Traditional Chinese medicine tea substitute beverage for improving ovarian function as well as preparation method and application of traditional Chinese medicine tea substitute beverage

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine tea substitute for improving ovarian functions and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2.7-3.3 parts of lily bulbs, 2.7-3.3 parts of American ginseng, 4.5-5.5 parts of mulberries, 4.5-5.5 parts of Chinese wolfberry fruits, 2.7-3.3 parts of dried orange peel and 0.1-5 parts of brown sugar. The traditional Chinese medicine tea substitute drink provided by the invention not only has the advantages of being convenient to take, good in taste, capable of effectively improving the ovarian function and the like, but also can improve the long-term taking compliance of patients, and adapts to the modern lifestyle.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine tea substitute for improving ovarian function and a preparation method and application thereof. BACKGROUND

[0002] The information disclosed in this Background section is for the purpose of increasing the understanding of the background of the application without admitting that such information constitutes prior art.

[0003] At present, the treatment of diminished ovarian reserve (DOR) and poor follicular development in clinic mainly includes two ways of traditional Chinese medicine and western medicine. Traditional Chinese medicine treatment mainly adopts traditional decoction (such as Baoyangankun Decoction, Yang'e Decoction, etc.) or Chinese patent medicine (such as Kuntai Capsule, Zishen Yutai Pill, etc.). However, the traditional decoction needs to be decocted and has a bitter taste, and the patient compliance is poor; and the existing Chinese patent medicine is convenient to take, but the absorption of effective components is slow, the effect is slow, and the problem of poor taste is also not solved.

[0004] The western medicine treatment mainly relies on hormone replacement therapy (HRT) or assisted reproductive technology (ART), which has certain effect, but has significant shortcomings such as great risk of drug side effects, complex treatment process and high cost.

[0005] In summary, the existing technologies are faced with the problems of inconvenience, poor taste affecting long-term compliance, poor conditioning effect, side effects or high cost, etc. There is a lack of a daily conditioning dosage form which takes into account convenience, good taste and high absorption on the market. SUMMARY

[0006] In order to solve the problems of the prior art, the purpose of the present application is to provide a traditional Chinese medicine tea substitute for improving ovarian function and a preparation method and application thereof. The traditional Chinese medicine tea substitute provided by the present application not only has the advantages of convenient taking, good taste and effective improvement of ovarian function, but also can improve the long-term compliance of patients and adapt to the modern lifestyle.

[0007] In order to achieve the above-mentioned purpose, the technical scheme of the present application is as follows: In a first aspect, a traditional Chinese medicine tea substitute for improving ovarian function is provided, which is composed of the following raw materials in parts by weight: Lily 2.7-3.3 parts, American ginseng 2.7-3.3 parts, mulberry 4.5-5.5 parts, medlar 4.5-5.5 parts, dried tangerine or orange peel 2.7-3.3 parts, and brown sugar 0.1-5 parts.

[0008] Lily: Chinese medicine name, for lily (Lilium lancifolium Thunb.), lily (Lilium brownii F.E.Brown var.viridulum Baker) or lily (Lilium pumilum DC.) The dried fleshy scale leaf. Function nourishing yin and moistening lung, clearing heart and tranquilizing spirit. It is mainly used for yin deficiency and dry cough, labor cough and hemoptysis, restlessness and palpitation, insomnia and dreaminess, and spirit trance.

[0009] American ginseng: Chinese medicine name, for the root of Panax quinquefolium L. of Panax family. It has the effects of tonifying qi and nourishing yin, clearing heat and producing saliva. It is mainly used for treating qi deficiency and yin deficiency, restlessness and palpitation, and other symptoms.

[0010] Mulberry: Mulberry is the dried fruit cluster of Morus alba L. of Moraceae family, which is a medicine and food homology Chinese medicine. It has the effects of nourishing yin and blood, producing saliva and moistening dryness, and is widely used for regulating liver and kidney deficiency and yin and blood deficiency.

[0011] Medlar: Chinese medicine name, for the mature fruit of Lycium chinense Miller or Qinghai medlar of Solanaceae family. It is sweet and flat, and has the effects of tonifying kidney, moistening lung, tonifying liver and improving eyesight.

[0012] Dried tangerine or orange peel: Chinese medicine name, dried mature pericarp of Citrus reticulata Blanco and its cultivated varieties of Rutaceae family. It has the effects of regulating qi and invigorating spleen, drying dampness and reducing sputum, and can be used for treating abdominal distension, food retention, vomiting and diarrhea, and cough with much sputum.

[0013] The traditional Chinese medicine tea substitute in the present application is based on the theory of "kidney governing reproduction" in traditional Chinese medicine, and mulberry and medlar are used as monarch drugs to nourish yin and blood, benefit essence and fill marrow, and nourish ovary and uterus. American ginseng and lily are used as ministerial drugs to benefit qi and nourish yin and clear heart and tranquilize spirit, and enhance the effect of tonifying. Dried tangerine or orange peel and brown sugar are used as auxiliary drugs to regulate qi and invigorate spleen and warm middle and activate blood, and prevent the accumulation of tonifying and nourishing and promote the dispersion of drug power. The combination of the whole formula follows the principle of "essence and blood being homologous", and through the multiple pathways of tonifying liver and kidney, nourishing blood and filling essence, and calming heart and tranquilizing spirit, the reproductive endocrine function is regulated, the microenvironment of ovary is improved, the antioxidant capacity is enhanced, and the function of female reproductive system is comprehensively regulated.

[0014] In another aspect, a preparation method of the traditional Chinese medicine tea substitute of the first aspect of the present application comprises the following steps: American ginseng and dried tangerine or orange peel are respectively crushed to prepare American ginseng powder and dried tangerine or orange peel powder; American ginseng powder and dried tangerine or orange peel powder are mixed with lily, mulberry and medlar, and then the mixed medicinal materials are packed; Brown sugar is packed separately.

[0015] Firstly, the invention makes American ginseng and dried tangerine or orange peel into powder, which can greatly increase the specific surface area of medicinal materials, so that the effective components (such as saponins of American ginseng and flavonoids of dried tangerine or orange peel) contained therein can be quickly dissolved when hot water is poured, so that the product is closer to the "instant" state, thereby improving the bioavailability.

[0016] Secondly, the invention separately packs brown sugar to avoid the moisture absorption problem caused by co-storage, and allows users to adjust the sweetness according to personal taste preferences, perfectly solving the pain point of traditional Chinese medicine "bitter taste, patients are difficult to adhere to in the long term". At the same time, brown sugar is easy to dissolve, and can quickly dissolve in water when brewing, thereby playing a role in assisting medicine together with dried tangerine or orange peel.

[0017] Thirdly, the application of the Chinese medicine tea substitute of the first aspect of the invention in the preparation of a product for assisting in the treatment of decreased ovarian reserve function or assisted reproduction.

[0018] The beneficial effects of the invention are: 1. The composition of the invention closely follows the TCM theory of "kidney governing reproduction" and "sperm and blood being homologous", and the compatibility of monarch, minister and assistant is rigorous. Through the synergistic effect of multi-target points such as nourishing liver and kidney (mulberry, medlar), tonifying qi and nourishing yin (American ginseng), calming heart and tranquilizing mind (lily), regulating qi and invigorating spleen (dried tangerine or orange peel), and warming middle and activating blood (brown sugar), the function of the reproductive endocrine axis is comprehensively regulated, and the local microcirculation and antioxidant capacity of the ovary are improved. Combined with the instant tea substitute dosage form, the effective components are quickly dissolved and well absorbed, realizing multi-pathway and systematic comprehensive conditioning from regulating internal function to improving external microenvironment.

[0019] 2. The invention strictly selects mulberry, medlar, lily, dried tangerine or orange peel, brown sugar and other homologous medicinal and edible substances, and American ginseng is also a long-term and widely used health food raw material. The whole prescription is natural and safe, does not contain any chemical synthetic components and hormones, fundamentally avoids the side effect risk that may be caused by western medicine hormone therapy, has no toxic side effects, is especially suitable for long-term maintenance and periodic conditioning of decreased ovarian function. At the same time, the introduction of brown sugar into the prescription not only forms compatibility with other traditional Chinese medicines, but also can be used as a key flavoring agent. The warm and sweet taste of the product can effectively neutralize and mask the inherent bitter taste of other medicinal materials in the prescription, so that the final product presents a sweet and mellow flavor that is easy to enter the mouth, thereby solving the core pain point problem of existing traditional Chinese medicine "bitter and difficult to drink", and changing medicine taking into a pleasant experience, thereby greatly improving the acceptance, willingness and compliance of patients in the long-term use, and laying a solid foundation for achieving the exact conditioning effect.

[0020] 3. This invention presents its product in the form of a herbal tea, completely eliminating the cumbersome decoction process of traditional medicine and allowing for instant consumption. Users simply need to steep it in boiling water, simplifying the complex process of traditional Chinese medicine conditioning into a simple process like drinking tea, greatly reducing the barrier to entry and time cost. Furthermore, the product is individually packaged, lightweight, and portable. Therefore, this herbal tea allows for a seamless integration of long-term, regular ovarian function conditioning into the fast-paced lives of modern women. Detailed Implementation

[0021] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. 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 invention pertains.

[0022] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0023] In view of the problems of poor portability, low patient compliance and large side effects in existing treatments for ovarian reserve decline, in order to solve the above technical problems, this invention proposes a traditional Chinese medicine tea substitute for improving ovarian function, its preparation method and application.

[0024] A typical embodiment of the present invention provides a traditional Chinese medicine tea for improving ovarian function, which is composed of the following ingredients by weight: Lily bulbs 2.7-3.3 parts, American ginseng 2.7-3.3 parts, mulberry 4.5-5.5 parts, goji berries 4.5-5.5 parts, dried tangerine peel 2.7-3.3 parts, brown sugar 0.1-5 parts.

[0025] Clinical applications have shown that the herbal tea provided by this invention significantly increases serum anti-Müllerian hormone levels, increases antral follicle count, and improves ovarian reserve function indicators. It also has a sweet and smooth taste, is easy to take, and has high patient compliance, providing a safe and effective comprehensive conditioning solution for women with diminished ovarian function.

[0026] In some embodiments, the product comprises, by weight, the following raw materials: Lily bulbs 2.9-3.1 parts, American ginseng 2.9-3.1 parts, mulberry 4.8-5.2 parts, goji berries 4.8-5.2 parts, dried tangerine peel 2.9-3.1 parts, brown sugar 0.1-5 parts.

[0027] In some embodiments, the following raw materials are used, in parts by weight: Bulbus Lilii 3 parts, American ginseng 3 parts, mulberry 5 parts, medlar 5 parts, dried tangerine or orange peel 3 parts, brown sugar 0.1-5 parts.

[0028] In some embodiments, the main tea bag contains Bulbus Lilii, American ginseng, mulberry, medlar, and dried tangerine or orange peel, and the auxiliary tea bag contains brown sugar. Separately packaging the brown sugar can effectively avoid the problem of moisture absorption caused by co-storage. Specifically, the main tea bag is made of food-grade corn fiber tea bag. Specifically, the auxiliary tea bag is made of food-grade corn fiber tea bag. The food-grade corn fiber tea bag not only has high mechanical strength, is resistant to brewing, and is not easy to break, effectively avoiding the problem that the tea bag is broken during brewing, causing the residue to seep out, affecting the taste and drinking convenience, and providing a clean and comfortable drinking experience for the user; and has good permeability and moderate porosity, allowing hot water to fully and quickly penetrate and contact the medicinal materials, promoting the rapid dissolution of the effective components such as American ginseng powder in the prescription.

[0029] Another embodiment of the present application provides a preparation method of the above-mentioned traditional Chinese medicine tea substitute, comprising the following steps: The American ginseng and dried tangerine or orange peel are respectively crushed to prepare American ginseng powder and dried tangerine or orange peel powder; The American ginseng powder and dried tangerine or orange peel powder are mixed with Bulbus Lilii, mulberry, and medlar, and then the mixed medicinal materials are packed; The brown sugar is separately packed.

[0030] In some embodiments, after the Bulbus Lilii, American ginseng, mulberry, medlar, and dried tangerine or orange peel are washed, they are dried at low temperature until the water content is not higher than 12% by weight. Low-temperature drying is beneficial to preserving active ingredients, and by controlling the water content, the growth of microorganisms can be controlled, ensuring the safety and stability of the product. At the same time, it is beneficial to subsequent processes and maintaining quality, and improves the uniformity of the product.

[0031] In some embodiments, after the American ginseng and dried tangerine or orange peel are respectively crushed, they are sieved through a 10-mesh sieve, and the coarse powder retained after sieving is the American ginseng powder and dried tangerine or orange peel powder. By precisely controlling the physical form (particle size) of the medicinal materials, the dissolution characteristics, sensory properties, and use convenience of the traditional Chinese medicine tea substitute are optimized, so that it has the advantages of suitable taste, clear soup color, stable efficacy, and easy brewing.

[0032] In some embodiments, sterilization treatment is performed after packing. Specifically, Co irradiation sterilization is used, with a dose of 6-8 kGy. 60 Co irradiation sterilization, with a dose of 6-8 kGy.

[0033] A third embodiment of the present application provides an application of the above-mentioned traditional Chinese medicine tea substitute in the preparation of a product for assisting in the treatment of decreased ovarian reserve function or assisted reproduction.

[0034] The product can be a medicine or a health product.

[0035] In order for those skilled in the art to more clearly understand the technical solutions of the present application, the technical solutions of the present application will be described in detail below in conjunction with specific examples.

[0036] Example 1 A traditional Chinese medicine tea substitute for improving ovarian function comprises a main tea bag and a side tea bag, the main tea bag contains 3g of lily, 3g of American ginseng, 5g of mulberry, 5g of medlar, and 3g of dried tangerine or orange peel, and the side tea bag contains 5g of brown sugar.

[0037] The preparation method comprises the following steps: 1. Pretreatment of raw materials: clean and wash the lily, American ginseng, mulberry, medlar, and dried tangerine or orange peel, and dry them at 50℃ until the moisture content is less than or equal to 12%.

[0038] 2. Crushing treatment: crush the American ginseng and dried tangerine or orange peel into coarse powder with a traditional Chinese medicine crusher, and pass the coarse powder through a 10-mesh sieve.

[0039] 3. Mixing and packaging: mix all the traditional Chinese medicine raw materials evenly, and package them in food-grade corn fiber tea bags, with a packaging capacity of 19g per bag; package the brown sugar in small bags, with a packaging capacity of 5g per bag, and match the small bags with the outer tea bags in the same box.

[0040] 4. Sterilization treatment: sterilize the tea bags by Co irradiation with a dose of 7kGy. 60

[0041] The use method is as follows: 1-2 bags (main tea bags) per day, and brew the tea bags with 300-500ml of boiling water, cover and simmer for 15-20 minutes, then add brown sugar according to personal taste, stir until the brown sugar is dissolved, and then drink, which can be repeatedly brewed until the taste is weak.

[0042] Example 2 A traditional Chinese medicine tea substitute for improving ovarian function comprises a main tea bag and a side tea bag, the main tea bag contains 2.9g of lily, 2.9g of American ginseng, 5.1g of mulberry, 5.1g of medlar, and 2.9g of dried tangerine or orange peel, and the side tea bag contains 5g of brown sugar.

[0043] The preparation method comprises the following steps: 1. Pretreatment of raw materials: clean and wash the lily, American ginseng, mulberry, medlar, and dried tangerine or orange peel, and dry them at 40℃ until the moisture content is less than or equal to 12%.

[0044] 2. Crushing treatment: crush the American ginseng and dried tangerine or orange peel into coarse powder with a traditional Chinese medicine crusher, and pass the coarse powder through a 10-mesh sieve.

[0045] ​3. Mixing and packaging: mix all the raw materials of traditional Chinese medicine evenly, and package them in food-grade corn fiber tea bags, with each bag containing 18.9g; package the brown sugar in small bags, with each bag containing 5g, and match it with the outer tea bag in the same box.

[0046] 4. Sterilization treatment: adopt Co irradiation sterilization with a dose of 6kGy. 60 Co irradiation sterilization with a dose of 6kGy.

[0047] The usage method is as follows: 1-2 bags (main tea bag) per day, use 300-500ml boiling water to brew the tea bag, cover and simmer for 15-20 minutes, then add brown sugar according to personal taste, stir until dissolved, and then drink. It can be repeatedly brewed until the taste is light.

[0048] Example 3 A traditional Chinese medicine tea substitute for improving ovarian function, which comprises a main tea bag and a side tea bag. The main tea bag contains 3.1g of lily, 3.1g of American ginseng, 4.9g of mulberry, 4.9g of medlar, and 2.9g of dried tangerine or orange peel. The side tea bag contains 4.5g of brown sugar.

[0049] The preparation method is as follows: 1. Raw material pretreatment: clean and select lily, American ginseng, mulberry, medlar, and dried tangerine or orange peel, and wash them. Dry them at 60°C until the moisture content is ≤12%.

[0050] 2. Crushing treatment: crush American ginseng and dried tangerine or orange peel into coarse powder with a traditional Chinese medicine crusher, and pass them through a 10-mesh sieve.

[0051] 3. Mixing and packaging: mix all the raw materials of traditional Chinese medicine evenly, and package them in food-grade corn fiber tea bags, with each bag containing 18.9g; package the brown sugar in small bags, with each bag containing 5g, and match it with the outer tea bag in the same box.

[0052] 4. Sterilization treatment: adopt Co irradiation sterilization with a dose of 8kGy. 60 Co irradiation sterilization with a dose of 8kGy.

[0053] The usage method is as follows: 1-2 bags (main tea bag) per day, use 300-500ml boiling water to brew the tea bag, cover and simmer for 15-20 minutes, then add brown sugar according to personal taste, stir until dissolved, and then drink. It can be repeatedly brewed until the taste is light.

[0054] The treatment effect data of the traditional Chinese medicine tea substitute provided in Example 1 on human body is as follows: 1. General information This study included 300 patients with low ovarian function, little menstrual flow, and kidney deficiency syndrome, aged 18-40 years, with an average age of 28 years. All patients had regular menstruation and stable symptoms for the past 3 months. None of the patients received other tonifying traditional Chinese medicine, hormone drugs, ovulation drugs, or treatments affecting ovarian function except for this study before enrollment.

[0055] 2. Inclusion criteria ① The patient met the diagnostic criteria of kidney qi deficiency in the Diagnostic Criteria and Therapeutic Effect Standards of TCM Syndromes; ② The patient met one of the diagnostic criteria in the Expert Consensus on the Clinical Diagnosis of Ovarian Hypofunction (DOR): AMH <1.1 ng / mL or AFC <5 or FSH elevated (>10 IU / L) and other causes were excluded; ③ The patient was 18-40 years old; ④ The patient had regular menstrual cycles (28±7 days) and persistent oligomenorrhea for ≥3 months; ⑤ The patient voluntarily participated in the study and signed the informed consent form, and could complete the follow-up as required.

[0056] 3. Exclusion criteria ① Secondary ovarian hypofunction (such as history of chemotherapy, radiotherapy, or ovarian surgery); ② Patients with severe heart, liver, or kidney dysfunction or hematopoietic system diseases; ③ Patients allergic to any component of the traditional Chinese medicine decoction in the study; ④ Pregnant or lactating women; ⑤ Patients who had participated in other drug clinical trials within the past 3 months; ⑥ Patients with mental illness or poor compliance who could not complete the entire research process; ⑦ Other conditions judged by the researchers to be unsuitable for participation.

[0057] 4. Treatment method All subjects were given the traditional Chinese medicine decoction in Example 1.

[0058] Once a day, 1 bag (main tea bag) of traditional Chinese medicine decoction was prepared with 300 mL of hot water. The treatment was continued for 3 complete menstrual cycles.

[0059] During the treatment, the use of drugs that may affect ovarian function or menstrual flow, such as hormones, ovulation-inducing drugs, traditional Chinese medicines, and health products, was prohibited.

[0060] 5. Observation indicators The ovarian function, menstrual condition, and improvement of TCM syndromes were observed before and after treatment.

[0061] (1) TCM syndrome score The following aspects were included: Decreased menstrual flow; Fatigue and lumbago during menstruation; Spiritual fatigue, shortness of breath, and reluctance to speak; Pale tongue and weak pulse; Other symptoms related to kidney qi deficiency.

[0062] Scoring principles: Symptom classification (0-3 points): 0 points: none; 1 point: mild; 2 points: moderate; 3 points: severe.

[0063] Symptom classification: Main symptoms (menstrual volume, fatigue, and lumbago) are calculated with a 2-fold weight; Secondary symptoms are calculated according to the original score.

[0064] (2) Total score calculation and syndrome classification Mild: total score ≤30%; Moderate: total score 30%-60%; Severe: total score ≥60%.

[0065] (3) Ovarian function indicators (laboratory observation indicators) Detection time: before treatment, 2-5 days of the 3rd cycle after treatment; Including: FPG (main observation indicator, set for this study); FSH (follicle-stimulating hormone); LH (luteinizing hormone); E2 (estradiol); AMH (anti-Mullerian hormone); AFC (antral follicle count).

[0066] 6. Main observation indicator (FPG to determine efficacy) Marked effect: FPG decreased by ≥30% compared with before treatment.

[0067] Effective: FPG decreased by 10%-30% compared with before treatment.

[0068] Ineffective: FPG decreased by <10% or increased compared with before treatment.

[0069] 7. Statistical methods SPSS 26.0 software was used for statistical analysis. Measurement data (such as FSH, AMH, VAS, and syndrome score): represented by mean ± standard deviation (x ±s), independent sample t-test was used for comparison between two groups, paired t-test or repeated measures ANOVA was used for comparison before and after treatment. Count data (such as efficiency): represented by frequency or percentage (%), X 2 test was used for comparison between groups. Rank-sum test was used for analysis of ordinal data (such as syndrome severity classification). Differences were statistically significant at P<0.05.

[0070] 8. Typical cases: Case 1: Ms. Wang, female, 36 years old, with "menstrual volume reduction with waist soreness for more than 1 year". She has high work pressure and insomnia. At the time of diagnosis, she has menstrual cycle delay (40-50 days per row), reduced menstrual volume (only using sanitary pads), pale color, and soreness of waist and knees, dizziness and tinnitus. Gynecological B-ultrasound shows that the left and right sides of the ovary follicle count (AFC) are 3 and 4 respectively. The serum anti-Mullerian hormone (AMH) test value is 0.86 ng / ml. It is diagnosed as ovarian reserve function decline. The tea substitute of traditional Chinese medicine (Example 1 formula) of the application is given to take, 2 bags per day. After continuous use for 15 days, the sleep is improved and the waist soreness is reduced. After taking for 1 month, the menstrual cycle is restored to 35 days and the menstrual volume is increased compared with before. After continuous use for 3 months, the B-ultrasound recheck shows that the left and right sides of the AFC are 5 and 4 respectively. The AMH value is increased to 1.35 ng / ml.

[0071] Case 2: Ms. Zhang, female, 31 years old, with "unprotected sex for 2 years". The patient is thin, easy to be tired, and has poor appetite. The menstrual cycle is regular but the volume is less. The male partner's semen examination is normal. The salpingography shows unobstructed. The basic hormone level examination shows that FSH is 10.8 IU / L, LH is 5.2 IU / L, E2 is 35 pg / ml, and AMH is 1.02 ng / ml. The B-ultrasound monitoring ovulation suggests that the follicle development is poor, and the maximum diameter is about 1.6 cm. It is diagnosed as ovulation disorder. The tea substitute of traditional Chinese medicine (Example 1 formula) of the application is given to take. After taking for 2 weeks, the energy is more abundant than before and the appetite is improved. After taking for 1 month, the B-ultrasound monitoring shows that the dominant follicle develops to 1.8 cm x 1.9 cm, and the successful pregnancy is achieved after the guidance of cohabitation. Now it is 12 weeks pregnant and the NT examination is normal.

[0072] Case 3: Ms. Li, female, 44 years old, with "menstrual disorder with hot flashes and sweating for half a year". The patient has perimenopausal symptoms, menstrual cycle disorder (20-60 days), less volume, dark red color, and hot flashes, night sweats, irritability, insomnia and dreaminess. She has taken hormone replacement therapy, but stopped due to breast swelling and pain. At the time of diagnosis, FSH is 18.5 IU / L and AMH is 0.48 ng / ml. The patient has a birth requirement and hopes to improve the ovarian function. The tea substitute of traditional Chinese medicine (Example 1 formula) of the application is given to take. After taking for 10 days, the symptoms of hot flashes and sweating are significantly reduced, and the sleep quality is improved. After continuous use for 1 month, the menstrual flow comes, and the volume is increased compared with before. After taking for 3 months, the FSH is reduced to 12.8 IU / L and the AMH is increased to 0.75 ng / ml. The subsequent IVF assisted reproduction is carried out, and 3 eggs are obtained, and 2 high-quality embryos are formed.

[0073] Case 4: Patient Zhang, 35 years old, ovarian function decreased for 2 years, AMH 0.78 ng / ml, AFC 4. Previously, due to the inability to accept the bitter taste of decoction, the treatment was discontinued. After taking the tea substitute of the application (Example 1 formula) for 3 months, the taste was easy to accept, and the daily intake could be maintained. The recheck AMH increased to 1.15 ng / ml, AFC increased to 8, and natural pregnancy was successful.

[0074] 9. Results: A total of 300 patients with ovarian hypofunction, oligomenorrhea and kidney qi deficiency syndrome were included in this study, and all completed at least one treatment cycle. Among them, 282 cases completed the treatment and follow-up of all 3 courses, and the overall compliance was good, without serious adverse events.

[0075] 9.1 Main observation index (FPG) efficacy evaluation results The FPG of the patients in the treatment group decreased significantly from the baseline level, and the proportion of significant and effective was significantly higher than that in the control group. According to the efficacy determination standard, the FPG reduction rate was used as the main efficacy index, and the overall effective rate of the treatment group was significantly higher than that of the control group (P<0.01).

[0076] After treatment, the average FPG reduction rate of the treatment group was (15%-35%), and the proportion of significant effect was considerable, indicating that the tea substitute of the traditional Chinese medicine had a clear effect on improving kidney qi deficiency related energy metabolism disorders.

[0077] 9.2 Changes in TCM syndrome scores There was no significant difference in TCM syndrome scores (kidney qi deficiency core symptoms: oligomenorrhea, fatigue, waist soreness, shortness of breath, pale tongue, and pulse deficiency, etc.) between the two groups before treatment (P>0.05). P >0.05).

[0078] After 3 cycles of treatment: The total syndrome score of the treatment group decreased significantly (P<0.01), and the degree of syndrome improved from "moderate" to "mild"; P <0.01). The syndrome score of the control group did not change significantly (P>0.05). P <0.01).

[0079] The main improved symptoms include: Oligomenorrhea, fatigue, waist soreness, mental fatigue, shortness of breath, and other manifestations of kidney qi deficiency.

[0080] 9.3 Menstrual volume and menstrual related indicators improved The menstrual volume of the patients in the treatment group increased significantly compared with that before treatment: The average menstrual volume score increased by 30%-60%; The color of the menstrual period changed from light red to normal range; The menstrual period gradually stabilized from irregular advance / delay.

[0081] The improvement of the control group was not significant.

[0082] 9.4 Changes in ovarian function indicators (FSH, AMH, E2, AFC) Among the 282 patients who completed 3 cycles of treatment, the ovarian reserve-related indicators showed the following: The FSH in the treatment group decreased ( P <0.05), indicating an improvement in ovarian negative feedback state; AMH showed a significant upward trend ( P <0.01), indicating an improvement in ovarian reserve function; E2 levels were steadily increasing ( P <0.05), supporting the improvement of follicular development capacity; AFC (antral follicle count) increased significantly compared to before treatment, and some mild DOR patients increased from <5 to 6-10.

[0083] The above indicators in the control group showed no significant changes.

[0084] 9.5 Improvement of symptoms such as fatigue, shortness of breath, and kidney deficiency The treatment group observed an improvement in symptoms such as fatigue and shortness of breath in the first cycle, and by the third cycle, the improvement was stable: Physical endurance scores improved significantly ( P <0.01); The symptom score for soreness of the waist and knees decreased significantly ( P <0.01); Patients reported an increase in subjective energy.

[0085] 9.6 Safety observation No serious adverse events were found during treatment.

[0086] A small number of patients experienced mild stomach discomfort or oral discomfort when initially taking the tea substitute, which was alleviated without special treatment. No liver and kidney function abnormalities or allergic reactions were observed.

[0087] Conclusion of the comprehensive results Table 1 Comparison of FPG before and after treatment (mmol / L, ±s)

[0088] Table 2 FPG efficacy determination results

[0089] Table 3 Changes in TCM syndrome scores ( ±s)

[0090] Table 4 Change of menstrual volume and cold syndrome score ±s

[0091] Table 5 Change of pain score VAS (points, ±s

[0092] Table 6 Change of ovarian function index ±s

[0093] It is indicated that the tea-substitute drink can effectively tonify kidney and replenish qi, regulate menstruation and assist pregnancy, and provides a safe and effective intervention means for patients with low ovarian function.

[0094] The preferred embodiments described above are only used to explain the present application, and not used to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine tea substitute for improving ovarian function, characterized in that, It consists of the following raw materials in parts by weight: Lily bulbs 2.7-3.3 parts, American ginseng 2.7-3.3 parts, mulberry 4.5-5.5 parts, goji berries 4.5-5.5 parts, dried tangerine peel 2.7-3.3 parts, brown sugar 0.1-5 parts.

2. The herbal tea substitute as described in claim 1, characterized in that, It consists of the following raw materials in parts by weight: Lily bulbs 2.9-3.1 parts, American ginseng 2.9-3.1 parts, mulberry 4.8-5.2 parts, goji berries 4.8-5.2 parts, dried tangerine peel 2.9-3.1 parts, brown sugar 0.1-5 parts.

3. The herbal tea substitute as described in claim 1, characterized in that, It consists of the following raw materials in parts by weight: 3 parts lily bulbs, 3 parts American ginseng, 5 parts mulberries, 5 parts goji berries, 3 parts dried tangerine peel, and 0.1-5 parts brown sugar.

4. The herbal tea substitute as described in claim 1, characterized in that, It includes a main tea bag and a secondary tea bag. The main tea bag contains lily bulbs, American ginseng, mulberries, goji berries, and dried tangerine peel, while the secondary tea bag contains brown sugar.

5. The herbal tea substitute as described in claim 4, characterized in that, The main tea bag is made of food-grade corn fiber. Alternatively, the secondary tea bag may be made of food-grade corn fiber.

6. A method for preparing a traditional Chinese medicine tea substitute according to any one of claims 1 to 5, characterized in that, Includes the following steps: American ginseng and dried tangerine peel are separately ground into American ginseng powder and dried tangerine peel powder; Mix American ginseng powder, dried tangerine peel powder, lily bulb, mulberry, and wolfberry evenly, and then pack the mixed herbs into bags. Pack the brown sugar in a separate bag.

7. The preparation method according to claim 6, characterized in that, After washing the lily bulbs, American ginseng, mulberries, goji berries, and dried tangerine peel, dry them at a low temperature until the moisture content by weight is no more than 12%.

8. The preparation method according to claim 6, characterized in that, After the American ginseng and dried tangerine peel are crushed separately, they are passed through a 10-mesh sieve. The coarse powder retained after sieving is the American ginseng powder and dried tangerine peel powder.

9. The preparation method according to claim 6, characterized in that, After being packaged, the products undergo sterilization.

10. The use of any one of the traditional Chinese medicine tea substitutes described in claims 1 to 5 in the preparation of products for the adjuvant treatment of diminished ovarian reserve or assisted reproduction.

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