Traditional Chinese medicine composition for treating climacteric depression

Abstract

The invention discloses a traditional Chinese medicine composition for treating climacteric depression. The traditional Chinese medicine composition is prepared from 10-30 parts of radix rehmanniae, 10-20 parts of radix paeoniae alba, 10-30 parts of bulbus lilii, 10-20 parts of rhizoma atractylodis macrocephalae fried with soil, 5-15 parts of radix bupleuri, 10-20 parts of radix curcumae, 10-30 parts of radix scutellariae and 10-20 parts of rhizoma polygonati with wine. The raw materials of the traditional Chinese medicine composition are all traditional Chinese medicinal materials and have the effects of soothing liver-qi stagnation, regulating qi and blood, tranquilizing and allaying excitement and the like; wherein the radix rehmanniae has the effects of nourishing yin, promoting the secretion of saliva or body fluid and nourishing yin to lessen fire, the radix paeoniae alba has the effects of nourishing blood, nourishing liver, astringing yin and stopping perspiration, the lily has the effects of nourishing yin, moistening lung, clearing away heart fire and tranquilizing mind, the bighead atractylodes rhizome has the effects of tonifying spleen, benefiting stomach, eliminating dampness and calming middle warmer, the radix bupleuri has the effects of soothing liver-qi stagnation, the radix curcumae has the effects of clearing away heart-fire, relieving restlessness, promoting qi circulation and relieving depression, the radix scutellariae has the effects of clearing heat, eliminating dampness, purging fire and relieving restlessness, and the The compatibility of the traditional Chinese medicine composition conforms to the principle of'monarch, minister, assistant and guide 'of traditional Chinese medicines, that is, various raw material medicines play different roles in combination and jointly coordinate to achieve the purpose of treating the climacteric depression.

Description

Technical Field

[0001] The present invention relates to the technical field of depression treatment, and more specifically, to a Chinese medicine composition for treating menopausal depression. Background Art

[0002] Menopausal major depressive disorder (PMDD) is a common mental disorder in women during menopause, mainly manifested by depression, anxiety, irritability, insomnia and other symptoms. The prevalence of depression in menopausal women worldwide is as high as 35.6%, of which the prevalence of major depression is as high as 24.4%. In the current medical field, although the treatment strategies for PMDD are diversified, they still face many challenges.

[0003] Western medicine treatments, especially the use of antidepressants, can effectively relieve depression symptoms to a certain extent, but their side effects are significant, including but not limited to gastrointestinal discomfort, sleep disorders, sexual dysfunction and potential cardiovascular risks. These side effects often lead to a decrease in patient compliance with treatment, thereby affecting the treatment effect and disease prognosis. In contrast, traditional Chinese medicine treatments have shown unique value in clinical practice with their rich theoretical system, diverse treatment methods (such as acupuncture, Chinese medicine treatment, emotional regulation, etc.) and relatively low side effects.

[0004] However, TCM treatment plans are mostly based on long-term clinical experience and accumulated case reports, and lack large-scale, high-quality clinical trial data support, which limits its widespread recognition and promotion in the international medical system. Therefore, developing a safe and effective Chinese medicine composition for the treatment of menopausal depression has important practical significance. Summary of the invention

[0005] The present invention provides a Chinese medicine composition for treating menopausal depression, so as to solve the problem that the traditional Chinese medicine treatment schemes in the prior art are mostly based on long-term clinical experience and accumulated case reports, lack large-scale, high-quality clinical trial data support, and most of them have unknown active ingredients, posing certain safety risks.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] A traditional Chinese medicine composition for treating menopausal depression comprises 10-30 parts of raw rehmannia, 10-20 parts of white peony root, 10-30 parts of lily, 10-20 parts of stir-fried atractylodes macrocephala, 5-15 parts of bupleurum, 10-20 parts of curcuma, 10-30 parts of scutellaria and 10-20 parts of polygonatum sibiricum.

[0008] A method for preparing a traditional Chinese medicine composition for treating menopausal depression comprises the following steps: S1: preparation of medicinal materials; S2: pretreatment; S3: extraction; S4: concentration; S5: spray drying; S6: classification and mixing; S7: finished product manufacturing; S8: quality control; S9: packaging; S10: storage.

[0009] Preferably, the S1 specifically includes: testing the prescribed Chinese medicinal materials according to the standards of the 2015 edition of the Chinese Pharmacopoeia to determine that the selected medicinal materials are qualified medicinal materials.

[0010] Preferably, the S1 specifically includes: investigating the origins of the raw medicinal materials in the prescription respectively, determining the sources of the medicinal materials, and confirming through sufficient investigation that none of the eight medicinal materials in the prescription are precious and endangered medicinal materials.

[0011] Preferably, S2 specifically includes: washing and drying the medicinal materials, and grinding all the medicinal materials into powder or fragments.

[0012] Preferably, S3 specifically includes: placing all powdered or fragmented medicinal materials into an extraction tank, adding an appropriate amount of water or other solvent (such as ethanol), decocting according to a traditional decoction method, and extracting the effective ingredients therein; and repeatedly extracting the medicinal materials according to the extraction conditions of different drugs.

[0013] Preferably, the step S4 specifically includes: using a vacuum concentration device to evaporate and concentrate the extract to reduce water content and increase concentration.

[0014] Preferably, the step S5 specifically includes: using a spray dryer to atomize and dry the concentrated liquid to form dry medicine powder.

[0015] Preferably, S6 specifically includes: mixing different medicinal material extracts according to the formula ratio to prepare a complete formula.

[0016] Preferably, S7 specifically includes: using equipment to make the finished drug powder into granules, capsules, or tablets according to the corresponding manufacturing method.

[0017] Preferably, the S8 specifically includes: conducting strict quality inspection on each batch of products, including determination of active ingredient content, heavy metal and pesticide residue detection, microbial limit inspection, etc.

[0018] Preferably, the step S9 specifically includes: classifying and packaging the finished drugs that have passed the quality inspection according to their different forms.

[0019] Preferably, the step S10 specifically includes: storing the final product in a dry, cool place, avoiding direct sunlight and moisture.

[0020] The principle and beneficial effects of this technical solution:

[0021] (1) The compatibility of the Chinese medicine composition involved in the present invention complies with the principle of "monarch, minister, assistant and messenger" of Chinese medicine; in the theory of traditional Chinese medicine, "monarch, minister, assistant and messenger" is the basic principle of prescription compatibility, which is divided into monarch, minister, assistant and messenger according to the different roles played by the drugs in the prescription; monarch is the drug that plays the main therapeutic effect on the main symptom in the prescription; minister is the drug that assists the monarch to strengthen the treatment of the main symptom, or plays a therapeutic effect on the secondary symptom; adjuvant is the drug that assists the minister to strengthen the therapeutic effect, or directly treats the secondary secondary symptom; messenger is the drug that guides the drugs to directly reach the diseased area or harmonizes the drugs;

[0022] In the formula, raw rehmannia and white peony root nourish the liver and kidneys and are the main medicines; bupleurum and curcuma soothe the liver and relieve depression to comply with the liver's nature, soften the liver and harmonize the liver as the assistant medicines; stir-fried atractylodes and polygonatum sibiricum invigorate the spleen and soothe the liver, which can not only strengthen the spleen and prevent it from being invaded by the liver, but also enable the spleen to generate qi and blood to nourish the liver as the adjuvant medicines; scutellaria baicalensis and lily assist the other medicines to clear away the deficiency fire, calm the mind and soothe the nerves as the guiding medicines. The whole formula is used together to regulate the liver, relieve depression, and harmonize qi and blood.

[0023] (2) The Chinese medicine composition involved in the present invention is not only based on the theory of traditional Chinese medicine, but also supported by modern pharmacological research. Modern pharmacological research shows that the effective ingredients in this Chinese medicine composition, such as rehmannia catalpol, paeoniflorin, saikosaponin, and curcumin, have significant antidepressant, antioxidant, heart, liver, and kidney protection effects, and can regulate the function of the hypothalamus-pituitary-ovarian axis, thereby coordinating the neuroendocrine network and relieving the anxiety, cognitive dysfunction, sleep disorders, and other symptoms of patients with menopausal depression; at the same time, this Chinese medicine composition can also effectively regulate the reproductive endocrine and immune systems, further promoting the recovery of patients.

[0024] (3) The Chinese medicine composition of the present invention can be made into granules for patients to take; at the same time, the preparation method of the composition of the present invention includes the steps of screening, crushing, extraction, concentration, drying, etc. to ensure that the effective ingredients of the medicine are fully extracted and retained. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a comparison chart of the Wb experimental results of mice in different experimental groups in the embodiment of the present invention; DETAILED DESCRIPTION

[0026] The present invention is further described in detail below in conjunction with the embodiments:

[0027] Example:

[0028] Study on the mechanism of action of Tiaogan Jieyu prescription (i.e. the Chinese medicine composition of the present invention, hereinafter referred to as TGJY) in treating menopausal depression

[0029] 1.1 Materials

[0030] 1.1.1 Experimental animals

[0031] Sixty 12-week-old clean-grade female C57BL / 6 mice weighing (20±3) g were selected and provided by Hunan Slake Jingda Experimental Animal Co., Ltd.

[0032] Rearing environment: half-cycle lighting during the day and night (i.e. maintain a 12-h day and night alternation), rearing temperature (22±2)℃, and humidity maintained at 55%±5%.

[0033] The breeding environment was quiet, clean and tidy. During the breeding period, each group of mice had free access to food and water. They were raised in the clean environment of Hunan Slake Jingda Experimental Animal Center.

[0034] This experiment was approved by the Experimental Animal Welfare and Ethics Committee of Guangzhou University of Chinese Medicine (approval number: 20210714011).

[0035] 1.1.2 Main reagents and instruments

[0036] Sterile PBS (cytiva, USA), glycerol (Xintai Biotechnology, China), normal saline, ampicillin (Sigma-Aldrich, USA), vancomycin (Teva, USA), metronidazole (Sanofi, France), amphotericin B (Sanofi, France), agar (BioFroxx), RIPA strong lysis buffer (Weijia Biotechnology, China), mouse dopamine (DA) kit (Jingmei Biotechnology, China); mouse norepinephrine (NE) kit (Jingmei Biotechnology, China); mouse serotonin (5-HT) kit (Jingmei Biotechnology, China); mouse gamma-aminobutyric acid (GABA) kit (Jingmei Biotechnology, China).

[0037] Brain stereotaxic instrument (stoelting, USA), high-speed centrifuge (DT5-22, Siemens, Germany), tissue grinder (SCIENTZ-48L, Scientz, China), microplate reader (DNM-9606, Boco, USA), gavage needle, 1mL syringe, blood collection tube, filter paper.

[0038] 1.2 Methods

[0039] 1.2.1 Experimental group design

[0040] After the successfully established FMT-P mice were adaptively raised for one week, they were randomly divided into:

[0041] (1) Normal group: germ-free mice, raised in a conventional manner, without any treatment;

[0042] (2) Control group: After successful modeling, the animals were raised in the usual manner without any drug intervention;

[0043] (3) miR-124inhibitor NC group: mice were injected with miR-124inhibitor NC via the anterior cortex;

[0044] (4) miR-124 inhibitor group: mice were injected with miR124 inhibitor via the anterior cortex;

[0045] (5) miR-124 inhibitor + fluoxetine (FLXT) group: mice were injected with miR124 inhibitor via the anterior cortex and intragastrically administered with 20 mg / kg of fluoxetine, which was prepared into 2 mg / mL (according to the ADDIN standard dosage in the "Expert Consensus on Diagnosis and Treatment of Elderly Depression Disorders" formulated by the Psychiatric Branch of the Chinese Association of Traditional Chinese Medicine in 2017, converted according to the human-mouse body surface ratio);

[0046] (6) miR-124 inhibitor + TGJY group: mice were injected with miR-124 inhibitor through the anterior cortex and gavaged with 10 mg / kg TGJY, which was prepared into 1 mg / mL (according to the results of the previous preliminary experiment, the clinical equivalent dose of 20 mg / kg was given by gavage; the proposed clinical dose of TGJY for adults is 45 g of crude drug / day, which is converted into a clinical equivalent dose of 4.2 g crude drug / kg in rats based on body surface area, and the equivalent dose converted into drug-containing serum is 1 mg / mL).

[0047] 1.2.2 Brain localization injection

[0048] First, anesthetize the mouse with isoflurane and then place it on a stereotaxic apparatus. Remove the hair on the head, cut the skull skin, and inject 10 μL of miR-124 inhibitor solution miR-124mimic into the brain using a microsyringe according to the coordinates x: 1.0 mm, y: 0.8 mm, z: 1.7 mm. The injection time is more than 5 minutes to allow slow diffusion.

[0049] Each group was intervened for a total of 2 weeks. After the intervention, the general condition and behavioral tests (tail suspension test, novel environment feeding test, and sugar water preference test) of the mice were observed. The levels of serum dopamine (DA), norepinephrine (NE), serotonin (5-HT), and gamma-aminobutyric acid (GABA) were measured by ELISA, and the levels of Sema3A / NRP1 pathway-related proteins in the brain and colon tissues of mice were detected by PCR and WB.

[0050] 1.2.3 Behavioral experiments

[0051] (1) Tail suspension experiment: The animal's tail was suspended with adhesive tape attached to 1 / 3 of the distance from the tip of the tail. The animal was suspended in a tail suspension box with its head facing about 10 cm from the bottom of the box. The TopScan behavioral analysis system was used to record the animal's immobility latency within 6 min and the duration of immobility within 4 min.

[0052] (2) Novel environment food suppression experiment: The inner wall of the box is painted black in a height of 15 cm and the bottom side is 60 cm long. A small piece of food is placed on a white paper at 1 / 3 of the bottom. The animals are fasted for 24 hours before the experiment (water is not allowed). During the experiment, mice are placed into the box from the other 2 / 3 of the corner of the box and the time is started. The time taken to start chewing food is recorded as the standard, that is, the food intake latency. The observation is 5 minutes, and the latency time from the placement of the mouse to the mouse starting to explore the food is recorded. The amount of activity of the mouse in eating in the new environment (the time to explore the food) is also observed.

[0053] (3) Sugar water preference experiment: Mice were housed in a single cage and trained to drink sucrose for 48 hours. They were given 1% to 2% sucrose water and drinking water throughout the experiment (the positions of the two water bottles were swapped during the experiment). After the experiment, the mice were deprived of water (but not food) for 9 to 16 hours. The amount of water (g) consumed by the mice from the two bottles was measured within 8 to 15 hours (the positions of the two bottles were swapped once during the experiment). The consumption of sucrose and drinking water was measured, and the sucrose preference rate was calculated. Sucrose preference rate = [sucrose consumption / (sucrose consumption + drinking water consumption)] × 100%.

[0054] 1.2.4 Specimen collection and processing

[0055] After the behavioral experiment, the mice were anesthetized and blood was collected from the abdominal aorta. The blood collection tube was left at room temperature for 2 hours. After centrifugation (3000r / min, 10min), the upper serum was aspirated and placed in a -80℃ refrigerator for later use. The mice were then killed and the abdomen was exposed. The colon tissue and whole brain tissue were obtained under a sterile environment. The colon and brain tissues were treated with PBS on ice, quickly frozen with liquid nitrogen, and stored at -80℃.

[0056] 1.3 Statistical analysis

[0057] The data obtained in this experiment were statistically analyzed using SPSS 22.0, and the measurement data were normal distribution using mean ± standard deviation Statistical description was performed, and one-way analysis of variance was used for comparison among multiple groups, LSD (Least-significant difference) method was used for comparison among groups when variance was equal, and Dunnet's test was used for comparison when variance was unequal. The test level was α=0.05, P<0.05 indicated that the difference was significant, and P<0.01 indicated that the difference was extremely significant.

[0058] 2. Experiment and result statistics

[0059] 2.1 Comparison of behavioral experimental results of mice in each group

[0060] Compared with the normal group, the despair time of mice in the control group was significantly prolonged, the feeding time was significantly shortened, and the sugar water preference index was significantly decreased (P<0.01); compared with the control group, the despair time of mice in the miR-124inhibitor group, miR-124inhibitor+FLXT group, and miR-124inhibitor+TGJY group was significantly shortened, the feeding time was significantly prolonged, and the sugar water preference index was significantly increased (P<0.01); compared with the miR-124inhibitor NC group, the despair time of mice in the miR-124inhibitor group was significantly shortened, the feeding time was significantly prolonged, and the sugar water preference index was significantly increased (P<0.01); compared with the miR-124inhibitor group, the feeding time of mice in the miR-124inhibitor+TGJY group was prolonged, and the sugar water preference index was significantly increased (P<0.05); see Table 1 for details.

[0061] Table 1 Comparison of mouse behavioral experimental results ( n=8)

[0062]

[0063] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the control group, c P<0.05, d P<0.01; compared with miR-124inhibitor NC group, e P<0.05, f P<0.01; compared with the miR-124 inhibitor group, g P<0.05, h P<0.01.

[0064] 2.2 Comparison of neurotransmitter levels in the cerebral cortex of mice in each group

[0065] Compared with the normal group, the NE, 5-HT and DA contents of the mice in the control group were significantly decreased (P<0.01), and the GABA content was decreased (P<0.05); compared with the control group, the NE, GABA, 5-HT and DA contents of the miR-124inhibitor group, miR-124inhibitor+FLXT group and miR-124inhibitor+TGJY group were significantly increased (P<0.05 or P<0.01); compared with the miR-124inhibitor NC group, the NE, GABA, 5-HT and DA contents of the miR-124inhibitor group were increased (P<0.05 or P<0.01); compared with the miR-124inhibitor group, the NE, GABA, 5-HT and DA contents of the miR-124inhibitor+FLXT group and miR-124inhibitor+TGJY group were increased (P<0.05 or P<0.01); see Table 2 for details.

[0066] Table 2 Comparison of neurotransmitter levels in mouse cerebral cortex ( n=8)

[0067]

[0068] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the control group, c P<0.05, d P<0.01; compared with the miR-124inhibitor NC group, e P<0.05, f P<0.01; compared with the miR-124 inhibitor group, g P<0.05, h P<0.01.

[0069] 2.3 Comparison of ERα, Sema3A, and RGMa expressions in the cerebral cortex and colon tissues of mice in each group

[0070] Compared with the normal group, the ERα content in the cerebral cortex and colon of the mice in the control group was significantly decreased (P<0.01), and the Sema3A and RGMa contents were significantly increased (P<0.01). Compared with the control group, the ERα content in the cerebral cortex and colon of the mice in the miR-124inhibitor group, miR-124inhibitor+FLXT group, and miR-124inhibitor+TGJY group was increased (P<0.05 or P<0.01), and the Sema3A and RGMa contents were significantly decreased (P<0.05 or P<0.01). Compared with the NC group, the ERα content in the cerebral cortex and colon of the mice in the miR-124inhibitor group was increased (P>0.05), and the Sema3A and RGMa contents were decreased (P<0.05); compared with the miR-124inhibitor group, the ERα content in the cerebral cortex and colon of the mice in the miR-124inhibitor+FLXT group and miR-124inhibitor+TGJY group was increased (P<0.05 or P<0.01), and the Sema3A and RGMa contents were significantly decreased (P<0.05 or P<0.01); see Table 3 for details.

[0071] Table 3 Expression levels of ERα, Sema3A, and RGMa in mouse cerebral cortex and colon ( n=8)

[0072]

[0073]

[0074] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the control group, c P<0.05, d P<0.01; compared with miR-124inhibitor NC group, e P<0.05, f P<0.01; compared with the miR-124 inhibitor group, g P<0.05, h P<0.01(the same below).

[0075] Note.Compared with blank group, aP <0.05, bP <0.01;Compared with CTRLgroup,

[0076] cP<0.05, d P<0.01; Compared with inhibitor NC group, e P<0.05, f P<0.01,Compared with miR124inhibitor group, g P<0.05, h P<0.01.

[0077] 2.4 Western blot results of each group of mice

[0078] like Figure 1 As shown, compared with the normal group, the ERα content of the mice in the control group was significantly decreased (P<0.01), and the NRP1, RGMa, β-actin, and Rock contents were significantly increased (P<0.01). Compared with the control group, the ERα content of the mice in the cerebral cortex and colon of the mice in the miR-124inhibitor group, miR-124inhibitor+FLXT group, and miR-124inhibitor+TGJY group was increased (P<0.05 or P<0.01), and the NRP1, RGMa, and Rock contents were significantly decreased (P<0.05 or P<0.01). Compared with the NC group, the ERα content in the cerebral cortex and colon of the mice in the miR-124inhibitor group was increased (P>0.05), and the NRP1, RGMa, and Rock contents were decreased (P<0.05); compared with the miR-124inhibitor group, the ERα content in the cerebral cortex and colon of the mice in the miR-124inhibitor+FLXT group and miR-124inhibitor+TGJY group was increased (P<0.05 or P<0.01), and the NRP1, RGMa, and Rock contents were significantly decreased (P<0.05 or P<0.01).

[0079] 3. Conclusion

[0080] This study showed that after treatment with miR-124 inhibitor + medicated serum for regulating liver and relieving depression, the despair time of mice was shortened, the feeding time and sugar water preference rate were significantly increased, the depressive-like behavior was significantly alleviated, the expression levels of serum NE, GABA, 5-HT, and DA were also significantly increased, and the arrangement of mouse cerebral cortical neurons and colon tissue cells became more neat and uniform, the cell activity was enhanced, the cell apoptosis was reduced and gradually recovered to normal morphology, and the Western blot experiment further proved that the medicated serum for regulating liver and relieving depression had a regulatory effect on the neuronal regeneration ability through the miR124-mediated Sema3A / NRP1 pathway, among which the ERα content in the miR124 inhibitor + TGJY serum group increased, and the NRP1, RGMa, and Rock contents were significantly decreased. This phenomenon indicates that the medicated serum for regulating liver and relieving depression activated the Sema3A / NRP1 pathway through miR124, and played a regulatory role in the brain-gut axis of PMDD mice, suggesting that the medicated serum for regulating liver and relieving depression participates in the PMDD neurogenesis and neuronal differentiation process through miR-124, which further deepens our understanding of the disease development mechanism of PMDD. In summary, miR-124 inhibitor combined with Tiaogan Jieyu recipe can significantly improve the depressive-like behavior of PMDD mice, and improve their serum NE, GABA, 5-HT, and DA levels, further restore the normal morphology of cerebral cortical neurons and colon tissue cells, and regulate the expression of brain-gut axis-related proteins in PMDD mice by regulating the Sema3A / NRP1 signaling pathway. These findings provide important clues for our in-depth understanding of the pathogenesis of PMDD and the development of new drugs. Future studies can further explore the mechanism of action of Tiaogan Jieyu recipe and miR124 in the regulation of the brain-gut axis of PMDD, and bring hope to the development of new drugs and improvement of the quality of life and health status of PMDD patients.

[0081] In order to verify the therapeutic effect of the Chinese medicine composition of the present invention, the following experiments were performed:

[0082] 60 female patients with menopausal depression were selected and randomly divided into an experimental group and a placebo group, with 30 cases in each group. The patients in the experimental group took the Chinese medicine composition of the present invention, and the patients in the placebo group took a placebo with similar properties. After a course of treatment (12 weeks), the therapeutic effects of the two groups of patients were compared.

[0083] Before treatment, the baseline data of the two groups were basically the same, and the difference was not statistically significant. The statistical results are as follows:

[0084]

[0085]

[0086] After one course of treatment (12 weeks), the patients' Greene total score and each dimension score, KI score, SDS score, and HAMA score all dropped significantly and had better efficacy than the placebo group. The results are as follows:

[0087]

[0088]

[0089] The test results showed that the depressive symptoms of patients in the test group were significantly improved, and the treatment effect was more obvious than that in the placebo group.

[0090] The invention provides a traditional Chinese medicine composition for treating menopausal depression, comprising 10-30 parts of raw rehmannia, 10-20 parts of white peony root, 10-30 parts of lily, 10-20 parts of stir-fried atractylodes macrocephala, 5-15 parts of bupleurum, 10-20 parts of curcuma, 10-30 parts of scutellaria and 10-20 parts of polygonatum sibiricum.

[0091] A method for preparing a traditional Chinese medicine composition for treating menopausal depression comprises the following steps: S1: preparation of medicinal materials; S2: pretreatment; S3: extraction; S4: concentration; S5: spray drying; S6: classification and mixing; S7: finished product manufacturing; S8: quality control; S9: packaging; S10: storage.

[0092] S1 specifically includes: testing the prescribed Chinese medicinal materials according to the standards of the 2015 edition of the "Chinese Pharmacopoeia" to ensure that the selected medicinal materials are qualified.

[0093] S1 specifically includes: investigating the origins of the raw medicinal materials in the prescription respectively, determining the sources of the medicinal materials, and after sufficient investigation, confirming that none of the eight medicinal materials in the prescription are precious or endangered medicinal materials.

[0094] S2 specifically includes: washing and drying the medicinal materials, and grinding all the medicinal materials into powder or fragments.

[0095] S3 specifically includes: placing all powdered or fragmented medicinal materials into an extraction tank, adding an appropriate amount of water or other solvents (such as ethanol), decocting according to the traditional decoction method, and extracting the effective ingredients therein; repeatedly extracting the medicinal materials according to the extraction conditions of different drugs.

[0096] S4 specifically includes: using vacuum concentration equipment to evaporate and concentrate the extract to reduce water content and increase concentration.

[0097] S5 specifically includes: using a spray dryer to atomize and dry the concentrated liquid to form dry medicine powder.

[0098] S6 specifically includes: mixing different medicinal material extracts according to the formula ratio to prepare a complete formula.

[0099] S7 specifically includes: using equipment to make the finished drug powder into granules, capsules, or tablets according to the corresponding manufacturing method.

[0100] S8 specifically includes: strict quality inspection of each batch of products, including determination of active ingredient content, heavy metal and pesticide residue testing, microbial limit testing, etc.

[0101] S9 specifically includes: classifying and packaging finished drugs that have passed quality inspection according to their different forms.

[0102] S10 specifically includes: storing the final product in a dry, cool place, away from direct sunlight and moisture.

[0103] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several modifications and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A Chinese medicine composition for treating menopausal depression, comprising 10-30 parts of raw rehmannia, 10-20 parts of white peony root, 10-30 parts of lily, 10-20 parts of stir-fried atractylodes, 5-15 parts of bupleurum, 10-20 parts of curcuma, 10-30 parts of scutellaria, and 10-20 parts of polygonatum sibiricum.

2. A method for preparing a Chinese medicine composition for treating menopausal depression as claimed in claim 1, characterized in that: The following steps are involved: S1: preparation of medicinal materials; S2: pretreatment; S3: extraction; S4: Concentrated; S5: spray drying; S6: Sorting and mixing; S7: Finished product manufacturing; S8: Quality control; S9: Packaging; S10: Storage.

3. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S1 specifically includes: testing the prescribed Chinese medicinal materials according to the standards of the 2015 edition of the "Chinese Pharmacopoeia" to determine whether the selected medicinal materials are qualified medicinal materials.

4. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 3, characterized in that: The S1 specifically includes: investigating the origins of the raw medicinal materials in the prescription respectively, determining the sources of the medicinal materials, and after sufficient investigation, confirming that the eight medicinal materials in the prescription are not precious and endangered medicinal materials.

5. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The step S2 specifically includes: washing and drying the medicinal materials, and grinding all the medicinal materials into powder or fragments.

6. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S3 specifically includes: placing all powdered or fragmented medicinal materials into an extraction tank, adding an appropriate amount of water or other solvent (such as ethanol), decocting according to the traditional decoction method, and extracting the effective ingredients therein; and repeatedly extracting the medicinal materials according to the extraction conditions of different drugs.

7. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S4 specifically includes: using vacuum concentration equipment to evaporate and concentrate the extract to reduce water content and increase concentration.

8. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The step S5 specifically includes: using a spray dryer to atomize and dry the concentrated liquid to form dry medicine powder.

9. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S6 specifically includes: mixing different medicinal material extracts according to the formula ratio to prepare a complete formula.

10. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S7 specifically includes: using equipment to make the finished drug powder into granules, capsules, or tablets according to the corresponding manufacturing method.

11. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S8 specifically includes: strict quality inspection of each batch of products, including determination of active ingredient content, heavy metal and pesticide residue detection, microbial limit inspection, etc.

12. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S9 specifically includes: classifying and packaging the finished drugs that have passed the quality inspection according to their different forms.

13. The method for preparing a Chinese medicine composition for treating menopausal depression according to claim 2, characterized in that: The S10 specifically includes: storing the final product in a dry, cool place, avoiding direct sunlight and moisture.

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