A Chinese medicine composition for maintaining ovarian follicles, and its preparation method and application

Abstract

The invention provides a traditional Chinese medicine composition for maintaining follicles, a preparation method and an application thereof. The active ingredients of the traditional Chinese medicine composition include the following raw materials in parts by weight: 10-20 parts of dendrobium, 12-25 parts of longan pulp, 8-15 parts of polygonatum, 5-8 parts of chicken foam gelatin, 6-15 parts of lily, 3-5 parts of ligustrum lucidum, 2-6 parts of milk thistle, 2-5 parts of mulberry, 1-6 parts of raspberry, 1-3 parts of dodder seed and 0.3-0.8 parts of saffron. The traditional Chinese medicine composition of the invention has a significant improvement effect on female patients with poor follicle quality and dysplasia, with a cure rate of 70.0-85.0%, a total effective rate of 80.0-91.6%, an obvious effect and can be used for maintaining follicles.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition for maintaining follicles, and a preparation method and application thereof. Background Art

[0002] Ovarian dysfunction may lead to anovulation, infrequent ovulation or follicular hypoplasia, which may lead to menstrual disorders, amenorrhea, dysfunctional uterine bleeding, insufficient secretion of progesterone, or premature degeneration of the corpus luteum, resulting in reduced endometrial secretion responsiveness, causing irregular menstruation, infertility, early miscarriage, etc. Western medicine ovulation drugs are mainly used to treat infertile women with ovarian hypoplasia and anovulation. While fulfilling the dream of infertile women to become mothers, the side effects of ovulation drugs should not be ignored. The random use of ovulation drugs can cause multiple pregnancies, ovarian hyperstimulation and ovarian torsion.

[0003] Traditional Chinese medicine believes that follicular hypoplasia is caused by congenital deficiency of qi and blood, and the follicles cannot get enough nutrition. It is inseparable from kidney deficiency, and the abnormal growth and decline transformation in the kidney is the main cause. If the kidney yin is sufficient, the kidney water will be sufficient and the kidney essence will be nourished; if the kidney yang is sufficient, the qi and blood will be warm, the Chong and Ren meridians will be unobstructed, the menstruation will be normal, and it will be easy to conceive. Therefore, strong kidney qi is a prerequisite for conception. The key to conception lies in the coordination of essence, qi, blood, and spirit. Through Chinese medicine conditioning, the local blood supply of the uterus and ovaries can be improved, and the growth of follicles and ovulation can be promoted. Secondly, Chinese medicine can regulate the hypothalamus-pituitary-ovarian axis, improve endocrine function, and provide strong protection for the growth, maturation and ovulation of eggs. Summary of the invention

[0004] In view of this, the present invention proposes a Chinese medicine composition for maintaining follicles and a preparation method and application thereof to solve the above problems.

[0005] The technical solution of the present invention is achieved as follows: a traditional Chinese medicine composition for maintaining follicles: its active ingredients include the following raw materials in parts by weight: 10-20 parts of dendrobium, 12-25 parts of longan pulp, 8-15 parts of polygonatum, 5-8 parts of chicken foam gelatin, and 6-15 parts of lily.

[0006] Preferably, a traditional Chinese medicine composition for maintaining follicles, whose active ingredients include the following raw materials in parts by weight: 15 parts of dendrobium, 22 parts of longan pulp, 9 parts of polygonatum, 7 parts of chicken foam gelatin, and 10 parts of lily.

[0007] Preferably, a traditional Chinese medicine composition for maintaining follicles, the active ingredients of which also include the following raw materials in parts by weight: 3-5 parts of Ligustrum lucidum, 2-6 parts of milk thistle, 2-5 parts of mulberry, 1-6 parts of raspberry, 1-3 parts of Cuscuta australis, and 0.3-0.8 parts of saffron.

[0008] Preferably, a traditional Chinese medicine composition for maintaining follicles, the active ingredients of which also include the following raw materials in parts by weight: 4 parts of Ligustrum lucidum, 4 parts of milk thistle, 4 parts of mulberry, 3 parts of raspberry, 2 parts of Cuscuta australis, and 0.5 parts of saffron.

[0009] Preferably, a method for preparing a Chinese medicine composition for maintaining follicles comprises the following steps:

[0010] S1, select the above-mentioned dendrobium, longan pulp, and polygonatum, add water and soak for 0.8-1.2h, and then distill at 80-90°C for 4-6h to obtain the first medicinal liquid and medicinal residue;

[0011] S2, take a small piece of chicken foam glue, add ginger slices and evaporate them together for 10-20 minutes, take it out, add ginger slices and soak it in warm water at 40-60°C for 5-10 hours, change the water every 1-1.5 hours, take it out, blanch it, and obtain the processed chicken foam glue;

[0012] S3, stewing the first liquid of S1 and the chicken foam gel and lily treated by S2 to obtain a Chinese medicine composition.

[0013] Preferably, a method for preparing a Chinese medicine composition for maintaining follicles further comprises the following steps:

[0014] S1, select the above-mentioned dendrobium, longan pulp, and polygonatum, add water and soak for 0.8-1.2h, and then distill at 80-90°C for 4-6h to obtain the first medicinal liquid and medicinal residue;

[0015] S2, take the above-mentioned Ligustrum lucidum, milk thistle, mulberry, raspberry, dodder seed, saffron six Chinese medicine raw materials by steam distillation, soak in water for 50-70h, distill for 3-8h, collect volatile oil for standby; take the residues respectively, add water and boil for 0.5-1.5h, filter, combine the decoction, and use it as the second medicinal liquid for standby;

[0016] S3, take a small piece of chicken foam glue, add ginger slices and evaporate them together for 10-20 minutes, take it out, add ginger slices and soak it in warm water at 40-60°C for 5-10 hours, change the water every 1-1.5 hours, take it out, blanch it, and obtain the processed chicken foam glue;

[0017] S4, stewing the first liquid medicine of S1, the second liquid medicine of S2 and the chicken foam gel and lily processed by S3 to obtain a Chinese medicine composition.

[0018] Preferably, the Chinese medicinal composition for maintaining ovarian follicles is used in the preparation of a medicament for maintaining ovarian follicles.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] According to the reproductive axis of "kidney-Tiangui-Chongren-Baogong" in traditional Chinese medicine and the activities and transformation of the qi and blood of the internal organs, the normal growth and discharge of follicles is the theoretical basis, which corresponds to the periodic changes and functions of the "hypothalamus-pituitary-ovary" axis in modern medicine. The growth of follicles depends on the abundance of kidney essence, which is the innate foundation, and is closely related to the spleen and stomach, which is the acquired foundation, to generate qi and blood, as well as other internal organs.

[0021] The prescription of the present invention mainly uses dendrobium, polygonatum and lily as the main drugs, which have the effects of nourishing the kidney and yin, invigorating qi and strengthening the spleen, moistening the lungs and calming the mind. The three drugs are used in conjunction with each other, nourishing the congenital kidney, replenishing the acquired spleen, regulating the mind, and are combined with the ingredients of blood and flesh to strengthen the spleen and kidney, regulate and replenish Chong and Ren meridians, increase follicular fluid, promote follicle growth, and improve egg quality, and have the effect of "1+1+1>3"; the assistant drugs mainly include chicken foam glue, Ligustrum lucidum and other drugs, which are helpful for promoting blood circulation and removing blood stasis, clearing away heat and detoxifying, balancing endocrine and the like, and have the effect of harmonizing the qi and blood of the human body, and have a certain therapeutic effect on ovarian problems; the milk thistle and mulberry as adjuvants can regulate the spleen and stomach functions of the body and promote the absorption and metabolism of drugs. DETAILED DESCRIPTION

[0022] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0023] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0024] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0025] The following introduces the basic information of the main raw materials based on the "Chinese Pharmacopoeia", "Chinese Dictionary" and "Chinese Herbal Medicine".

[0026] Dendrobium was first recorded in Shennong's Herbal Classic. It is sweet and slightly cold. It enters the stomach and kidney meridians. It is beneficial to the stomach and produces body fluids, nourishes yin and clears away heat. This product is sweet and cold, and mainly enters the stomach meridian. It can "clear the stomach and remove virtual heat, produce body fluids and have been damaged by fatigue" (Supplement to Compendium of Materia Medica). "There is nourishment in the clearing, and there is clearing in the nourishing" (Depei Materia Medica). Dendrobium can also nourish kidney yin and clear away virtual heat. It can be used together with Anemarrhena asphodeloides and Phellodendron chinense. It can treat weakness of tendons and bones due to kidney deficiency and deficiency of essence, excessive yin fire, and bone steaming and fatigue heat. Shennong's Herbal Classic says: "It is used to treat injuries, remove numbness, reduce qi, nourish the five internal organs, and strengthen yin. Long-term use thickens the intestines and stomach, lightens the body and prolongs life."

[0027] Polygonatum odoratum is sweet and mild in nature. It enters the spleen, lung, and kidney meridians. It can replenish qi and nourish yin, strengthen the spleen, moisten the lungs, and benefit the kidneys. Polygonatum odoratum can replenish both qi and yin, and is both a qi-tonifying and yin-tonifying drug, but it focuses more on yin-tonifying. It takes into account the spleen, lungs, and kidneys, and benefits the foundation of the acquired and acquired constitutions.

[0028] Lily is cold in nature, sweet in taste, and enters the heart and lung meridians. It has the functions of nourishing yin and moistening the lungs, clearing the heart and relieving troubles, calming the mind and regulating emotions. Modern pharmacological research shows that lily also has estrogen-like effects, which can improve the function of the uterus, especially the function of female sex hormones.

[0029] Longan meat is sweet and warm in nature, and belongs to the heart and spleen meridians. Its main effects and functions are to nourish the heart and spleen, nourish blood and calm the mind.

[0030] Chicken foam gel is taken from pufferfish, which is the swim bladder of pufferfish. Most people call pufferfish "chicken foam fish", hence the name. Because it looks like a big tooth, it is also called "tooth mother glue". The chicken foam gel on the market basically comes from farmed pufferfish, which is a marine food. Chicken foam gel has the effects of nourishing blood, nourishing yin, strengthening the kidney, and cultivating essence. It is rich in collagen, vitamins and various trace elements, and can also effectively improve sun spots, age spots, chloasma, etc., and play a role in beauty and anti-aging. It can also improve the body's immunity and regulate endocrine function. It has a relieving and therapeutic effect on symptoms such as soreness of the waist and knees, dizziness, insomnia, tinnitus, etc. caused by kidney deficiency.

[0031] Fructus Ligustri Lucidi: [Nature and flavor and meridians] Sweet, bitter, cool. Enters the liver and kidney meridians; [Functions and indications] Nourishes the liver and kidneys, improves eyesight and darkens hair. Used for liver and kidney yin deficiency, dizziness and tinnitus, soreness of waist and knees, premature graying of hair, blurred vision, internal heat and thirst, and bone steaming and hot flashes.

[0032] Raspberry: [Nature and flavor and meridians] Sweet, sour, warm. Enters the liver, kidney, and bladder meridians. [Functions and indications] Nourishes the kidney, consolidates essence, reduces urine, nourishes the liver, and improves eyesight. Used for spermatorrhea, nocturnal emission, frequent urination, impotence, premature ejaculation, and blurred vision.

[0033] Cuscuta: [Nature and flavor and meridians] Pungent, sweet, neutral. Enters the liver, kidney, and spleen meridians. [Functions and indications] Nourishes the liver and kidneys, consolidates the essence and reduces urine, stabilizes the fetus, improves eyesight, and stops diarrhea; used externally to eliminate wind and remove spots. Used for liver and kidney deficiency, soreness of the waist and knees, impotence and spermatorrhea, enuresis and frequent urination, kidney deficiency and fetal leakage, restless fetal movement, blurred vision and tinnitus, diarrhea due to spleen and kidney deficiency: external treatment of vitiligo.

[0034] Saffron: [Nature and flavor and meridians] Sweet, neutral, enters the heart and liver meridians. [Functions and indications] Promotes blood circulation and removes blood stasis, relieves depression and relieves knots. Treats depression due to worry, chest tightness, vomiting blood, typhoid fever, fright and confusion, amenorrhea in women, abdominal pain due to blood stasis after childbirth, and swelling and pain due to falls.

[0035] Example 1

[0036] A traditional Chinese medicine composition for maintaining ovarian follicles, wherein the active ingredients include the following raw materials by weight: 10 grams of dendrobium, 12 grams of longan pulp, 8 grams of polygonatum, 5 grams of chicken foam gelatin, and 6 grams of lily.

[0037] Example 2

[0038] A traditional Chinese medicine composition for maintaining follicles, wherein the active ingredients include the following raw materials by weight: 20 grams of dendrobium, 25 grams of longan pulp, 15 grams of polygonatum, 8 grams of chicken foam gelatin, and 15 grams of lily.

[0039] Example 3

[0040] A traditional Chinese medicine composition for maintaining follicles, wherein the active ingredients include the following raw materials by weight: 15 grams of dendrobium, 22 grams of longan pulp, 9 grams of polygonatum, 7 grams of chicken foam gelatin, and 10 grams of lily.

[0041] The above examples 1-3 adopt the following preparation method:

[0042] S1, selecting the above-mentioned dendrobium, longan pulp, and polygonatum, adding water to soak for 1 hour, and then distilling at 85° C. for 5 hours to obtain a first medicinal liquid and medicinal residue;

[0043] S2, take a small piece of chicken foam glue, add ginger slices and evaporate them together for 15 minutes, take it out, add ginger slices and soak it in warm water at 45°C for 8 hours, change the water every 1.3 hours, take it out, blanch it, and get the processed chicken foam glue;

[0044] S3, stewing the first liquid of S1 and the chicken foam gel and lily treated by S2 to obtain a Chinese medicine composition.

[0045] Example 4

[0046] A traditional Chinese medicine composition for maintaining follicles, wherein the active ingredients include the following raw materials by weight: 10 grams of dendrobium, 12 grams of longan pulp, 8 grams of polygonatum, 5 grams of chicken foam gelatin, 6 grams of lily, 3 grams of privet fruit, 2 grams of milk thistle, 2 grams of mulberry, 1 gram of raspberry, 1 gram of dodder seed, and 0.3 grams of saffron.

[0047] Example 5

[0048] A traditional Chinese medicine composition for maintaining follicles, wherein the active ingredients include the following raw materials by weight: 20 grams of dendrobium, 25 grams of longan pulp, 15 grams of polygonatum, 8 grams of chicken foam gel, 15 grams of lily, 5 grams of privet fruit, 6 grams of milk thistle, 5 grams of mulberry, 6 grams of raspberry, 3 grams of dodder seed, and 0.8 grams of saffron.

[0049] The above-mentioned Examples 4 and 5 adopt the following preparation method:

[0050] S1, selecting the above-mentioned dendrobium, longan pulp, and polygonatum, adding water to soak for 1 hour, and then distilling at 85° C. for 5 hours to obtain a first medicinal liquid and medicinal residue;

[0051] S2, take the above-mentioned Ligustrum lucidum, milk thistle, mulberry, raspberry, dodder seed, saffron six Chinese medicine raw materials by steam distillation, soak in water for 60h, distill for 5h, collect volatile oil for standby; take the residues respectively, add water and boil for 1h, filter, combine the decoction, and use it as the second medicinal liquid for standby;

[0052] S3, take a small piece of chicken foam glue, add ginger slices and evaporate it for 15 minutes, take it out, add ginger slices and soak it in warm water at 50°C for 8 hours, change the water every 1.2 hours, take it out, blanch it, and get the processed chicken foam glue;

[0053] S4, stewing the first liquid medicine of S1, the second liquid medicine of S2 and the chicken foam gel and lily processed by S3 to obtain a Chinese medicine composition.

[0054] The various embodiments of the Chinese medicine composition of the present invention are applied clinically, and the therapeutic effects are as follows:

[0055] 1. Basic information: This study formulated diagnostic criteria and efficacy evaluation criteria according to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" of the State Administration of Traditional Chinese Medicine, and collected 300 female patients with poor follicular quality and dysplasia, aged 30-40 years old, divided into 5 groups, 60 cases in each group, corresponding to the Chinese medicine compositions of Examples 1-5 respectively; "poor follicular quality and dysplasia" is reflected in the testosterone / estradiol ratio, AMH level is too high or too low, and follicular dysplasia;

[0056] 2. Treatment method and course of treatment: 2 doses per day, 28 consecutive days as a course of treatment, 3 courses of treatment are required.

[0057] 3. Symptom judgment criteria:

[0058] (1) Testosterone / estradiol ratio:

[0059] a. A testosterone / estradiol ratio below 10:1 indicates insufficient testosterone or excessive estradiol;

[0060] b. A testosterone / estradiol ratio higher than 15:1 usually indicates too much testosterone or not enough estradiol in the body;

[0061] c. The testosterone / estradiol ratio for women should be between 10:1 and 15:1.

[0062] (2) AMH level (31-40 years old):

[0063] a.AMH less than 0.1 may be a symptom of premature ovarian failure, characterized by amenorrhea and elevated gonadotropins.

[0064] b.AMH between 0.1-1.48 may be a sign of ovarian reserve impairment, which is often manifested as irregular menstruation, endocrine disorders, infertility, etc.

[0065] c.AMH is in the normal range of 1.48-7, and there is no abnormality in ovarian reserve function.

[0066] d.AMH greater than 7 may indicate polycystic ovary syndrome, a common endocrine and metabolic disorder in women of childbearing age.

[0067] (3) Follicle size: The normal value of a mature follicle is between 18mm and 24mm.

[0068] 4. Criteria for judging efficacy:

[0069] Effective: Testosterone / estradiol ratio is 10:1-15:1, AMH is 1.48-7, follicle size is 18mm-24mm, ovarian reserve function is normal, and conception can be normal;

[0070] Cure: Testosterone / estradiol ratio is 10:1-15:1, AMH is 1.48-7, follicle size is 18mm-24mm; no abnormality in ovarian reserve function;

[0071] Ineffective: The follicles are of poor quality and poorly developed, and the symptoms do not change.

[0072] 5. Results and efficacy

[0073]

[0074] 6. Treatment Outcomes

[0075] According to the statistics in the above table, the Chinese medicine composition of the present invention has a significant improvement effect on female patients with "poor follicle quality and poor development", with a cure rate of 70.0-85.0%, a total effective rate of 80.0-91.6%, and no patients with adverse reactions occurred in the cases observed during medication.

[0076] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for maintaining follicles, characterized in that: The active ingredients are prepared from the following raw materials in parts by weight: 10-20 parts of dendrobium, 12-25 parts of longan pulp, 8-15 parts of polygonatum, 5-8 parts of chicken foam gelatin, 6-15 parts of lily, 3-5 parts of privet fruit, 2-6 parts of milk thistle, 2-5 parts of mulberry, 1-6 parts of raspberry, 1-3 parts of dodder seed, and 0.3-0.8 parts of saffron; The preparation method of the Chinese medicine composition comprises the following steps: S1, select the above-mentioned dendrobium, longan pulp, and polygonatum, add water and soak for 0.8-1.2h, and then distill at 80-90°C for 4-6h to obtain the first medicinal liquid and medicinal residue; S2, take the above-mentioned Ligustrum lucidum, milk thistle, mulberry, raspberry, dodder seed, saffron six Chinese medicine raw materials by steam distillation, soak in water for 50-70h, distill for 3-8h, collect volatile oil for standby; take the residues respectively, add water and boil for 0.5-1.5h, filter, combine the decoction, and use it as the second medicinal liquid for standby; S3, take a small piece of chicken foam glue, add ginger slices and evaporate them together for 10-20 minutes, take it out, add ginger slices and soak it in warm water at 40-60°C for 5-10 hours, change the water every 1-1.5 hours, take it out, blanch it, and obtain the processed chicken foam glue; S4, stewing the first liquid medicine of S1, the second liquid medicine of S2 and the chicken foam gel and lily processed by S3 to obtain a Chinese medicine composition.

2. A Chinese medicine composition for maintaining follicles as claimed in claim 1, characterized in that: The active ingredients are prepared from the following raw materials in parts by weight: 15 parts of dendrobium, 22 parts of longan pulp, 9 parts of polygonatum, 7 parts of chicken foam gelatin, 10 parts of lily, 4 parts of privet fruit, 4 parts of milk thistle, 4 parts of mulberry, 3 parts of raspberry, 2 parts of dodder seed and 0.5 part of saffron.

3. Use of the Chinese medicine composition for maintaining follicles as described in any one of claims 1 or 2 in the preparation of a medicine for maintaining follicles.

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