Traditional Chinese medicine composition for oral administration and external use for treating spleen-deficiency phlegm-congealing children sexual precocity and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses an oral and external traditional Chinese medicine composition for treating spleen-deficiency phlegm-congealing children sexual precocity and a preparation method thereof. The oral and external traditional Chinese medicine composition comprises an oral traditional Chinese medicine composition and an external traditional Chinese medicine composition, the oral traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 8 to 10 parts of radix rehmanniae, 8 to 10 parts of radix arnebiae seu lithospermi, 8 to 10 parts of spica prunellae, 8 to 10 parts of fructus foeniculi, 8 to 10 parts of cortex phellodendri, 8 to 10 parts of herba lycopi, 8 to 10 parts of rhizoma alismatis, 8 to 10 parts of semen coicis, 12 to 15 parts of fructus hordei germinatus, 8 to 10 parts of radix scrophulariae, 8 to 10 parts of loofah sponge, 8 to 10 parts of rhizoma anemarrhenae, 15 to 20 parts of tortoise shell, 8 to 10 parts of rhizoma pinelliae and 8 to 10 parts of radix gentianae; the external pharmaceutical preparation and the oral traditional Chinese medicine composition have the same components; the invention further discloses the preparation method of the traditional Chinese medicine composition for oral administration and external use for treating spleen-deficiency phlegm-congealing children sexual precocious puberty. The traditional Chinese medicine is mainly based on spleen deficiency and phlegm coagulation, has the fundamental principle of tonifying spleen, removing food retention and eliminating mass, and also purges phase fire. Clinical application results show that the clinical symptoms of children with precocious puberty due to spleen deficiency and phlegm coagulation are obviously improved and even eliminated, and the total treatment effective rate is 98.59%.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for internal and external use for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome. Background Art

[0002] Precocious puberty refers to an endocrine disorder characterized by abnormal growth and development in children, with the onset of puberty, or secondary sexual characteristics, in girls before the age of 7.5 and boys before the age of 9. In recent years, with rising living standards, factors such as overnutrition and the abuse of supplements have led to a growing incidence of precocious puberty, making it one of the three major hot issues in child growth and development, alongside dwarfism, obesity, and precocious puberty. The incidence of precocious puberty in girls is four to five times higher than that in boys. This poses a serious threat to children's physical and mental health and development, significantly impacting their future fitness and quality of life.

[0003] In the past, precocious puberty was generally treated with progestins or antiandrogens. While these drugs can control the symptoms and signs of precocious puberty, they cannot slow epiphyseal fusion or improve final height, and they are associated with significant side effects, making them suboptimal treatments. Currently, the most internationally recognized effective treatment for idiopathic true precocious puberty is a gonadotropin-releasing hormone analog (GnRHa). This drug, by suppressing sex hormones, slows bone age, delays epiphyseal fusion, and improves final height. While side effects are relatively minimal, it is expensive, making it difficult for families to accept. Traditional Chinese medicine (TCM) is increasingly gaining attention in clinical research due to its proven efficacy, minimal side effects, and significant cost advantages in treating precocious puberty in children. Summary of the Invention

[0004] In order to solve and improve the above problems, the present invention provides a treatment plan for children with spleen deficiency and phlegm stagnation syndrome, which can effectively alleviate and eliminate the clinical symptoms of children and improve the final height development of children. It is a Chinese medicine composition for internal and external use and its preparation method.

[0005] The main clinical symptoms are: spleen deficiency and dysfunction, resulting in phlegm-damp accumulation. Clinically, single or multiple swellings of varying sizes appear on the limbs. These swellings are soft, non-tender, and removable. The skin color is normal, or they may be concave when pressed and convex when released, appearing as if filled with air or with brown spots. The tongue is coated with a greasy white coating and has a wiry, slippery pulse. Symptoms include obesity, heaviness in the head and body, a bland or sticky mouth, abdominal distension, and loose stools.

[0006] Children often have insufficient spleen function and often eat inappropriately, which can easily lead to dampness stagnation in the body, where dampness and heat collide and block the liver meridian. If the dampness attacks the meridians upward, the breast meridians will not be smooth, resulting in discomfort in the ribs. If the breast nodules follow the meridians downward, yellow vaginal discharge will appear. The spleen belongs to the middle jiao, and the spleen is responsible for transporting and transforming the essence of water and grain. Although the disease is in the chest, it is actually a spleen disease, so the main treatment is to transport the spleen to eliminate dampness and eliminate nuclei. The inventor has extensive clinical experience in treating precocious puberty. For children with spleen deficiency and phlegm stagnation who are fond of eating rich and greasy foods, have a plump body, and have dampness accumulated in the body, the inventor treats them from the perspective of the spleen. If the spleen fails to transport and transform, the essence of water and grain cannot be transformed into liquid and dampness into phlegm. However, dampness is sticky and stagnant inside the body, causing imbalance between yin and yang, disorder of Chong and Ren meridians, and floating blood sea, leading to the premature arrival of Tiangui. "Secrets of Infant Care" says: "Kidney deficiency refers to insufficient innate Qi after birth from parents." "Discussion on the Relationship between the Two Elements" mentions: "The Yin of the liver and kidneys all contain Relationship between the two elements, and humans are the same as nature... Relationship between the two elements is easy to arise, and the fire of the five elements, Jue Yang, fan each other, and then it moves recklessly. Fire arises from recklessness, changes unpredictably, and occurs at all times, tormenting the true Yin. Yin deficiency causes illness, and Yin extinction causes death." The kidneys are 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. They house the original Yin and Yang, and are the source of Tiangui and the basis of Chong and Ren. They are responsible for growth, development, and reproduction. If the kidneys are full of essence and Qi, children will grow and develop normally.

[0007] The technical solution of the present invention:

[0008] A Chinese medicine composition for internal and external use for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome, characterized by comprising a Chinese medicine composition for internal use and a Chinese medicine composition for external use:

[0009] The Chinese medicine composition for internal use comprises the following raw materials in parts by weight: 8-10 parts of Rehmannia root, 8-10 parts of Lithospermum erythrorhizon, 8-10 parts of Prunella vulgaris, 8-10 parts of Cuminum officinale, 8-10 parts of Phellodendron amurense, 8-10 parts of Zedoariae rhizome, 8-10 parts of Alisma orientalis, 8-10 parts of Coix seed, 12-15 parts of malt, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Luffa sponge, 8-10 parts of Anemarrhena asphodeloides, 15-20 parts of Carapax tortoise shell, 8-10 parts of Pinellia ternata, and 8-10 parts of Gentiana scabra.

[0010] The external-use pharmaceutical preparation includes the following raw materials in parts by weight: 8-10 parts of Rehmannia root, 8-10 parts of Lithospermum erythrorhizon, 8-10 parts of Prunella vulgaris, 8-10 parts of fennel, 8-10 parts of Phellodendron amurense, 8-10 parts of Eupatorium fortunei, 8-10 parts of Alisma orientale, 8-10 parts of Coix seed, 12-15 parts of malt, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Luffa sponge, 8-10 parts of Anemarrhena asphodeloides, 15-20 parts of Tortoise shell, 8-10 parts of Pinellia ternata, and 8-10 parts of Gentiana scabra.

[0011] Furthermore, the Chinese medicine composition for internal use comprises the following raw materials in parts by weight: 8 parts of Rehmannia root, 8 parts of Lithospermum erythrorhizon, 8 parts of Prunella vulgaris, 8 parts of fennel, 8 parts of Phellodendron chinense, 8 parts of Zedoariae rhizome, 8 parts of Alisma orientalis, 8 parts of Coix seed, 12 parts of malt, 8 parts of Scrophularia ningpoensis, 8 parts of Luffa, 8 parts of Anemarrhena asphodeloides, 20 parts of Carapax tortoise shell, 8 parts of Pinellia ternata, and 8 parts of Gentiana scabra.

[0012] Furthermore, the external use pharmaceutical preparation includes the following raw materials in parts by weight: 10 parts of Rehmannia root, 10 parts of Lithospermum erythrorhizon, 10 parts of Prunella Vulgaris, 10 parts of fennel, 10 parts of Phellodendron amurense, 10 parts of Zedoariae rhizome, 10 parts of Alisma orientalis, 10 parts of Coix seed, 15 parts of malt, 10 parts of Scrophulariae ningpoensis, 10 parts of Luffa sponge, 10 parts of Anemarrhena asphodeloides, 20 parts of Tortoise shell, 10 parts of Pinellia ternata, and 10 parts of Gentiana scabra.

[0013] Furthermore, the preparation method of the oral Chinese medicine composition comprises the following steps:

[0014] (1) Soaking: taking tortoise shells according to the mass fraction and soaking them in water to obtain product 1, and taking other raw materials other than tortoise shells according to the mass fraction and soaking them in water to obtain product 2;

[0015] (2) Decoction: First decoct product 1, then add product 2 and continue decoction;

[0016] (3) After decoction is completed, filter and concentrate to obtain the product.

[0017] Furthermore, the preparation method of the external-use pharmaceutical preparation comprises the following steps:

[0018] Weigh the raw materials according to the ratio, mix and grind them, and pass them through an 80-mesh sieve for later use; heat the malt sugar in a water bath, add vinegar and stir evenly, add the above powders, stir until it becomes a uniform thick paste, and evenly apply it to the entire external dressing.

[0019] Furthermore, in the preparation method of the oral Chinese medicine composition, the amount of water used for soaking the tortoise shell in step (1) is 150-250 parts, and the amount of water used for soaking other raw materials other than the tortoise shell is 800-1200 parts; the soaking time is 20-30 minutes; in step (2), the time for decocting product one is 30-40 minutes, and the decocting time after adding product two is 45-60 minutes.

[0020] Furthermore, the external medicinal preparation is a Chinese medicine external acupuncture point application.

[0021] Furthermore, the external-use pharmaceutical preparation is an umbilical therapy patch.

[0022] Furthermore, the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome.

[0023] Furthermore, the present invention provides a use of the above-mentioned oral and topical pharmaceutical preparation in the preparation of a medicine for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome.

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

[0025] Rehmannia root: Sweet, cold. It enters the Heart, Liver, and Kidney meridians. Its effects include clearing heat, cooling blood, nourishing Yin, and promoting fluid production. This sweet and cold herb enters the Ying and Blood meridians, effectively clearing heat and cooling blood. It nourishes Yin and clears heat, entering the Kidney meridian, nourishing Kidney Yin and reducing internal heat, nourishing Yin and fluid, and relieving latent heat. It treats internal heat due to Yin deficiency, as well as hot flashes caused by bone steaming.

[0026] Lithospermum officinale: Sweet, salty, and cold. It enters the Heart and Liver meridians. Its effects include clearing heat and cooling blood, promoting blood circulation and detoxifying, and clearing rashes and removing freckles. Its salty and cold properties can clear heat and cool blood, as well as promoting blood circulation and reducing swelling. Modern pharmacology suggests that lithospermum officinale can act on the pituitary gland, inhibiting the synthesis of LH (luteinizing hormone) and FSH (follicle-stimulating hormone), and blocking the effects of human chorionic gonadotropin. Furthermore, animal studies have shown that long-term use of lithospermum officinale extract can reduce pituitary, ovarian, and uterine weights without causing tissue damage, and its inhibitory effects are reversible.

[0027] Prunella Vulgaris: Pungent, bitter, and cold. It enters the Liver and Gallbladder Meridians. Its benefits include clearing the liver and purging heat, dispersing stagnation and reducing swelling, and treating mastitis, breast ulcers, and breast tenderness. Its pungent properties dissipate stagnation, while its bitter properties dissipate heat, making it effective for treating goiters and scrofula, clearing liver heat and dispersing phlegm.

[0028] Cumin: Pungent and warm. It enters the Liver, Kidney, Spleen, and Stomach meridians. Its effects include dispelling cold, relieving pain, regulating Qi, and soothing the stomach. This pungent and warm herb can treat liver qi stagnation and testicular swelling and pain.

[0029] Huang Bai: Bitter, cold. Enters the kidney and bladder meridians. Its effects include clearing heat and dampness, purging fire and detoxifying, and relieving bone steaming. Dan Xi said: "Xiang fire is heavenly fire, the fire of dragon and thunder, and Yin fire. It cannot be controlled by water or dampness; it should be subdued according to its nature. Only Huang Bai can subdue it."

[0030] Ze Lan (Ze Lan): Bitter, pungent, and slightly warm. It enters the liver and spleen meridians. Its effects include removing blood stasis, dissolving carbuncles, promoting diuresis, and reducing swelling. Modern pharmacology suggests that a decoction of Ze Lan can reduce blood viscosity, improve microcirculation, and regulate lipid metabolism.

[0031] Alisma: Sweet, mild, and cold. It enters the kidney and bladder meridians. Its benefits include promoting diuresis and dispelling dampness, relieving heat, and reducing turbidity and lipids. This herb is cold in nature, clearing heat from the bladder and relieving internal heat in the kidneys, making it particularly suitable for those with damp-heat in the lower jiao.

[0032] Coix seed: Sweet, light, and cooling. It enters the spleen, stomach, and lung meridians. Its benefits include promoting diuresis and dispelling dampness, strengthening the spleen and stopping diarrhea, eliminating numbness, draining pus, and detoxifying and dispersing stagnation. This product clears heat from the lungs and intestines, drains pus, eliminates carbuncles, and detoxifies and dissipates stagnation.

[0033] Barley malt: Sweet, neutral. It enters the spleen and stomach meridians. Its benefits include promoting qi and aiding digestion, strengthening the spleen and appetizing, and promoting lactation and relieving bloating. Raw barley malt invigorates the spleen and stomach, soothes the liver and promotes qi, while roasted barley malt promotes qi and aids digestion and lactation. It is used to relieve food stagnation and help women wean themselves. Modern pharmacology shows that barley malt has effects similar to bromocriptine, inhibiting prolactin secretion.

[0034] Scrophularia: Sweet, bitter, salty, and slightly cold. It enters the lung, stomach, and kidney meridians. Its effects include clearing heat and cooling blood, nourishing yin and reducing internal heat, and detoxifying and dispersing stagnation. This sweet, cold, and moistening herb clears heat, promotes fluid production, nourishes yin, and moistens dryness. The "Compendium of Materia Medica" states: "Its cold properties dissipate internal heat, while its salty properties soften hard masses, making it a primary treatment for scrofula and tuberculosis."

[0035] Luffa: Sweet, neutral. Enters the lung, stomach, and liver meridians. Its effects include dispelling wind, unblocking meridians, promoting blood circulation, and promoting lactation.

[0036] Anemarrhena: Bitter, sweet, and cold. It enters the Lung, Stomach, and Kidney meridians. Its effects include clearing heat and purging fire, nourishing yin and moistening dryness. This herb enters the Kidney meridian, nourishing kidney yin, purging kidney fire, and relieving bone steaming. It is used to treat kidney yin deficiency, yin deficiency and excessive fire, bone steaming, hot flashes, spermatorrhea, and night sweats. The "Compendium of Materia Medica" records that Anemarrhena moistens kidney dryness and nourishes yin, entering the Qi component of the two meridians. Phellodendron chinense enters the Blood component of the two meridians, so the two herbs must be used together.

[0037] Turtle Shell: Salty, sweet, and slightly cold. It enters the Liver, Kidney, and Heart meridians. This product, a product of flesh and blood, is salty, sweet, and slightly cold. It nourishes the Yin of the liver and kidneys to reduce internal heat, while also lowering the Yang of the liver to calm internal wind. It treats Yin deficiency, internal heat, bone steaming, hot flashes, night sweats, and spermatorrhea.

[0038] Pinellia: Pungent and warm. It enters the spleen, stomach, and lung meridians. Its effects include drying dampness and resolving phlegm, relieving nausea and vomiting, and dissolving lumps and masses. This herb is pungent, warm, and dry, effectively drying dampness and turbidity and resolving phlegm and fluid. It is a key herb for drying dampness and resolving phlegm, warming and resolving cold phlegm, and is particularly effective in treating damp phlegm in the internal organs. Internally, it can resolve phlegm, dissolve lumps and masses, and externally, it can dissolve masses, reduce swelling, and relieve pain.

[0039] Gentiana: Bitter and cold. It enters the Liver and Gallbladder Meridians. Its effects include clearing heat and dampness, and purging liver and gallbladder fire. This bitter and cold herb, while clearing heat and dampness, benefits the liver and gallbladder and purges fire, particularly effective in clearing damp-heat in the lower abdomen. It is commonly used to treat symptoms associated with damp-heat in the lower abdomen. Modern pharmacological studies have shown that a decoction of Gentiana can significantly inhibit the activity of the steroid Δ4-reductase in hyperthyroid rats, suggesting that Gentiana can inhibit the liver's inactivation of cortisol, confirming its pharmacological effect of purging liver fire. This inhibition of the liver's inactivation of cortisol suggests a clear target for the treatment of hyperthyroidism.

[0040] Beneficial effects of the present invention:

[0041] The present inventors mainly treat spleen deficiency and phlegm stagnation type, with strengthening the spleen, eliminating stagnation and resolving abdominal distension as the fundamental principle, and also purging the fire of the liver. Qingpi Drink combined with self-prescribed additions and subtractions is used to treat children with spleen deficiency and phlegm stagnation type precocious puberty, which helps to strengthen the spleen, dry dampness and eliminate phlegm, soften and disperse lumps, and can effectively improve the clinical symptoms of children with precocious puberty. "Yi Lin Zong Yao" states: "Fennel greatly nourishes the Mingmen and rises above the Tanzhong point. When the Mingmen fire is solidified, the spleen and stomach can transform food and water, generating qi and blood, and dispelling all forms of cold." "Compendium of Materia Medica" also states: "Liver meridian diseases do not belong to the kidney meridian. The Foot Jueyin Liver Meridian, which connects the chest and flanks to the genitals, is often caused by cold and dampness." Therefore, fennel is used in the formula. The liver and gallbladder also regulate the Mingmen fire. When the liver's wood qi is flowing, dampness is not retained and deficient wind is not generated. Because dampness accumulates for a long time and turns into heat, it attacks the Xiang fire, causing it to move recklessly. Therefore, malt and Pinellia are used, supplemented with Anemarrhena astragali and Tortoise Shell to nourish yin and reduce fire, thereby purging the Xiang fire. The formula heavily uses Zexie, which is biased towards blood heat. For symptoms such as hard and painful breast nodules, Ze Lan (Baierju) is used. "Lei Gong Pao Zhi Lun" states: "It breaks up blood stasis and relieves long-standing accumulations." "Compendium of Materia Medica" states: "Bitterness dispels heat, sweetness harmonizes blood, pungentness dissipates depression, and fragrantness soothes the spleen. It enters the Foot Taiyin spleen and Foot Jueyin liver meridians." It can eliminate tumors and masses, dissipate edema, nourish without stagnation, and promote circulation without harshness. It is an essential medicine for women's health. "

[0042] Umbilical therapy is a transdermal drug administration that is directly absorbed into the blood through the skin. It can reduce the damage to liver and kidney function and gastric mucosa during oral drug metabolism, shorten the treatment cycle of children, and also avoid the pain of long-term medication for children. The umbilical therapy patch is centered on the umbilical fossa, namely the Shenque point, for application treatment. The Shenque point corresponds to the Mingmen point, and is the exterior and interior of the Ren and Du meridians. It can connect the twelve meridians and the five internal organs internally, and the limbs externally. It can connect the upper and lower parts, balance yin and yang, and restore body functions. At the same time, the umbilical therapy patch of the present invention can also cover the Zhongwan, Qihai, and Guanyuan points. The umbilical therapy patch of the present invention has been clinically proven to be safe and effective, and has the advantages of convenience, simplicity, and easy operation, and is suitable for widespread promotion and use.

[0043] Dosage: Oral administration of the Chinese herbal composition: Take the decocted liquid and take 100ml-120ml each time, three times a day, morning, noon and evening, after meals. Six doses constitute a course of treatment.

[0044] Directions for topical medication: Apply to the Shenque acupoint of the child, once daily, for 4 hours or more. A course of treatment is 4 weeks. DETAILED DESCRIPTION

[0045] To make the purpose, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions 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, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0046] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0047] 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 commercially available conventional products.

[0048] Example 1

[0049] The Chinese herbal composition for internal use includes: 8 parts of Rehmannia root, 8 parts of Lithospermum officinale, 8 parts of Prunella vulgaris, 8 parts of fennel, 8 parts of Phellodendron chinense, 8 parts of Zedoariae rhizome, 8 parts of Coix seed, 12 parts of malt, 8 parts of Scrophulariae ningpoensis, 8 parts of Luffa, 8 parts of Anemarrhena, 20 parts of Tortoise shell, 8 parts of Pinellia, 8 parts of Gentiana scabra

[0050] The external-use pharmaceutical preparation comprises the following raw materials in parts by weight: 10 parts of Rehmannia root, 10 parts of Lithospermum erythrorhizon, 10 parts of Prunella vulgaris, 10 parts of fennel, 10 parts of Phellodendron amurense, 10 parts of Zedoariae rhizome, 10 parts of Alisma orientalis, 10 parts of Coix seed, 15 parts of malt, 10 parts of Scrophularia ningpoensis, 10 parts of Luffa sponge, 10 parts of Anemarrhena asphodeloides, 20 parts of Carapax tortoise shell, 10 parts of Pinellia ternata, and 10 parts of Gentiana scabra.

[0051] The preparation method of Example 1 of the present invention is:

[0052] The preparation method of the Chinese medicine composition for internal use comprises the following steps:

[0053] (1) Soaking: taking tortoise shells according to the mass fraction and soaking them in water to obtain product 1, and taking other raw materials other than tortoise shells according to the mass fraction and soaking them in water to obtain product 2;

[0054] (2) Decoction: First decoct product 1, then add product 2 and continue decoction;

[0055] (3) After decoction is complete, filter and concentrate to 720 ml of liquid;

[0056] The preparation method of the external drug preparation includes the following steps: weighing the raw materials according to the ratio, mixing and crushing the raw materials, and passing through an 80-mesh sieve for later use; heating malt sugar in a water bath, adding vinegar and stirring evenly, adding the above drug powder, stirring until it becomes a uniform thick paste, and evenly applying it to the entire external dressing.

[0057] Clinical observation report of the present invention:

[0058] 1. Patient Source

[0059] The study cases were all children with precocious puberty who sought treatment from the applicant in Kunming, Yunnan Province, between May 2020 and May 2023. Medical records were collected and recorded by long-term students who followed the patient. These records included general patient information, visit dates, information on the four diagnostic methods of Traditional Chinese Medicine (TCM), diagnoses by both Chinese and Western medicine, corresponding TCM treatments, specific prescriptions, and a questionnaire collected from the patients' parents. A total of 142 children with spleen deficiency and phlegm stagnation-type precocious puberty were included.

[0060] 2. Case criteria

[0061] Data collection principles refer to the "General Technical Specifications for Real-World Studies in Traditional Chinese Medicine (2017)" to ensure authenticity, integrity, standardization, and traceability. Data collection includes basic patient information, current medical history, symptoms, four diagnostic information, syndrome types, traditional Chinese and Western medicine diagnoses, treatment methods, and prescriptions.

[0062] The original data of the included cases were referred to the "Terminology of Clinical Diagnosis and Treatment in Traditional Chinese Medicine" and the "Terminology Standards for Common Clinical Symptoms in Traditional Chinese Medicine". The symptoms, syndrome types and treatment methods of the children involved were structured after communication among all the applicants of the present invention. The names of the drugs involved were standardized in combination with the "Dictionary of Chinese Medicine" and the "Chinese Materia Medica" standards.

[0063] 3. Effect evaluation

[0064] With reference to the relevant standards of "Chinese Medicine Clinical Diagnosis and Treatment Terminology Part 2: Syndromes" and "Guiding Principles 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) = (pre-treatment score - post-treatment score) / pre-treatment score * 100%.

[0065] Cure: All symptoms disappear after treatment, n≥95%.

[0066] Markedly effective: All symptoms were significantly relieved after treatment, 70%≤n<95%.

[0067] Effective: All symptoms were relieved after treatment, 30%≤n<70%.

[0068] Ineffective: Symptoms did not improve or worsened after treatment, n < 30%.

[0069] Among the 142 children with precocious puberty of liver depression and phlegm stagnation type, 133 were significantly effective, 7 were effective, and 2 were ineffective, with an overall effective rate of 98.59%.

[0070] Typical case report 1:

[0071] Patient: Wang Moumou, female, 7 years old

[0072] First diagnosis date: January 31, 2023.

[0073] Chief complaint: Found that the breasts on both sides were half-moon developed.

[0074] Current medical history: The child has bilateral breast development with palpable and tender nuclei. Pubic and axillary hair are absent. A small amount of yellow vaginal discharge is observed. The child has a voracious appetite and a preference for meat. She has dry stools, only defecating once daily, and regular urination. She is currently 127 cm tall and weighs 26 kg.

[0075] Auxiliary examination: On January 28, 2023, an external hospital examination revealed (1) six hormone levels: estradiol: 25.7 pg / ml, crude follicle-stimulating hormone: 1.25 mIU / ml, luteinizing hormone: 0.1 mIU / ml, prolactin: 121.10 ng / ml. (2) Bone age examination revealed: 6 years old. (3) B-ultrasound revealed: uterus 3.5*1.4*0.7 cm, left ovary: 2.4*1.7*1.3 cm, 3 follicles visible, the largest of which was 0.5*0.4 cm, right ovary 2.3*1.8*1.4 cm, 4 follicles visible, the largest of which was 0.5*0.4 cm.

[0076] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention, and the treatment was carried out orally and topically according to the method described in "Example 1", and the medication was taken for a total of 2 courses of treatment.

[0077] Follow-up and outcome: On February 17, 2023, there was no progressive development of bilateral breasts, appetite and sleep were good, height increased by 1 cm, and weight decreased by 0.5 kg.

[0078] Although the present application has been described with reference to preferred embodiments, various modifications may be made thereto and components may be replaced with equivalents without departing from the scope of the present application. In particular, the various technical features described in the various embodiments may be combined in any manner as long as there are no structural conflicts. The present application is not limited to the specific embodiments disclosed herein, but includes all technical solutions within the scope of the claims.

Claims

1. A Chinese medicine composition for internal and external use for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome, characterized in that: Including Chinese medicine compositions for internal use and Chinese medicine compositions for external use: The Chinese medicine composition for internal use comprises the following raw materials in parts by weight: 8-10 parts of Rehmannia root, 8-10 parts of Lithospermum erythrorhizon, 8-10 parts of Prunella vulgaris, 8-10 parts of Cuminum officinale, 8-10 parts of Phellodendron amurense, 8-10 parts of Zedoariae rhizome, 8-10 parts of Alisma orientalis, 8-10 parts of Coix seed, 12-15 parts of malt, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Luffa sponge, 8-10 parts of Anemarrhena asphodeloides, 15-20 parts of Carapax tortoise shell, 8-10 parts of Pinellia ternata, and 8-10 parts of Gentiana scabra. The external-use pharmaceutical preparation includes the following raw materials in parts by weight: 8-10 parts of Rehmannia root, 8-10 parts of Lithospermum erythrorhizon, 8-10 parts of Prunella vulgaris, 8-10 parts of fennel, 8-10 parts of Phellodendron amurense, 8-10 parts of Eupatorium fortunei, 8-10 parts of Alisma orientale, 8-10 parts of Coix seed, 12-15 parts of malt, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Luffa sponge, 8-10 parts of Anemarrhena asphodeloides, 15-20 parts of Tortoise shell, 8-10 parts of Pinellia ternata, and 8-10 parts of Gentiana scabra.

2. A Chinese medicine composition for internal and external use for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome according to claim 1, characterized in that: The Chinese medicine composition for internal use comprises the following raw materials in parts by weight: 8 parts of Rehmannia root, 8 parts of Lithospermum erythrorhizon, 8 parts of Prunella vulgaris, 8 parts of fennel, 8 parts of Phellodendron amurense, 8 parts of Zedoariae rhizome, 8 parts of Alisma orientalis, 8 parts of Coix seed, 12 parts of malt, 8 parts of Scrophularia ningpoensis, 8 parts of Luffa, 8 parts of Anemarrhena asphodeloides, 20 parts of Carapax tortoise shell, 8 parts of Pinellia ternata, and 8 parts of Gentiana scabra. The external-use pharmaceutical preparation includes the following raw materials in parts by weight: 10 parts of Rehmannia root, 10 parts of Lithospermum erythrorhizon, 10 parts of Prunella vulgaris, 10 parts of fennel, 10 parts of Phellodendron amurense, 10 parts of Eupatorium fortunei, 10 parts of Alisma orientale, 10 parts of Coix seed, 15 parts of malt, 10 parts of Scrophularia ningpoensis, 10 parts of Luffa sponge, 10 parts of Anemarrhena asphodeloides, 20 parts of Tortoise shell, 10 parts of Pinellia ternata, and 10 parts of Gentiana scabra.

3. The method for preparing the Chinese medicine composition according to claim 1 or 2, wherein: The preparation method of the Chinese medicine composition for internal use comprises the following steps: (1) Soaking: taking tortoise shells according to the mass fraction and soaking them in water to obtain product 1, and taking other raw materials other than tortoise shells according to the mass fraction and soaking them in water to obtain product 2; (2) Decoction: First decoct product 1, then add product 2 and continue decoction; (3) After decoction is completed, filter and concentrate to obtain the product. The preparation method of the external drug preparation includes the following steps: weighing the raw materials according to the ratio, mixing and crushing the raw materials, and passing through an 80-mesh sieve for later use; heating malt sugar in a water bath, adding vinegar and stirring evenly, adding the above drug powder, stirring until it becomes a uniform thick paste, and evenly applying it to the entire external dressing.

4. The preparation method of the Chinese medicine composition according to claim 3, wherein the Chinese medicine composition for oral administration is characterized in that the amount of water used for soaking the tortoise shell is 150-250 parts, and the amount of water used for soaking other raw materials other than the tortoise shell is 800-1200 parts; the soaking time is 20-30 minutes; in step S2, the time for decocting product one is 30-40 minutes, and the decocting time after adding product two is 45-60 minutes.

5. The method for preparing the Chinese medicine composition according to claim 3, wherein the external medicine preparation is a Chinese medicine external acupuncture point application.

6. The method for preparing the Chinese medicine composition according to claim 5, wherein the external medicine is characterized in that the medicine preparation is an umbilical therapy patch.

7. Use of the Chinese medicine composition according to any one of claims 1 to 2 in the preparation of a medicament for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome.

8. Use of the oral and external pharmaceutical preparation according to any one of claims 3 to 6 in the preparation of a medicament for treating precocious puberty in children with spleen deficiency and phlegm stagnation syndrome.