Traditional Chinese medicine composition for improving liver yin deficiency, pharmaceutical preparation and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for improving liver yin deficiency, a pharmaceutical preparation and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 6 to 10 parts of radix bupleuri, 10 to 15 parts of radix paeoniae alba, 6 to 10 parts of liquorice root, 6 to 10 parts of cassia twig, 25 to 30 parts of dragon bone, 25 to 30 parts of oyster, 20 to 25 parts of malt, 10 to 15 parts of radix scutellariae, 25 to 30 parts of radix pseudostellariae, 25 to 30 parts of light wheat, 10 to 15 parts of rhizoma corydalis and 15 to 20 parts of fried jujube kernel. According to the invention, radix bupleuri, radix paeoniae alba, liquorice, cassia twig, dragon bone, oyster, malt, scutellaria baicalensis, radix pseudostellariae, blighted wheat, rhizoma corydalis and fried jujube kernel are prepared according to a specific proportion, so that deficiency-heat can be relieved, the coefficient of uterus visceral organs can be increased, endocrine dysfunction can be improved, and the symptom of liver yin deficiency can be improved.

Description

Technical Field

[0001] This disclosure relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition, pharmaceutical preparation and preparation method for improving liver yin deficiency. Background Technology

[0002] The liver's main physiological function is to regulate the flow of Qi throughout the body, its nature is to promote upward movement and dislike stagnation, thus facilitating the smooth flow of Qi and regulating emotions; it also regulates the flow of bile, aids the spleen and stomach in digestion, and promotes the circulation of blood and body fluids. Common symptoms of liver disease include depression, irritability, chest, rib, and lower abdominal distension and pain, dizziness, tremors, convulsions of the hands and feet, as well as eye diseases, menstrual irregularities, and testicular pain. Liver diseases can be classified into various syndromes, such as liver blood deficiency, liver Yin deficiency, liver Qi stagnation, liver fire excess, liver Yang hyperactivity, cold stagnation in the liver meridian, liver stagnation with phlegm disturbance, internal liver wind, and liver Yin deficiency.

[0003] Among them, liver yin deficiency syndrome is a syndrome caused by the depletion of liver yin fluid, resulting in yin failing to control yang and internal disturbance due to weakness. It is often caused by emotional distress, qi stagnation transforming into fire, which scorches liver yin; or by the depletion of liver yin in the later stages of febrile diseases; or by insufficient kidney yin, resulting in water failing to nourish wood. Currently, Western medicine treats this disease by addressing the symptoms but not the root cause, with significant side effects and a high risk of dependence.

[0004] Traditional Chinese medicine (TCM) can pinpoint the root cause of the disease and treat it accordingly, thus eliminating the underlying cause. Moreover, Chinese herbal medicines have no toxic side effects, are safe and reliable, and are convenient and easy to administer, making them the first choice in clinical practice. Summary of the Invention

[0005] To address the aforementioned technical problems, this disclosure provides a traditional Chinese medicine composition, pharmaceutical preparation, and preparation method for improving liver yin deficiency.

[0006] In a first aspect, this disclosure provides a traditional Chinese medicine composition for improving liver yin deficiency, wherein, by weight, the traditional Chinese medicine composition comprises: Bupleurum chinense 6-10 parts, Paeonia lactiflora 10-15 parts, Glycyrrhiza uralensis 6-10 parts, Cinnamomum cassia 6-10 parts, Os draconis 25-30 parts, Ostrea gigas 25-30 parts, Hordeum vulgare 20-25 parts, Scutellaria baicalensis 10-15 parts, Pseudostellaria heterophylla 25-30 parts, Triticum aestivum 25-30 parts, Corydalis yanhusuo 10-15 parts, and Ziziphus jujuba var. spinosa 15-20 parts.

[0007] Specifically, the amount of Bupleurum can be 6, 7, 8, 9 or 10 parts, etc. The number of parts of white peony root can be 10, 11, 12, 13, 14 or 15, etc. The amount of licorice can be 6, 7, 8, 9, or 10 parts, etc. The number of cinnamon twigs can be 6, 7, 8, 9, or 10, etc. The number of keel portions can be 25, 26, 27, 28, 29, or 30, etc. The number of servings of oysters can be 25, 26, 27, 28, 29, or 30, etc. The number of malt portions can be 20, 21, 22, 23, 24, or 25, etc. The number of parts of Scutellaria baicalensis can be 10, 11, 12, 13, 14 or 15, etc. The dosage of Codonopsis pilosula can be 25, 26, 27, 28, 29, or 30 portions, etc. The number of parts of floating wheat can be 25, 26, 27, 28, 29, or 30, etc. The number of portions of Corydalis can be 10, 11, 12, 13, 14, or 15, etc. The number of servings of fried jujube seeds can be 15, 16, 17, 18, 19, or 20, etc. However, this is not limited to the listed values; other unlisted values ​​within the above range also apply.

[0008] In this disclosure, adding too much or too little of any medicinal material will affect the efficacy.

[0009] The following are preferred technical solutions of this disclosure, but are not intended to limit the technical solutions provided by this disclosure. The technical objectives and beneficial effects of this disclosure can be better achieved through the following technical solutions.

[0010] As a preferred technical solution of this disclosure, the traditional Chinese medicine composition comprises, by weight: Bupleurum chinense 7-9 parts, Paeonia lactiflora 12-14 parts, Glycyrrhiza uralensis 7-9 parts, Cinnamomum cassia 7-9 parts, Os draconis 26-28 parts, Ostrea gigas 26-28 parts, Hordeum vulgare 22-24 parts, Scutellaria baicalensis 12-14 parts, Pseudostellaria heterophylla 26-28 parts, Triticum aestivum 26-28 parts, Corydalis yanhusuo 12-14 parts, and Ziziphus jujuba var. spinosa 16-18 parts.

[0011] As a preferred technical solution of this disclosure, the traditional Chinese medicine composition comprises, by weight: Bupleurum chinense 8 parts, Paeonia lactiflora 13 parts, Glycyrrhiza uralensis 8 parts, Cinnamomum cassia 8 parts, Os draconis 28 parts, Ostrea gigas 28 parts, Hordeum vulgare 23 parts, Scutellaria baicalensis 13 parts, Codonopsis pilosula 28 parts, Triticum aestivum 28 parts, Corydalis yanhusuo 13 parts, and Ziziphus jujuba var. spinosa 17 parts.

[0012] Secondly, this disclosure provides a pharmaceutical preparation for improving liver yin deficiency, the pharmaceutical preparation containing the effective components of the traditional Chinese medicine composition as described in the first aspect.

[0013] As a preferred embodiment of this disclosure, the pharmaceutical preparation further contains pharmaceutically acceptable excipients.

[0014] As a preferred technical solution of this disclosure, the dosage form of the pharmaceutical preparation is any one of granules, powders, capsules, tablets, mixtures, or oral liquids.

[0015] Thirdly, this disclosure provides a method for preparing the pharmaceutical preparation for improving liver yin deficiency as described in the second aspect, the preparation method comprising the following steps: (1) The traditional Chinese medicine composition is mixed with water and decocted to obtain an aqueous extract; (2) The aqueous extract is prepared into the dosage form of the drug preparation.

[0016] As a preferred technical solution of this disclosure, the steps for preparing the aqueous extract include: decocting the traditional Chinese medicine composition with water at least twice, each time for 1-4 hours, filtering after each decoction, and combining the filtrates to obtain the aqueous extract.

[0017] As a preferred technical solution of this disclosure, in the step of preparing the aqueous extract, the total mass of water is 18-35 times the mass of the traditional Chinese medicine composition, such as 18 times, 20 times, 22 times, 24 times, 26 times, 28 times, 30 times, 32 times or 35 times, but is not limited to the listed values. Other unlisted values ​​within the above range are also applicable.

[0018] As a preferred technical solution of this disclosure, in the step of preparing the aqueous extract, the decoction is performed twice. In the first decoction, the mass of water is 10-20 times the mass of the traditional Chinese medicine composition, and the decoction time is 2-3 hours, such as 2 hours, 2.2 hours, 2.4 hours, 2.6 hours, 2.8 hours, or 3 hours. In the second decoction, the mass of water is 8-15 times the mass of the traditional Chinese medicine composition, such as 8, 10, 11, 12, 14, or 15 times, and the decoction time is 1-3 hours, such as 1 hour, 1.5 hours, 2 hours, 2.5 hours, or 3 hours, but it is not limited to the listed values. Other unlisted values ​​within the above range are also applicable.

[0019] The technical solution provided in this disclosure has the following advantages compared with the prior art: This invention discloses a formula containing Bupleurum chinense, Paeonia lactiflora, Glycyrrhiza uralensis, Cinnamomum cassia, Os draconis, Ostrea gigas, Malt, Scutellaria baicalensis, Codonopsis pilosula, Triticum aestivum, Corydalis yanhusuo, and Ziziphus jujuba seeds in a specific ratio to relieve deficiency heat, improve the uterine organ coefficient, and improve endocrine dysfunction, thereby improving symptoms of liver yin deficiency. Attached Figure Description

[0020] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure.

[0021] To more clearly illustrate the technical solutions in the embodiments of this disclosure or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a comparison chart of rectal temperature of rats in each group in this experimental case and rats after the end of the experiment; Figure 2 This is a comparison of the general physical characteristics of rats in each group in this experimental case with those after the experiment; Figure 3 This is a graph showing the syndrome scores of rats in each group in this experimental case and the rats after the experiment. Figure 4 This report presents a comparison of E2 levels in the serum of rats in each group and at the end of the experiment. Figure 5 Comparison of FSH levels in the serum of rats in each group and at the end of the experiment in this published experimental case; Figure 6 This report presents a comparison of LH levels in the serum of rats in each group and at the end of the experiment. Figure 7 This paper presents a comparison chart of PRL levels in the serum of rats in each group and rats after the experiment. Figure 8 This is a comparison chart of the uterine organ coefficients of rats in each group in this experimental case and the rats after the end of the experiment.

[0023] It should also be noted that, in the above attached figures, compared to the blank group, *** represent P <0.001; Compared with the model group, # represent P <0.05, ## represent P <0.01, ### represent P <0.001; Compared with the positive control group, @ represent P <0.05, @@@ represent P <0.001. Detailed Implementation

[0024] To better understand the above-mentioned objectives, features, and advantages of this disclosure, the solutions disclosed herein will be further described below. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0025] Numerous specific details are set forth in the following description in order to provide a full understanding of this disclosure, but this disclosure may also be implemented in other ways different from those described herein; obviously, the embodiments in the specification are only some, and not all, of the embodiments of this disclosure.

[0026] Example 1 This embodiment provides a traditional Chinese medicine composition for improving liver yin deficiency, which, by weight, comprises: Bupleurum chinense 9 parts, Paeonia lactiflora 15 parts, Glycyrrhiza uralensis 9 parts, Cinnamomum cassia 9 parts, Os draconis 30 parts, Ostrea gigas 30 parts, Hordeum vulgare 24 parts, Scutellaria baicalensis 15 parts, Pseudostellaria heterophylla 30 parts, Triticum aestivum 30 parts, Corydalis yanhusuo 12 parts, and Ziziphus jujuba var. spinosa 20 parts.

[0027] The preparation method of its concentrate includes the following steps: (1) Bupleurum, white peony root, licorice root, cinnamon twig, dragon bone, oyster shell, malt, scutellaria, codonopsis, floating wheat, corydalis rhizome and stir-fried jujube seed were decocted for 3 hours, and then the first aqueous extract and mixed solid were obtained by solid-liquid separation. The weight of water added is 15 times the total weight of the traditional Chinese medicine composition; (2) The resulting mixed solid was boiled again in water at 90°C for 2 hours, and then the solid and liquid were separated to obtain the second aqueous extract; The weight of water added is 10 times the total weight of the traditional Chinese medicine composition; (3) Mix the first aqueous extract with the second aqueous extract, and then concentrate the solution under vacuum to a concentration of 6.075 g crude drug / mL to obtain the concentrate.

[0028] Example 2 This embodiment provides a traditional Chinese medicine composition for improving liver yin deficiency, which, by weight, comprises: Bupleurum chinense 7 parts, Paeonia lactiflora 12 parts, Glycyrrhiza uralensis 7 parts, Cinnamomum cassia 7 parts, Os draconis 26 parts, Ostrea gigas 26 parts, Hordeum vulgare 22 parts, Scutellaria baicalensis 12 parts, Codonopsis pilosula 26 parts, Triticum aestivum 26 parts, Corydalis yanhusuo 12 parts, and Ziziphus jujuba var. spinosa 16 parts.

[0029] The preparation method of its concentrate includes the following steps: (1) Bupleurum, white peony root, licorice root, cinnamon twig, dragon bone, oyster shell, malt, scutellaria, codonopsis, floating wheat, corydalis rhizome and stir-fried jujube seed were decocted for 2.5 hours, and then the first aqueous extract and mixed solid were obtained by solid-liquid separation. The weight of water added is 10 times the total weight of the traditional Chinese medicine composition; (2) The resulting mixed solid was boiled again in water at 90°C for 2 hours, and then the solid and liquid were separated to obtain the second aqueous extract; The weight of water added is 12 times the total weight of the traditional Chinese medicine composition; (3) Mix the first aqueous extract with the second aqueous extract, and then concentrate the solution under vacuum to a concentration of 6.075 g crude drug / mL to obtain the concentrate.

[0030] Example 3 This embodiment provides a traditional Chinese medicine composition for improving liver yin deficiency, which, by weight, comprises: Bupleurum 10 parts, white peony root 12 parts, licorice root 10 parts, cinnamon twig 10 parts, dragon bone 30 parts, oyster shell 30 parts, malt 25 parts, scutellaria baicalensis 15 parts, codonopsis pilosula 30 parts, floating wheat 30 parts, corydalis yanhusuo 15 parts, and stir-fried jujube seed 20 parts.

[0031] The preparation method of its concentrate includes the following steps: (1) Bupleurum, white peony root, licorice root, cinnamon twig, dragon bone, oyster shell, malt, scutellaria, codonopsis, floating wheat, corydalis rhizome and stir-fried jujube seed were decocted for 3 hours, and then the first aqueous extract and mixed solid were obtained by solid-liquid separation. The weight of water added is 20 times the total weight of the traditional Chinese medicine composition; (2) The resulting mixed solid was boiled again in water at 90°C for 3 hours, and then the solid and liquid were separated to obtain the second aqueous extract; The weight of water added is 15 times the total weight of the traditional Chinese medicine composition; (3) Mix the first aqueous extract with the second aqueous extract, and then concentrate the solution under vacuum to a concentration of 6.075 g crude drug / mL to obtain the concentrate.

[0032] Test case Animal experiment: Taking the concentrated solution obtained in Example 1 as an example 1. Materials 1.1 Experimental animals: 67 male SPF-grade SD rats, weighing 180-220g, were purchased from Speford (Suzhou) Biotechnology Co., Ltd., with production license number SCXK (Su) 2022-0006 and certificate of conformity number A202502210154.

[0033] Rearing environment conditions: The rearing environment conditions shall conform to the national standard of the People's Republic of China GB14925-2010; the temperature shall be 20-26℃ (daily temperature difference ≤4℃); the relative humidity shall be 40-70%; the pressure in the rearing room shall be ≥10Pa; and there shall be a 12 / 12-hour day-night light-dark cycle.

[0034] 1.2 Test reagents: Prescription reagent: Dilute the concentrate obtained in Example 1 to the required concentration using sterile water for injection.

[0035] Gengnian'an Capsules, 24 capsules / box, sealed, store in a cool place. Manufacturer: Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd.; Product Approval Number: Z20053985. Preparation method: Open the Gengnian'an Capsules and grind them into powder using a mortar and pestle. Then dilute with sterile water for injection to the required concentration.

[0036] Carbon tetrachloride solution, 500ml / bottle, 98% concentration, batch number C11588428, store at 2-8℃, CAS number: 56-23-5, manufacturer: Shanghai Maclean Biochemical Technology Co., Ltd.

[0037] Olive oil solution, 500ml / bottle, batch number C13659019, sealed, store in a cool place, CAS number: 8001-25-0, manufacturer: Shanghai Maclean Biochemical Technology Co., Ltd.

[0038] Thyroid tablets, specification 40mg×100 tablets / box, approval number H31022151, should be stored protected from light and sealed. The manufacturer is Shanghai Zhonghua Pharmaceutical Co., Ltd. Preparation method: Grind the thyroid tablets into powder using a mortar and pestle, then dilute with sterile water for injection to the required concentration.

[0039] Sterile water for injection, 500ml / bottle, batch number 240621, to be stored in a sealed container, manufactured by Shaanxi Shengao Animal Pharmaceutical Co., Ltd.; product approval number is Veterinary Drug No. 270071791.

[0040] 1.3 Test Instruments The pipette is manufactured by Eppendorf and has a model number of 200 μl. The electronic balance is manufactured by Shanghai Yaoxin Electronic Technology Co., Ltd., and its model number is LQ-C12001. The benchtop high-speed refrigerated microcentrifuge is manufactured by Thermo and is model Sorvall Legand Micro 17R. Mini mixing centrifuge, manufacturer: LABGIC, model: L-CM-MINI; The microplate reader is manufactured by Thermo and is model VARIOSKAN LUX. The dehydrator is manufactured by DIAPATH and its model is Donatello. The embedding machine is manufactured by Wuhan Junjie Electronics Co., Ltd., and its model number is JB-P5. The freezing station is manufactured by Wuhan Junjie Electronics Co., Ltd., and its model number is JB-L5. The pathology slider is manufactured by Leica Instruments Shanghai Co., Ltd., and its model number is RM2016. The sheet spreader is manufactured by Zhejiang Jinhua Kedi Instrument Equipment Co., Ltd., and its model is KD-P. The oven is manufactured by Tianjin Laiborui Instrument Equipment Co., Ltd., and its model is GFL-230. An upright optical microscope, manufactured by Nikon Japan, model Nikon Eclipse E100; The imaging system is manufactured by Nikon of Japan, and its model is NIKON DS-U3. An upright white light photographic microscope, manufactured by Nikon Japan, model Eclipse Ci-L.

[0041] The electrocardiogram (ECG) was manufactured by Nanjing Calvin Biotechnology Co., Ltd., model Medlab, and device number KW2024092704.

[0042] 2. Methods 2.1 Grouping and administration of experimental animals A menopausal rat model of liver yin deficiency was established using bilateral ovariectomy combined with thyroid tablets and carbon tetrachloride. After passing quarantine, rats were randomly divided into a sham-operated group (blank group, n=11) and a model rat model (n=56). The model rats were anesthetized, and two small incisions were made on each side of their backs to surgically remove both ovaries. The sham-operated group rats only underwent incisions without ovarian removal. For 7 days post-surgery, the model rats were administered thyroid tablet suspension at a dose of 30 mg / kg daily by gavage for 2 weeks, and were also intraperitoneally injected weekly with 1.5 mL / kg of 20% carbon tetrachloride-olive oil solution. The sham-operated group (blank group) rats were administered an equal volume of physiological saline daily by gavage and were intraperitoneally injected weekly with an equal volume of olive oil. After modeling, the researchers used a blinded method to assess the liver yin deficiency symptom scores of rats according to Table 1, and screened successfully modeled rats by measuring rectal temperature. These rats were randomly divided into a model group, a low-dose prescription group, a medium-dose prescription group, a high-dose prescription group, and a positive control group (Gengnian'an capsule group). Each group of rats was administered the corresponding treatment drug by gavage for 74 consecutive days. The specific administration regimen is shown in Table 2.

[0043] Table 1

[0044] Table 2

[0045]

[0046] 2.2 Observation Indicators (1) Rectal temperature; (2) Symptom score of rats with liver yin deficiency syndrome; (3) ELISA: serum estradiol (E2) concentration, serum follicle-stimulating hormone (FSH) concentration, serum luteinizing hormone (LH) concentration, and serum prolactin (PRL) concentration; (4) Organ coefficient: Uterus; The rats were euthanized, and their uteruses were weighed. The organ coefficient was calculated using the following formula: Organ coefficient = Organ weight / Body weight. 2.3 Detection Methods 2.3.1 ELISA detection ① Sample collection Serum: Use test tubes free of pyrogens and endotoxins, and avoid any cell stimulation during the operation. After collecting blood, centrifuge at 3000 rpm for 10 minutes to quickly and carefully separate serum and red blood cells. ② Remove the required strips from the aluminum foil bag after equilibration at room temperature for 20 minutes, and seal the remaining strips in a self-sealing bag and return them to 4℃; ③ Set up standard wells and sample wells, and add 50 μl of standard at different concentrations to each standard well; ④ Add 10 μl of the sample to be tested to the sample well first, then add 40 μl of sample diluent; do not add any to the blank wells; ⑤ Except for the blank wells, add 100 μl of horseradish peroxidase (HRP) labeled detection antibody to each of the standard wells and sample wells, seal the reaction wells with sealing film, and incubate at 37°C in a water bath or incubator for 60 min. ⑥ Discard the liquid, pat dry on absorbent paper, fill each well with washing liquid, let stand for 1 minute, shake off the washing liquid, pat dry on absorbent paper, and repeat this washing process 5 times (or a plate washer can be used).

[0047] ⑦ Add 50 μl of substrate A and 50 μl of substrate B to each well and incubate at 37°C in the dark for 15 min; ⑧ Add 50 μl of stop solution to each well, and measure the OD value of each well at a wavelength of 450 nm within 15 min. ⑨ Plot the standard curve: In an Excel worksheet, plot the linear regression curve of the standard with the concentration of the standard on the x-axis and the corresponding OD value on the y-axis. Calculate the concentration value of each sample according to the curve equation.

[0048] The reagent kits used include: Enzyme-linked biological rat estradiol receptor (ER) ELISA kit, catalog number: ml002869; Rat prolactin (PRL) ELISA kit, catalog number: ml002881; Rat luteinizing hormone (LH) ELISA kit, catalog number: ml064293; Rat prolactin (PRL) ELISA kit, catalog number: ml002881.

[0049] 2.4 Results Analysis and Processing GraphPad 9.5.0 and SPSS 26 software were used for plotting and statistical analysis. Data are expressed as mean ± SEM. One-way ANOVA was used for statistical analysis to test for significant differences between the two groups. P <0.05 indicates statistical significance.

[0050] 3. Test Results (1) Rectal temperature Figure 1 This is a comparison chart of rectal temperature of rats in each group in this experimental case and rats after the end of the experiment.

[0051] according to Figure 1 It can be seen that, compared with the blank group, the anal temperature of rats in the model group was significantly higher ( P <0.001); while the rectal temperature of rats in the low-dose group, medium-dose group, high-dose group, and Gengnian'an capsule group was significantly lower than that of rats in the model group ( P< The difference was 0.001, and there was no significant difference between the drug groups.

[0052] (II) Symptom scoring of rats with liver yin deficiency syndrome Figure 2 This is a comparison of the general physical characteristics of rats in each group in this experimental case with those after the experiment; Figure 3 This is a diagram showing the syndrome scores of rats in each group in this experimental case and the rats after the experiment.

[0053] Observe the general condition of each group of rats after the experiment and according to... Figure 2 and Figure 3 It can be seen that, compared with the blank group, the rats in the model group were agitated and irritable, with dry, brittle, easily falling out, dark-colored, and dull fur; their feces were wet and soft; their urine was yellow; and their physical signs scores were significantly higher. P <0.001); Compared to the model group, rats in the low-dose, medium-dose, and high-dose prescription groups, as well as the Gengnian'an capsule group, showed more stable emotions, normalized hair growth, improved bowel and bladder characteristics, and lower physical signs scores. P <0.05, P <0.001, and the efficacy of the prescription in improving the signs of rats in the medium-dose and high-dose groups was better than that in the positive control group ( P <0.001).

[0054] (III) ELISA test results Figure 4 This report presents a comparison of E2 levels in the serum of rats in each group and at the end of the experiment. Figure 5 Comparison of FSH levels in the serum of rats in each group and at the end of the experiment in this published experimental case; Figure 6 This report presents a comparison of LH levels in the serum of rats in each group and at the end of the experiment. Figure 7 This publication presents a comparison of PRL levels in the serum of rats in each group and at the end of the experiment.

[0055] according to Figures 4-7 It can be seen that the E2 level in the model group rats decreased ( P <0.001), FSH, LH, PRL ( P E2 levels were elevated in rats in the low-dose, medium-dose, and high-dose prescription groups and the Menopause Relief Capsule group compared to the model group. FSH, LH, and PRL levels were also elevated. P All levels decreased (<0.001). Except for the Gengnian'an capsule group, where the E2 level was slightly higher than that of the prescription low-dose group ( P <0.05), and there were no significant differences in various indicators among the rats in other drug-treated groups.

[0056] (iv) Organ coefficient Figure 8 This is a comparison chart of the uterine organ coefficients of rats in each group in this experimental case and the rats after the end of the experiment.

[0057] according to Figure 8 It can be seen that the uterus of the model group rats was significantly atrophied, and the uterine organ coefficient was significantly reduced. P <0.001), while the uterine atrophy of rats in the low-dose group, medium-dose group, high-dose group and Gengnian'an capsule group was slightly improved, and the uterine organ coefficient of rats in the medium-dose group and high-dose group increased ( P <0.05).

[0058] In summary, this invention discloses that by preparing Bupleurum, White Peony Root, Licorice Root, Cinnamon Twig, Dragon Bone, Oyster Shell, Malt, Scutellaria baicalensis, Codonopsis pilosula, Floating Wheat, Corydalis Rhizome, and Fried Jujube Seed in a specific ratio, it can alleviate deficiency heat, improve the uterine organ coefficient, and improve endocrine dysfunction, thereby improving symptoms of liver yin deficiency.

[0059] The above description is merely a specific embodiment of this disclosure, enabling those skilled in the art to understand or implement it. 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 this disclosure. Therefore, this disclosure is not to be limited to the embodiments described herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for improving liver yin deficiency, characterized in that, The traditional Chinese medicine composition comprises, by weight: Radix Bupleuri 6-10 parts, Radix Paeoniae Alba 10-15 parts, Radix Glycyrrhizae 6-10 parts, Ramulus Cinnamomi 6-10 parts, Cornu Bonis 25-30 parts, Ostreae 25-30 parts, Fructus Hordei Germinatus 20-25 parts, Radix Scrophulariae 10-15 parts, Radix Pseudostellariae 25-30 parts, Fructus Tritici Levis 25-30 parts, Rhizoma Corydalis 10-15 parts, and Semen Ziziphi Preparatum 15-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight: Radix Bupleuri 7-9 parts, Radix Paeoniae Alba 12-14 parts, Radix Glycyrrhizae 7-9 parts, Ramulus Cinnamomi 7-9 parts, Cornu Bonis 26-28 parts, Ostreae 26-28 parts, Fructus Hordei Germinatus 22-24 parts, Radix Scrophulariae 12-14 parts, Radix Pseudostellariae 26-28 parts, Fructus Tritici Levis 26-28 parts, Rhizoma Corydalis 12-14 parts, and Semen Ziziphi Preparatum 16-18 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition comprises, by weight: Radix Bupleuri 8 parts, Radix Paeoniae Alba 13 parts, Radix Glycyrrhizae 8 parts, Ramulus Cinnamomi 8 parts, Cornu Bonis 28 parts, Ostreae 28 parts, Fructus Hordei Germinatus 23 parts, Radix Scrophulariae 13 parts, Radix Pseudostellariae 28 parts, Fructus Tritici Levis 28 parts, Rhizoma Corydalis 13 parts, and Semen Ziziphi Preparatum 17 parts.

4. A pharmaceutical preparation for improving liver yin deficiency, characterized by, The pharmaceutical preparation contains the effective components of the traditional Chinese medicine composition as claimed in any one of claims 1-3.

5. The pharmaceutical preparation according to claim 4, characterized in that, The pharmaceutical preparation further contains pharmaceutically acceptable adjuvants.

6. The pharmaceutical preparation according to claim 4 or 5, characterized in that, The dosage form of the pharmaceutical preparation is any one of granules, powder, capsules, tablets, mixture, or oral liquid.

7. A method of preparing a pharmaceutical preparation for improving liver yin deficiency according to any one of claims 4-6, characterized by, The preparation method comprises the following steps: (1) mixing the traditional Chinese medicine composition with water to perform decoction, to obtain a water extract; (2) preparing the water extract into the dosage form of the pharmaceutical preparation.

8. The preparation method according to claim 7, characterized in that, The step of preparing the water extract comprises: decocting the traditional Chinese medicine composition with water for at least 2 times, each time for 1-4 h, filtering after each time, and combining the filtrates to obtain the water extract.

9. The production method according to claim 7 or 8, characterized by, In the step of preparing the water extract, the total mass of water is 18-35 times the mass of the traditional Chinese medicine composition.

10. The preparation method according to claim 8, characterized in that, In the step of preparing the water extract, the decoction is performed for 2 times, the mass of water is 10-20 times the mass of the traditional Chinese medicine composition for the first time, and the decoction time is 2-3 h; the mass of water is 8-15 times the mass of the traditional Chinese medicine composition for the second time, and the decoction time is 1-3 h.

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