1:10, and then placing electrodes of a pulsed electric field device and an ultrasonic probe of an ultrasonic device in the water, setting parameters of the pulsed electric field device: the distance between electrodes is 30 mm, the constant voltage of the pulse power supply is 10 V and the pulse period is 5 ms, setting parameters of the ultrasonic device: the ultrasonic power is 450 W, and simultaneously turning on the pulsed electric field device and the ultrasonic device to perform the ultrasonic synergistic pulsed electric field pretreatment for 10 minutes to obtain a mixture;

[0071] Step (2): boiling the mixture obtained in step (1) for 60 minutes, and collecting the drug vapor condensate to obtain the drug vapor condensate and the decoction liquid;

[0072] Step (3): extracting and collecting volatile oil from the medicinal vapor condensate obtained in step (2) through a volatile oil extractor to obtain the traditional Chinese medicine volatile oil.

[0073] Example 4

[0074] This example provides a Chinese medicine granule, and the preparation method of the Chinese medicine granule includes the following process:

[0075] Step (1): the volatile oil obtained in Example 1, hydroxypropyl-β-cyclodextrin and water are mixed in a weight ratio of 1:15:48, and then ground at a rotation speed of 2600 rpm for 2 minutes and spray-dried to obtain an inclusion compound;

[0076] Step (2): concentrating and drying the decoction obtained in Example 1 to obtain an extract;

[0077] Step (3): the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin are mixed in a weight ratio of 0.5:10:1.7, and then granulated to obtain the Chinese medicine granules.

[0078] Example 5

[0079] This example provides a Chinese medicine granule, and the preparation method of the Chinese medicine granule includes the following process:

[0080] Step (1): the volatile oil obtained in Example 2, hydroxypropyl-β-cyclodextrin and water are mixed in a weight ratio of 1:10:30, and then ground at a rotation speed of 2600 rpm for 2 minutes and spray-dried to obtain an inclusion compound;

[0081] Step (2): concentrating and drying the decoction obtained in Example 2 to obtain an extract;

[0082] Step (3): the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin are mixed in a weight ratio of 0.3:10:1.5, and then granulated to obtain the Chinese medicine granules.

[0083] Example 6

[0084] This example provides a Chinese medicine granule, and the preparation method of the Chinese medicine granule includes the following process:

[0085] Step (1): the volatile oil obtained in Example 3, hydroxypropyl-β-cyclodextrin and water are mixed in a weight ratio of 1:20:60, and then ground at a rotation speed of 2600 rpm for 2 minutes and spray-dried to obtain an inclusion compound;

[0086] Step (2): concentrating and drying the decoction obtained in Example 3 to obtain an extract;

[0087] Step (3): the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin are mixed in a weight ratio of 0.6:10:2.0, and then granulated to obtain the Chinese medicine granules.

[0088] Example 7

[0089] This example provides a Chinese medicine granule, and the preparation method of the Chinese medicine granule includes the following process:

[0090] Step (1): adding raw materials of Ling Gui Zhu Gan Tang prescription consisting of Poria cocos, cinnamon twig, Atractylodes macrocephala and liquorice in a weight ratio of 4:3:3:2 into water and soaking for 1 hour to obtain a mixture;

[0091] Step (2): boiling the mixture obtained in step (1) for 2 hours to obtain a decoction;

[0092] Step (3): concentrating and drying the decoction obtained in step (2) to obtain an extract;

[0093] Step (4): The extract obtained in step (3) and maltodextrin are mixed in a weight ratio of 10:1.7, and then granulated to obtain the Chinese medicine granules.

[0094] Test Example 1

[0095] In this example, the content of cinnamaldehyde in each gram of the obtained volatile oil of traditional Chinese medicine was measured according to the test method disclosed in the prior art CN 114632099 A. The test results are shown in Table 1.

[0096] Table 1

[0097]

[0098] Test Example 2

[0099] This example aims to evaluate the therapeutic effect of the Chinese medicine granules provided in Examples 4 to 7 on osteoporosis by using OVX (bilaterally ovariectomized) mice as an animal model of type I osteoporosis.

[0100] The experimental materials and methods are as follows:

[0101] 1. Experimental animals and groups:

[0102] 1.1. 30 20-week-old C57 / B6J female mice were selected as experimental subjects and randomly divided into 5 groups, with 6 mice in each group.

[0103] 1.2. Grouping:

[0104] Normal control group (NC group): normal mice that did not undergo any surgery or medication and served as the control benchmark for the experiment.

[0105] Bilateral ovariectomy group (OVX group): Mice underwent bilateral ovariectomy surgery to simulate the osteoporosis disease model, and no drug treatment was given after surgery.

[0106] Drug treatment groups (4 groups in total, respectively marked as Example 4 drug treatment group, Example 5 drug treatment group, Example 6 drug treatment group, Example 7 drug treatment group): The mice also underwent bilateral ovariectomy surgery, and were given the Chinese medicine granules provided in Examples 4 to 7 for treatment after the surgery, by gavage, at a dose of 10 mg / kg / day.

[0107] 2. Experimental cycle:

[0108] The experiment lasted for 6 weeks, during which the mice's growth status, activity and abnormal reactions were regularly observed.

[0109] 3. Dosage method:

[0110] The mice in the drug treatment group were given a specified dose of Chinese medicine granules by oral gavage every day to ensure the accuracy and consistency of the dosage.

[0111] 4. Sample collection and testing:

[0112] After the experiment, serum samples of mice in each group were collected by orbital bleeding.

[0113] Enzyme-linked immunosorbent assay (ELISA) was used to detect the level of β-CTX (carboxyl terminal peptide of type I collagen) in the serum of each group of mice. This index is an important marker reflecting bone resorption activity and the degree of osteoporosis.

[0114] 5. Data statistics and analysis:

[0115] The β-CTX levels of mice in each group were statistically analyzed, the differences between the groups were compared, and the therapeutic effect of Chinese herbal granules on osteoporosis was evaluated. The test results are shown in Table 2.

[0116] Table 2

[0117]

[0118]

[0119] As shown in Table 2, bilateral ovariectomy in mice can increase β-CTX, and the drug treatment group can effectively reduce the high β-CTX level caused by OVX, indicating that the Chinese medicine granules prepared from the extract of Ling Gui Zhu Gan Tang exhibit certain anti-osteoporosis activity; and the anti-osteoporosis activity of the Chinese medicine granules obtained by taking Examples 4 to 6 is better.

[0120] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0121] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A method for preparing a volatile oil of traditional Chinese medicine, characterized in that: The preparation method comprises the following steps: The raw materials of Ling Gui Zhu Gan Tang are added into water, and then pre-treated by ultrasound-assisted pulse electric field to obtain a mixture; The mixed material is boiled and the drug vapor condensate is collected to obtain the drug vapor condensate and the boiled liquid; The drug vapor condensate is extracted through a volatile oil extractor and volatile oil is collected to obtain the traditional Chinese medicine volatile oil.

2. The method for preparing volatile oil of traditional Chinese medicine according to claim 1, characterized in that: The step of ultrasound-assisted pulsed electric field pretreatment The process includes: The electrodes of the pulse electric field device are placed in water, and the distance between the electrodes is set to 20-30 mm, the constant voltage of the pulse power supply is set to 5-10 V, and the pulse period is set to 1-5 ms; Insert the ultrasonic probe of the ultrasonic equipment into the water and set the ultrasonic power to 200-450W; The pulse electric field device and the ultrasonic device are turned on simultaneously to perform the ultrasonic coordinated pulse electric field pretreatment for 10 to 20 minutes.

3. The method for preparing the volatile oil of Chinese medicine according to claim 2, characterized in that: The distance between the electrodes is 25 mm, the constant voltage of the pulse power supply is 7 V, the pulse period is 2 ms, and the ultrasonic power is 350 W.

4. The method for preparing the volatile oil of traditional Chinese medicine according to any one of claims 1 to 3, characterized in that: The raw materials of the Ling Gui Shu Gan Tang prescription are composed of Poria cocos, cinnamon twig, Atractylodes macrocephala and liquorice in a weight ratio of 4:3:3:2, and the weight ratio of the raw materials of the Ling Gui Shu Gan Tang prescription and the water is 1:(5-10).

5. A Chinese medicine volatile oil, characterized in that: The Chinese medicine volatile oil is prepared by the preparation method described in any one of claims 1 to 4.

6. Use of the Chinese herbal volatile oil or Ling Gui Zhu Gan Tang according to any one of claims 1 to 5 in the preparation of a drug for treating osteoporosis.

7. A Chinese medicine granule, characterized in that: The Chinese medicine granules include the Chinese medicine volatile oil according to any one of claims 1 to 5.

8. The Chinese medicine granules according to claim 7, characterized in that: Preparation method of the Chinese medicine granules The process includes: The volatile oil, β-cyclodextrin compound and water are mixed, and then ground and dried to obtain an inclusion compound; The decoction is concentrated and dried to obtain an extract; The inclusion compound, the extract and maltodextrin are mixed and then granulated to obtain the traditional Chinese medicine granules.

9. The Chinese medicine granules according to claim 8, characterized in that: The weight ratio of the volatile oil, the β-cyclodextrin compound and the water is 1:(10-20):(30-60), the β-cyclodextrin compound includes at least one of β-cyclodextrin, hydroxypropyl-β-cyclodextrin, dimethyl-β-cyclodextrin, carboxymethyl-β-cyclodextrin and p-toluenesulfonyl-β-cyclodextrin; the weight ratio of the inclusion compound, the extract and the maltodextrin is (0.3-0.6):10:(0-2.0).

10. The Chinese medicine granules according to any one of claims 7 to 9, characterized in that: The types of diseases treated by the Chinese medicine granules include osteoporosis.

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