Traditional Chinese medicine composition for treating infant sexual precocity caused by breast collateral obstruction

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, and particularly discloses a traditional Chinese medicine composition for treating infant sexual precocity caused by breast collateral obstruction. Comprising the following raw materials in parts by weight: 8-15 parts of szechwan chinaberry fruit, 8-15 parts of green tangerine peel, 8-12 parts of fructus aurantii, 8-15 parts of golden cypress, 8-15 parts of radix bupleuri, 8-15 parts of radix rehmanniae, 8-15 parts of radix scrophulariae, 8-15 parts of radix curcumae, 15-20 parts of tortoise shell, 8-15 parts of lithospermum, 10-20 parts of tangerine seed, 10-20 parts of semen litchi, 8-15 parts of selfheal, 8-15 parts of rhizoma anemarrhenae, 8-15 parts of radix gentianae and 5-10 parts of liquorice. According to the traditional Chinese medicine composition provided by the invention, the szechwan chinaberry fruit is used as a monarch drug, the radix bupleuri, the fructus aurantii, the radix curcumae and the pericarpium citri reticulatae viride are used as ministerial drugs, the tangerine seed, the lychee seed, the rhizoma anemarrhenae, the cortex phellodendri, the radix rehmanniae recen, the tortoise shell, the radix scrophulariae and the selfheal are used as assistants, and the radix gentianae, the lithospermum erythrorhizon and the liquorice are used as guides, so that through mutual compatibility of the drugs, the sexual precocity of sick children can be effectively inhibited, and the normal growth the final height of the child patient is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine compositions, and in particular relates to a traditional Chinese medicine composition for treating milk network obstruction type precocious puberty in children. Background Art

[0002] Precocious puberty is one of the most important diseases in the field of pediatric endocrinology. With the development of global social economy, the improvement of living standards and the influence of environmental factors, the incidence of precocious puberty has shown an increasing trend year by year. At present, the incidence of precocious puberty in children worldwide is 0.6%, of which the male to female ratio is about 1:5. The age of puberty development in children worldwide has been significantly advanced, and precocious puberty has ranked second among pediatric endocrine diseases, which seriously threatens children's physical and mental health and physical development, and seriously affects children's future physical fitness and quality.

[0003] Traditional Chinese medicine doesn't mention "precocious puberty" as a condition; it falls under the rubric of "breast disease," "breast disease," and "premature menstruation" in ancient texts. The ancients considered it abnormal for a girl to conceive before the age of fourteen. For example, the Chujishi book describes twelve women who became pregnant after the age of fourteen. The Huangdi Neijing Suwen (Suwen) states: "Discussion on Ancient Innocence": "At seven, a girl's kidney qi is strong, her teeth change, and her hair grows. At twenty-seven, the celestial essence arrives, the Ren meridian opens, the Taichong meridian flourishes, and menstruation occurs on time, allowing her to have children." "At eight, a man's kidney qi is strong, his hair grows, and his teeth change. At twenty-eight, his kidney qi is strong, the celestial essence arrives, and his essence and qi overflow, balancing yin and yang, allowing him to have children."

[0004] Traditional Chinese medicine treats precocious puberty in children primarily by "nourishing kidney yin and draining yang fire." The Suwen (Suwen) treatise on the Yingxiang of Yin and Yang states that "strong yang fire consumes qi, while weak yang fire generates qi," suggesting that excessive yang fire depletes vital qi, and that treatment should prioritize balancing yin and yang. The Suwen treatise on the Secret Classic of Linglan states that "the kidneys are the organ of strength and the source of skill," emphasizing that the kidneys are fundamental to growth, development, and sexual function, and that precocious puberty is directly linked to premature decline of kidney qi.

[0005] However, in the existing treatment theories, most of them are aimed at using drugs to treat children with liver-kidney yin deficiency and premature ejaculation of fire, and no empirical medication has been found for children with precocious puberty due to milk channel obstruction. Summary of the Invention

[0006] Clinical symptoms include breast development and internal and external genital development in girls, along with menstruation; and testicular and penis enlargement, a deepening voice, or erections in boys. These symptoms are accompanied by malar redness, hot flashes, night sweats, dizziness, restless fever, a red tongue with scanty coating, and a thready, rapid pulse. The syndrome of milk channel obstruction is caused by liver qi disharmony, qi stagnation, and the accumulation of phlegm and blood stasis, which block the milk channels. Clinically, symptoms include breast tenderness and palpable phlegm-like masses that are firm, smooth, and easily dislodged. Symptoms fluctuate with mood swings, a pale or dark tongue, and a wiry or slippery pulse. Symptoms may include chest and flank discomfort, sighing, depression, and irritability.

[0007] In view of the shortcomings of the existing technology, the present invention summarizes the clinically targeted medications for precocious puberty caused by milk network obstruction and provides a Chinese medicine composition and preparation method thereof. In terms of clinical efficacy, the present invention can not only effectively inhibit precocious puberty in children, but also maintain normal growth rate and improve the final height of children.

[0008] The technical solution of the present invention is as follows: a traditional Chinese medicine composition for treating precocious puberty in children due to milk duct obstruction, which comprises Toosendan fruit as the main medicine, bupleurum, fructus aurantii, turmeric and citrus peel as the auxiliary medicines, tangerine seed, litchi seed, rhizoma anemarrhenae, phellodendron, radix rehmanniae, tortoise shell, scrophulariae and prunella vulgaris as the auxiliary medicines, and gentian, lithospermum officinale and liquorice as the guiding medicines.

[0009] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 8-15 parts of Toosendan fruit, 8-15 parts of Citrus aurantium, 8-12 parts of Citrus aurantium, 8-15 parts of Phellodendron amurense, 8-15 parts of Bupleurum chinense, 8-15 parts of Rehmannia root, 8-15 parts of Scrophularia ningpoensis, 8-15 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 8-15 parts of Lithospermum officinale, 10-20 parts of Citrus aurantium, 10-20 parts of Litchi seed, 8-15 parts of Prunella vulgaris, 8-15 parts of Anemarrhena asphodeloides, 8-15 parts of Gentiana scabra and 5-10 parts of Licorice root.

[0010] Furthermore, the Chinese medicine composition for treating precocious puberty of children with milk network obstruction type includes the following raw materials in parts by weight: 8-10 parts of Toosendan fruit, 8-10 parts of green peel, 8-10 parts of Citrus aurantium, 8-10 parts of Phellodendron amurense, 8-10 parts of Bupleurum chinense, 8-10 parts of Rehmannia root, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 8-10 parts of Lithospermum officinale, 10-15 parts of Citrus aurantium, 10-15 parts of Litchi seed, 8-10 parts of Prunella vulgaris, 8-10 parts of Anemarrhena asphodeloides, and 8-15 parts of Gentiana scabra. And 5-10 parts of licorice.

[0011] Furthermore, the traditional Chinese medicine composition for treating precocious puberty in children due to milk network obstruction includes the following raw materials in parts by weight: 10-12 parts of Toosendan fruit, 12-15 parts of Citrus aurantium, 10-12 parts of Citrus aurantium, 12-15 parts of Phellodendron amurense, 12-15 parts of Bupleurum chinense, 12-15 parts of Rehmannia glutinosa, 12-15 parts of Scrophularia ningpoensis, 12-15 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 12-15 parts of Lithospermum erythrorhizon, 15-20 parts of Citrus aurantium, 15-20 parts of Litchi seed, 12-15 parts of Prunella vulgaris, 12-15 parts of Anemarrhena asphodeloides, 12-15 parts of Gentiana scabra and 5-6 parts of Licorice.

[0012] Furthermore, the traditional Chinese medicine composition for treating precocious puberty in children due to milk duct obstruction includes the following raw materials in parts by weight: 10 parts of Toosendan fruit, 10 parts of Citrus aurantium, 10 parts of Citrus aurantium, 10 parts of Phellodendron amurense, 10 parts of Bupleurum chinense, 10 parts of Rehmannia glutinosa, 10 parts of Scrophularia ningpoensis, 10 parts of Curcuma aromatica, 20 parts of Tortoise Shell, 10 parts of Lithospermum erythrorhizon, 15 parts of Citrus seed, 15 parts of Litchi seed, 10 parts of Prunella vulgaris, 10 parts of Anemarrhena asphodeloides, 8 parts of Gentiana scabra and 5 parts of Licorice.

[0013] Furthermore, in a traditional Chinese medicine composition for treating precocious puberty in children due to milk duct obstruction, the green peel is vinegar green peel, the Anemarrhena Rhizoma is salt Anemarrhena Rhizoma, the Phellodendron Amurense is salt Phellodendron Amurense, and the tortoise shell is vinegar tortoise shell.

[0014] Furthermore, the quality requirements of the API are as follows: Toosendan fruit: stir-fried, contains toosendanin (C 30 H 38 O 11 ) shall not be less than 0.040%-0.20%; Green peel: vinegar, contains hesperidin (C 28 H 34 O 15 ) shall not be less than 3.0%; Citrus aurantium: cut, containing naringin (C 27 H 32 O 14 ) shall not be less than 4.0%, neohesperidin (C 28 H 34 O 15 ) shall not be less than 3.0%; Huangbai: Salted, contains berberine and berberine hydrochloride (C 20 H 17 NO4·HCI) shall not be less than 3.0%, and the amount of phellodendron alkali shall be phellodendron alkali hydrochloride (C 20 H 23 NO4·HCI) shall not be less than 0.34%; Bupleurum: cut, containing saikosaponin a (C 42 H 68 O 13 ) and saikosaponin d(C 42 H 68 O 13 ) shall not be less than 0.30%; Raw Rehmannia root: cut, containing catalpa root (C 15 H 22 O 10 ) shall not be less than 0.20%, containing rehmannia glutinosa D(C 27 H 42 O 20 ) shall not be less than 0.10%; Scrophulariaceae: cut, containing harpagine (C 15 H 24 O 10 ) and harpagoside (C 24 H 30 O 11 ) shall not be less than 0.45%; Curcuma zedoaria: Cut, its moisture content shall not exceed 15.0% (General Rule 0832, Method 4); Turtle shell: Made with vinegar, the extract should not be less than 8.0%; Lithospermum officinale: cut, containing hydroxy naphthoquinone total pigment as L-shikonin (C 16 H 16 O5) shall not be less than 0.80%; Orange seeds: clean and select, crush when using; Lychee seeds: clean and crush before use; Prunella vulgaris: clean selection, containing rosmarinic acid (C 18 H 16 O8) shall not be less than 0.20%; Anemarrhena: Salt-processed, containing mangiferin (C 19 H 18 O 11 ) shall not be less than 0.50%, containing timosaponin B II (C 45 H 76 O 19 ) shall not be less than 3.0%; Gentiana: cut, containing gentiopicroside (C 16 H 20 O9) shall not be less than 2.0%; Licorice: cut, containing liquiritin (C 21 H 22 O9) shall not be less than 0.45%, containing glycyrrhizic acid (C 42 H 62 O 16 ) shall not be less than 1.80%.

[0015] The present invention also provides a method for preparing a traditional Chinese medicine composition for treating precocious puberty in children due to milk network obstruction, comprising the following steps: uniformly mixing all raw materials according to their weight fractions, adding water for decocting, filtering and concentrating after the decocting is completed, to obtain the composition.

[0016] Furthermore, the preparation method of the traditional Chinese medicine composition for treating precocious puberty in children due to milk network obstruction comprises the following steps: S1, soaking: taking vinegar tortoise shells according to the mass fraction, adding water to soak, to obtain product 1, taking other raw materials other than vinegar tortoise shells according to the mass fraction, adding water to soak, to obtain product 2; S2, decoction: first decoct product 1, then add product 2 and continue decoction; S3. After decoction is completed, filter and concentrate to obtain the product.

[0017] Furthermore, in step S1, the amount of water used for soaking the vinegar tortoise shell is 150-250 parts, and the amount of water used for soaking other raw materials other than the vinegar 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.

[0018] The present invention also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition for treating precocious puberty in children of milk channel obstruction type.

[0019] The pharmaceutical preparation is a decoction, granules, pills, tablets, powder or oral liquid. Preferably, the pharmaceutical preparation is a decoction.

[0020] The present invention also provides an application of the traditional Chinese medicine composition in preparing a medicine for treating precocious puberty in children with milk network obstruction type.

[0021] Those skilled in the art can directly or indirectly add the traditional Chinese medicine composition for treating precocious puberty in children with milk network obstruction to various commonly used pharmaceutically acceptable excipients required for preparing different dosage forms, such as disintegrants, wetting agents, adhesives, etc., and prepare common pharmaceutical preparations using conventional pharmaceutical preparation methods.

[0022] The preparation method of a Chinese medicinal composition decoction for treating precocious puberty in children due to milk network obstruction comprises the following steps:

[0023] Step (1) soaking: taking the vinegar tortoise shell according to the mass fraction, adding 150-250 parts of water and soaking for 30 minutes, so that the medicinal material can fully absorb water, to obtain product 1; taking the other raw materials other than the vinegar tortoise shell according to the mass fraction, adding 800-1200 parts of water and soaking for 30 minutes, so that the medicinal material can fully absorb water, to obtain product 2;

[0024] Step (2) decoction: first decoct product 1 for 30-40 minutes, then add product 2 and continue decoction for 45-60 minutes;

[0025] Step (3) filtration: After the decoction is completed, the medicinal liquid is filtered to separate the medicinal residue and the medicinal liquid to obtain the original medicinal liquid;

[0026] Step (4) concentration: the original drug solution obtained in step (3) is concentrated to 720 parts of drug solution;

[0027] Step (5) Packaging: 720 portions of the medicinal solution obtained in step (4) are packaged into bags of 120 ml each, with six bags constituting one dose, to obtain the decoction.

[0028] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects:

[0029] The efficacy of the described raw material medicine is as follows:

[0030] Toosendan fruit: Bitter and cold. It enters the liver, small intestine, and bladder meridians. Its effects include soothing the liver, relieving heat, promoting qi circulation, and alleviating pain. This bitter, cold, and purging herb can clear liver fire and promote qi circulation, relieving pain. It is an excellent remedy for pain caused by liver depression and qi stagnation, and is particularly effective in treating symptoms of liver depression transforming into fire.

[0031] Qingpi: Bitter, pungent, and warming. It enters the Liver, Gallbladder, and Stomach meridians. Its effects include soothing the liver, dispersing qi, and dissolving stagnation. This bitter, pungent, and warming herb has a potent effect on the liver, effectively regulating liver and gallbladder qi. It is particularly effective for treating liver depression and qi stagnation, chest and flank pain, breast lumps, and painful mastitis.

[0032] Citrus aurantium: Bitter, pungent, sour, and slightly cold. It enters the spleen and stomach meridians. It promotes qi and resolves phlegm to eliminate abdominal distension, dissipates qi and relieves fullness, and relieves pain. According to the "Compendium of Materia Medica," this herb is used to treat chest pain, food accumulation in the five diaphragms, phlegm accumulation, and edema and swelling in the ribs.

[0033] 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."

[0034] Bupleurum: Pungent, bitter, and slightly cold. It enters the liver, gallbladder, and lung meridians. Its effects include dispersing and reducing fever, soothing the liver and relieving depression, and elevating Yang Qi. According to the "Compendium of Materia Medica," Bupleurum treats sunken Yang Qi, guiding clear Qi upward and calming pathogenic heat in the Shaoyang and Jueyin meridians. It promotes the flow of Qi and blood, dissipates stagnation, and regulates menstruation. (Note: People only know that Bupleurum can dissipate external energy, but are not aware of its greater internal harmonization. Therefore, it is often used in fatigue-inducing and blood-clearing medicines.)

[0035] Raw 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.

[0036] 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."

[0037] Curcuma: Pungent, bitter, and cold. It enters the Liver, Gallbladder, Heart, and Lung meridians. Its effects include promoting blood circulation and relieving pain, promoting Qi and relieving depression, clearing the heart and cooling the blood, and promoting bile secretion and relieving jaundice. It treats chest pain and chest and rib pain caused by Qi and blood stagnation.

[0038] Turtle Shell: 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."

[0039] 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.

[0040] Tangerine Seed: Bitter, neutral. Enters the Liver and Kidney meridians. Its effects include regulating Qi, dispersing stagnation, and relieving pain. Suitable for testicular swelling and pain, mastitis, and breast abscesses.

[0041] Litchi seed: Sweet, slightly bitter, and warm. It enters the liver and kidney meridians. Its benefits include promoting qi circulation, dispersing stagnation, and relieving pain. This product, with its pungent, bitter, and purgative properties, is warm and dispels cold. It primarily enters the liver meridian, promoting liver qi, dispersing stagnation and reducing swelling, and dispelling cold and relieving pain. It can be used in combination with gentian, Toosendan fruit, and Phellodendron amurense for treating testicular swelling and pain due to damp-heat.

[0042] 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.

[0043] 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.

[0044] 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 scabra significantly inhibits the activity of the steroid Δ4-reductase in hyperthyroid rats, suggesting that Gentiana scabra 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.

[0045] Licorice: Sweet, neutral. It enters the Heart, Lung, Spleen, and Stomach meridians. Its effects include tonifying the spleen and replenishing Qi, clearing away heat and detoxifying, relieving pain, and harmonizing various other medicinal ingredients.

[0046] The commentary on Jinlingzi San in the "Selected Annotations to Jiangxueyuan Ancient Prescriptions" states: "All pains belong to the heart, while heat syncope belongs to liver reversal. Jinlingzi not only relieves the liver, but also specifically guides away heat from the small intestine and bladder, guiding the pericardium fire downward." Therefore, the inventors secretly combined Jinlingzi with Zhiqiao, Bupleurum, and Curcuma to form Sini San, which can relieve breast distension and pain, chest and flank discomfort. Prunella vulgaris replenishes liver blood, relieves liver fire, resolves internal heat, disperses qi stagnation, and eliminates phlegm nodules and lumps. Although the symptoms are seen in the liver, the disease is actually rooted in the kidneys, so the liver and kidneys are treated together. The foot Shaoyin Kidney Meridian and the foot Jueyin Liver Meridian both run along the inner side of the lower limbs and intersect at the Sanyinjiao point. Both meridians belong to the Chong Meridian. With the help of Anemarrhena, Phellodendron, Tortoise Shell, and Scrophularia, it is modified from Dabuyin Pills. The easily nourishing Rehmannia is replaced with Raw Rehmannia to increase its ability to clear heat and cool blood. The vinegar and Tortoise Shell, which are combined with blood and flesh, nourish Yin and suppress Yang, strengthen water to nourish the foundation. In addition, Anemarrhena, Phellodendron, Raw Rehmannia, Scrophularia, and Zexie imitate the purpose of Zhibai Dihuang Pills to purge the fire, consolidate kidney yin to clear the source.

[0047] The treatment concept of this prescription embodies the holistic treatment concept and dialectical treatment principle of traditional Chinese medicine, providing children with more accurate and effective treatment plans, and making an important contribution to making up for the shortcomings of existing technologies.

[0048] In terms of clinical effects, the present invention can not only effectively inhibit precocious puberty in children, but also maintain the normal growth rate of children and improve the final height of children. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 It is the central diagram of cluster analysis of the Chinese medicine composition of the present invention.

[0050] Figure 2 This is a cluster analysis regression simulation of the Chinese medicine composition of the present invention.

[0051] Figure 3 This is a schematic diagram of the prescription for a patient in typical case report 1 of the present invention.

[0052] Figure 4 This is a schematic diagram of the prescription for the patient in the typical case report 2 of the present invention.

[0053] Figure 5 This is a schematic diagram of the prescription for patient 3 in the typical case report of the present invention. DETAILED DESCRIPTION

[0054] 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.

[0055] 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.

[0056] 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.

[0057] The present invention fully incorporates the principles of "differentiation and treatment based on syndrome differentiation," "dosage tailored to symptoms," and "three-factor-based treatment." The present invention proposes a traditional Chinese medicine composition for treating precocious puberty in children due to milk channel obstruction, taking into account the properties, compatibility, dosage form, and applicable children of the traditional Chinese medicine composition and the raw materials. The formula comprises Toosendan fruit as the monarch ingredient, Bupleurum chinense, Citrus aurantium, Curcuma aromatica, and Citrus aurantium as assistant ingredients, Tangerine seed, Litchi seed, Anemarrhena asphodeloides, Phellodendron chinense, Radix Rehmanniae, Carapax tricolor, Scrophulariae ningpoensis, and Herba Prunellae as adjuvant ingredients, and Gentiana scabra, Lithospermum officinale, and Licorice root as guiding ingredients.

[0058] The invention is composed of the following raw materials in parts by weight: 8-15 parts of Toosendan fruit, 8-15 parts of Citrus aurantium, 8-12 parts of Citrus aurantium, 8-15 parts of Phellodendron amurense, 8-15 parts of Bupleurum chinense, 8-15 parts of Rehmannia root, 8-15 parts of Scrophularia ningpoensis, 8-15 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 8-15 parts of Lithospermum officinale, 10-20 parts of Citrus aurantium, 10-20 parts of Litchi seed, 8-15 parts of Prunella vulgaris, 8-15 parts of Anemarrhena asphodeloides, 8-15 parts of Gentiana scabra, and 5-10 parts of Licorice root.

[0059] 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.

[0060] Example 1:

[0061] The Chinese medicine composition for treating precocious puberty in children due to milk channel obstruction is as follows: stir-fried Toosendan fruit 10g, vinegar-soaked green peel 10g, Citrus aurantium 10g, salted Phellodendron chinense 10g, Bupleurum 10g, Rehmannia glutinosa 10g, Scrophularia ningpoensis 10g, Curcuma 10g, vinegar-soaked tortoise shell 20g, Lithospermum officinale 10g, citrus seed 15g, litchi seed 15g, Prunella vulgaris 10g, salted Anemarrhena 10g, Gentiana 10g, and liquorice 5g.

[0062] Preparation of a Chinese medicine composition for treating premature puberty of children with milk network obstruction type: (1) Soaking: Take the vinegar tortoise shell according to the formula and add 200ml of water to soak for 20min, so that the medicinal material can fully absorb water, to obtain product 1; Take the other raw materials other than the vinegar tortoise shell according to the formula and add 1000ml of water to soak for 20min, so that the medicinal material can fully absorb water, to obtain product 2. (2) Decoction: First, decoct product 1 for 30min, then add product 2 and continue to decoct for 60min; (3) Filtration: After decoction is completed, filter to separate the medicinal liquid from the medicinal residue to obtain the original medicinal liquid; (4) Concentration: Concentrate the original medicinal liquid obtained in step (3) to 720ml of medicinal liquid; (5) Packaging: Pack the 720ml medicinal liquid obtained in step (4) into bags of 120ml each, six bags as one dose, take three times a day, and take one dose every two days.

[0063] Example 2:

[0064] The Chinese medicine composition for treating precocious puberty in children due to milk channel obstruction is as follows: stir-fried Toosendan fruit 8g, vinegar-soaked green peel 8g, Citrus aurantium 8g, salted Phellodendron 8g, Bupleurum 8g, Rehmannia glutinosa 8g, Scrophularia 8g, Curcuma 8g, vinegar-soaked tortoise shell 15g, Lithospermum officinale 8g, citrus seed 10g, litchi seed 10g, Prunella vulgaris 8g, salted Anemarrhena 8g, Gentiana 8g, and Licorice 5g.

[0065] Preparation of a Chinese medicine composition for treating premature puberty of children with milk network obstruction type: (1) Soaking: Take the tortoise shell with vinegar according to the formula and add 150ml of water to soak for 20min, so that the medicinal material can fully absorb water, to obtain product 1; Take the other raw materials other than the tortoise shell with vinegar according to the formula and add 900ml of water to soak for 30min, so that the medicinal material can fully absorb water, to obtain product 2. (2) Decoction: First decoct product 1 for 30min, then add product 2 and continue to decoct for 45min; (3) Filtration: After decoction is completed, filter to separate the medicinal liquid from the medicinal residue to obtain the original medicinal liquid; (4) Concentration: Concentrate the original medicinal liquid obtained in step (3) to 600ml of medicinal liquid; (5) Packaging: Pack the 600ml medicinal liquid obtained in step (4) into bags of 100ml each, six bags as one dose, take three times a day, and take one dose every two days.

[0066] Example 3:

[0067] The Chinese medicine composition for treating precocious puberty in children due to milk channel obstruction is as follows: stir-fried Toosendan fruit 12g, vinegar-soaked green peel 12g, Citrus aurantium 12g, salted Phellodendron chinense 12g, Bupleurum 12g, Rehmannia glutinosa 12g, Scrophularia ningpoensis 12g, Curcuma 12g, vinegar-soaked tortoise shell 20g, Lithospermum officinale 12g, citrus seed 15g, litchi seed 15g, Prunella vulgaris 12g, salted Anemarrhena 12g, Gentiana 10g, and Licorice 5g.

[0068] Preparation of a Chinese medicine composition for treating premature puberty of children with milk network obstruction type: (1) Soaking: Take the vinegar tortoise shell according to the formula and add 200ml of water to soak for 20 minutes to allow the medicinal material to fully absorb water, thereby obtaining product 1; take the other raw materials other than the vinegar tortoise shell according to the formula and add 1200ml of water to soak for 30 minutes to allow the medicinal material to fully absorb water, thereby obtaining product 2. (2) Decoction: First, decoct product 1 for 30 minutes, then add product 2 and continue to decoct for 60 minutes; (3) Filtration: After decoction is completed, filter to separate the medicinal liquid from the medicinal residue to obtain the original medicinal liquid; (4) Concentration: Concentrate the original medicinal liquid obtained in step (3) to 900ml of medicinal liquid; (5) Packaging: Pack the 900ml medicinal liquid obtained in step (4) into bags of 150ml each, with six bags as one dose, and take 3 times a day, or one dose every two days.

[0069] Clinical observation report on the Chinese medicine composition of the present invention for treating precocious puberty in children due to milk network obstruction

[0070] Diagnostic Criteria: Traditional Chinese Medicine (TCM) Diagnostic and Differentiating Standards (refer to "Chinese Medicine Pediatrics" (4th Edition) and "TCM Clinical Diagnosis and Treatment Terminology, Part 2: Syndromes"). Main symptoms: Breast development and internal and external genitalia in girls, or menstruation; testicular and penile enlargement, deepening of the voice, or erection in boys. Accompanied by malar redness, hot flashes, night sweats, dizziness, and fever in the five hearts. A red tongue with scanty coating and a thready, rapid pulse. The symptoms of milk channel obstruction are caused by liver qi disharmony, qi stagnation, and the accumulation of phlegm and blood stasis, which block the milk channel. Clinically, symptoms include breast tenderness and palpable phlegm-like masses with a firm, smooth surface that can be moved with push. Symptoms fluctuate with mood swings. A pale or dark tongue and a wiry or slippery pulse may be present. Symptoms include chest and flank discomfort, sighing, depression, and irritability.

[0071] Research methods: This study included 191 children with precocious puberty due to milk network obstruction who were seen in the inventor's clinic, with a total of 458 visits and 458 prescriptions. The general information, basic conditions, syndrome distribution, tongue images, and TCM syndrome scores before and after TCM treatment of the children were collected to evaluate the therapeutic effect of the Chinese medicine composition of the present invention on precocious puberty in children.

[0072] Syndrome scoring: A scoring scale for precocious puberty in children was developed with reference to the relevant standards of "Terminology for Clinical Diagnosis and Treatment of Traditional Chinese Medicine Part 2: Syndromes" and "Guiding Principles for Clinical Research of New Chinese Medicines". The treatment effect was calculated using the nimodipine method: efficacy index (n) = (pre-treatment score - post-treatment score) / pre-treatment score * 100%.

[0073] Cure: All symptoms disappear after treatment, n≥95%.

[0074] Markedly effective: All symptoms were significantly relieved after treatment, 70%≤n<95%.

[0075] Effective: All symptoms were relieved after treatment, 30%≤n<70%.

[0076] Ineffective: Symptoms did not improve or worsened after treatment, n < 30%.

[0077] Clinical effect score:

[0078] Table 1: Clinical treatment effect statistics Effect cure Significantly effective efficient invalid number of people 158 23 10 0 Effectiveness (%) 82.73％ 12.04％ 5.23％ 0

[0079] Cluster analysis of clinical medication: Using the "Traditional Chinese Medicine Inheritance Assistance Platform (V3.0)" software, the core combination of 76 drugs in 458 prescriptions was extracted, the "number of clusters" option was adjusted to 4, and unsupervised cluster analysis was performed. The analysis of 458 prescriptions resulted in 3 cluster centers and 5 cluster combinations, which were sorted according to frequency. See Table 2 for details. Figure 1 and Figure 2 The colors in the figure distinguish different groups, and the number of points of different colors is related to the number of prescriptions. The degree of proximity to the curve and the density represent the distance from the cluster center.

[0080] Table 2: Drug combinations included in the cluster analysis of prescriptions for "milk channel obstruction type" Serial number Drug composition 1 Bupleurum, Citrus aurantium, Curcuma aromatica, Prunella vulgaris 2 Toosendan fruit, Citrus aurantium, Bupleurum root, Citrus aurantium 3 Tangerine seeds, lychee seeds, Prunella vulgaris, Lithospermum officinale 4 Tortoise shell, Anemarrhena asphodeloides, Scrophularia ningpoensis, Gentiana scabra, Rehmannia root 5 Bupleurum, Anemarrhena, Prunella Vulgaris, Tortoise Shell, Scrophularia

[0081] Typical case report 1:

[0082] Patient: Yang Moumou, female, 6 years and 1 month old

[0083] The child was first diagnosed on June 7, 2022, and complained of bilateral breast pain for more than 2 years. She had been treated in a local hospital and diagnosed with "precocious puberty". She was given "Zhi Bai Di Huang Wan" orally for 3 months, but the effect was still poor. At the time of consultation, bilateral breasts were developed, breast nuclei could be touched, hard, and accompanied by obvious tenderness. There was no growth of axillary hair or pubic hair, and no abnormal vaginal secretions. She usually had spontaneous sweating and night sweats, impatience and irritability, a strong appetite, good appetite, and normal bowel movements. She had good nutrition in the past, no history of chronic liver and kidney diseases, no history of special medications, no history of psychological diseases, and vaccinations were given on time as needed.

[0084] Family history: The mother began menstruating at 14 years old, with periods lasting 3-5 days and 30-35 days, and had one gestational age and one child. Neither parent had delayed puberty. The father was 174 cm tall, the mother 160 cm tall, and no male in the family was shorter than 160 cm, nor was any female shorter than 150 cm.

[0085] Physical examination: The child was 132.0 cm tall and weighed 33.5 kg. There was no difference in facial features and body shape. The sexual development stage was Tanner stage III.

[0086] Ancillary examinations: On June 4, 2022, a breast ultrasound examination at Kaiyuan People's Hospital revealed breast nuclei in both breasts. A six-item sexual examination revealed prolactin: 455.8 ng / mL, luteinizing hormone: 2.8 mIU / mL, follicle-stimulating hormone: 3.25 mIU / mL, estradiol: 16.14 pg / mL, and progesterone: 0.48 ng / mL.

[0087] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention. The decoction was prepared according to the method described in "Example 1". The decoction was taken once every two days, three times in the morning, noon and evening. The prescription is detailed in Figure 3 , a total of 3 courses of medication, 6 doses per course.

[0088] Follow-up and Outcome: On September 30, 2022, the patient returned to our hospital for a follow-up examination. The breasts were tender and nontender to the touch, with no growth of axillary or pubic hair. There was no abnormal vaginal discharge. The patient had grown significantly in height by 8 cm and lost 3 kg. The patient's current height was 140 cm and weight was 30.5 kg.

[0089] Typical case report 2:

[0090] Patient: Yan Moumou, female, 1 year and 7 months old

[0091] The patient was first seen on September 10, 2019, complaining of bilateral breast nodules for over a year. She had previously been treated at Kunming Children's Hospital and diagnosed with precocious puberty. At the time of presentation, she had bilateral breast lumps with adequate mobility and a shallow margin. Pressure was tender and she cried. She had no axillary or pubic hair growth, and no abnormal vaginal discharge. She had a poor appetite, insomnia, and preferred to sleep on her stomach. Her bowel movements were dry at first but then loose, with two bowel movements per day, and her urination was regular. She had good nutrition, no history of chronic liver or kidney disease, no special medications, and all vaccinations were up to date and as needed.

[0092] Family history: The mother's menstruation began at age 12, with a 5-7 day / 28 day gestational age of one and a single birth. Neither parent had delayed puberty. The father was 170 cm tall, the mother 158 cm tall, and no male in the family was shorter than 160 cm, nor was any female shorter than 150 cm.

[0093] Physical examination: There were no special features in facial features and body shape, and the sexual development stage was Tanner stage III.

[0094] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention. The decoction was prepared according to the method described in "Example 2". The decoction was taken once every two days, three times in the morning, noon and evening. The prescription is detailed in Figure 4 , a total of 2 courses of medication were taken, with 6 doses per course.

[0095] Follow-up and outcome: On October 22, 2022, the patient came to our hospital for a follow-up examination. There was no progressive development of the bilateral breasts, the breasts were soft and non-tender to the touch, the bilateral lumps disappeared, there was no growth of axillary hair and pubic hair, and no abnormal vaginal secretions were found.

[0096] Typical case report 3:

[0097] Patient: Wang Moumou, female, 7 years old

[0098] The child was first diagnosed on September 8, 2024, with the chief complaint of precocious puberty, which had been diagnosed at another hospital more than a year earlier. The child's parents reported that they had discovered bilateral breast development and tenderness in their child a year prior. They were diagnosed with precocious puberty at the Children's Hospital and the symptoms were alleviated after taking Xiaoyao Pills. Over the past two months, after consuming excessive amounts of junk food, the child's breasts have shown progressive development, with prominent breast contours, firm texture, and significant tenderness. The breast nucleus is palpable, but no axillary or pubic hair growth is observed, and no abnormal vaginal discharge is observed. The child has a stuffy nose, mouth breathing, impatience and irritability, but a good appetite and sleep, bowel movements every 2-3 days, and regular urination.

[0099] Past medical history: Henoch-Schonlein purpura, specific treatment course unknown.

[0100] Family history: The mother's menstruation began at age 14, lasting 6-7 days and 28-30 days, with two pregnancies and two births. Neither parent had delayed puberty. The father was 178 cm tall, the mother 163 cm tall, and no male in the family was shorter than 160 cm, nor was any female shorter than 150 cm.

[0101] Physical examination: The child was 140.3 cm tall and weighed 32 kg. There was no difference in facial features and body shape. The sexual development stage was Tanner stage IV.

[0102] Ancillary Examinations: On April 9, 2024, a breast ultrasound examination at Kunming Children's Hospital revealed breast nuclei in both breasts. A six-item sexual examination revealed prolactin: 123.7 ng / mL, luteinizing hormone: 0.24 mIU / mL, follicle-stimulating hormone: 2.85 mIU / mL, estradiol: 18.40 pg / mL, progesterone: 0.16 ng / mL, and testosterone: 0.09 nmol / L. A GH stimulation test revealed 25-hydroxyvitamin D: 44.93 nmol / L, adrenocorticotropic hormone: 8.61 pg / mL, and cortisol: 110.5 nmol / L.

[0103] Clinical cases were included and the children were treated with the Chinese medicine composition of the present invention. The decoction was prepared according to the method described in "Example 3". The decoction was taken once every two days, three times in the morning, noon and evening. The prescription is detailed in Figure 5 , a total of 1 course of medication, 6 doses per course.

[0104] Follow-up and Outcome: On September 22, 2024, a follow-up examination at our hospital revealed no progressive breast development, tenderness to the touch, no growth of axillary or pubic hair, and no abnormal vaginal discharge. Her height had increased significantly by 1.5 cm. Her current height was 141.8 cm, and her weight was 32 kg. On September 15, 2024, a follow-up examination at the Jinning District People's Hospital in Kunming revealed the following six sex hormone levels: prolactin: 4.54 ng / mL, luteinizing hormone: <0.07 mIU / mL, follicle-stimulating hormone: 4.39 mIU / mL, estradiol: 21.37 pg / mL, progesterone: 0.29 ng / mL, and testosterone: 8.48 nmol / L.

[0105] 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 make equivalent replacements for some or all of the technical features therein. Any equivalent replacements or changes based on the technical solutions and inventive concepts of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating precocious puberty in children due to milk network obstruction, characterized in that: The invention comprises the following raw materials in parts by weight: 8-15 parts of Toosendan fruit, 8-15 parts of Citrus aurantium, 8-12 parts of Citrus aurantium, 8-15 parts of Phellodendron amurense, 8-15 parts of Bupleurum chinense, 8-15 parts of Rehmannia root, 8-15 parts of Scrophularia ningpoensis, 8-15 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 8-15 parts of Lithospermum erythrorhizon, 10-20 parts of Citrus seed, 10-20 parts of Litchi seed, 8-15 parts of Prunella vulgaris, 8-15 parts of Anemarrhena asphodeloides, 8-15 parts of Gentiana scabra and 5-10 parts of Licorice.

2. The Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 8-10 parts of Toosendan fruit, 8-10 parts of Citrus aurantium, 8-10 parts of Citrus aurantium, 8-10 parts of Phellodendron amurense, 8-10 parts of Bupleurum chinense, 8-10 parts of Rehmannia root, 8-10 parts of Scrophularia ningpoensis, 8-10 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 8-10 parts of Lithospermum erythrorhizon, 10-15 parts of Citrus seed, 10-15 parts of Litchi seed, 8-10 parts of Prunella vulgaris, 8-10 parts of Anemarrhena asphodeloides, 8-15 parts of Gentiana scabra and 5-10 parts of Licorice root.

3. The Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 10-12 parts of Toosendan fruit, 12-15 parts of Citrus aurantium, 10-12 parts of Citrus aurantium, 12-15 parts of Phellodendron amurense, 12-15 parts of Bupleurum chinense, 12-15 parts of Rehmannia root, 12-15 parts of Scrophularia ningpoensis, 12-15 parts of Curcuma aromatica, 15-20 parts of Tortoise shell, 12-15 parts of Lithospermum erythrorhizon, 15-20 parts of Citrus seed, 15-20 parts of Litchi seed, 12-15 parts of Prunella vulgaris, 12-15 parts of Anemarrhena asphodeloides, 12-15 parts of Gentiana scabra and 5-6 parts of Licorice root.

4. The Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 10 parts of Toosendan fruit, 10 parts of Citrus aurantium, 10 parts of Citrus aurantium, 10 parts of Phellodendron amurense, 10 parts of Bupleurum chinense, 10 parts of Rehmannia glutinosa, 10 parts of Scrophularia ningpoensis, 10 parts of Curcuma aromatica, 20 parts of Tortoise shell, 10 parts of Lithospermum officinale, 15 parts of Citrus aurantium, 15 parts of Litchi seed, 10 parts of Prunella vulgaris, 10 parts of Anemarrhena asphodeloides, 8 parts of Gentiana scabra and 5 parts of Licorice.

5. The Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claims 1-4, characterized in that: The green peel is vinegar green peel, the Anemarrhena Rhizoma is salt Anemarrhena Rhizoma, the Phellodendron Amurense is salt Phellodendron Amurense, and the tortoise shell is vinegar tortoise shell.

6. The Chinese medicinal composition for treating precocious puberty in children due to milk network obstruction according to claims 1-4, characterized in that: The quality requirements for APIs are as follows: Toosendan fruit: stir-fried, contains toosendanin (C 30 H 38 O 11 ) shall not be less than 0.040%-0.20%; Green peel: vinegar, contains hesperidin (C 28 H 34 O 15 ) shall not be less than 3.0%; Citrus aurantium: cut, containing naringin (C 27 H 32 O 14 ) shall not be less than 4.0%, neohesperidin (C 28 H 34 O 15 ) shall not be less than 3.0%; Huang Bai: Salted, contains berberine and berberine hydrochloride (C 20 H 17 NO4·HCI) shall not be less than 3.0%, and the amount of phellodendron alkali shall be phellodendron alkali hydrochloride (C 20 H 23 NO4·HCI) shall not be less than 0.34%; Bupleurum: cut, containing saikosaponin a (C 42 H 68 O 13 ) and saikosaponin d(C 42 H 68 O 13 ) shall not be less than 0.30%; Raw Rehmannia root: cut, containing catalpa root (C 15 H 22 O 10 ) shall not be less than 0.20%, containing rehmannia glutinosa D(C 27 H 42 O 20 ) shall not be less than 0.10%; Scrophulariaceae: cut, containing harpagine (C 15 H 24 O 10 ) and harpagoside (C 24 H 30 O 11 ) shall not be less than 0.45%; Curcuma zedoaria: Cut, its moisture content shall not exceed 15.0% (General Rule 0832, Method 4); Turtle shell: Made with vinegar, the extract should not be less than 8.0%; Lithospermum officinale: cut, containing hydroxy naphthoquinone total pigment as L-shikonin (C 16 H 16 O5) shall not be less than 0.80%; Orange seeds: clean and select, crush when using; Lychee seeds: clean and crush before use; Prunella vulgaris: clean selection, containing rosmarinic acid (C 18 H 16 O8) shall not be less than 0.20%; Anemarrhena: Salt-processed, containing mangiferin (C 19 H 18 O 11 ) shall not be less than 0.50%, containing timosaponin B II (C 45 H 76 O 19 ) shall not be less than 3.0%; Gentiana: cut, containing gentiopicroside (C 16 H 20 O9) shall not be less than 2.0%; Licorice: cut, containing liquiritin (C 21 H 22 O9) shall not be less than 0.45%, containing glycyrrhizic acid (C 42 H 62 O 16 ) shall not be less than 1.80%.

7. The method for preparing the Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claims 1-6, characterized in that: The method comprises the following steps: uniformly mixing all raw materials according to weight proportions, adding water for decoction, filtering and concentrating after decoction is completed, and obtaining the product.

8. The method for preparing the Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claim 7, characterized in that: The following steps are involved: S1, soaking: taking the vinegar tortoise shell according to the mass fraction, adding water to soak, to obtain product 1, taking the other raw materials other than the vinegar tortoise shell according to the mass fraction, adding water to soak, to obtain product 2; S2, decoction: first decoct product 1, then add product 2 and continue decoction; S3. After decoction is completed, filter and concentrate to obtain the product.

9. The method for preparing the Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to claim 8, characterized in that: In step S1, the amount of water used for soaking the vinegar tortoise shell is 150-250 parts, and the amount of water used for soaking other raw materials other than the vinegar 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.

10. A pharmaceutical preparation, characterized in that: A Chinese medicine composition for treating precocious puberty in children due to milk network obstruction according to any one of claims 1 to 6.

11. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicine for treating precocious puberty in children due to milk network obstruction.

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