A Chinese medicine volatile oil and its preparation method and application, Chinese medicine granules

Abstract

The present invention relates to a Chinese herbal volatile oil, a preparation method and application thereof, and Chinese herbal granules, and relates to the technical field of Chinese medicine. The preparation method comprises the following steps: adding the raw materials of the Ling Gui Shu Gan Tang prescription to water, and then performing ultrasound-assisted pulsed electric field pretreatment to obtain a mixture; decocting the mixture and collecting drug vapor condensate to obtain drug vapor condensate and a decoction; extracting the drug vapor condensate through a volatile oil extractor and collecting volatile oil to obtain the Chinese herbal volatile oil. Targeting the classic prescription Ling Gui Shu Gan Tang, the present invention introduces ultrasound-assisted pulsed electric field pretreatment based on the existing technology, utilizing the composite field formed by the cavitation effect of ultrasound and the electroporation effect of the pulsed electric field to promote the dissolution of the drug's active ingredients, thereby improving drug utilization and work efficiency; at the same time, the present invention finds that the obtained extract has good anti-osteoporosis activity, a discovery that opens up a new clinical application field for the classic prescription Ling Gui Shu Gan Tang.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, 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, a treasured traditional Chinese medicine formula, originates from the Treatise on Febrile and Miscellaneous Diseases. Its original formula precisely combines 4 liang of Poria cocos, 3 liang each of cinnamon twig and white atractylodes, and 2 liang of licorice. Through a meticulous decoction process—using 6 liters of water, boiling it down to 3 liters, removing the residue, and then taking it warm in three portions—it demonstrates remarkable efficacy in warming yang, transforming fluid, and strengthening the spleen and eliminating dampness. This prescription primarily targets phlegm and fluid symptoms caused by deficiency of middle yang. Patients often experience symptoms such as chest and flank fullness, dizziness, palpitations, shortness of breath, and cough, along with a white, slippery tongue coating and a stringy or deep pulse. In modern medicine, Ling Gui Zhu Gan Tang is widely used to treat a variety of conditions, including chronic bronchitis, bronchial asthma, cardiogenic edema, edema caused by chronic glomerulonephritis, and Meniere's disease.

[0003] However, although the traditional decoction form is convenient for clinical diagnosis and treatment of symptoms and flexible addition and subtraction in traditional Chinese medicine, it also has limitations that cannot be ignored: poor taste, inconvenience in carrying, and potential loss of active ingredients (such as volatile oils) during the decoction process. These factors often reduce patient acceptance and the convenience of treatment. To meet 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 convert Ling Gui Zhu 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 the time-consuming preparation process and the need to further improve the drug utilization rate, which limit its wider application and promotion. Summary of the Invention

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

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

[0006] The raw materials of Ling Gui Zhu Gan Tang are added into water, and then pretreated with ultrasound-assisted pulsed electric field to obtain a mixture.

[0007] decoct the mixed material, and collect the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction liquid;

[0008] The medicinal 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] Place the electrodes of the pulsed electric field device in water, set the distance between the electrodes to 20-30 mm, the pulse power supply constant voltage to 5-10 V, and the pulse period 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 simultaneously turned on 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 Zhu 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 Zhu Gan Tang prescription and the water is 1:(5-10).

[0015] In a second aspect, the present invention provides a Chinese herbal volatile oil, 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 and second aspects in the preparation of a drug for treating osteoporosis.

[0017] In a fourth aspect, the present invention provides a Chinese medicine granule, comprising the Chinese medicine volatile oil according to any one of the first and second aspects.

[0018] Furthermore, the preparation method of the Chinese medicine granules includes the following steps:

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

[0020] Concentrating and drying the decoction 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. Targeting the classic prescription Ling Gui Zhu Gan Tang, the present invention introduces ultrasound-assisted pulsed electric field pretreatment on the basis of existing technology, and utilizes the composite field formed by the cavitation effect of ultrasound and the electroporation effect of the pulsed electric field to promote the dissolution of the medicinal active ingredients 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. This discovery has opened up a new clinical application field for the classic prescription Ling Gui Zhu 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 flow chart of a method for preparing a volatile oil of traditional Chinese medicine.

[0029] Figure 2 Schematic diagram of the formation of a stable inclusion complex between the enal group of 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 a stable inclusion complex formed by the enal group of cinnamaldehyde contained in the volatile oil of the present invention and the -OH bond of the β-cyclodextrin compound, cinnamaldehyde, and a physical mixture of the two. DETAILED DESCRIPTION

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying 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 making creative efforts shall fall 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 pretreated with ultrasound-assisted pulsed electric field to obtain a mixture.

[0035] decoct the mixed material, and collect the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction liquid;

[0036] The medicinal 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 Zhu Gan Tang, the present invention introduces ultrasound-assisted pulsed electric field pretreatment on the basis of existing technology, and utilizes the composite field formed by the cavitation effect of ultrasound and the electroporation effect of the pulsed electric field to promote the dissolution of the medicinal active ingredients 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. This discovery has opened up a new clinical application field for the classic prescription Ling Gui Zhu Gan Tang.

[0038] In the present invention, medicinal vapor condensate refers to the water vapor that evaporates and rises during the traditional Chinese medicine decoction process as the water heats and boils. When this water vapor encounters a cooler pot lid or other condensation surface, it condenses into water droplets. However, these water droplets are not pure distilled water, as they contain various volatile components and other medicinal ingredients released during the decoction process. These water droplets containing medicinal ingredients are called "medicinal vapor condensate."

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

[0040] Place the electrodes of the pulsed electric field device in water, set the distance between the electrodes to 20-30 mm, the pulse power supply constant voltage to 5-10 V, and the pulse period 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 simultaneously turned on 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 a 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 and second aspects 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 Ling Gui Zhu Gan Tang, especially providing 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, which 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 steps:

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

[0051] Concentrating and drying the decoction 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] The present invention grinds the volatile oil and the β-cyclodextrin compound in advance, so that the active ingredients such as cinnamaldehyde in the volatile oil and the β-cyclodextrin compound react with each other through hydrogen bonds to form a more stable inclusion complex, such as 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 granules include osteoporosis.

[0056] It should be noted that, unless otherwise specified or described, the components and raw materials involved in the Chinese herbal volatile oil, preparation method, and application thereof, and Chinese herbal granules provided in the embodiments of the present invention can be directly commercially available or homemade according to processes disclosed in the prior art. Furthermore, unless otherwise specified or described, the steps involved can be performed according to the steps and parameters disclosed in prior art such as CN108653387A, CN 112294869A, CN 112263609A, and CN 114632099A, or using existing equipment, and the present invention document will not further elaborate on each of them.

[0057] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended to illustrate the present invention only and are not intended to limit the scope of the invention. The experimental methods in the following examples where specific conditions are not specified are generally measured in accordance with national standards. If there are no corresponding national standards, then the methods are carried out in accordance with general international standards, conventional conditions, or the conditions recommended by the manufacturer.

[0058] Example 1

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

[0060] Step (1): adding raw materials of a 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 Ling Gui Shu Gan Tang prescription raw materials 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: a distance between electrodes of 25 mm, a pulse power constant voltage of 7 V and a pulse period of 2 ms, setting parameters of the ultrasonic device: an ultrasonic power of 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): decocting the mixture obtained in step (1) for 60 minutes, and collecting the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction;

[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 Chinese medicinal volatile oil.

[0063] Example 2

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

[0065] Step (1): adding raw materials of a 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 Ling Gui Shu Gan Tang prescription raw materials 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 the 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): decocting the mixture obtained in step (1) for 60 minutes, and collecting the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction;

[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 Chinese medicinal volatile oil.

[0068] Example 3

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

[0070] Step (1): adding raw materials of a 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 Ling Gui Shu Gan Tang prescription raw materials 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 the 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): decocting the mixture obtained in step (1) for 60 minutes, and collecting the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction;

[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 Chinese medicinal 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 steps:

[0075] Step (1): The volatile oil obtained in Example 1, hydroxypropyl-β-cyclodextrin and water were mixed in a weight ratio of 1:15:48, and then ground at 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): mixing the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin in a weight ratio of 0.5:10:1.7, and then granulating 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 steps:

[0080] Step (1): The volatile oil obtained in Example 2, hydroxypropyl-β-cyclodextrin and water were mixed in a weight ratio of 1:10:30, and then ground at 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): mixing the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin in a weight ratio of 0.3:10:1.5, and then granulating 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 steps:

[0085] Step (1): The volatile oil obtained in Example 3, hydroxypropyl-β-cyclodextrin, and water were mixed in a weight ratio of 1:20:60, and then ground at 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): mixing the inclusion compound obtained in step (1), the extract obtained in step (2) and maltodextrin in a weight ratio of 0.6:10:2.0, and then granulating 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 steps:

[0090] Step (1): adding raw materials of Ling Gui Zhu Gan Tang prescription consisting of Poria cocos, cinnamon twig, Atractylodes macrocephala and Licorice root 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): mixing the extract obtained in step (3) and maltodextrin in a weight ratio of 10:1.7, and then granulating to obtain the traditional Chinese medicine granules.

[0094] Test Example 1

[0095] In this example, the content of cinnamaldehyde in each gram of the obtained Chinese herbal volatile oil was determined 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 effects of the Chinese herbal 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 drug treatment 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] Treatment groups (4 groups in total, labeled as Example 4 treatment group, Example 5 treatment group, Example 6 treatment group, and Example 7 treatment group): The mice also underwent bilateral ovariectomy surgery and were treated with the Chinese herbal granules provided in Examples 4 to 7 after surgery, by gavage, at a dose of 10 mg / kg / day.

[0107] 2. Experimental period:

[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 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 indicator 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 a range format is only for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention; therefore, the range description should be considered to have specifically disclosed all possible subranges and single numerical values ​​within the range. For example, the description of a range from 1 to 6 should be considered to have specifically disclosed subranges 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, regardless of the range. In addition, whenever a numerical range is indicated herein, it is intended to include any cited numeral (fractional or integer) within the indicated range.

[0121] The foregoing description is intended only to provide specific embodiments of the present invention, which will enable those skilled in the art to understand and implement the present invention. Various modifications to these embodiments will be readily 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 is not intended to be limited to the embodiments shown herein, but is intended to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A Chinese medicine granule prepared from the raw materials of Ling Gui Zhu Gan Tang or the use of Ling Gui Zhu Gan Tang in preparing a medicine for treating osteoporosis, characterized in that: The preparation method of the Chinese medicine granules comprises the following steps: Step (1): adding the 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 the electrodes of a pulsed electric field device and the ultrasonic probe of an ultrasonic device in the water, setting the parameters of the pulsed electric field device: the distance between the electrodes is 25 mm, the constant voltage of the pulse power supply is 7 V and the pulse period is 2 ms, setting the 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 ultrasonic synergistic pulsed electric field pretreatment for 15 minutes to obtain a mixture; Step (2): boiling the mixture obtained in step (1) for 60 minutes, and collecting the medicinal vapor condensate to obtain the medicinal vapor condensate and the decoction; Step (3): extracting the medicinal vapor condensate obtained in step (2) through a volatile oil extractor and collecting volatile oil to obtain Chinese medicinal volatile oil; Step (4): mixing the volatile oil of the traditional Chinese medicine obtained in step (3), the β-cyclodextrin compound and water, and then grinding and drying to obtain an inclusion compound; Step (5): Concentrating and drying the decoction obtained in step (2) to obtain an extract; Step (6): the inclusion compound obtained in step (4), the extract obtained in step (5) and maltodextrin are mixed, and then granulated to obtain the Chinese medicine granules.

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