A traditional Chinese medicine composition and application thereof in preparation of a medicine for preventing and / or treating polycystic ovary syndrome

Abstract

The present application relates to the field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating polycystic ovary syndrome, wherein 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 reduce the estrus interval rate, ovary index, serum T, E2, LH, IL-6, IL-1beta and TNF-alpha of rats with polycystic ovary syndrome, and increase serum FSH. The traditional Chinese medicine composition can regulate sex hormone level in rats, slow down development of chronic inflammation, and has a good treatment effect on polycystic ovary syndrome.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition and its use in the preparation of a medicament for the prevention and / or treatment of polycystic ovary syndrome. Background Technology

[0002] Polycystic ovary syndrome (PCOS), also known as Stein-Leventhal syndrome, is the most common endocrine and metabolic disorder among women of reproductive age. PCOS is characterized by abnormally high androgen levels, persistent anovulation, and the presence of multiple cysts on the ovaries.

[0003] Treatment for polycystic ovary syndrome (PCOS) primarily involves symptomatic relief, including lifestyle modifications and oral medications. Dietary improvements can help with weight loss, prevent weight gain, maintain overall health, and enhance quality of life. Drug therapy varies depending on the clinical presentation of PCOS, including medications to regulate menstrual cycles, lower androgen levels, improve insulin resistance, and induce ovulation.

[0004] However, current treatment methods are not very effective. Western medicine treatments have many side effects. Hormonal drugs (such as birth control pills, metformin, letrozole, etc.) may cause weight gain, gastrointestinal reactions, breast tenderness, and mood swings. Ovulation-inducing drugs (such as clomiphene) may cause ovarian hyperstimulation syndrome (OHSS), with risks such as abdominal distension, ascites, and ovarian enlargement, especially for obese patients or those with severe insulin resistance. After discontinuing Western medicine treatment, hormone levels tend to rebound, requiring long-term medication control. Therefore, providing traditional Chinese medicine compositions and their application in the preparation of drugs for treating polycystic ovary syndrome is of significant practical importance. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition and its application in the preparation of drugs for the prevention and / or treatment of polycystic ovary syndrome (PCOS). The composition of the present invention can significantly reduce the interestrus cycle rate, ovarian index, serum T, E2, LH, IL-6, IL-1β, and TNF-α in PCOS rats, while increasing serum FSH. It regulates sex hormone levels in rats and slows the development of chronic inflammation, suggesting that this traditional Chinese medicine composition has a good therapeutic effect on PCOS.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition, comprising, by weight, the following components:

[0008]

[0009] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0010]

[0011] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0012]

[0013] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0014]

[0015]

[0016] Secondly, the present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0017] 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.

[0018] 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.

[0019] Step 3: Combine the first extract and the second extract and mix well.

[0020] 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

[0021] The amount of water added in step 1 is 8 times the original amount of medicine; and / or

[0022] The decoction process described in step 1 is performed three times, each time for one hour; and / or

[0023] The addition of ethanol in step 1 is to achieve an alcohol content of 60% (v / v); and / or

[0024] The settling time mentioned in step 1 is at least 12 hours; and / or

[0025] The second concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0026] The third concentration mentioned in step 2 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0027] The amount of water added in step 2 is 8 times the original amount of medicine; and / or

[0028] The simmering process described in step 1 is repeated 3 times, with each simmering lasting 1 hour.

[0029] Thirdly, the present invention also provides the use of any of the following in the preparation of a medicament for the prevention and / or treatment of polycystic ovary syndrome;

[0030] (I) The aforementioned traditional Chinese medicine composition; or

[0031] (II) The traditional Chinese medicine composition prepared by the above preparation method.

[0032] Fourthly, the present invention also provides a medicament comprising any of the following and pharmaceutically acceptable excipients:

[0033] (I) The aforementioned traditional Chinese medicine composition; or

[0034] (II) The traditional Chinese medicine composition prepared by the above preparation method.

[0035] In some specific embodiments of the present invention, the excipients include steviol glycosides and / or dextrin;

[0036] Preferably, by weight, it includes:

[0037] 5 parts of steviol glycosides;

[0038] 40-70 parts dextrin;

[0039] Preferably, the dosage form of the drug includes one or more of oral dosage forms, injectable dosage forms, or topical dosage forms;

[0040] 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.

[0041] Fifthly, the present invention also provides a method for preparing the aforementioned drug, comprising the following steps:

[0042] The traditional Chinese medicine composition was prepared according to the described preparation method;

[0043] Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

[0044] The traditional Chinese medicine composition provided by this invention can significantly reduce the interestrus period rate, ovarian index, serum T, E2, LH, IL-6, IL-1β, and TNF-α in rats with polycystic ovary syndrome (PCOS), while increasing serum FSH. It regulates sex hormone levels in rats and slows the development of chronic inflammation, suggesting that the traditional Chinese medicine composition of this invention has a certain therapeutic effect on PCOS in rats. Detailed Implementation

[0045] This invention discloses a traditional Chinese medicine composition and its application in the preparation of drugs for the prevention and / or treatment of polycystic ovary syndrome. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired results. 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 clearly modify or appropriately change and combine 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.

[0046] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for polycystic ovary syndrome (PCOS). This 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 of the patient, including treatment or prevention.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] Specifically, the drug dosage forms for polycystic ovary syndrome provided by the present invention include oral dosage forms, injectable dosage forms, or topical dosage forms.

[0052] 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.

[0053] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0054] 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.

[0055] Step 2: Boil turtle shell, wolfberry and poria cocos in water three times, filter, combine the filtrates, concentrate to extract, filter and set aside;

[0056] 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.

[0057] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0058] 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.

[0059] 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.

[0060] 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.

[0061] The herbal composition of this invention can significantly reduce the interestrus cycle rate, ovarian index, serum T, E2, LH, IL-6, IL-1β, and TNF-α in rats with polycystic ovary syndrome (PCOS), while increasing serum FSH. It regulates sex hormone levels in rats and slows the development of chronic inflammation, suggesting that the herbal composition of this invention has a certain therapeutic effect on PCOS in rats.

[0062] The raw materials and reagents used in the traditional Chinese medicine composition provided by this invention and its application in the preparation of drugs for treating polycystic ovary syndrome are all commercially available.

[0063] 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.

[0064] 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.

[0065] The present invention will be further illustrated below with reference to the embodiments:

[0066] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0067] 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.

[0068] Example 2: Effects on a letrozole-induced polycystic ovary syndrome model rat

[0069] 1. Experimental Materials

[0070] Animals: 48 female SD rats, SPF grade, weighing 190-200g. Purchased from Spiford (Suzhou) Biotechnology Co., Ltd., Certificate No.: A202501070378.

[0071] Drugs: Letrozole, Jiangsu Hengrui Medicine Co., Ltd., batch number 230906KB; Diane-35, Bayer Healthcare Co., Ltd., batch number KT05L5J2.

[0072] Reagents: Rat sex hormones testosterone (T), catalog number H090-1-2; estradiol (E2), catalog number H102-1-2; luteinizing hormone (LH), catalog number H206-1-2; follicle-stimulating hormone (FSH), catalog number H101-1-2; ELISA kit, Nanjing Jiancheng Bioengineering Institute.

[0073] Instruments: Ultra-low temperature freezer, Haier, model: DW-86L728; Electronic balance, Sartorius Scientific Instruments, model: BSA224S-CW; Microplate reader, American Microplate Molecular, model: Flexstation 3; BX53 microscope, Olympus, Japan.

[0074] 2. Dosage design

[0075] The daily dose of Diane-35 is 3.28 mg, and the clinical dose for adults (based on a weight of 60 kg) is 0.054 mg / kg. The equivalent dose for rats is calculated to be 0.339 mg / kg.

[0076] The daily human dose of the traditional Chinese medicine composition is 14g, and the clinical dose for an adult (based on a weight of 60kg) is 0.23g / kg. The equivalent dose for rats is calculated to be 1.45g / kg. Using this dose as the medium dose, and designing a dose ratio of 0.5:1:2, the low, medium, and high doses of the traditional Chinese medicine composition are 0.725, 1.45, and 2.9g / kg, respectively.

[0077] 3. Experimental Methods

[0078] SD rats were acclimatized for one week and randomly divided into a control group (n=8) and a model group (n=40). A polycystic ovary syndrome (PCOS) rat model was established by continuous gavage administration of letrozole at 1 mg / kg / d for 21 days. Rats exhibiting no / irregular estrous cycles were defined as PCOS positive by observing their estrous cycles. Forty successfully modeled rats were randomly divided into a model group, a Diane-35 positive group (0.339 mg / kg), and low (0.725 g / kg), medium (1.45 g / kg), and high (2.9 g / kg) groups of the herbal composition of this invention, with 8 rats in each group. The corresponding drug solution was administered by gavage at a volume of 10 mL / kg for 28 days, while the control group received an equal volume of pure water. Estrous cycles were continuously monitored during the last 10 days of treatment. After treatment, rat body weight was measured, and blood was collected from the abdominal aorta under intraperitoneal anesthesia. Serum was separated, and bilateral rat ovaries were removed and weighed.

[0079] Detection indicators: ① Interestrus rate = Number of days in estrus / Number of days observed (10); ② ELISA kit was used to detect the levels of rat sex hormones testosterone (T), estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH) in serum.

[0080] 4. Experimental Results

[0081] The results showed that letrozole could induce irregular estrus in rats, successfully inducing a rat PCOS model. Compared with the control group, the model group showed higher interestrus rate, ovarian index, and serum T, E2, and LH levels.

[0082] The levels of certain indicators were significantly increased (P < 0.01), while serum FSH was significantly decreased (P < 0.01). Compared with the model group, the medium and high dose groups of the traditional Chinese medicine composition significantly reduced the interestrus rate, ovarian index, serum T, E2, LH, and other indicators, and increased serum FSH (P < 0.05, P < 0.01). The results are shown in Table 1 and Table 2. Table 1 shows the effect of the traditional Chinese medicine composition on the interestrus rate and ovarian index in model rats.

[0083]

[0084] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0085] Table 2 Effects on serum T, E2, LH and FSH levels

[0086]

[0087] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01. Effect of Example 3 on a rat model of polycystic ovary syndrome induced by dehydroepiandrosterone (DHEA).

[0088] 1. Experimental Materials

[0089] Animals: 48 female SD rats, SPF grade, weighing 160-180g. Purchased from Spiefolk (Suzhou) Biotechnology Co., Ltd., Certificate No.: A202406130585.

[0090] Drug: Dehydroepiandrosterone (DHEA), Shanghai Aladdin Biochemical Technology Co., Ltd., Product No.:

[0091] D468511-10mg; Diane-35, Bayer Healthcare Co., Ltd., batch number KT05L5J2.

[0092] Reagents: Rat interleukin-6 (IL-6), catalog number H007-1-2; interleukin-1β (IL-1β), catalog number H002-1-2; tumor necrosis factor-α (TNF-α), catalog number H052-1-2 ELISA kit, Nanjing Jiancheng Bioengineering Institute; 0.9% sodium chloride injection, Zhejiang Guojing Pharmaceutical Co., Ltd., batch number: C23072207.

[0093] Instruments: Ultra-low temperature freezer, Haier, model: DW-86L728; Electronic balance, Sartorius Scientific Instruments, model: BSA224S-CW; Microplate reader, American Microplate Molecular, model: Flexstation 3; BX53 microscope, Olympus, Japan.

[0094] 2. Dosage design

[0095] The daily dose of Diane-35 is 3.28 mg, and the clinical dose for adults (based on a weight of 60 kg) is 0.054 mg / kg. The equivalent dose for rats is calculated to be 0.339 mg / kg.

[0096] The daily human dose of the traditional Chinese medicine composition is 14g, and the clinical dose for an adult (based on a weight of 60kg) is 0.23g / kg. The equivalent dose for rats is calculated to be 1.45g / kg. Using this dose as the medium dose, and designing a dose ratio of 0.5:1:2, the low, medium, and high doses of the traditional Chinese medicine composition are 0.725, 1.45, and 2.9g / kg, respectively.

[0097] 3. Experimental Methods

[0098] SD rats were acclimatized for one week and randomly divided into a control group (n=8) and a model group (n=40). A rat model of polycystic ovary syndrome (PCOS) was established by subcutaneous injection of 0.06 mg / g into the back of the rats for 21 consecutive days. Rats exhibiting no or irregular estrous cycles were defined as PCOS positive by observing their estrous cycles. Forty successfully modeled rats were randomly divided into a model group, a Diane-35 positive group (0.339 mg / kg), and low (0.725 g / kg), medium (1.45 g / kg), and high (2.9 g / kg) groups of the herbal composition of this invention, with 8 rats in each group. The corresponding drug solution was administered by gavage at a volume of 10 mL / kg for 28 consecutive days, while the control group received an equal volume of pure water. The estrous cycles of the rats were continuously monitored during the last 10 days of treatment. After treatment, the rats were anesthetized by intraperitoneal injection, and blood was collected from the abdominal aorta. Serum was separated and used for later use.

[0099] Detection indicators: ① Interestrus rate = number of days of estrus / number of days of observation (10); ② Detection of rat serum IL-6, IL-1β and TNF-α using reagent kits.

[0100] 4. Experimental Results

[0101] The results showed that dehydroepiandrosterone (DHEA) induced irregular estrus in rats, successfully inducing a rat PCOS model. The interestrus rate, serum IL-6, IL-1β, and TNF-α levels were compared with the control group in the model group.

[0102] The levels of these indicators were significantly elevated (P < 0.01). Compared with the model group, the low, medium, and high dose groups of the traditional Chinese medicine composition significantly reduced the interestrus rate and serum IL-6, IL-1β, and TNF-α levels (P < 0.05, P < 0.01). The results are shown in Table 3.

[0103] Table 3. Effects on interestrus period rate, serum IL-6, IL-1β and TNF-α levels.

[0104]

[0105] Note: Compared with the blank control group, ## P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0106] The herbal composition of this invention can significantly reduce the interestrus cycle rate, ovarian index, serum T, E2, LH, IL-6, IL-1β, and TNF-α in rats with polycystic ovary syndrome (PCOS), while increasing serum FSH. It regulates sex hormone levels in rats and slows the development of chronic inflammation, suggesting that the herbal composition of this invention has a certain therapeutic effect on PCOS in rats.

[0107] The above embodiments of the present invention are merely examples to clearly illustrate the present invention and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. 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. A traditional Chinese medicine composition, characterized in that, Based on parts by weight, it comprises the following components:

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

3. The traditional Chinese medicine composition according to claim 1, characterized in that, Based on parts by weight, it comprises the following components:

4. The traditional Chinese medicine composition according to claim 1, characterized in that, Based on parts by weight, it comprises the following components:

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, 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 preparation method according to 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 use of any of the following in the preparation of a medicine for the prevention and / or treatment of polycystic ovary syndrome; (I) The traditional Chinese medicine composition as described in any one of claims 1 to 4; or (II) The traditional Chinese medicine composition prepared by the preparation method as described in claim 5 or 6.

8. A drug, characterized in that, Includes any of the following and pharmaceutically acceptable excipients: (I) The traditional Chinese medicine composition as described in any one of claims 1 to 4; or (II) The traditional Chinese medicine composition prepared by the preparation method as described in claim 5 or 6.

9. The drug as described in claim 8, characterized in that, The excipients include steviol glycosides and / or dextrin; Preferably, by weight, it includes: 5 parts of steviol glycosides; 40-70 parts dextrin; Preferably, 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 method for preparing the drug as described in claim 8 or 9, characterized in that, Includes the following steps: The traditional Chinese medicine composition was prepared according to the preparation method described in claim 5 or 6; Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

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