Eight-treasure brewing paste for dealing with ovarian reserve function decline and preparation method of eight-treasure brewing paste

Abstract

The invention relates to the technical field of traditional Chinese medicine conditioning, in particular to eight-treasure brewing paste for treating ovarian reserve hypofunction and a preparation method of the eight-treasure brewing paste. The eight-treasure brewing paste is prepared from the following raw materials: prepared rehmannia root, white paeony root, Chinese angelica, ligusticum wallichii, radix pseudostellariae, poria cocos, bighead atractylodes rhizome, liquorice, astragalus membranaceus, parasitic loranthus, bran-fried Chinese yam, salted fructus alpiniae oxyphyllae, cortex albiziae, vinegar-processed rhizoma cyperi, fructus akebiae, donkey-hide gelatin, tortoise-shell glue, fingered citron, wine-processed rhizoma polygonati, caulis spatholobi, mulberry and pericarpium citri reticulatae through pretreatment, water decoction extraction, vacuum concentration, glue melting and mixing and paste collection. The prepared eight-treasure brewing paste has the effects of benefiting qi, nourishing blood, tonifying kidney, soothing liver and regulating Chong and Ren meridians, can improve related symptoms of ovarian reserve hypofunction and regulate the balance of qi, blood, yin and yang of a body, and is scientific in preparation process, sufficient in effective component dissolution, convenient to take and absorb in dosage form and suitable for large-scale popularization and application. And a safe and convenient new choice is provided for the traditional Chinese medicine conditioning of the ovarian reserve hypofunction.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine conditioning, and in particular to a Bazhen Chongtiao Paste for dealing with diminished ovarian reserve and a preparation method thereof. Background Art

[0002] Diminished Ovarian Reserve (DOR) refers to a clinical syndrome in which the number or quality of oocytes in the ovary decreases, resulting in reduced fertility or abnormal sex hormone secretion. It is often manifested as decreased menstrual volume, menstrual cycle disorders, perimenopausal symptoms, etc. In severe cases, it can develop into premature ovarian insufficiency, which is an important threat to female reproductive health. According to statistics, the incidence of DOR in women of childbearing age has been increasing year by year, and it is related to various factors such as age growth, environmental factors, surgical trauma, and genetics, and has become a research hotspot in the fields of gynecology and reproductive medicine.

[0003] Currently, the treatment of DOR in Western medicine mainly relies on hormone replacement therapy (such as Climen, etc.). Although it can improve some symptoms, long-term use has potential side effects, such as increasing the risk of cardiovascular diseases and causing breast distension pain, etc., and it is easy to relapse after drug withdrawal, and it is difficult to fundamentally improve ovarian function. Traditional Chinese medicine has unique advantages in conditioning DOR. Through overall syndrome differentiation and multi-target regulation, it can improve ovarian blood supply, regulate endocrine and immune functions, and has relatively small side effects. The traditional classic formula "Bazhen Decoction" focuses on replenishing qi and nourishing blood, and is widely used in gynecological diseases of qi and blood deficiency type. However, for the complex pathogenesis of DOR (such as spleen and kidney deficiency, liver depression and blood stasis, thoroughfare and conception vessel disharmony, etc.), a single formula is difficult to take effect comprehensively, and it is necessary to optimize the compatibility on the basis of the classic formula.

[0004] Modern pharmacological research shows that various traditional Chinese medicine components can improve ovarian reserve function through regulating the hypothalamus-pituitary-ovary axis, improving ovarian microcirculation, antioxidant and anti-apoptosis and other ways. For example, Rehmannia glutinosa can enhance the response of the ovary to gonadotropin, donkey-hide gelatin can promote hematopoiesis and regulate immunity, and astragalus polysaccharide has the effect of protecting ovarian granulosa cells. However, there is still room for improvement in the formula combination, preparation process and clinical efficacy of existing traditional Chinese medicine preparations, especially the lack of an efficient and convenient compound preparation for the core pathogenesis of DOR. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to propose a Bazhen Chongtiao Paste for dealing with diminished ovarian reserve and a preparation method thereof, aiming to provide a safe, efficient and convenient-to-take traditional Chinese medicine preparation, solve the deficiencies of existing treatments, and meet the diversified treatment needs of clinical DOR.

[0006] For the above purposes, the present invention provides a Bazhen Chongtiao Paste for coping with diminished ovarian reserve function, comprising the following raw materials in parts by weight: cooked rehmannia root: 6 - 12 parts, white peony root: 5 - 9 parts, Chinese angelica: 5 - 9 parts, chuanxiong rhizome: 4 - 8 parts, heterophylly falsestarwort root: 15 - 20 parts, poria cocos: 6 - 10 parts, bighead atractylodes rhizome: 6 - 10 parts, liquorice root: 2 - 4 parts, astragalus root: 15 - 20 parts, taxillus twig: 6 - 10 parts, stir-fried yam: 6 - 10 parts, salted semen alpiniae oxyphyllae: 5 - 8 parts, cortex albiziae: 5 - 8 parts, vinegar-processed cyperus rotundus rhizome: 5 - 8 parts, fructus aurantii carnosae: 5 - 8 parts, donkey-hide gelatin: 4 - 8 parts, tortoise shell gelatin: 4 - 8 parts, fingered citron: 4 - 8 parts, wine-processed polygonatum sibiricum rhizome: 5 - 8 parts, suberect spatholobus stem: 6 - 10 parts, mulberry: 5 - 8 parts, dried tangerine peel: 4 - 8 parts.

[0007] Preferably, the Bazhen Chongtiao Paste for coping with diminished ovarian reserve function comprises the following raw materials in parts by weight: cooked rehmannia root: 9 parts, white peony root: 7 parts, Chinese angelica: 7 parts, chuanxiong rhizome: 6 parts, heterophylly falsestarwort root: 17 parts, poria cocos: 9 parts, bighead atractylodes rhizome: 9 parts, liquorice root: 3 parts, astragalus root: 17 parts, taxillus twig: 9 parts, stir-fried yam: 9 parts, salted semen alpiniae oxyphyllae: 7 parts, cortex albiziae: 7 parts, vinegar-processed cyperus rotundus rhizome: 7 parts, fructus aurantii carnosae: 7 parts, donkey-hide gelatin: 6 parts, tortoise shell gelatin: 6 parts, fingered citron: 6 parts, wine-processed polygonatum sibiricum rhizome: 7 parts, suberect spatholobus stem: 9 parts, mulberry: 7 parts, dried tangerine peel: 6 parts.

[0008] Preferably, the cooked rehmannia root can enrich blood and nourish yin, replenish essence and marrow, and is good at treating sallow complexion due to blood deficiency and irregular menstruation. Modern pharmacology has confirmed that it can enhance the response of the ovary to gonadotropins, and improve ovarian reserve and the endometrial cycle.

[0009] Preferably, the white peony root can nourish blood and astringe yin, soothe the liver and relieve pain, and is mainly used for irregular menstruation due to blood deficiency and abdominal pain. Modern research shows that it can regulate ovarian endocrine and improve the uterine environment to promote egg discharge.

[0010] Preferably, the Chinese angelica can enrich blood and promote blood circulation, regulate menstruation and relieve pain, and is an important herb for treating blood deficiency and blood stasis in gynecology. Its active ingredients can delay ovarian function decline and improve endocrine homeostasis.

[0011] Preferably, the chuanxiong rhizome can promote blood circulation and qi movement, dispel wind and relieve pain, and is good at treating irregular menstruation of blood stasis and qi stagnation type. Modern pharmacology shows that it has antioxidant, anti-aging and heart function improvement effects.

[0012] Preferably, the heterophylly falsestarwort root can replenish qi and promote the production of body fluid, invigorate the spleen and benefit the lungs. Its medicinal properties are mild and suitable for those with weak spleen and stomach. Modern research has confirmed that it can regulate immunity, have anti-inflammatory effects and inhibit tumors.

[0013] Preferably, the poria cocos can invigorate the spleen and promote diuresis, calm the mind and soothe the nerves, and is mainly used for loose stools due to weakness of the spleen and less food intake. Modern pharmacology shows that it has antioxidant, immune regulation and liver protection effects.

[0014] Preferably, the Atractylodes macrocephala can invigorate qi and strengthen the spleen, dry dampness and prevent abortion, and is good at treating qi deficiency of the spleen and stomach and fetal movement restlessness. After processing, its antioxidant activity is enhanced, and it also has the effects of regulating the gastrointestinal tract and anti-tumor.

[0015] Preferably, the Astragalus membranaceus can invigorate qi and lift yang, secure the exterior and stop sweating, and is a key herb for various syndromes of qi deficiency. Its polysaccharide component can enhance immunity, protect the cardiovascular system and regulate metabolism.

[0016] Preferably, the Taxillus chinensis can tonify the liver and kidney, strengthen the bones and muscles, and replenish the kidney and essence. It is mainly used to treat scanty menstruation and fetal movement restlessness due to deficiency of the liver and kidney. Modern research has confirmed that it can regulate hormone metabolism, anti-inflammatory and antioxidant.

[0017] Preferably, the stir-fried Dioscorea opposita with bran can invigorate the spleen and stomach, tonify the kidney and astringe essence, and is good at treating anorexia caused by deficiency of the spleen and kidney. It can regulate the balance of intestinal flora and gonadal axis hormone secretion.

[0018] Preferably, the salt-processed Alpinia oxyphylla can warm the kidney and secure essence, warm the spleen and stop diarrhea. It is mainly used to treat clear and thin leucorrhea and diarrhea during menstruation due to deficiency of kidney yang. Modern pharmacology shows that it has antibacterial, blood sugar metabolism regulation and anti-tumor potential.

[0019] Preferably, the Cortex Albiziae can soothe the liver and relieve depression, calm the mind and tranquilize the spirit, and is good at treating irregular menstruation and insomnia caused by stagnation of liver qi. Its components have anti-anxiety, anti-inflammatory and antioxidant effects.

[0020] Preferably, the Cyperus rotundus processed with vinegar can soothe the liver and relieve depression, regulate menstruation and relieve pain, and is a key herb for regulating qi in gynecology. After being processed with vinegar, its antidepressant effect is significant, and it also has anti-inflammatory and anti-tumor effects.

[0021] Preferably, the Fructus Forsythiae can soothe the liver and regulate qi, activate blood circulation and relieve pain. It is mainly used to treat dysmenorrhea and amenorrhea caused by stagnation of liver qi and blood stasis. Modern research shows that it has anti-tumor, anti-depressant and antibacterial activities.

[0022] Preferably, the Colla Corii Asini can enrich blood and stop bleeding, nourish yin and moisten dryness, and is a key herb for enriching blood. It can promote hematopoiesis function, and also has immune regulation, anti-aging and anti-inflammatory effects.

[0023] Preferably, the Colla Plastri Testudinis can nourish yin and suppress yang, strengthen the kidneys and bones, and is good at treating irregular menstruation due to yin deficiency and blood heat. Modern pharmacology shows that it can regulate thyroid function, enhance immunity and anti-osteoporosis.

[0024] Preferably, the Fructus Citri Sarcodactylis can soothe the liver and regulate qi, harmonize the stomach and relieve pain. It is mainly used to treat distending pain in the chest and hypochondrium and dyspepsia caused by stagnation of liver qi. It has antioxidant, immune regulation and antibacterial effects.

[0025] Preferably, the Rhizoma Polygonati processed with wine can invigorate qi and nourish yin, strengthen the spleen and moisten the lungs, and is good at treating deficiency of both qi and blood and deficiency of the lung and kidney. After being processed with wine, its dispersing effect is enhanced, and it also has the effects of regulating blood sugar, blood lipid and anti-aging.

[0026] Preferably, the millettia reticulata can activate blood circulation and enrich blood, regulate menstruation and relieve pain, and is a holy medicine for the blood system. It is mainly used to treat irregular menstruation of the blood deficiency and blood stasis type, and has antiviral, antioxidant and immunomodulatory effects.

[0027] Preferably, the mulberry can nourish yin and enrich blood, promote the production of body fluid and moisten dryness, and is good at treating dizziness and insomnia of the liver and kidney yin deficiency type. Modern research has confirmed that it has liver protection, antioxidant and immune function regulation effects.

[0028] Preferably, the tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, and is mainly used to treat anorexia and abdominal distension of the spleen deficiency and qi stagnation type, and has antioxidant, cardiovascular regulation and anti-inflammatory effects.

[0029] Preferably, the licorice can invigorate the spleen and replenish qi, harmonize various medicines, and is good at treating spleen and stomach weakness and qi and blood deficiency, and has anti-inflammatory, antiviral, immune regulation and estrogen-like effects.

[0030] Furthermore, the present invention also provides a preparation method of the Bazhen Chongtiao Paste for coping with ovarian reserve function decline, specifically including the following steps:

[0031] S1. Pretreatment of herbal raw materials: Remove impurities from prepared rehmannia root, white peony root, Chinese angelica, chuanxiong rhizome, heterophylly falsestarwort root, poria cocos, largehead atractylodes rhizome, licorice root, astragalus membranaceus, taxillus sutchuenensis, stir-fried yam, salted semen alpiniae oxyphyllae, albizia bark, vinegar-processed cyperus rotundus, glossy privet fruit, fingered citron, wine-processed polygonatum sibiricum, millettia reticulata, mulberry, tangerine peel, wash and dry them to obtain pretreated herbal raw materials;

[0032] S2. Water decoction extraction: Add the pretreated herbal raw materials obtained in S1 into water, soak for 30 - 60 min, conduct the first decoction for 2 - 4 h, filter, and collect the filtrate; add water to the medicinal residues, decoct again for 1 - 2 h, filter, and combine the two filtrates to obtain the combined filtrate;

[0033] S3. Vacuum concentration: Concentrate and dry the combined filtrate obtained in S2 at 60 - 80 °C and a vacuum degree of 0.04 - 0.08 MPa until the relative density is 1.20 - 1.25 to obtain a clear paste;

[0034] S4. Melting of gelatinous raw materials: Add donkey-hide gelatin and tortoise plastron gelatin into yellow rice wine, heat in a water bath at 60 - 80 °C until completely melted to obtain a gelatinous melted solution;

[0035] S5. Mixing and collecting the paste: Add the gelatinous melted solution obtained in S4 into the clear paste obtained in S3, stir, heat to 95 - 105 °C, concentrate until it reaches the flagging state, and cool to room temperature to obtain the Bazhen Chongtiao Paste for coping with ovarian reserve function decline.

[0036] Preferably, the weight ratio of the water used for the first decoction in S2 to the pretreated herbal raw materials is 8 - 12:1, and the weight of the water used for the second decoction is half of that of the first time.

[0037] Preferably, the weight of the yellow rice wine in S4 is 2-4 times the total weight of the donkey-hide gelatin and tortoise shell gelatin.

[0038] Advantages of the present invention:

[0039] 1. The Bazhen Chongtiao Ointment provided by the present invention is based on traditional Chinese medicine theory, targeting the core pathogenesis of decreased ovarian reserve function, and is scientifically formulated on the basis of the classic Bazhen Decoction. In the formula, Rehmannia glutinosa, Angelica sinensis, Paeonia lactiflora, donkey-hide gelatin, etc. nourish blood and yin, Pseudostellaria heterophylla, Astragalus membranaceus, Atractylodes macrocephala, Poria cocos invigorate qi and strengthen the spleen, Taxillus chinensis, Alpinia oxyphylla salted, tortoise shell gelatin tonify the kidney and replenish essence, Albizia julibrissin, Cyperus rotundus vinegar processed, Polygonatum officinale soothe the liver and relieve depression, Spatholobus suberectus, Ligusticum wallichii activate blood circulation and regulate menstruation, Citrus reticulata regulate qi and harmonize the middle-jiao. The combination of various herbs achieves the effects of invigorating qi and nourishing blood, tonifying the kidney and soothing the liver, and regulating thoroughfare and conception vessels, and can improve ovarian reserve function from multiple dimensions and regulate the balance of qi, blood, yin and yang of the body.

[0040] 2. In terms of the preparation process, through steps such as water decoction extraction, vacuum concentration and melting of glue-like medicines, it not only ensures the full dissolution and fusion of water-soluble components in herbs and the effective components of glue-like medicines, but also enhances the effect of nourishing yin and blood by melting donkey-hide gelatin and tortoise shell gelatin with yellow rice wine. At the same time, the formed Chongtiao Ointment dosage form is convenient for taking and absorption, providing a safe, efficient and convenient choice of traditional Chinese medicine preparation for the clinical treatment of decreased ovarian reserve function. Description of the drawings

[0041] Figure 1 Comparison of PBAC scores of two groups of patients before and after treatment;

[0042] Figure 2 Comparison of the main symptoms scores of traditional Chinese medicine syndromes of two groups of patients before and after treatment;

[0043] Figure 3 Comparison of the secondary symptoms scores of traditional Chinese medicine syndromes of two groups of patients before and after treatment;

[0044] Figure 4 Comparison of the total scores of traditional Chinese medicine syndromes of two groups of patients before and after treatment;

[0045] Figure 5 Change of serum FSH in two groups of patients before and after treatment;

[0046] Figure 6 Change of serum LH in two groups of patients before and after treatment;

[0047] Figure 7 Change of serum FSH / LH in two groups of patients before and after treatment;

[0048] Figure 8 Change of serum E2 in two groups of patients before and after treatment;

[0049] Figure 9 Change of endometrial thickness in two groups of patients before and after treatment. Detailed implementation manners

[0050] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below in conjunction with specific embodiments.

[0051] Example 1: A Bazhen Chongtiao Paste for dealing with decreased ovarian reserve function and its preparation method, comprising the following steps:

[0052] S1. Pretreatment of herbal raw materials: Remove impurities from 6 g of prepared rehmannia root, 5 g of white peony root, 5 g of Chinese angelica, 4 g of chuanxiong rhizome, 15 g of pseudostellaria root, 6 g of poria cocos, 6 g of atractylodes macrocephala, 2 g of licorice root, 15 g of astragalus membranaceus, 6 g of taxillus sutchuenensis, 6 g of stir-fried yam, 5 g of salted semen alpiniae oxyphyllae, 5 g of albizia julibrissin bark, 5 g of cyperus rotundus, 5 g of fructus aurantii carpophthorum, 4 g of fingered citron, 5 g of processed polygonatum sibiricum, 6 g of millettia reticulata, 5 g of mulberry fruit, 4 g of dried tangerine peel, wash, and dry to obtain pretreated herbal raw materials;

[0053] S2. Water decoction extraction: Add the 120 g of pretreated herbal raw materials obtained in S1 to 960 g of water, soak for 30 min, conduct the first decoction for 2 h, filter, and collect the filtrate; Add 480 g of water to the medicinal residues, decoct again for 1 h, filter, and combine the two filtrates to obtain the combined filtrate;

[0054] S3. Vacuum concentration: Concentrate and dry the combined filtrate obtained in S2 at 60 °C and a vacuum degree of 0.04 MPa until the relative density reaches 1.20 to obtain a clear paste;

[0055] S4. Melting of glue raw materials: Add 4 g of donkey-hide gelatin and 4 g of tortoise shell glue to 16 g of yellow rice wine, heat in a water bath at 60 °C until completely melted to obtain a melted glue solution;

[0056] S5. Mixing and paste collection: Add the melted glue solution obtained in S4 to the clear paste obtained in S3, while stirring, heat up to 95 °C, concentrate until the state of "hanging the flag" is reached, and cool to room temperature to obtain the Bazhen Chongtiao Paste for dealing with decreased ovarian reserve function.

[0057] Example 2: A Bazhen Chongtiao Paste for dealing with decreased ovarian reserve function and its preparation method, comprising the following steps:

[0058] S1. Pretreatment of herbal raw materials: Remove impurities from 9 g of prepared rehmannia root, 7 g of white peony root, 7 g of Chinese angelica, 6 g of chuanxiong rhizome, 17 g of pseudostellaria root, 9 g of poria cocos, 9 g of atractylodes macrocephala, 3 g of licorice root, 17 g of astragalus membranaceus, 9 g of taxillus sutchuenensis, 9 g of stir-fried yam, 7 g of salted semen alpiniae oxyphyllae, 7 g of albizia julibrissin bark, 7 g of cyperus rotundus, 7 g of fructus aurantii carpophthorum, 6 g of fingered citron, 7 g of processed polygonatum sibiricum, 9 g of millettia reticulata, 7 g of mulberry fruit, 6 g of dried tangerine peel, wash, and dry to obtain pretreated herbal raw materials;

[0059] S2. Water decoction extraction: Add 165 g of the pretreated herbal raw materials obtained in S1 to 1.65 Kg of water, soak for 45 min, conduct the first decoction for 3 h, filter, and collect the filtrate; add 835 g of water to the medicinal residues, decoct again for 1.5 h, filter, and combine the two filtrates to obtain the combined filtrate;

[0060] S3. Vacuum concentration: Concentrate and dry the combined filtrate obtained in S2 at 70 °C and a vacuum degree of 0.06 MPa until the relative density reaches 1.23 to obtain a clear extract;

[0061] S4. Melting of gelatinous raw materials: Add 6 g of donkey-hide gelatin and 6 g of tortoise-shell gelatin to 36 g of yellow rice wine, heat in a water bath to 70 °C until completely melted to obtain a gelatinous melted solution;

[0062] S5. Mixing and obtaining the extract: Add the gelatinous melted solution obtained in S4 to the clear extract obtained in S3, while stirring, heat up to 100 °C, concentrate until it reaches the state of "hanging flag", and after cooling to room temperature, obtain the Babao Tiaochong Extract for coping with ovarian reserve function decline.

[0063] Example 3: A Babao Chongtiao Extract for coping with ovarian reserve function decline and its preparation method, comprising the following steps:

[0064] S1. Pretreatment of herbal raw materials: Remove impurities from 12 g of prepared rehmannia root, 9 g of white peony root, 9 g of Chinese angelica, 8 g of chuanxiong rhizome, 20 g of heterophylly falsestarwort root, 10 g of poria cocos, 10 g of atractylodes macrocephala, 4 g of licorice root, 20 g of astragalus root, 10 g of taxillus twig, 10 g of stir-fried yam, 8 g of salted semen alpiniae oxyphyllae, 8 g of albizia bark, 8 g of vinegar-processed cyperus rotundus, 8 g of schizandra sphenanthera, 8 g of fingered citron, 8 g of wine-processed polygonatum sibiricum, 10 g of suberect spatholobus stem, 8 g of mulberry fruit, 8 g of dried tangerine peel, wash, dry, and obtain the pretreated herbal raw materials;

[0065] S2. Water decoction extraction: Add 196 g of the pretreated herbal raw materials obtained in S1 to 2.352 Kg of water, soak for 60 min, conduct the first decoction for 4 h, filter, and collect the filtrate; add 1.176 Kg of water to the medicinal residues, decoct again for 2 h, filter, and combine the two filtrates to obtain the combined filtrate;

[0066] S3. Vacuum concentration: Concentrate and dry the combined filtrate obtained in S2 at 80 °C and a vacuum degree of 0.08 MPa until the relative density reaches 1.25 to obtain a clear extract;

[0067] S4. Melting of gelatinous raw materials: Add 8 g of donkey-hide gelatin and 8 g of tortoise-shell gelatin to 64 g of yellow rice wine, heat in a water bath to 80 °C until completely melted to obtain a gelatinous melted solution;

[0068] S5. Mixing and collecting the paste: Add the melted glue solution obtained in S4 to the clear paste obtained in S3. While stirring, heat up to 105°C and concentrate until it reaches the flagging state. After cooling to room temperature, the Babao Tiaochong Paste for treating diminished ovarian reserve is obtained.

[0069] Clinical application:

[0070] The following is the clinical research situation of the Babao Chongtiao Paste of the present invention, indicating the role of the present invention in the treatment of diminished ovarian reserve:

[0071] General situation:

[0072] For diminished ovarian reserve (DOR), 66 patients who met the inclusion criteria for oligomenorrhea caused by DOR were selected clinically and signed the relevant informed consent forms. According to the principle of randomization, they were divided into a treatment group of 33 cases treated with Babao Tiaochong Paste and a control group of 33 cases treated with Climen.

[0073] Diagnostic criteria:

[0074] Western medicine diagnostic criteria

[0075] There is no unified diagnostic standard for DOR. Referring to the 9th edition of "Obstetrics and Gynecology" edited by Xie Xing, Kong Beihua, etc. in 2018, "Integrated Traditional Chinese and Western Medicine Reproductive Medicine" edited by Lian Fang in 2017, "Practical Gynecological Endocrinology" edited by Yu Chuanxin, Li Songxian, etc. in 2004, "Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency" edited by Chen Zijiang, Tian Qinjie, etc. in 2017, and "Expert Consensus on Poor Ovarian Response" edited by Wu Xueqing, Kong Rui, etc. in 2015, the following relevant standards were formulated:

[0076] 1. The onset age is 20 - 40 years old, and the menstrual cycle is normal;

[0077] 2. Clinical manifestations: Progressive reduction of menstrual volume (<20 ml), or the menstrual volume is reduced by 1 / 2 compared with the usual menstrual volume, and perimenopausal symptoms such as hot flashes, night sweats, insomnia, and palpitations may occur;

[0078] 3. Laboratory tests: AMH ≤ 1.1 ng / ml, 10 mIU / ml < bFSH < 40 mIU / ml with or without bFSH / bLH > 2, or ovarian volume < 3 cm 3 , or the number of antral follicles < 5 - 7 (mainly counting the number of follicles with a diameter of 2 - 10 mm in both ovaries).

[0079] Traditional Chinese medicine syndrome diagnostic criteria

[0080] Refer to "Diagnostics of Traditional Chinese Medicine" (the 4th edition, July 2016, China Press of Traditional Chinese Medicine) and "Gynecology of Traditional Chinese Medicine" (the 4th edition, August 2016, China Press of Traditional Chinese Medicine) to comprehensively formulate the diagnostic criteria for scanty menstruation:

[0081] 1. Main symptoms: The menstrual cycle is regular, and the menstrual volume is less than 20 ml for two consecutive menstrual cycles or more, or the menstrual volume is significantly less than 1 / 2 of the usual menstrual volume, or the menstrual period is less than 2 days, or even only a little bit and then stops immediately;

[0082] 2. Secondary symptoms: The menstrual color is light red or dull, and the quality is thin; dizziness; fatigue; pale or sallow complexion; palpitations and insomnia;

[0083] 3. Tongue and pulse: The tongue is pale, the coating is white, and the pulse is thready and weak;

[0084] Diagnosis can be made based on the necessary main symptoms, combined with at least two secondary symptoms, and comprehensively considering the tongue image and pulse condition.

[0085] Inclusion criteria:

[0086] 1. Meet the Western medicine diagnostic criteria for DOR as specified above;

[0087] 2. Meet the traditional Chinese medicine diagnostic criteria for scanty menstruation as clearly defined above;

[0088] 3. During this medical visit, the patient presented with the main complaint of "scanty menstrual volume";

[0089] 4. In the three months before entering this trial, the patient had not taken sex hormone drugs and had no experience of uterine cavity operations;

[0090] 5. The subjects must sign the corresponding informed consent document and participate in this study on a voluntary basis.

[0091] Exclusion criteria:

[0092] 1. Patients who do not meet the inclusion criteria of this study;

[0093] 2. Patients with the following conditions: suffering from important organ diseases such as liver and kidney diseases, blood system diseases, thyroid diseases, and pituitary diseases, complicated with genital tumors, congenital malformations or dysplasia of the reproductive system;

[0094] 3. DOR is caused by pelvic-related surgeries, or iatrogenic factors such as radiotherapy and chemotherapy; or DOR patients caused by primary diseases such as systemic lupus erythematosus and mumps;

[0095] 4. Patients with severe intrauterine adhesions;

[0096] 5. Patients in special periods, such as those in the early pregnancy, lactation period, or those in the planned pregnancy period;

[0097] 6. Patients with allergic reactions to estrogen or progesterone, or those with adverse reactions to traditional Chinese medicine paste prescriptions;

[0098] 7. Persons with poor compliance, unable to take medicine on time according to the research protocol, or having incomplete data, etc., thus affecting the determination of efficacy or safety;

[0099] 8. Persons who do not meet the diagnostic criteria of this study and clearly refuse to participate in this trial study.

[0100] Those who meet any one of the above can be excluded.

[0101] Exclusion and withdrawal criteria:

[0102] 1. Subjects who experience serious adverse reactions or adverse events;

[0103] 2. Participants who develop serious comorbidities or complications;

[0104] 3. Persons who, during the trial process, do not take medicine according to the prescribed medication method or take other medications simultaneously;

[0105] 4. Subjects who are confirmed to be pregnant during the trial;

[0106] 5. Trials that, due to personal factors, voluntarily decide to withdraw from this trial study;

[0107] 6. Subjects who fail to go to the hospital for a follow-up visit on time and, during the follow-up stage, lose contact or cannot be followed up due to various reasons.

[0108] As long as any one of the above is met, it is determined as withdrawal.

[0109] Treatment plan:

[0110] 1. Basic treatment

[0111] During the treatment period, instruct the patient to keep a happy mood, avoid wind and cold, have a light diet, and avoid spicy, stimulating, greasy and other foods; ensure sufficient sleep, combine work and rest, and avoid staying up late; stop using other relevant medications.

[0112] 2. Treatment drugs and administration methods

[0113] Control group: Oral climen (estradiol valerate tablets / estradiol cyproterone acetate tablets compound preparation, registration number: National Medicine Standard J20171040, manufacturer: DELPHARM Lille, France, packaging specifications: 21 biphasic tablets per box). The dosing regimen is as follows: starting from the 5th day of menstruation, take 1 tablet of white film-coated tablet orally every evening for 11 days in the first stage; then change to pink film-coated tablets for 10 consecutive days, and the entire treatment cycle is 21 days. Patients need to start the next cycle of treatment on the 5th day of drug withdrawal bleeding, repeat the medication according to the above regimen, and complete 3 consecutive treatment cycles.

[0114] Treatment group: The treatment group was treated with the Bazhen Chongdiao paste prepared with the formula in Example 2 above. After dissolving the Bazhen Chongdiao paste in warm water, it was taken orally, once in the morning and before going to bed every day. The recommended single dose is 15-20 grams (equivalent to a standard tablespoon and a flat spoon), and it is necessary to ensure that the gastric contents are emptied before meals. In terms of taboos, it is strictly forbidden to mix with milk to prevent affecting the absorption of effective ingredients. In the event of acute upper respiratory tract infection, diarrhea, fever or large amount of menstrual bleeding, the medication should be discontinued immediately. After the clinical symptoms are completely relieved or the menstrual volume returns to the normal range, the standardized course of treatment can be continued to ensure the safety of medication.

[0115] Treatment course:

[0116] The intervention measures were implemented immediately after the end of the menstrual cycle in both groups. Each course of treatment lasted for 21 days, and the menstrual period had to be strictly avoided during the treatment period. The treatment was repeated in this way for a total of 3 menstrual cycles.

[0117] Observation indicators:

[0118] Efficacy indicators:

[0119] 1. Menstrual days and menstrual volume: Before the start of treatment and after the end of the 3-month course of treatment, the duration of menstruation and the changes in menstrual blood volume of the subjects must be recorded in detail. This study uses the menstrual blood loss chart method to estimate the menstrual volume. The study requires all participating subjects to use the same brand of super-absorbent pure cotton imported sanitary napkins with a length of 240mm. At the same time, inform the patients to strictly follow the scoring method presented below and carefully record the number of menstrual days and PBAC points before and after treatment.

[0120] Determination of menstrual bleeding degree:

[0121] Mild penetration: The area covered by menstrual blood is less than 33% of the surface area of ​​the sanitary napkin, 1 point for each piece;

[0122] Moderate penetration: The diffusion range of menstrual blood staining reaches the interval of 33%-60% of the total surface area of the sanitary napkin, with 5 points for each piece; Severe penetration: The range of menstrual blood staining exceeds 60% of the effective area of the sanitary napkin, with 20 points for each piece.

[0123] Calculation method for blood clot size:

[0124] Small blood clot: The size of the blood clot < the size of a 1-yuan coin, with 1 point for each clot;

[0125] Large blood clot: The size of the blood clot > the size of a 1-yuan coin, with 5 points for each clot.

[0126] Supplementary instructions:

[0127] (1) When there is blood loss that cannot be measured by blood clots, it should be estimated and recorded according to the blood staining range on the surface of the sanitary napkin.

[0128] (2) Total blood loss score calculation formula:

[0129] Σ = (20×number of severely penetrated pieces) + (5×number of moderately penetrated pieces) + (1×number of mildly penetrated pieces)) + (5×number of large blood clots) + (1×number of small blood clots)

[0130] 2. Traditional Chinese medicine syndrome score

[0131] Before the start of treatment and after the end of the 3-month treatment course, record the changes in the traditional Chinese medicine syndrome score. According to "Diagnostics of Traditional Chinese Medicine" published by China Traditional Chinese Medicine Press in 2016 and "Gynecology of Traditional Chinese Medicine" published by the same press in the same year, draw up the following traditional Chinese medicine syndrome score table.

[0132]

[0133] 3. Sex hormone levels

[0134] Record the changes in the serum sex hormone levels of the subjects before and after treatment. The specific operation process is as follows: The subjects need to go to the laboratory of the outpatient building of the hospital on the 2nd - 4th day of the menstrual cycle, complete venous blood collection on an empty stomach, and then test the collected blood samples. The test indicators include bFSH, bLHb, FSH / bLH, and bE2.

[0135] 4. Endometrial thickness

[0136] Record the dynamic changes in the endometrial thickness of the subjects before and after treatment in detail. The specific operation process is as follows: The subjects need to go to the color Doppler ultrasound room of the outpatient building of the hospital on the 21st day of the menstrual cycle and undergo vaginal color Doppler ultrasound examination to obtain data related to the endometrial thickness.

[0137] Efficacy judgment criteria:

[0138] "Guiding Principles for Clinical Research of New Chinese Medicines" edited by Zheng Xiaoyu and published in 2001, "Gynecology of Traditional Chinese Medicine" edited by Tan Yong in the 2016 edition, and "Diagnostic and Therapeutic Criteria for Traditional Chinese Medicine Syndromes and Diseases" compiled by the State Administration of Traditional Chinese Medicine in the 2016 edition. The specific formulated efficacy evaluation criteria are as follows:

[0139] Efficacy Index (N) = (Total score before treatment - Total score after treatment) / Total score before treatment × 100%

[0140] 1. Recovery: After the treatment, the PBAC score ≥ 26, and at the same time, other related symptoms completely disappear, and N ≥ 95%.

[0141] 2. Marked effect: After the treatment, the PBAC score increases by ≥ 70%, and other related symptoms except menstrual volume basically disappear or significantly relieve, 70% ≤ N < 95%.

[0142] 3. Effective: After the treatment, the PBAC score increases by 30% - 70%, and other related symptoms are alleviated compared with before treatment, 30% ≤ N < 70%.

[0143] 4. Ineffective: After the treatment, the PBAC score does not change, and the remaining related symptoms do not show any degree of improvement, N < 30%.

[0144] Statistical methods

[0145] After completing the clinical trial, all collected clinical case data are processed, a data summary table and a database are established, and SPSS 27.0 software is used to perform statistical analysis operations. For each measurement data, it is expressed as "mean ± standard deviation". If the data shows a normal distribution and has the characteristics of homogeneity of variance after testing, an independent samples t-test method is used for between-group comparison, and a paired samples t-test method is used for within-group comparison; if the data does not meet the normal distribution condition or the variance is inhomogeneous, then a non-parametric rank sum test method is used. When comparing ranked data, a non-parametric rank sum test statistical method is used. The test level α is set to 0.05. When P < 0.01 and P < 0.001, it indicates that the difference is highly significant statistically; when P < 0.05, it means that the difference is statistically significant; and when P > 0.05, it shows that the difference is not statistically significant.

[0146] Clinical application results:

[0147] 1. Enrollment and completion status

[0148] This study was conducted on 66 cases of oligomenorrhea caused by DOR that met the inclusion criteria, and they were randomly divided into a treatment group (Bazhen Tiaochong Ointment) with 33 cases and a control group (Climen) with 33 cases. During the treatment period, 2 cases dropped out in the control group (1 case voluntarily withdrew from the study because of failure to take medicine on time due to business trips, and 1 case dropped out due to poor compliance), and 1 case dropped out in the treatment group (terminated treatment due to pregnancy during the treatment process). Finally, 63 cases actually completed this clinical study, with 32 cases in the treatment group and 31 cases in the control group.

[0149] 2. Baseline data analysis

[0150] After comparing the ages and disease courses of the patients in the treatment group and the control group, it was found that the differences between the groups did not show statistical significance (P>0.05), indicating that the two groups of patients were highly comparable in terms of age and disease course. See Table 1 for details.

[0151] Table 1 Comparison of baseline data of two groups of patients (±S)

[0152]

[0153] 3. Comparison of menstrual volume before and after treatment in two groups of patients

[0154] Before treatment, the PBAC scores of the two groups of patients were compared, and the results showed that the differences were not statistically significant (P>0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the PBAC scores of both groups of patients increased, and the differences were significantly statistically significant (P<0.001); in the between-group comparison, the PBAC score of the treatment group was significantly higher than that of the control group, and the differences were statistically significant (P<0.05). See Table 2 for details.

[0155] Table 2 Comparison of PBAC scores before and after treatment in two groups of patients (±S)

[0156] Group Number of cases Before treatment After treatment Z P Treatment group 32 14.19±2.6 32.13±2.8 4.95 ＜0.001 Control group 31 14.90±1.92 30.26±3.56 4.94 ＜0.001 Z 1.11 2.15 P 0.2 0.3

[0157] 4. Comparison of TCM syndrome scores

[0158] Comparison of main TCM syndrome scores before and after treatment in two groups of patients

[0159] Before treatment, the main TCM syndrome scores of the two groups of patients were compared, and the results showed that the differences were not statistically significant (P>0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the main TCM syndrome scores of both groups of patients decreased, and the differences were significantly statistically significant (P<0.001); in the between-group comparison, the main TCM syndrome score of the treatment group was significantly lower than that of the control group, and the differences were statistically significant (P<0.05). See Table 3 for details.

[0160] Table 3 Main symptoms scores of traditional Chinese medicine syndromes in two groups of patients before and after treatment (±S)

[0161] Group Number of cases Before treatment After treatment Z P Treatment group 32 4.13±0.7 2.03±0.74 5.09 ＜0.001 Control group 31 4.23±0.43 2.48±0.85 4.74 ＜0.001 Z 0.21 2.08 P 0.83 0.04

[0162] Comparison of secondary symptoms scores of traditional Chinese medicine syndromes in two groups of patients before and after treatment

[0163] Before treatment, the secondary symptoms scores of traditional Chinese medicine syndromes in two groups of patients were compared, and the results showed that there was no significant difference (P>0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the secondary symptoms scores of traditional Chinese medicine syndromes in both groups of patients decreased, and the difference was statistically significant (P<0.001); in the between-group comparison, the secondary symptoms scores of traditional Chinese medicine syndromes in the treatment group were significantly lower than those in the control group, and the difference was statistically significant (P<0.05). For details, see Table 4

[0164] Table 4 Secondary symptoms scores of traditional Chinese medicine syndromes in two groups of patients before and after treatment

[0165] Group Number of cases Before treatment After treatment Z P Treatment group 32 3.16±0.45 1.15±0.68 5.02 ＜0.001 Control group 31 3.26±0.51 1.52±0.51 4.95 ＜0.001 Z 0.65 2.13 P 0.52 0.03

[0166] Comparison of total scores of traditional Chinese medicine syndromes in two groups of patients before and after treatment

[0167] Before treatment, the total scores of traditional Chinese medicine syndromes in two groups of patients were compared, and the results showed that there was no significant difference (P>0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the total scores of traditional Chinese medicine syndromes in both groups of patients decreased, and the difference was statistically significant (P<0.001); in the between-group comparison, the total scores of traditional Chinese medicine syndromes in the treatment group were significantly lower than those in the control group, and the difference was statistically significant (P<0.01). For details, see Table 5

[0168] Table 5 Total scores of traditional Chinese medicine syndromes in two groups of patients before and after treatment

[0169] Group Number of columns Before treatment After treatment Z P Treatment group 32 7.28±0.68 3.19±0.9 4.99 ＜0.001 Control group 31 7.48±0.68 4.0±1.06 4.90 ＜0.001 Z 0.95 2.84 P 0.34 0.005

[0170] 5. Comparison of sex hormone results

[0171] Changes in serum FSH values in two groups of patients before and after treatment

[0172] Before treatment, the serum FSH values in two groups of patients were compared, and the results showed that there was no significant difference (P>0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the serum FSH values in both groups of patients decreased, and the difference was statistically significant (P<0.001); in the between-group comparison, the decrease in serum FSH values in the treatment group and the control group was comparable, and the difference was not statistically significant (P>0.05). For details, see Table 6

[0173] Table 6 Changes in serum FSH levels of two groups of patients before and after treatment (IU / L, )

[0174] Group Number of cases Before treatment After treatment T P Treatment group 32 19.53±3.24 11.09±1.53 13.34 0.001 Control group 31 19.56±3.35 10.37±1.75 12.81 0.001 T 0.04 1.58 P 0.97 0.12

[0175] Changes in serum LH levels of two groups of patients before and after treatment

[0176] Before treatment, the serum LH levels of the two groups of patients were compared, and the results showed no statistically significant difference (P > 0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the serum LH levels of both groups of patients decreased, and the difference was statistically significant (P < 0.001); in the between-group comparison, the decrease in serum LH levels in the treatment group and the control group was comparable, and the difference was not statistically significant (P > 0.05). For details, see Table 7.

[0177] Table 7 Changes in serum LH levels of two groups of patients before and after treatment (IU / L, )

[0178] Group Number of cases Before treatment After treatment T P Treatment group 32 9.45±1.35 6.96±1.0 8.14 0.001 Control group 31 9.23±1.57 6.53±1.11 7.32 0.001 T 0.57 1.62 P 0.57 0.11

[0179] Changes in serum FSH / LH levels of two groups of patients before and after treatment

[0180] Before treatment, the serum FSH / LH levels of the two groups of patients were compared, and the results showed no statistically significant difference (P > 0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the serum FSH / LH levels of both groups of patients decreased, and the difference was statistically significant (P < 0.001); in the between-group comparison, the decrease in serum FSH / LH levels in the treatment group and the control group was comparable, and the difference was not statistically significant (P > 0.05). For details, see Table 8.

[0181] Table 8 Changes in serum FSH / LH levels of two groups of patients before and after treatment

[0182] Group Number of cases Before treatment After treatment T P Treatment group 32 2.11±0.44 1.61±0.28 6.29 0.001 Control group 31 2.19±0.57 1.65±0.47 3.72 0.001 T 0.62 0.47 P 0.54 0.64

[0183] Changes in serum E2 levels of two groups of patients before and after treatment

[0184] Before treatment, the serum E2 levels of the two groups of patients were compared, and the results showed no statistically significant difference (P > 0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the serum E2 levels of both groups of patients increased, and the difference was statistically significant (P < 0.001); in the between-group comparison, the increase in serum E2 levels in the treatment group and the control group was comparable, and the difference was not statistically significant (P > 0.05). For details, see Table 9.

[0185] Table 9 Changes in serum E2 levels in two groups of patients before and after treatment (pmol / L, )

[0186]

[0187] 6. Comparison of endometrial thickness

[0188] Before treatment, the endometrial thickness of the two groups of patients was compared, and the results showed that there was no statistically significant difference (P > 0.05), indicating that the two groups were comparable. After treatment, in the within-group comparison, the endometrial thickness of both groups of patients increased, and the difference was statistically significant (P < 0.001); in the between-group comparison, the endometrial thickness of the treatment group increased significantly compared with the control group, and the difference was statistically significant (P < 0.05). For details, see Table 10.

[0189] Table 10 Changes in endometrial thickness in two groups of patients before and after treatment (mm, ±S)

[0190]

[0191] 7. Comparison of comprehensive curative effects

[0192] The effective rate of the treatment group reached 90.6%, while that of the control group was 82.9%. Obviously, the effective rate of the treatment group was higher than that of the control group. In the between-group comparison, in terms of the clinical comprehensive curative effect, the treatment group performed better than the control group, and the difference was statistically significant (P < 0.05). For details, see Table 11.

[0193] Table 11 Comparison of clinical comprehensive curative effects between two groups

[0194]

[0195] Analysis of the results of clinical application:

[0196] A total of 66 cases were collected in this study, and 63 effective cases completed the study (3 cases were lost to follow-up, 2 cases in the control group and 1 case in the treatment group). Among them, there were 31 cases in the control group and 32 cases in the treatment group. Before treatment, the two groups of patients were compared in terms of age, course of disease, etc., and the differences were not statistically significant, indicating that the two groups of patients were comparable and could meet the requirements of this study.

[0197] 1. Analysis of the results of changes in menstrual volume before and after treatment

[0198] After the treatment of the two groups of patients, in the within-group comparison, the PBAC scores increased compared with before (P < 0.001), indicating that both groups could improve the menstrual volume; in the between-group comparison, the PBAC score of the treatment group increased more significantly (P < 0.05), indicating that Bazhen Tiaochong Ointment had a better curative effect on improving menstrual volume than Climen.

[0199] 2. Analysis of the Results of Traditional Chinese Medicine Syndrome Scores before and after Treatment

[0200] After the treatment of the two groups of patients, within the group comparison, the scores of the main symptoms of traditional Chinese medicine syndrome, the scores of the secondary symptoms of traditional Chinese medicine syndrome, and the total scores of traditional Chinese medicine syndrome all decreased (P < 0.001), indicating that both groups could effectively improve the symptoms of the number of menstruation days, menstrual volume, menstrual color and texture, dizziness, fatigue, pale or sallow complexion, palpitations and insomnia; between-group comparison, the scores of the main symptoms of traditional Chinese medicine syndrome, the scores of the secondary symptoms of traditional Chinese medicine syndrome, and the total scores of traditional Chinese medicine syndrome in the treatment group decreased more significantly (P < 0.05, P < 0.01), indicating that Bazhen Tiaochong Ointment was superior to Climen in improving various clinical symptoms.

[0201] 3. Analysis of the Results of Serum Sex Hormones before and after Treatment

[0202] After the treatment of the two groups of patients, within the group comparison, the values of serum sex hormones FSH, LH, and FSH / LH all decreased, and the value of E2 increased, with significant statistical differences (P < 0.001), indicating that both Bazhen Tiaochong Ointment and Climen could improve the serum sex hormone levels; between-group comparison, the changes in the values of serum sex hormones FSH, LH, and FSH / LH before and after treatment in the two groups were not significant, and the differences were not statistically significant (P > 0.05), indicating that Bazhen Tiaochong Ointment and Climen had comparable curative effects in improving sex hormones.

[0203] 4. Analysis of the Results of Endometrial Thickness before and after Treatment

[0204] After the treatment of the two groups of patients, the endometrial thickness was measured on the 21st day of the menstrual cycle. Within the group comparison, the endometrial thickness increased in both groups (P < 0.001), indicating that both groups could improve the endometrial thickness; between-group comparison, the increase in the endometrial thickness in the treatment group was more obvious (P < 0.05), indicating that Bazhen Tiaochong Ointment was superior to Climen in improving the endometrial thickness.

[0205] 5. Comprehensive Curative Effect

[0206] Clinical efficacy analysis was performed on 63 patients who completed this study. The efficacy of the control group (n = 31) was as follows: 1 case was cured (3.2%), 14 cases were markedly effective (45.2%), 11 cases were effective (35.5%), 5 cases were ineffective (16.1%), and the total effective rate was 83.9%. The efficacy of the treatment group (n = 32) was as follows: 3 cases were cured (9.4%), 21 cases were markedly effective (65.6%), 5 cases were effective (15.6%), 3 cases were ineffective (9.4%), and the total effective rate was 90.6%. The difference was statistically significant (P < 0.05), indicating that both Bazhen Tiaochong Ointment and Climen could effectively improve the clinical symptoms of patients with oligomenorrhea caused by DOR, and the comprehensive curative effect of Bazhen Tiaochong Ointment was superior to that of Climen.

[0207] Those of ordinary skill in the art should understand that the discussion of any of the above embodiments is merely exemplary and is not intended to imply that the scope of the present invention is limited to these examples; under the concept of the present invention, the technical features in the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations in different aspects of the present invention as described above, which are not provided in detail for the sake of brevity.

Claims

1. A Bazhen Chongtiao Ointment for coping with diminished ovarian reserve function, characterized in that, It comprises the following raw materials in parts by weight: Rehmannia glutinosa preparata: 6 - 12 parts, White peony root: 5 - 9 parts, Chinese angelica: 5 - 9 parts, Chuanxiong rhizome: 4 - 8 parts, Pseudostellaria heterophylla: 15 - 20 parts, Poria cocos: 6 - 10 parts, Atractylodes macrocephala: 6 - 10 parts, Licorice root: 2 - 4 parts, Astragalus membranaceus: 15 - 20 parts, Taxillus chinensis: 6 - 10 parts, Stir-fried Chinese yam: 6 - 10 parts, Salt-processed Alpinia oxyphylla: 5 - 8 parts, Albizia julibrissin bark: 5 - 8 parts, Vinegar-processed Cyperus rotundus: 5 - 8 parts, Akebia trifoliata: 5 - 8 parts, Donkey-hide gelatin: 4 - 8 parts, Tortoise shell gelatin: 4 - 8 parts, Fingered citron: 4 - 8 parts, Wine-processed Polygonatum sibiricum: 5 - 8 parts, Millettia reticulata: 6 - 10 parts, Mulberry: 5 - 8 parts, Dried tangerine peel: 4 - 8 parts.

2. The Bazhen Chongtiao Ointment for coping with diminished ovarian reserve according to claim 1, characterized in that, It comprises the following raw materials in parts by weight: Rehmannia glutinosa preparata: 9 parts, White peony root: 7 parts, Chinese angelica: 7 parts, Chuanxiong rhizome: 6 parts, Pseudostellaria heterophylla: 17 parts, Poria cocos: 9 parts, Atractylodes macrocephala: 9 parts, Licorice root: 3 parts, Astragalus membranaceus: 17 parts, Taxillus chinensis: 9 parts, Stir-fried Chinese yam: 9 parts, Salt-processed Alpinia oxyphylla: 7 parts, Albizia julibrissin bark: 7 parts, Vinegar-processed Cyperus rotundus: 7 parts, Akebia trifoliata: 7 parts, Donkey-hide gelatin: 6 parts, Tortoise shell gelatin: 6 parts, Fingered citron: 6 parts, Wine-processed Polygonatum sibiricum: 7 parts, Millettia reticulata: 9 parts, Mulberry: 7 parts, Dried tangerine peel: 6 parts.

3. The preparation method of the Bazhen Chongtiao Paste for coping with diminished ovarian reserve according to any one of claims 1-2, characterized in that, It comprises the following steps: S1. Pretreatment of herbal raw materials: Remove impurities from Rehmannia glutinosa preparata, White peony root, Chinese angelica, Chuanxiong rhizome, Pseudostellaria heterophylla, Poria cocos, Atractylodes macrocephala, Licorice root, Astragalus membranaceus, Taxillus chinensis, Stir-fried Chinese yam, Salt-processed Alpinia oxyphylla, Albizia julibrissin bark, Vinegar-processed Cyperus rotundus, Akebia trifoliata, Fingered citron, Wine-processed Polygonatum sibiricum, Millettia reticulata, Mulberry, and Dried tangerine peel, wash them, and dry them to obtain pretreated herbal raw materials; S2. Water decoction extraction: Add the pretreated herbal raw materials obtained in S1 to water, soak for 30 - 60 min, conduct the first decoction for 2 - 4 h, filter, and collect the filtrate; add water to the medicinal residues, decoct again for 1 - 2 h, filter, and combine the two filtrates to obtain the combined filtrate; S3. Vacuum concentration: Concentrate and dry the combined filtrate obtained in S2 at 60 - 80 °C and a vacuum degree of 0.04 - 0.08 MPa until the relative density is 1.20 - 1.25 to obtain a clear extract; S4. Melting of gelatinous raw materials: Add donkey-hide gelatin and tortoise shell gelatin to yellow rice wine, heat in a water bath at 60 - 80 °C until completely melted to obtain a gelatinous melted solution; S5. Mixing and obtaining the extract: Add the gelatinous melted solution obtained in S4 to the clear extract obtained in S3, stir, heat to 95 - 105 °C, concentrate until it reaches the state of "hanging the flag", and cool to room temperature to obtain the Bazhen Tiaochong Extract for coping with ovarian reserve function decline.

4. The preparation method of the Bazhen Chongtiao Paste for coping with diminished ovarian reserve function according to claim 3, characterized in that, The weight ratio of the water used in the first decoction in S2 to the pretreated herbal raw materials is 8 - 12:1, and the weight of the water used in the second decoction is half of that in the first time.

5. The preparation method of the Bazhen Chongtiao Paste for coping with diminished ovarian reserve function according to claim 3, characterized in that, The weight of the yellow rice wine in S4 is 2 - 4 times the total weight of donkey-hide gelatin and tortoise shell gelatin.

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