Use of a traditional Chinese medicine composition in the preparation of a drug for preventing and / or treating osteoporosis

Abstract

The present application belongs to the technical field of traditional Chinese medicine, and relates to a new use of a traditional Chinese medicine composition, in particular to application of the traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating osteoporosis. The traditional Chinese medicine composition is prepared from turtle shell, radix falcaliae, rhizoma discontinu, medlar, rhizoma atractylodis macrocephalae and poria cocos. The composition can significantly improve bone density of rats with osteoporosis caused by retinoic acid, and improve bone strength and flexibility; can significantly improve bone density reduction of rats caused by ovary removal, promote bone formation, inhibit bone absorption, delay bone mass loss, maintain bone homeostasis, and indicate that the traditional Chinese medicine composition has a good treatment effect on osteoporosis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology and relates to a new use of a traditional Chinese medicine composition, specifically the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of osteoporosis. Background Technology

[0002] Osteoporosis is a group of bone diseases caused by various factors. While bone tissue exhibits normal calcification and a normal ratio of calcium salts to matrix, it is characterized by a decrease in bone tissue volume per unit volume, a metabolic bone disorder. In most cases of osteoporosis, the reduction in bone tissue is primarily due to an imbalance between increased bone resorption and osteoblast bone deposition. The onset is often slow, but can be rapid in some cases. Symptoms include bone pain and susceptibility to fractures, with generally normal biochemical tests. Pathological anatomy reveals a thin cortical bone, sparse and atrophied trabeculae, and a thin osteoid layer.

[0003] Osteoporosis is common in middle-aged and elderly people, and its prevalence increases with age. Currently, the commonly used drugs for treating osteoporosis in clinical practice are mainly calcitonin, bisphosphonates, estrogen regulators, and thyroid hormones. However, the toxic side effects of long-term use of these drugs are also very significant. Therefore, there is a huge demand and market for effective and safe anti-osteoporosis drugs.

[0004] Traditional Chinese medicine has shown promising prospects in this area. Many compound prescriptions and extracts of traditional Chinese medicine have been proven to have anti-osteoporosis effects. Finding safe and effective anti-osteoporosis treatments from traditional Chinese medicine or natural drugs is becoming a hot topic in drug research and development.

[0005] However, the current treatment methods are not very effective. Therefore, providing traditional Chinese medicine compositions and their application in the preparation of drugs for treating osteoporosis is of great practical significance. Summary of the Invention

[0006] In view of this, the present invention provides a novel use of a traditional Chinese medicine composition, specifically relating to its application in the preparation of a drug for treating osteoporosis. The composition of the present invention can significantly increase bone mineral density in retinoic acid-induced osteoporotic rats, improve bone strength and toughness; it can also significantly improve the decreased bone mineral density in ovariectomized rats, promote bone formation, inhibit bone resorption, delay bone loss, and maintain bone homeostasis, suggesting that this traditional Chinese medicine composition has a good therapeutic effect on osteoporosis.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0008] This invention provides the use of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of osteoporosis, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0009]

[0010] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0011]

[0012] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0013]

[0014] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0015]

[0016]

[0017] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0018] Step 1: Add water to the prescribed amount of Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala and decoct. Filter the solution, combine the filtrates, concentrate them into an extract, cool to room temperature, add ethanol to the extract, let it stand, take the supernatant, recover the ethanol, concentrate it into a second concentration to obtain the first extract, filter it for later use.

[0019] Step 2: Add water to the prescribed amounts of turtle shell, wolfberry, and poria cocos and decoct. Filter the decoction, combine the filtrates, and concentrate them in a third stage to obtain the second extract. Filter the extract and set it aside.

[0020] Step 3: Combine the first extract and the second extract and mix well.

[0021] In some specific embodiments of the present invention, the first concentration in step 1 is: concentrating at 50-80°C to a relative density of 1.10-1.15; and / or

[0022] The amount of water added in step 1 is 8 times the original amount of medicine; and / or

[0023] The decoction process described in step 1 is performed three times, each time for one hour; and / or

[0024] The addition of ethanol in step 1 is to achieve an alcohol content of 60% (v / v); and / or

[0025] The settling time mentioned in step 1 is at least 12 hours; and / or

[0026] The second concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0027] The third concentration mentioned in step 2 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0028] The amount of water added in step 2 is 8 times the original amount of medicine; and / or

[0029] The simmering process described in step 1 is repeated 3 times, with each simmering lasting 1 hour.

[0030] In some specific embodiments of the present invention, the drug comprises any of the following and pharmaceutically acceptable excipients:

[0031] (I) The traditional Chinese medicine composition; or

[0032] (II) The traditional Chinese medicine composition prepared by the above method.

[0033] In some specific embodiments of the present invention, the excipients include steviol glycosides and / or dextrin;

[0034] Preferably, by weight, it includes:

[0035] 5 parts of steviol glycosides;

[0036] 40-70 parts of dextrin.

[0037] In some specific embodiments of the present invention, the dosage form of the drug includes one or more of oral dosage forms, injectable dosage forms, or topical dosage forms;

[0038] Preferably, the dosage form of the drug includes one or more of the following: decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, gels, sprays, or injections.

[0039] In some specific embodiments of the present invention, the method for preparing the drug includes the following steps:

[0040] The traditional Chinese medicine composition was prepared according to the described preparation method;

[0041] Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

[0042] This invention provides the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of osteoporosis. The traditional Chinese medicine composition is prepared from turtle shell, Polygonum multiflorum, Dipsacus asper, Lycium barbarum, Atractylodes macrocephala, and Poria cocos. The composition of this invention can significantly increase bone mineral density in retinoic acid-induced osteoporotic rats, improve bone strength and toughness; it can also significantly improve the decreased bone mineral density in ovariectomized rats, promote bone formation, inhibit bone resorption, delay bone loss, and maintain bone homeostasis, suggesting that this traditional Chinese medicine composition has a good therapeutic effect on osteoporosis. Detailed Implementation

[0043] This invention discloses the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of osteoporosis. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0044] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for osteoporosis. The composition is prepared from turtle shell, Polygonum multiflorum, Dipsacus asper, Lycium barbarum, Atractylodes macrocephala, and Poria cocos. The term "used for" can refer to any method beneficial to improving the corresponding symptoms in patients, including treatment or prevention.

[0045] The traditional Chinese medicine composition includes: 1-100 parts of turtle shell, 1-100 parts of Polygonum multiflorum, 1-100 parts of Dipsacus asper, 1-100 parts of Lycium barbarum, 1-100 parts of Atractylodes macrocephala, and 1-100 parts of Poria cocos.

[0046] Furthermore, the traditional Chinese medicine composition includes: 1-70 parts of turtle shell, 1-70 parts of Polygonum multiflorum, 1-70 parts of Dipsacus asper, 1-70 parts of Lycium barbarum, 1-70 parts of Atractylodes macrocephala, and 1-70 parts of Poria cocos.

[0047] Preferably, the traditional Chinese medicine composition includes: 10-50 parts of turtle shell, 10-50 parts of Polygonum multiflorum, 10-50 parts of Dipsacus asper, 10-50 parts of Lycium barbarum, 10-50 parts of Atractylodes macrocephala, and 10-50 parts of Poria cocos.

[0048] Most preferably, the traditional Chinese medicine composition includes: 35 parts of turtle shell, 35 parts of Polygonum multiflorum, 35 parts of Dipsacus asper, 35 parts of Lycium barbarum, 35 parts of Atractylodes macrocephala, and 35 parts of Poria cocos.

[0049] The above-mentioned composition can be made by directly grinding raw materials into powder and mixing, or it can be an extract or other form obtained by conventional means. The raw materials used can also be used by directly grinding them into powder, extracting them, or using other processed forms.

[0050] Specifically, the dosage forms of the osteoporosis drugs provided by the present invention include oral dosage forms, injectable dosage forms, or topical dosage forms.

[0051] The dosage form of the drug of the present invention is prepared by weighing the raw material in proportion, and then adding pharmaceutically acceptable excipients or additives, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices, in accordance with conventional pharmaceutical production methods, to produce a pharmaceutically acceptable conventional dosage form, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0052] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0053] Step 1: Boil Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala in water three times, filter, combine the filtrates, concentrate to extract, cool to room temperature, add ethanol to extract until the alcohol content reaches 60%, let stand, take the supernatant, recover the ethanol and concentrate to extract, filter for later use.

[0054] Step 2: Boil turtle shell, wolfberry and poria cocos in water three times, filter, combine the filtrates, concentrate to extract, filter and set aside;

[0055] Step 3: Combine the two groups of extracts and mix well; add appropriate amounts of steviol glycosides and dextrin, granulate, and the product is obtained.

[0056] More preferably, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0057] Step 1: Boil Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala in 8 times the amount of water three times, 1 hour each time. Filter the decoction, combine the filtrates, and concentrate them to an extract with a relative density of 1.10-1.15. Cool to room temperature, add ethanol to make the alcohol content reach 60%, let stand for more than 12 hours, take the supernatant, recover the ethanol and concentrate it to an extract with a relative density of 1.20-1.23. Filter and set aside.

[0058] Step 2: Add 8 times the amount of water to turtle shell, wolfberry, and poria cocos and decoct three times, one hour each time. Filter, combine the filtrates, concentrate to an extract with a relative density of 1.20-1.23, filter, and set aside.

[0059] Step 3: Combine the two extracts, mix well, add 5g of steviol glycosides and an appropriate amount of dextrin, granulate, and the product is ready.

[0060] The composition of this invention can significantly increase bone mineral density in retinoic acid-induced osteoporotic rats, improve bone strength and toughness; it can significantly improve the decrease in bone mineral density in rats induced by ovariectomy, promote bone formation, inhibit bone resorption, delay bone loss, maintain bone homeostasis, and has a good therapeutic effect on osteoporosis.

[0061] The raw materials and reagents used in the application of the traditional Chinese medicine composition provided by this invention in the preparation of drugs for the prevention and / or treatment of osteoporosis are all commercially available.

[0062] To enable those skilled in the art to more clearly understand the technical solution of this application, the technical solution of this application will be described in detail below with reference to specific embodiments. Unless otherwise specified, the following experiments were conducted under conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments whose manufacturers are not specified, are all commercially available conventional products. Experimental methods without specified detailed conditions were conducted according to conventional testing methods or the supplier's recommended operating instructions.

[0063] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The following embodiments are merely for further illustrating the technical solutions of this application and are not intended to limit the scope of protection of this application.

[0064] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0065] Take 357g of Polygonum multiflorum, 357g of Dipsacus asper, and 357g of Atractylodes macrocephala, add 8 times the amount of water and decoct three times, one hour each time. Filter, combine the filtrates, and concentrate (at 80℃) to obtain an extract with a relative density of 1.10-1.15 (60℃). Cool to room temperature (20℃±5℃), add ethanol to make the alcohol content reach 60%, let stand for 12 hours, take the supernatant, recover the ethanol and concentrate (at 70℃) to obtain an extract with a relative density of 1.20-1.23 (60℃). Filter and set aside. Take 357g of turtle shell, 357g of Lycium barbarum, and 357g of Poria cocos, add 8 times the amount of water and decoct three times, one hour each time. Filter, combine the filtrates, and concentrate (at 80℃) to obtain an extract with a relative density of 1.20-1.23 (60℃). Filter and set aside. Combine the two extracts mentioned above, mix them well, add 5g of steviol glycosides and 500g of dextrin, granulate, and the product is obtained.

[0066] Effect of Experiment 2 on a rat model of retinoic acid-induced osteoporosis

[0067] 1. Experimental Materials

[0068] Animals: SD rats, SPF grade, female, 48 in total, weighing 200-220g. Purchased from Spiford (Suzhou) Biotechnology Co., Ltd., license number: SCXK(Su)2022-0006.

[0069] Drug: Gusongbao Granules, Guizhou Fuhua Pharmaceutical Co., Ltd., batch number 20230408.

[0070] Reagents: Retinoic acid, A9120, Beijing Solarbio Science & Technology Co., Ltd.; Sodium carboxymethyl cellulose, 230104, Shanghai Chemical Reagent Co., Ltd.

[0071] Instruments: InAlyzer small animal dual-energy X-ray bone densitometer, Shenzhen Baianuo Technology Co., Ltd.; CSS-44010 electronic universal testing machine (1 ton), Changchun Testing Machine Research Institute.

[0072] 2. Dosage design

[0073] The daily dosage of Gusongbao granules for humans is 15g. Based on the ratio of the effective dose to the human body surface area of ​​animals, the equivalent dose for rats is 1.35g / kg.

[0074] The daily human dosage of the traditional Chinese medicine composition is 14g. Based on the ratio of effective dose per unit body surface area in humans and animals, the equivalent dose for rats is calculated to be 1.26g / kg. Low, medium, and high doses are set at a ratio of 0.5:1:2, with values ​​of 0.63:1.26:2.52 respectively.

[0075] 3. Experimental Methods

[0076] Forty-eight female SD rats were randomly divided into six groups according to their body weight: a blank control group, a model control group, a Gusongbao granule group (positive control drug, 1.35 g / kg), and low (0.63 g / kg), medium (1.26 g / kg), and high (2.52 g / kg) dose groups of the composition of this invention, with eight rats in each group. In the morning, except for the blank control group which was administered 10 ml / kg of 1% sodium carboxymethyl cellulose by gavage, the other groups were administered retinoic acid (70 mg / kg) prepared with 1% sodium carboxymethyl cellulose by gavage. In the afternoon, except for the blank control group and the model group which were administered distilled water by gavage, the other groups were administered the corresponding drug by gavage at a volume of 10 ml / kg. This was continued for two weeks. Retinoic acid administration was stopped in the third week, and the drug administration continued for another four weeks.

[0077] Animals were euthanized 1 hour after the last administration. Both femurs were removed, and the attached muscles and connective tissues were removed. The femurs were then wrapped with gauze soaked in physiological saline and stored at -80°C.

[0078] Testing indicators: ① Bone mineral density: The left tibia was sampled and tested using a bone densitometer. The scanning location was 1 cm below the articular surface, and two scans were performed, with the average value taken. ② Tibial biomechanical measurement: A three-point fracture test was performed using an electronic universal testing machine. The parameters were calibrated to 1 / 50, the speed was 2 mm / min, a 100 kg pressure sensor was used, and the function relationship between load and deflection was recorded using a function recorder. Fm is the maximum bending force (fracture point), Y is the deflection under maximum bending stress, and Eb is the flexural modulus of elasticity.

[0079] 4. Experimental Results

[0080] The results showed that compared with the blank control group, the tibial bone mineral density, maximum bone bending force and bending elastic modulus of rats in the model group were significantly decreased (P<0.01). Compared with the model control group, the bone mineral density of the positive drug Gusongbao Granule group and the low, medium and high dose groups of the composition of the present invention was significantly increased (P<0.05, P<0.01), and the maximum bone bending force and bending elastic modulus were significantly improved (P<0.05, P<0.01), which proves that this product has the effects of increasing bone mineral density, improving bone strength and toughness. The results are shown in Table 1 and Table 2.

[0081] Table 1 Effects on bone mineral density in the rat osteoporosis model induced by retinoic acid

[0082]

[0083] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0084] Table 2 Effects on bone biomechanics in the rat osteoporosis model induced by retinoic acid

[0085]

[0086] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0087] Experimental Example 3 Effects on the rat osteoporosis model induced by ovariectomy

[0088] 1. Experimental materials

[0089] Animals: 40 SPF-grade female SD rats, weighing 180-200g. Purchased from Zhejiang Vital River Laboratory Animal Technology Co., Ltd., License No.: SCXK(Zhe)2019-0001.

[0090] Reagents: Rat bone alkaline phosphatase (BALP) ELISA kit, D731033, Shanghai Sangon Biotech Co., Ltd.; Type I procollagen amino-terminal peptide (PINP) ELISA kit, E-EL-R1414; Type I collagen carboxy-terminal peptide (CTX-I) ELISA kit, E-EL-R1456; pro-inflammatory cytokine (Interleukin-1β, IL-1β), E-EL-R0012, E-EL-R0012, Elite Biotechnology Co., Ltd.

[0091] Instruments: InAlyzer small animal dual-energy X-ray bone densitometer, Shenzhen Baianuo Technology Co., Ltd.; refrigerated centrifuge, eppendorf; microplate reader, American Valley Molecular Technology Co., Ltd.

[0092] 2. Dosage design

[0093] The daily human dosage of the traditional Chinese medicine composition is 14g. Based on the ratio of effective dose per unit body surface area in humans and animals, the equivalent dose for rats is calculated to be 1.45g / kg. Low, medium, and high doses are set at a ratio of 0.5:1:2, with proportions of 0.63:1.26:2.52.

[0094] 3. Experimental Methods

[0095] Forty female SD rats were randomly divided into five groups according to their body weight: a sham-operated control group, a model control group, and low (0.63 g / kg), medium (1.26 g / kg), and high (2.52 g / kg) dose groups of the composition of this invention, with 10 rats in each group. In the model control group and the low and high dose groups of the composition of this invention, the bilateral ovaries were removed through a dorsal incision under anesthesia. In the sham-operated control group, the surrounding adipose tissue was removed without removing the ovaries. One week post-surgery, the sham-operated control group and the model control group were administered 10 ml / kg of physiological saline by gavage, while the low and high dose groups of the composition of this invention were administered the corresponding drug by gavage at a volume of 10 ml / kg, once daily for seven consecutive weeks.

[0096] After administration, the animals were anesthetized by intraperitoneal injection of 1% sodium pentobarbital. Blood was collected from the abdominal aorta, and serum was collected by centrifugation. After the above operations were completed, the animals were euthanized by vertebral dislocation. Both femurs were removed, and the attached muscles and connective tissues were removed. The femurs were then wrapped with gauze soaked in physiological saline and stored at -80°C.

[0097] Detection indicators: ① Bone mineral density: Tibial bone was sampled and measured using a bone densitometer. The scanning site was 1 cm below the articular surface, and two scans were performed, with the average value taken. ② ELISA kit was used to detect the serum levels of bone alkaline phosphatase (BALP), type I procollagen amino-terminal peptide (PINP), type I collagen carboxy-terminal peptide (CTX-I), and pro-inflammatory cytokines (interleukin-1β, IL-1β).

[0098] 4. Experimental Results

[0099] The results showed that compared with the control group, the tibial bone mineral density of rats in the model control group was significantly reduced (P<0.01), serum BALP and PINP levels were significantly decreased, and CTX-I and IL-1β levels were significantly increased (P<0.01). With increasing dosage of the composition of the present invention, the BALP and PINP levels in the low, medium, and high dose groups increased, while the CTX-I and IL-1β levels decreased, with statistically significant differences compared with the model control group (P<0.05, P<0.01). This indicates that the product can increase bone mineral density, promote bone formation and inhibit bone resorption by regulating bone metabolism, suggesting that the composition of the present invention has the effect of increasing bone mineral density, maintaining bone homeostasis, and delaying bone loss in osteoporotic rats. The results are shown in Tables 3 and 4.

[0100] Table 3. Effects of ovariectomy on bone mineral density in a rat model of osteoporosis.

[0101]

[0102] Note: Compared with the model group, *P<0.05, **P<0.01.

[0103] Table 4. Effects of ovariectomy on bone metabolism parameters in rats with osteoporosis.

[0104]

[0105]

[0106] Note: Compared with the sham surgery control group. ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0107] The composition proposed in this invention can significantly increase bone mineral density in retinoic acid-induced osteoporotic rats, improve bone strength and toughness; it can also significantly improve the decreased bone mineral density in ovariectomy-induced rats, promote bone formation, inhibit bone resorption, and maintain bone homeostasis. In summary, the composition of this invention has a definite therapeutic effect on osteoporosis.

[0108] The above embodiments of the present invention are merely illustrative examples to clearly illustrate the invention, and are not intended to limit the implementation of the invention. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively describe all possible implementations. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of osteoporosis, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

2. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

3. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

4. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

5. The application as described in any one of claims 1 to 4, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: Step 1: Add water to the prescribed amount of Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala and decoct. Filter the solution, combine the filtrates, concentrate them into an extract, cool to room temperature, add ethanol to the extract, let it stand, take the supernatant, recover the ethanol, concentrate it into a second concentration to obtain the first extract, filter it for later use. Step 2: Add water to the prescribed amounts of turtle shell, wolfberry, and poria cocos and decoct. Filter the decoction, combine the filtrates, and concentrate them in a third stage to obtain the second extract. Filter the extract and set it aside. Step 3: Combine the first extract and the second extract and mix well.

6. The application as described in claim 5, characterized in that, The first concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.10–1.15; and / or The amount of water added in step 1 is 8 times the original amount of medicine; and / or The decoction process described in step 1 is performed three times, each time for one hour; and / or The addition of ethanol in step 1 is to achieve an alcohol content of 60% (v / v); and / or The settling time mentioned in step 1 is at least 12 hours; and / or The second concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or The third concentration mentioned in step 2 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or The amount of water added in step 2 is 8 times the original amount of medicine; and / or The simmering process described in step 1 is repeated 3 times, with each simmering lasting 1 hour.

7. The application as described in any one of claims 1 to 6, characterized in that, The drug includes any of the following and pharmaceutically acceptable excipients: (I) The traditional Chinese medicine composition; or (II) The traditional Chinese medicine composition prepared by the above method.

8. The application as described in claim 7, characterized in that, The excipients include steviol glycosides and / or dextrin; Preferably, by weight, it includes: 5 parts of steviol glycosides; 40-70 parts of dextrin.

9. The application as described in any one of claims 1 to 8, characterized in that, The dosage form of the drug includes one or more of oral dosage forms, injectable dosage forms, or topical dosage forms; Preferably, the dosage form of the drug includes one or more of the following: decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, gels, sprays, or injections.

10. The application as described in any one of claims 7 to 9, characterized in that, The method for preparing the drug includes the following steps: The traditional Chinese medicine composition was prepared according to the described preparation method; Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

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