Application of traditional Chinese medicine composition in preparation of medicine for treating endocrine diseases of children

Abstract

The invention discloses application of a traditional Chinese medicine composition in preparation of a medicine for treating endocrine diseases of children, and belongs to the technical field of traditional Chinese medicines, the traditional Chinese medicine composition comprises lotus leaves, hawthorn, cassia seeds, radix rehmanniae recen, pinellia ternate, rhizoma anemarrhenae, herba lycopi, rhizoma smilacis glabrae, radix gentianae, golden cypress, fennel, coix seeds, radix scrophulariae, selfheal, tortoise shells and liquorice. The invention further provides application of the traditional Chinese medicine composition for treating endocrine-related diseases of children. The inventor has rich clinical experience in the aspect of treating endocrine diseases of children, the children who are addicted to thick taste of fat paste, plump in body form, excessive phlegm-dampness caused by dampness accumulation, vein blocking and uterus accumulation can be effectively prevented / treated from dampness treatment, early mortality of girls can be effectively prevented / treated, and the traditional Chinese medicine composition has a good treatment effect on early occurrence of second sexual characteristics of the children.

Description

Technical Field

[0001] The invention discloses application of a traditional Chinese medicine composition in preparing medicines for children's endocrine diseases, and belongs to the technical field of traditional Chinese medicines. Background Art

[0002] Due to changes in living environment, nutrition and lifestyle, the incidence of childhood endocrine diseases has been on the rise in recent years, gradually attracting people's attention. The more common childhood endocrine diseases include dwarfism, precocious puberty, diabetes, hyperthyroidism, hypothyroidism, etc. Timely diagnosis, treatment and control of childhood endocrine diseases can slow down the progression of the disease, promote growth and development, and improve the quality of life.

[0003] According to statistics, the most common endocrine disease in children is precocious puberty, accounting for 24.05%. Precocious puberty is a pediatric endocrine disease caused by the early activation of the hypothalamic-pituitary-gonadal axis (HPGA) function, the increase of gonadotrophic raleasing hormone (GnRH), which causes gonadal development and sex hormone secretion, and eventually forms internal and external genitalia and secondary sexual characteristics. Precocious puberty refers to breast development before the age of 7.5 in girls or menarche before the age of 10, and testicular development before the age of 9 in boys.

[0004] The cause of precocious puberty is still unclear, but studies suggest that it may be related to a variety of factors, including genetics, intrauterine development environment, nutrition, region and environment, and exposure to endocrine disruptors. In addition, as the incidence of childhood obesity increases year by year, childhood obesity has become an important risk factor for precocious puberty.

[0005] At present, there are many studies on the treatment of precocious puberty at home and abroad. Due to the above reasons, the hypothalamus-pituitary-gonadal axis function of the human body is activated prematurely in children, and the hypothalamus increases the secretion and release of gonadotropin-releasing hormone in advance, leading to gonadal development, secretion of sex hormones, development of internal and external genitalia, and the appearance and functional maturity of secondary sexual characteristics. The main treatment method is the use of gonadotropin-releasing hormone analogs, which inhibit the pituitary-gonadal axis through receptor downregulation, reduce the secretion of luteinizing hormone and follicle-stimulating hormone, thereby controlling sexual development and improving adult height.

[0006] In traditional medicine, precocious puberty can be classified as "milk plague", "early menstruation" and "leucorrhea". There is no name of "precocious puberty" in ancient Chinese medical books, and related documents are rare. Traditional Chinese medicine believes that precocious puberty is closely related to the kidney, liver and Chong and Ren meridians. The kidney is the foundation of congenitality, containing the original yin and yang, responsible for bone marrow storage, growth and development and reproduction; children are immature yin and immature yang, and the kidney is often insufficient, and the yin and yang in the kidney are easily unbalanced, resulting in pathological conditions of kidney yin deficiency and excessive yang fire. The heat damages the Chong and Ren meridians, and the Chong and Ren meridians fail to meet their promises, the Tiangui sprouts, and sexual characteristics appear early. The liver is a hard organ, with yin in the body and yang in the function, responsible for dredging and regulating qi. Children's "liver is often in excess", liver yin is easily damaged, and liver yang is easily hyperactive. If the emotions are not comfortable, liver qi is stagnant, and it turns into fire over time. The liver and kidney are of the same origin, and the liver fire consumes the true yin, causing the yang fire to move rashly, so the Tiangui arrives early. "Chong is the sea of ​​blood" and "Ren is responsible for leukorrhea". The Chong and Ren meridians are connected to the liver and kidney meridians. If the Chong and Ren meridians are damaged, the yin and yang of the human body will be out of balance, the essence will not come out at the right time, and puberty will start prematurely.

[0007] Existing literature currently shows that this disease is based on liver and kidney yin deficiency, with liver depression transforming into fire as the symptom. The treatment should be to nourish the liver and kidney yin, drain the corresponding fire, and clear the liver and drain the fire, so as to achieve the balance of yin and yang. Summary of the invention

[0008] The main clinical symptoms are: breast development and internal and external genital development in girls, or menstruation, testicular and penis enlargement in boys, deepening of voice, or erection of penis. Accompanied by red cheeks, hot flashes, night sweats, dizziness, fever in the five parts of the body, red tongue, less coating, and fine pulse. The symptoms of milk collateral obstruction are: due to excessive phlegm and dampness, which block the collaterals and accumulate in the uterus. Clinically, there is a lot of vaginal discharge, which is white, clear or turbid, obesity, drowsiness and fatigue, pale tongue, white and greasy tongue coating, and slippery or soft pulse.

[0009] The present invention provides an application of a Chinese medicine composition in the preparation of medicines for children's endocrine diseases. Another technical solution of the present invention provides a method for preparing the Chinese medicine composition.

[0010] The pediatric endocrine disease described in the present invention is a disease that can cause the early appearance of secondary sexual characteristics in children and / or early menarche in girls.

[0011] The children's endocrine diseases mainly involve children's precocious puberty caused by phlegm-coagulated uterus syndrome.

[0012] Furthermore, the application is the use of the Chinese medicine composition in the preparation of a medicine for the early appearance of secondary sexual characteristics in children.

[0013] Furthermore, the application is the application of the traditional Chinese medicine composition in the preparation of a medicine for early menarche in children.

[0014] Furthermore, the child is a child with precocious puberty due to phlegm-coagulated uterus syndrome.

[0015] Furthermore, the raw materials of the Chinese medicine composition, measured by weight, include 8-12 parts of lotus leaves, 8-12 parts of hawthorn, 10-20 parts of cassia seeds, 8-12 parts of raw rehmannia, 8-12 parts of pinellia, 8-12 parts of anemarrhena, 8-12 parts of zedoaria, 8-12 parts of smilax glabra, 8-12 parts of gentian, 8-12 parts of phellodendron, 8-12 parts of fennel, 8-12 parts of coix seeds, 8-12 parts of Scrophularia, 8-12 parts of selfheal, 15-20 parts of tortoise shell and 5-10 parts of licorice.

[0016] Furthermore, in the Chinese medicine composition, the pinellia is French pinellia, the anemarrhena is salt anemarrhena, the phellodendron is salt phellodendron, and the tortoise shell is vinegar tortoise shell.

[0017] Furthermore, the Chinese medicine composition is prepared from the raw drug powder or water extract of the raw drug as the active ingredient, and pharmaceutically acceptable excipients or auxiliary ingredients are added to form a commonly used pharmaceutical preparation.

[0018] Furthermore, the preparation is an oral preparation.

[0019] Furthermore, the oral preparation is a powder, tablet, pill, granule or oral liquid.

[0020] The present invention provides a Chinese medicine composition for preparing a medicine for children's endocrine diseases, which comprises the following steps:

[0021] a. Weigh the raw materials of each weight ratio;

[0022] b. Grind into powder, or boil and extract with water, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare into commonly used pharmaceutical preparations.

[0023] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects:

[0024] The efficacy of the raw material medicine is as follows:

[0025] Lotus leaf: bitter, neutral. Enters the liver, spleen, and stomach meridians. Its effects are: clearing away heat and dampness, promoting the development of clear yang, cooling blood and stopping bleeding. "Compendium of Materia Medica" records: "Zheng Dianyi said: Grind lotus leaves into powder and take three grams of wine, which is very effective in treating spermatorrhea."

[0026] Hawthorn: sour, sweet, slightly warm. It enters the spleen, stomach, and liver meridians. Its effects are: helping digestion and strengthening the stomach, promoting qi and dispersing blood stasis, clearing turbidity and reducing fat. It is especially important for digesting greasy meat stagnation. Modern pharmacology shows that the fatty acids contained in this product can promote fat digestion and increase the secretion of gastric digestive enzymes; hawthorn acid and other substances can increase the activity of proteolytic enzymes, and lipase can promote fat decomposition.

[0027] Cassia seed: sweet, bitter, salty, slightly cold. Enters the liver and large intestine meridians. Modern pharmacology shows that Cassia seed decoction has a weight-loss effect, can inhibit the increase in body weight of nutritionally obese rats, improve insulin resistance, but does not affect appetite.

[0028] Shengdihuang: sweet, cold. Enters the heart, liver, and kidney meridians. Its effects are: clearing heat and cooling blood, nourishing yin and producing body fluid. This product is sweet and cold, enters the blood and is good at clearing heat and cooling blood. Nourishing yin and clearing heat, entering the kidney meridian, can nourish kidney yin and reduce virtual fire, nourish yin and body fluid and relieve latent heat. Treats yin deficiency internal heat, bone steaming and hot flashes.

[0029] Pinellia: pungent, warm. Enters the spleen, stomach, and lung meridians. Its effects are: drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and dissolving lumps and knots. This product is pungent, warm, and dry, and is good at drying dampness and turbidity and resolving phlegm and fluid. It is an essential medicine for drying dampness and resolving phlegm, warming and resolving cold phlegm, and is especially good at treating damp phlegm in the internal organs. It can resolve phlegm, dissolve lumps and knots when taken internally, and can dissolve knots, reduce swelling, and relieve pain when used externally.

[0030] Anemarrhena: bitter, sweet, cold. Enters the lung, stomach, and kidney meridians. Its effects are: clearing away heat and purging fire, nourishing yin and moistening dryness. This product enters the kidney meridian, can nourish kidney yin, purge kidney fire, and relieve bone steaming. It is used to treat kidney yin deficiency, yin deficiency and excessive fire, bone steaming, hot flashes, spermatorrhea, and night sweats. "Compendium of Materia Medica" records that Anemarrhena can moisten the kidney dryness and nourish yin, and enter the qi of the two meridians. Phellodendron enters the blood of the two meridians, so the two medicines must be used together.

[0031] Ze Lan: bitter, pungent, slightly warm. Enters the liver and spleen meridians. Its effects are: removing blood stasis and eliminating carbuncle, promoting diuresis and reducing swelling. Modern pharmacology shows that Ze Lan decoction can reduce blood viscosity, improve microcirculation, and regulate blood lipid metabolism.

[0032] Smilax glabra: sweet, light, neutral. Enters the liver and stomach meridians. Its effects are: detoxification, dehumidification, clearing away heat and detoxification, and reducing swelling and dispersing nodules. This product is sweet and light, penetrating and beneficial, detoxifying and removing dampness. It is used to treat hot stranguria, leucorrhea, scabies, eczema, and wet sores caused by damp heat. The "Classic" says: dampness harms people, including the skin, flesh, tendons and veins. Smilax glabra is light and can penetrate, sweet and can replenish, and is mainly used to treat scrofula, sores and swelling. "Southern Yunnan Materia Medica" records that this product can be used alone in water for decoction to treat vaginal itching, leucorrhea, and damp-heat skin itching.

[0033] Gentian: bitter, cold. Enters the liver and gallbladder meridians. Its effects are: clearing heat and drying dampness, purging liver and gallbladder fire. This product is bitter and cold, clearing heat and drying dampness, benefiting the liver and gallbladder and purging fire, especially good at clearing damp heat in the lower jiao, and is often used to treat various symptoms caused by damp heat in the lower jiao. Modern pharmacological studies have shown that Gentiana decoction can significantly inhibit the activity of steroid Δ4-reductase in hyperthyroid rats, indicating that Gentiana can inhibit the inactivation of cortisol by the liver, proving the pharmacological effect of Gentiana in purging liver fire. It can inhibit the inactivation of cortisol by the liver, and pharmacological experiments have clear targets for the treatment of hyperthyroidism.

[0034] Huangbai: bitter, cold. Enters the kidney and bladder meridians. Its effects are: clearing away heat and drying dampness, purging fire and detoxifying, and removing bone steaming. Danxi said: Xianghuo is heavenly fire, dragon and thunder fire, and Yin fire. It cannot be controlled by water and moisture, but should be suppressed according to its nature. Only Huangbai can suppress it.

[0035] Fennel: pungent, warm. Enters the liver, kidney, spleen, and stomach meridians. Its effects are: dispelling cold and relieving pain, regulating qi and harmonizing the stomach. This product is pungent and warm, and can treat liver qi stagnation and testicular swelling and pain.

[0036] Coix seeds: sweet, light, cool. Enter the spleen, stomach, and lung meridians. Its effects are: diuresis and dampness, spleen-strengthening and diarrhea-stopping, arthralgia-removing, pus-discharging, detoxification and stagnation-dispersing. This product clears heat from the lungs and intestines, discharges pus and eliminates carbuncle, detoxifies and dissipates stagnation.

[0037] Scrophularia: sweet, bitter, salty, slightly cold. Enters the lung, stomach, and kidney meridians. Its effects are: clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dispersing nodules. This product is sweet, cold and moist, and can clear heat and produce body fluid, nourish yin and moisten dryness. "Compendium of Materia Medica" records: It is cold and dispersing fire, salty and softening, and is mainly used to treat scrofula and tuberculosis.

[0038] Prunella Vulgaris: pungent, bitter, cold. Enters the liver and gallbladder meridians. Its effects are: clearing the liver and purging fire, dispersing stagnation and reducing swelling, and can treat breast abscess, breast lumps, and breast pain. This product is pungent to disperse stagnation and bitter to relieve heat, and can treat goiter and scrofula, and has the effect of clearing liver fire and dispersing phlegm.

[0039] Turtle shell: salty, sweet, slightly cold. Enters the liver, kidney, and heart meridians. This product is a product of blood and flesh, salty, sweet, and slightly cold. It can nourish the yin of the liver and kidney to reduce internal heat, and can also lower the liver yang to calm the internal wind. Treat yin deficiency and internal heat, bone steaming and hot flashes, night sweats and spermatorrhea.

[0040] Licorice: sweet, neutral. Enters the heart, lung, spleen, and stomach meridians. Its effects are: tonifying the spleen and replenishing qi, clearing away heat and detoxifying, relieving pain, and harmonizing various medicines.

[0041] In the prescription, the Chinese smilax and coix seeds are used to represent the four wonders, to clear away heat and dry dampness. The use of zelan (hair chrysanthemum), "Leigong Paozhi Lun" says: "It can break blood stasis and clear long-term accumulation", "Bencao Beiyao" says: "It is bitter to dispel heat, sweet to harmonize blood, pungent to disperse depression, fragrant to soothe the spleen, and enters the Taiyin spleen and Jueyin liver meridians. It can eliminate tumors and lumps, disperse edema, nourish without stagnation, and move without being harsh, and is an important medicine for women. "Yi Lin Zuan Yao" says: "Fennel greatly nourishes the gate of life, and rises above the Tanzhong. When the fire of the gate of life is solid, the spleen and stomach can transform water and grain, and qi and blood are generated, and all colds are dispersed. "Bencao Beiyao" also says that "liver meridian diseases do not belong to the kidney meridian, because the Jueyin liver meridian of the foot connects the chest and flanks to the genitals, and are mostly caused by cold and dampness", so fennel is selected in the prescription. The liver and gallbladder also carry out the fire of the life gate. When the liver's wood qi is flowing, water and dampness will not remain, and virtual wind will not arise. Because dampness accumulates for a long time and turns into heat, it attacks the phase fire, and the phase fire moves recklessly. "Gezhi Yu Lun·Phase Fire Theory" mentioned: "The yin of the liver and kidney all have phase fire, and people are the same as heaven... Phase fire is easy to arise, and the five elements of the yang fire fan each other, then it moves recklessly. Fire arises from recklessness, changes unpredictably, and occurs all the time, tormenting the true yin. Yin deficiency will cause illness and yin extinction will cause death." The kidney is responsible for closure and storage, storing the innate essence given by parents, and relying on the essence of water and grain produced by the spleen and stomach. It contains the original yin and original yang, and is the source of Tiangui and the basis of Chong and Ren. It is responsible for growth, development, and reproduction. If the kidney is full of essence and qi, the child will grow and develop normally. Therefore, Anemarrhena asphodeloides and Phellodendron chinense are selected to nourish kidney yin, drain phase fire, and clear dampness and heat.

[0042] The treatment concept of this prescription embodies the holistic treatment concept of traditional Chinese medicine and the principle of dialectical treatment, providing children with more accurate and effective treatment plans, and making an important contribution to making up for the shortcomings of existing technologies.

[0043] The inventor has rich clinical experience in treating precocious puberty. For children who are fond of eating greasy and rich food, have a plump body, and have internal dampness that leads to excessive phlegm and dampness, blocking the meridians and accumulating in the uterus, the inventor treats them from the perspective of dampness. Dampness is sticky, stagnant inside, imbalance of yin and yang, disorder of Chong and Ren meridians, and floating of the sea of ​​blood, leading to early menstruation. This treatment plan can effectively prevent / treat early menarche in girls and has a good therapeutic effect on the early appearance of secondary sexual characteristics in children. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Figure 1 It is a schematic diagram of the prescription note of the patient in the typical case report 1 of the present invention.

[0045] Figure 2 It is a schematic diagram of the prescription note of the patient in the typical case report 2 of the present invention. DETAILED DESCRIPTION

[0046] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below. Obviously, the described embodiments are only partial descriptions of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0047] It should be noted that the following detailed descriptions are illustrative and are intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present application belongs.

[0048] If the specific conditions are not specified in the examples, the experiments were carried out under conventional conditions. If the manufacturers of the reagents or instruments are not specified, they are all conventional products that can be purchased from the market.

[0049] The raw medicinal materials used in this prescription all meet the requirements of the "Pharmacopoeia of the People's Republic of China (2020 Edition)" (abbreviated as: Pharmacopoeia) published by China Medical Science and Technology Press.

[0050] Example 1: Preparation of the drug of the present invention

[0051] Take 10g of lotus leaf, 10g of hawthorn, 12g of cassia seed, 10g of raw rehmannia, 10g of French pinellia, 10g of anemarrhena, 10g of zedoaria, 10g of wild smilax, 10g of gentian, 10g of phellodendron, 10g of fennel, 10g of coix seed, 10g of Scrophularia, 10g of selfheal, 10g of tortoise shell, and 5g of licorice, add water and boil to prepare an oral solution.

[0052] Example 2: Preparation of the drug of the present invention

[0053] Take 8g of lotus leaf, 8g of hawthorn, 10g of cassia seed, 8g of raw rehmannia, 8g of French pinellia, 8g of anemarrhena, 8g of zedoaria, 8g of wild smilax, 8g of gentian, 8g of phellodendron, 8g of fennel, 8g of coix seed, 8g of Scrophularia, 8g of Prunella vulgaris, 15g of tortoise shell, and 5g of licorice, mix and grind into powder to prepare a powder.

[0054] Example 3: Clinical efficacy verification

[0055] 1. Sources

[0056] All the research cases were from children with precocious puberty caused by phlegm-coagulated uterus syndrome who came to the inventor for treatment during his medical practice in Kunming City, Yunnan Province from May 2019 to October 2023. The medical records were collected and recorded by long-term follow-up students. The medical record information included general information of the patient, date of consultation, information on the four examinations of Traditional Chinese Medicine, Chinese and Western medicine diagnoses and corresponding TCM treatments, specific prescriptions and medicines, and questionnaires collected from the parents of the children.

[0057] 2. Diagnostic criteria

[0058] TCM diagnostic and differentiation standards (refer to "Chinese Pediatrics" (4th edition), "Chinese Clinical Diagnosis and Treatment Terminology Part 2: Syndromes").

[0059] Phlegm-coagulated uterus syndrome: Girls develop breasts and internal and external genitalia, or menstruation, boys enlarge testicles and penis, voice becomes deeper, or penis erection. Accompanied by red cheeks, hot flashes, night sweats, dizziness, fever in the five parts of the body, obesity, drowsiness, fatigue, abdominal distension and pain, abdominal pain that refuses to be pressed, frequent, urgent, painful urination, or fishy, ​​loose stools, a large amount of vaginal discharge, white, clear, or turbid, yellow and smelly, anal and genital eczema, itching, or lower limb sores, ulceration, water retention, yellow and greasy tongue coating, slippery or weak pulse, etc.

[0060] 3. Case criteria

[0061] The data collection principles refer to the "General Technical Specifications for Real-World Research in Traditional Chinese Medicine (2017)" to ensure its authenticity, integrity, standardization and traceability. The collected content includes the patient's basic information, current medical history, symptoms, four diagnostic information, syndrome type, Chinese and Western medicine diagnosis, treatment methods, prescriptions and other information.

[0062] 4. Research Methods

[0063] A total of 91 children with precocious puberty due to bear phlegm coagulation in the uterus syndrome were included in this study, with a total of 358 visits and 358 prescriptions. The general information, basic conditions, syndrome distribution, tongue images, and TCM syndrome scores before and after Chinese medicine treatment of the children were collected to evaluate the therapeutic effect of the treatment of precocious puberty in children.

[0064] 5. Statistical methods

[0065] The database was established using the TCM inheritance auxiliary platform (V3.0) and SPSS Modeler 18.0: the counting data were expressed as frequency and percentage, the measurement data were expressed as mean ± standard deviation, the counting data were tested by Х², and the measurement data were tested by independent sample t test. P < 0.05 was considered statistically significant. The chi-square test (cross-analysis) was used for the difference analysis and correlation between categorical variables, and P < 0.05 was considered statistically significant. One-way ANOVA was used to compare the means of multiple groups of data and the pairwise comparison of the means.

[0066] 6. Clinical case analysis

[0067] (1) Age distribution of onset

[0068] Table 1: Age distribution of children with sputum clotting type precocious puberty included in the statistics

[0069] (2) Syndrome scoring

[0070] With reference to the relevant standards of "Terminology of Clinical Diagnosis and Treatment of Traditional Chinese Medicine Part 2: Syndrome" and "Guidelines for Clinical Research of New Chinese Medicines", a scoring scale for precocious puberty in children was developed, and the treatment effect calculation formula adopted the nimodipine method: efficacy index (n) = (score before treatment - score after treatment) / score before treatment * 100%.

[0071] Cure: All symptoms disappear after treatment, n≥95%.

[0072] Markedly effective: All symptoms were significantly relieved after treatment, 70%≤n<95%.

[0073] Effective: All symptoms were relieved after treatment, 30%≤n<70%.

[0074] Ineffective: Symptoms did not improve or worsened after treatment, n < 30%.

[0075] Table 2: Treatment effect statistics

[0076] (3) Distribution of the four properties of the medication

[0077] Using the software "TCM Inheritance Auxiliary Platform (V3.0)", the 358 prescriptions included were counted, and the four properties of the drugs in the 358 prescriptions were counted. Among all the prescriptions obtained, cold drugs appeared most frequently, reaching 124 times, accounting for 56.14%; followed by neutral drugs, appearing 47 times, accounting for 21.02%; and then warm drugs, appearing 40 times, accounting for 17.89%. The cumulative frequency of the three reached 95.05%.

[0078] Table 3: Distribution of the four qi of the prescription drugs included in the statistics

[0079] (4) Distribution of the five flavors of the medicine

[0080] Using the software "TCM Inheritance Auxiliary Platform (V3.0)", the 358 prescriptions included were counted, and the five flavors of the drugs in the 358 prescriptions were counted. Among all the prescriptions obtained, bitter drugs appeared most frequently, reaching 2871 times, accounting for 34.38%; followed by sweet drugs, with a cumulative frequency of 2480 times, accounting for 30.00%; then pungent drugs, with a cumulative frequency of 1201 times, accounting for 14.42%; fourth was salty drugs, with a cumulative frequency of 1197 times, accounting for 14.24%. The cumulative frequency of the four reached 93.04%.

[0081] Table 4: Distribution of five flavors of prescription drugs included in the statistics

[0082] (5) Distribution of the five flavors of the medicine

[0083] Using the software "TCM Inheritance Auxiliary Platform (V3.0)", the 358 prescriptions included were counted, and multiple meridians were split up, and all meridians involved were taken into account. Among them, the number of drugs entering the liver meridian was the largest, with a cumulative frequency of 3,175 times, accounting for 24.76%. According to the analysis of the number of drugs, the majority entered the liver, stomach, lung, and kidney meridians.

[0084] Table 5: Distribution of prescription drugs included in the statistics

[0085] (6) Statistics on drug efficacy

[0086] Using the software "TCM Inheritance Auxiliary Platform (V3.0)", the 358 included prescriptions were counted, and the drug efficacy of the 358 prescriptions was counted. Among all the prescriptions obtained, heat-clearing drugs were used most frequently, with a total of 1010 times. The second was antipyretic drugs, which were used a total of 128 times. They were then ranked in order of high to low frequency.

[0087] Table 6: Statistics of efficacy of included prescription drugs

[0088] (7) Association rule analysis

[0089] The 358 Chinese medicine prescriptions included were analyzed, and the Apriori function in SPSS Modeler18.0 software was used to perform association rule analysis on the Chinese medicines included in the statistics, with the conditions set as support ≥ 15%, confidence 80%, and the maximum number of preceding items being 3. As a result, 106 association rule combinations were obtained, which were ranked according to support, and the top 5 association rules were selected in combination with the actual application analysis of the present invention.

[0090] Table 7: Association rule analysis of prescription drugs included in statistics

[0091] Typical case report 1:

[0092] Patient: Kang, female, 9 years old

[0093] Date of first diagnosis: November 10, 2020.

[0094] Chief complaint: Found bilateral breast development for more than 10 months, menstruation for 3 months.

[0095] Current medical history: The patient has hard, tender, and movable breast nuclei on both sides. The menstrual flow is scanty and coffee-colored, lasting for 1 week each month, and pain around the umbilicus. No pubic hair development, only a small amount of axillary hair. Pain in the right knee joint. Appetite and sleep are good, and bowel movements are normal.

[0096] Auxiliary examination: Color Doppler ultrasound at Kunming Children's Hospital showed: 1. Sonogram of uterus (prepuberty), size: 5.1*2.5*1.5cm; 2. Sonogram of ovary (prepuberty), size on the left: 2.6*1.3*1.2cm; size on the right: 2.9*1.5*1.3cm.

[0097] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention. The oral solution was prepared according to the method described in "Example 1" and taken three times in the morning, noon and evening. The prescription is detailed in Figure 1 , a total of 3 courses of medication were taken, each course lasting 12 days.

[0098] Follow-up and outcome: After taking the medicine, the parents reported that the child's breasts had no progressive development, were soft and non-tender to the touch, had no pubic hair development, had less menstrual flow each month, had a significant increase in height of 6 cm, and had lost 3 kg in weight.

[0099] Typical case report 2:

[0100] Patient: Wang, female, 3 years old

[0101] Date of first diagnosis: August 6, 2019.

[0102] Chief complaint: The child had frequent friction of the vulva with discharge for one and a half years.

[0103] Current medical history: The child has often used a pole to stimulate the vulva since he was 1 and a half years old. He also rubbed his external genitalia frequently when sitting on his grandmother's lap and taking a bath. The child is now 3 years old. He will rub his vulva with his legs together without the help of external objects. Accompanied by facial flushing and spontaneous sweating. He can stop when he is stopped. There is secretion on his underwear, which is white and talcum powder-like. His appetite is good, his sleep is poor, his bowel movements are regular, and his tongue is red with a greasy yellow coating.

[0104] Past medical history: "Adhesions of vaginal opening, had vaginal opening stripping surgery in a children's hospital.

[0105] Auxiliary examination: The parents of the child reported that they had been treated in a hospital in Kunming (the details are unknown) for liver function and cranial pituitary plain scan examinations, and no abnormalities were found. An "EEG" examination was performed at Kunming Children's Hospital, which showed the presence of bilateral mid-temporal spikes and slow waves when awake. Six sex hormone tests showed: estradiol: 107.2pmol / L, total testosterone: 0.09 nmol / L, progesterone: 0.55nmol / L, gynecological B-ultrasound (transabdominal) showed: immature uterus; follicles and pelvic effusion were visible in the right ovary.

[0106] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention. Granules were prepared according to the method described in "Example 2" and taken three times a day in the morning, noon and evening. The prescription is detailed in Figure 2 , a total of 3 courses of medication were taken, each course lasting 12 days.

[0107] Follow-up and outcome: The patient was followed up until January 2020, with no recurrence and recovery. Six sex hormone tests showed: estradiol: 14 pmol / L. Total testosterone: 0.13 nmol / L, progesterone <0.1nmol / L.

[0108] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein by equivalents. Any equivalent replacement or change of the technical solutions and inventive concepts of the present invention should be covered within the protection scope of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicine for children's endocrine diseases, characterized in that: The traditional Chinese medicine composition comprises lotus leaf, hawthorn, cassia seed, raw rehmannia root, pinellia tuber, rhizoma anemarrhenae, herba zedoariae, rhizoma smilax, gentian, phellodendron, fennel, coix seed, figwort, herba phellodendri, herba tortoise shell and liquorice.

2. The use according to claim 1, characterized in that: The pediatric endocrine disease is a disease that can cause the early appearance of secondary sexual characteristics in children and / or early menarche in girls.

3. The use according to claim 1, characterized in that: The children's endocrine diseases mainly involve children's precocious puberty caused by phlegm-coagulated uterus syndrome.

4. Use of a Chinese medicine composition in the preparation of a drug for early onset of secondary sexual characteristics in children, characterized in that: The traditional Chinese medicine composition comprises lotus leaf, hawthorn, cassia seed, raw rehmannia root, pinellia tuber, rhizoma anemarrhenae, herba zedoariae, rhizoma smilax, gentian, phellodendron, fennel, coix seed, figwort, herba phellodendri, herba tortoise shell and liquorice.

5. Use of a Chinese medicine composition in preparing a medicine for early menarche in children, characterized in that: The traditional Chinese medicine composition comprises lotus leaf, hawthorn, cassia seed, raw rehmannia root, pinellia tuber, rhizoma anemarrhenae, herba zedoariae, rhizoma smilax, gentian, phellodendron, fennel, coix seed, figwort, herba phellodendri, herba tortoise shell and liquorice.

6. The use according to claim 1, characterized in that: The patient described is a child suffering from precocious puberty due to phlegm-coagulated uterus syndrome.

7. The use according to claim 1, characterized in that: The raw materials of the traditional Chinese medicine composition include, by weight, 8-12 parts of lotus leaf, 8-12 parts of hawthorn, 10-20 parts of cassia seed, 8-12 parts of raw rehmannia root, 8-12 parts of pinellia tuber, 8-12 parts of anemarrhena, 8-12 parts of zedoaria, 8-12 parts of smilax glabra, 8-12 parts of gentian, 8-12 parts of phellodendron, 8-12 parts of fennel, 8-12 parts of coix seeds, 8-12 parts of figwort, 8-12 parts of selfheal, 15-20 parts of tortoise shell and 5-10 parts of liquorice.

8. The use according to claim 1, characterized in that: The pinellia is French pinellia, the Anemarrhena asphodeloides is salt Anemarrhena asphodeloides, the Phellodendron chinense is salt Phellodendron chinense, and the tortoise shell is vinegar tortoise shell.

9. The use according to any one of claims 4-5, characterized in that: The Chinese medicine composition is prepared from the raw drug powder or water extract of the raw drug as the active ingredient, and pharmaceutically acceptable excipients or auxiliary ingredients are added to form a commonly used pharmaceutical preparation.

10. The Chinese medicine composition according to claim 9, characterized in that: The preparation is an oral preparation.

11. The Chinese medicine composition according to claim 10, characterized in that: The oral preparation is powder, tablet, pill, granule or oral liquid.

12. A Chinese medicine composition for preparing medicines for children's endocrine diseases according to claim 1, characterized in that: The preparation method thereof is characterized by comprising the following steps: a. Weigh the raw materials of each weight ratio; b. Grind into powder, or boil and extract with water, and then add pharmaceutically acceptable excipients or auxiliary ingredients to prepare into commonly used pharmaceutical preparations.

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