Traditional chinese medicine composition, preparation method therefor, and use thereof

Abstract

A traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 7-13 parts of Acori Tatarinowii Rhizoma, 14-22 parts of Curcuma phaeocaulis, 14-22 parts of Cuscuta chinensis, 11-19 parts of oyster, 18-30 parts of Verbena officinalis, 12-19 parts of Schisandra chinensis, 14-22 parts of Poria cocos, 24-37 parts of Rhizoma Dioscoreae Hypoglaucae, 4-8 parts of licorice, and 4-9 parts of Indigo naturalis. The traditional Chinese medicine composition tonifies the kidney to consolidate the essence, and treats osteoporosis and prostatitis.

Description

A traditional Chinese medicine composition, its preparation method and application Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Osteoporosis (OP) is a systemic metabolic skeletal disease characterized by decreased bone mass and destruction of bone microstructure, resulting in increased bone fragility and a higher risk of fractures. It primarily affects postmenopausal women and elderly men. Current treatments for osteoporosis mainly focus on long-term oral calcium supplements, vitamin D supplementation, or bisphosphonates, calcitonin injections or related hormones, traditional Chinese medicine, and exercise. Osteoporosis is a chronic disease with a long treatment period, and long-term medication or injections can place a significant burden on the patient's body.

[0003] Chronic prostatitis / chronic pelvic pain syndrome (CP / CPPS) refers to chronic inflammation of the prostate tissue caused by various etiologies, and is the most common type of prostatitis. The main clinical manifestations include dysuria, urinary frequency, lower back pain, and premature ejaculation, with some patients also experiencing depression and anxiety. The pathogenesis of CP / CPPS is not yet fully understood. Some researchers believe that the disease is caused by multiple factors, such as infection, neuropsychological factors, immune disorders, oxidative stress, intraprostatic duct reflux, and pelvic floor muscle abnormalities. It is prone to recurrence, severely impacting patients' quality of life and making clinical treatment challenging.

[0004] Currently, modern medicine aims to control symptoms, not cure, chronic prostatitis (CP / CPPS) in its treatment. Clinically, antibiotics, alpha-adrenergic receptor blockers, nonsteroidal anti-inflammatory drugs (NSAIDs), and some herbal preparations are commonly used. Antibiotics are currently the first-line treatment for chronic prostatitis, showing good efficacy against bacterial factors and certain microbial infections. However, due to the prostate's unique anatomical structure, drugs sometimes have difficulty penetrating the gland to exert their therapeutic effect, and long-term use of antibiotics can easily lead to drug resistance and intestinal flora imbalance. Alpha-adrenergic receptor blockers can reduce the hyperresponsiveness of adrenergic nerves, showing some effect in relieving pelvic pain and lower urinary tract obstruction. However, their adverse reactions and high price limit their use, and their efficacy remains controversial. NSAIDs and some herbal preparations have some effect in relieving symptoms such as pain and discomfort.

[0005] Traditional Chinese medicine has unique advantages in the treatment of chronic prostatitis. Traditional Chinese medicine classifies chronic prostatitis into the categories of "jingzhuo", "baiyin", "linzheng", etc. according to its main clinical manifestations. The pathogenesis is deficiency in origin and excess in superficiality. Kidney deficiency, spleen deficiency, damp-heat, qi stagnation, and blood stasis are considered the main pathogenic factors. The treatment mostly starts from both deficiency and excess, with the main principle of strengthening the healthy qi and eliminating pathogenic factors.

[0006] Cui Hongliang disclosed a traditional Chinese medicine composition in the clinical study on the urodynamic effects of Baojing Tablets on patients with chronic prostatitis (Nanjing University of Traditional Chinese Medicine, 2006, dissertation). The prescription composition of this traditional Chinese medicine composition is 10 traditional Chinese medicines, namely indigo naturalis, dodder seed, oyster, licorice root, schisandra fruit, dioscorea septemlobata, verbena officinalis, poria cocos, acorus tatarinowii, and zedoary turmeric. It was initially proved to be effective for chronic prostatitis. Although this technology only analyzed the single traditional Chinese medicines of Baojing Tablets, it did not give the specific dosages of each medicine, nor the compatibility relationship of monarch, minister, assistant, and guide, nor the treatment guidance related to osteoporosis.

[0007] At present, there is an urgent need to provide a traditional Chinese medicine composition with better efficacy in treating chronic prostatitis and also having the function of treating osteoporosis at the same time. Summary of the Invention

[0008] In order to solve the above technical problems, the object of the present invention is to provide a traditional Chinese medicine composition, its preparation method and application. This traditional Chinese medicine composition has better efficacy for prostatitis and also has the function of treating osteoporosis at the same time.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] In the first aspect, the present invention provides a traditional Chinese medicine composition, which is made from the following raw materials in parts by weight: acorus tatarinowii 7 - 13 parts, zedoary turmeric 14 - 22 parts, dodder seed 14 - 22 parts, oyster 11 - 19 parts, verbena officinalis 18 - 30 parts, schisandra fruit 12 - 19 parts, poria cocos 14 - 22 parts, dioscorea septemlobata 24 - 37 parts, licorice root 4 - 8 parts, and indigo naturalis 4 - 9 parts.

[0011] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: acorus tatarinowii 9 - 11 parts, zedoary turmeric 16 - 20 parts, dodder seed 16 - 20 parts, oyster 13 - 17 parts, verbena officinalis 21 - 25 parts, schisandra fruit 14 - 17 parts, poria cocos 16 - 20 parts, dioscorea septemlobata 27 - 33 parts, licorice root 4 - 8 parts, and indigo naturalis 5 - 8 parts; preferably, acorus tatarinowii 9 - 11 parts, zedoary turmeric 16 - 20 parts, dodder seed 16 - 20 parts, oyster 13 - 17 parts, verbena officinalis 21 - 25 parts, schisandra fruit 14 - 17 parts, poria cocos 16 - 20 parts, dioscorea septemlobata 30 parts, licorice root 4 - 8 parts, and indigo naturalis 5 - 8 parts.

[0012] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 8-10 parts of Acorus tatarinowii, 17-19 parts of Curcuma zedoaria, 16-19 parts of Cuscuta chinensis, 13-16 parts of Ostrea gigas, 23-25 ​​parts of Verbena officinalis, 14-16 parts of Schisandra chinensis, 17-19 parts of Poria cocos, 29-31 parts of Dioscorea hypoglauca, 4-6 parts of Glycyrrhiza uralensis, and 6-8 parts of Indigo naturalis. More preferably, the composition is: 8-10 parts of Acorus tatarinowii, 17-19 parts of Curcuma zedoaria, 16-19 parts of Cuscuta chinensis, 13-16 parts of Ostrea gigas, 23-25 ​​parts of Verbena officinalis, 14-16 parts of Schisandra chinensis, 17-19 parts of Poria cocos, 30 parts of Dioscorea hypoglauca, 4-6 parts of Glycyrrhiza uralensis, and 6-8 parts of Indigo naturalis.

[0013] In some embodiments, the traditional Chinese medicine composition is an extract.

[0014] The *Acorus tatarinowii* used in this invention is the dried rhizome of *Acorus tatarinowii* Schott (Araceae family); the *Curcuma phaeocauls* Val., *Curcuma kwangsiensis* SGLee et CFLiang, or *Curcuma wenyujin* YHChen et C.Ling (Zingiberaceae family) are the dried rhizomes; the *Cuscuta australis* R.Br. or *Cuscuta chinensis* Lam. (Convolvulaceae family) are the dried mature seeds; the oyster shell is the shell of *Ostrea gigas* Thunberg, *Ostrea talienwhanensis* Crosse, or *Ostrea rivularis* Gould (Ostreaaceae family); and the verbena is *Verbena officinalis* (Verbena family). The dried aerial parts of L.; Schisandra chinensis is the dried mature fruit of Schisandra chinensis (Turcz.) Baill., a plant of the Magnoliaceae family; Poria cocos is the dried sclerotium of Poria cocos (Schw.) Wolf, a fungus of the Polyporaceae family; Dioscorea hypoglauca Palibin or Dioscorea spongiosa JQXi, M. Mizuno et WLZhao or Dioscoreafutschauensis Uline ex R. Kunth, a plant of the Dioscoreaceae family; Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L., a plant of the Fabaceae family; Indigo naturalis is Baphicacanthus, a plant of the Acanthaceae family. Dry powder, lumps, or granules obtained from the processed leaves or stems of *Polygonum tinctorium* Ait. (Polygonaceae family) or *Isatis indigotica* Fort. (Brassicaceae family).

[0015] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0016] Weigh out 20%-40% of the prescribed dosage of Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder. Mix the powder with Indigo Naturalis to obtain a mixed fine powder for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, soak them in ethanol, heat under reflux, filter to obtain the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract. Keep the residue for later use. Soak the alcohol extract residue and the remaining herbs in water, decoct them, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, and dry.

[0017] In some embodiments, the extract of the traditional Chinese medicine composition is prepared by the following method: 20%-40% of the dosage of Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria are weighed separately, mixed and pulverized into a fine powder, and then mixed with Indigo naturalis to obtain a mixed fine powder for later use; the remaining Acorus tatarinowii and Curcuma zedoaria are appropriately crushed, soaked in ethanol, heated under reflux, filtered to obtain the alcohol extract, and the ethanol is recovered under reduced pressure to an appropriate amount to obtain an alcohol extract, with the residue for later use; the alcohol extract residue and the remaining herbs are soaked in water and decocted, filtered, and the filtrates are combined, concentrated under reduced pressure to a thick paste, and mixed with the above mixed fine powder and alcohol extract.

[0018] In some embodiments, the preparation method includes the following steps:

[0019] Take one-third of the dosage of Acorus tatarinowii in the prescription, mix Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, grind them into a fine powder, mix with Indigo naturalis to obtain a mixed fine powder, and set aside. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, soak them in 5-10 times 95% v / v ethanol for 40-60 hours, heat under reflux for 2.5-3.5 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain an alcohol extract, and set aside the residue. Soak the alcohol extract residue and the remaining herbs in 6-12 times water, decoct 1-3 times, each time for 1.5-3 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix with the above mixed fine powder and alcohol extract, vacuum dry, and grind into a fine powder.

[0020] The fine powder involved in this invention passes through a sieve of at least 40 mesh, preferably 60 mesh, and more preferably 80 mesh.

[0021] The traditional Chinese medicine composition described in this invention or the traditional Chinese medicine composition prepared by the above preparation method can also be used as one of the raw materials in feed, cosmetics, daily chemical products, food and medicine, including oral rinses, toothpaste, oral sprays, oral ointments, oral patches, oral varnishes, gum massage creams and chewing gum, noodles and jelly, which can be used to prevent or improve periodontitis or reduce the occurrence of inflammation.

[0022] Thirdly, the present invention provides that the aforementioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the aforementioned preparation method can be used to tonify the kidney and strengthen essence. Furthermore, the present invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of drugs for treating prostatitis or osteoporosis.

[0023] The prostatitis described in this invention is chronic prostatitis, specifically chronic prostatitis of the kidney deficiency and seminal vesicle instability, damp-heat accumulation, and seminal turbidity type. Symptoms include frequent urination, urgency, painful urination, burning sensation, urethral discharge of white turbidity during urination or defecation, perineal, lumbosacral, and testicular distending pain, yellow and greasy tongue coating, and slippery and rapid pulse; or dizziness, fatigue, lower back pain, cold knees, impotence, premature ejaculation, and even urethral discharge of white turbidity after slight exertion, pale and swollen tongue with white coating, and deep and thready pulse.

[0024] Fourthly, the present invention provides a medicine comprising the aforementioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the aforementioned preparation method and pharmaceutically acceptable excipients.

[0025] In specific implementation schemes, the traditional Chinese medicine composition described in this invention is provided in the drug in an effective amount (e.g., a therapeutically effective amount).

[0026] The "pharmaceuticalally acceptable excipients" described in this invention include inert diluents, dispersants and / or granulators, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or oils. The pharmaceutical compositions may also contain excipients (e.g., cocoa butter and suppository waxes), colorants, coating agents, sweeteners, flavoring agents, and aroma agents.

[0027] The "medicine" described in this invention can be prepared by any method known in pharmaceutical science. Generally, these preparation methods involve associating the aforementioned traditional Chinese medicine composition or the aforementioned traditional Chinese medicine extract (i.e., the first active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then, if desired and / or expected, shaping and / or packaging the product into desired single-dose or multi-dose units.

[0028] The drug of this invention can be prepared according to known methods, such as those described in the General Rules for Preparation of the Japanese Pharmacopoeia 16th Edition, the United States Pharmacopeia, and the European Pharmacopoeia 9th Edition. The specific method depends on the dosage form.

[0029] The first active ingredient and pharmaceutically acceptable excipients in the "medicine" described in this invention will vary depending on the identity, body type, and / or condition of the treated subject and further on the route of administration of the composition. The medicine may contain between 0.1% and 100% (w / w) of the first active ingredient.

[0030] The "medicine" described in this invention may optionally include other therapeutic ingredients for use in combination, especially those other therapeutic ingredients disclosed herein, such as "other active ingredients with therapeutic effects on chronic prostatitis" (i.e., second active ingredients), specifically such as traditional Chinese medicine, chemical drugs, or prepared Chinese medicine formulations. The traditional Chinese medicine composition and the second active ingredient in the medicine of this invention may be directly mixed together or individually packaged and then combined.

[0031] As used herein, “treatment” means, unless otherwise stated, reversing or alleviating the condition or disease to which the term applies, or one or more symptoms of such condition or disease, inhibiting the progression of said condition or disease or one or more symptoms thereof, or preventing said condition or disease or one or more symptoms thereof. As used in this invention, the term “treatment” refers to a therapeutic act, as defined above.

[0032] The term "effective amount" as used in this invention refers to an amount sufficient to elicit the desired biological response. The effective amount of the active ingredient of this invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the administration pattern, and the age and health status of the subject. In some embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the first active ingredient described in this invention in a single dose. In some embodiments, the effective amount is a combined amount of the active ingredient described in this invention in multiple doses.

[0033] The term "therapeuticly effective amount" as used in this invention refers to an amount sufficient to provide therapeutic benefit in the treatment of a condition or sufficient to delay or minimize one or more symptoms associated with that condition. In traditional Chinese medicine compositions, a therapeutically effective amount means an amount in which the therapeutic agent, alone or in combination with other therapies, provides therapeutic benefit in the treatment of a condition. The term "therapeuticly effective amount" may encompass amounts that improve overall therapy, reduce or avoid symptoms, signs, or causes of a condition, and / or enhance the therapeutic efficacy of another therapeutic agent. In some embodiments, a therapeutically effective amount is an amount sufficient to treat any of the diseases or conditions described.

[0034] As used herein, the terms "subject" or "patient" are well known in the art and are used interchangeably to refer to mammals, including dogs, cats, rats, mice, monkeys, cows, horses, goats, sheep, pigs, camels, and most preferably humans. This term does not imply a specific age or sex. Therefore, adult and neonatal subjects, whether male or female, are included.

[0035] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, which should be understood to include values ​​close to them. For numerical ranges, one or more new numerical ranges can be obtained by combining the endpoint values ​​of the ranges, the endpoint values ​​of the ranges with individual point values, and individual point values ​​with each other, and these numerical ranges should be considered as specifically disclosed herein. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein include both singular and plural indicators. Numerical ranges expressed by endpoints include all numerical values ​​and fractions within the corresponding range, as well as the expressed endpoints.

[0036] Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without inventive effort should fall within the scope of protection of this invention. Unless otherwise specified, the experimental methods described in the following embodiments are conventional methods; the reagents and materials described, unless otherwise specified, are commercially available. Unless otherwise specified, the traditional Chinese medicine composition and traditional Chinese medicine extract of this invention have the same meaning.

[0037] The dodder seed used in this invention is the dried, mature seed of *Cuscuta australis* R.Br. or *Cuscuta chinensis* Lam., belonging to the Convolvulaceae family. It has the effects of tonifying the liver and kidneys, strengthening essence and reducing urination, calming the fetus, improving eyesight, and stopping diarrhea. The dioscorea rhizome is the dried rhizome of *Dioscorea hypoglauca* Palibin, *Dioscorea spongiosa* JQXi, M.Mizuno et WLZhao, or *Dioscorea afutschauensis* Uline ex R.Kunth, belonging to the Dioscoreaceae family. It has the effects of promoting diuresis and removing turbidity, dispelling wind and relieving numbness. The schisandra chinensis is the dried, mature fruit of *Schisandra chinensis* (Turcz.) Baill., belonging to the Magnoliaceae family. It has the effects of astringing and consolidating, replenishing qi and promoting body fluids, tonifying the kidneys and calming the mind. Poria cocos (Schw.) Wolf, a fungus belonging to the Polyporaceae family, is a dried sclerotium with diuretic, spleen-strengthening, and heart-calming effects. Indigo naturalis (Qingdai) is a dried powder, lumps, or granules obtained from the processed leaves or stems of plants such as Baphicacanthus cusia (Nees) Bremek. (Acanthaceae), Polygonum tinctorium Ait. (Polygonaceae), or Isodon satis indigotica Fort. (Brassicaceae). It has heat-clearing, detoxifying, blood-cooling, spot-reducing, fire-purging, and calming effects. Licorice (Glycyrrhiza uralensis Fisch.), Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. (Fabaceae) has spleen-tonifying, qi-boosting, heat-clearing, detoxifying, phlegm-reducing, cough-relieving, pain-relieving, and harmonizing effects of other herbs. Oyster shells are the shells of the Ostreae family, including *Ostrea gigas* Thunberg, *Ostrea talienwhanensis* Crosse, and *Ostrea rivularis* Gould. They are believed to have calming, sedative, and yin-nourishing properties, as well as softening and dispersing hard masses. Curcuma zedoaria is the dried rhizome of the Zingiberaceae family plants *Curcuma phaeocauls* Val., *Curcuma kwangsiensis* SGLee et CFLiang, or *Curcuma wenyujin* YHChen et C.Ling. It is believed to promote qi circulation, break up blood stasis, eliminate stagnation, and relieve pain. Verbena officinalis is the dried aerial part of the Verbena officinalis L. family plant. It is believed to have blood-activating, stasis-removing, detoxifying, diuretic, jaundice-reducing, and malaria-preventing properties.Sweet flag (Acorus tatarinowii) is the dried rhizome of the Araceae plant Acorus tatarinowii Schott. It has the effects of clearing the orifices and resolving phlegm, refreshing the mind and improving intelligence, and resolving dampness and stimulating appetite.

[0038] In this invention, *Acorus tatarinowii* includes *Acorus tatarinowii* medicinal material and its processed slices; in some embodiments, the processed slices are *Acorus tatarinowii* after processing. In this invention, *Curcuma zedoaria* includes *Curcuma zedoaria* medicinal material and its processed slices; in some embodiments, the processed slices are *Curcuma zedoaria* after processing, and in some embodiments, the processed slices are *Curcuma zedoaria* treated with vinegar. In this invention, *Cuscuta chinensis* includes *Cuscuta chinensis* medicinal material and its processed slices; in some embodiments, the processed slices are *Cuscuta chinensis* after processing. In this invention, *Ostrea gigas* includes *Ostrea gigas* medicinal material and its processed slices; in some embodiments, the processed slices are *Ostrea gigas* after processing, and in some embodiments, the processed slices are *Ostrea gigas* after processing. In this invention, *Verbena officinalis* includes *Verbena officinalis* medicinal material and its processed slices; in some embodiments, the processed slices are *Verbena officinalis* after processing. The ingredients are: Verbena officinalis (processed); Schisandra chinensis (processed) in this invention includes Schisandra chinensis medicinal material and its processed slices, in some embodiments the processed slices are processed Schisandra chinensis, in some embodiments the processed slices are vinegar-processed Schisandra chinensis; Poria cocos (processed) in this invention includes Poria cocos medicinal material and its processed slices, in some embodiments the processed slices are processed Poria cocos; Dioscorea hypoglauca (processed) in this invention includes Dioscorea hypoglauca medicinal material and its processed slices, in some embodiments the processed slices are processed Dioscorea hypoglauca; Glycyrrhiza uralensis (processed) in this invention includes Glycyrrhiza uralensis medicinal material and its processed slices, in some embodiments the processed slices are processed Glycyrrhiza uralensis; Indigo naturalis (processed) in this invention includes Indigo naturalis medicinal material and its processed slices, in some embodiments the processed slices are processed Indigo naturalis. The Indigo naturalis, Cuscuta chinensis, Ostrea gigas, Glycyrrhiza uralensis, Schisandra chinensis, Dioscorea hypoglauca, Verbena officinalis, Poria cocos, Acorus tatarinowii, and Curcuma zedoaria of this invention are preferably processed according to the methods described in Part I of the 2020 edition of the Chinese Pharmacopoeia for the above-mentioned medicinal materials.

[0039] The present invention has the following beneficial effects:

[0040] In this invention, Cuscuta chinensis is the principal herb for tonifying the kidneys; Schisandra chinensis astringes essence, and Ostrea gigas consolidates and strengthens the kidney-tonifying and essence-consolidating effects of Cuscuta chinensis. Dioscorea hypoglauca, Indigo naturalis, Glycyrrhiza uralensis, and Poria cocos act as assistant herbs to clear heat and eliminate turbidity; Curcuma zedoaria and Verbena officinalis invigorate blood circulation, dispel blood stasis, detoxify, and reduce swelling; Acorus tatarinowii clears phlegm, opens the orifices, and guides the medicine to the kidneys as the guiding herb. Together, these herbs form a wonderful formula that combines tonification and elimination. Based on the above research on the relationships between the principal, assistant, and guiding herbs, a traditional Chinese medicine composition for treating chronic prostatitis was obtained by optimizing the dosage of Cuscuta chinensis and Ostrea gigas and adjusting the specific dosage of each herb. Compared with existing technologies, the traditional Chinese medicine composition of this invention has stronger activity and better therapeutic effects on prostatitis. Detailed Implementation

[0041] The present invention will be described below through specific embodiments to make the technical solution of the present invention easier to understand and master. However, the present invention is not limited thereto. The described embodiments are only some embodiments of the present invention, and not all embodiments.

[0042] In this embodiment, the following herbs—Acorus tatarinowii, Curcuma zedoaria, Cuscuta chinensis, Ostrea gigas, Verbena officinalis, Schisandra chinensis, Poria cocos, Dioscorea hypoglauca, Glycyrrhiza uralensis, and Indigo naturalis—were prepared according to the processing methods described in Part I of the 2020 edition of the Chinese Pharmacopoeia. Unless otherwise specified in this application, the fine powder described is obtained by passing it through a No. 5 sieve.

[0043] The specific medicinal ingredients used in this application embodiment are as follows: Cuscuta australis R.Br. (dried mature seeds of Cuscuta australis R.Br., Convolvulaceae family); Dioscorea spongiosa JQXi, M. Mizuno et WLZhao (dried rhizome of Dioscorea spongiosa JQXi, M. Mizuno et WLZhao); Schisandra chinensis (dried mature fruit of Schisandra chinensis (Turcz.) Baill., Magnoliaceae family); Poria cocos (dried sclerotium of Poria cocos (Schw.) Wolf, Polyporaceae family); Indigo naturalis (dried powder, lumps, or granules obtained by processing the leaves or stems of Baphicacanthus cusia (Nees) Bremek, Acanthaceae family); Glycyrrhiza uralensis Fisch (dried root and rhizome of Glycyrrhiza uralensis Fisch, Fabaceae family); and Ostrea gigas (Ostrea gigas, Ostrea family). Thunberg's shell, Curcuma zedoaria (dried rhizome of Curcuma zedoaria Val., Zingiberaceae family), Verbena officinalis L. (dried aerial parts of Verbena officinalis L., Verbena officinalis family), and Acorus tatarinowii Schott (dried rhizome of Acorus tatarinowii, Araceae family). Specific sources are shown in Table 1 below.

[0044] Table 1 Sources of Traditional Chinese Medicine Raw Materials

[0045] Example 1: Prescription and preparation method of the traditional Chinese medicine composition

[0046] 80-90g of Acorus tatarinowii, 170-190g of Curcuma zedoaria, 170-190g of Cuscuta chinensis, 140-150g of calcined oyster shell, 230-240g of Verbena officinalis, 150-160g of Schisandra chinensis, 170-190g of Poria cocos, 290g of Dioscorea hypoglauca, 50-60g of Glycyrrhiza uralensis, and 60-70g of Indigo naturalis.

[0047] One-third of the dosage of Acorus tatarinowii in the prescription is taken separately from Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria. These are mixed and pulverized into a fine powder. This powder is then mixed with Indigo Naturalis to obtain a mixed fine powder, which is passed through a No. 5 sieve for later use. The remaining Acorus tatarinowii and Curcuma zedoaria are appropriately crushed, soaked in 6 times the amount of 95% v / v ethanol for 48 hours, heated under reflux for 3 hours, cooled, and the ethanol extract is filtered. The ethanol is recovered under reduced pressure to a suitable amount, yielding an ethanol extract and ethanol extract residue for later use. The ethanol extract residue and the remaining herbs are soaked in 10 times the amount of water for 2 hours, decocted twice, 3 hours each time, filtered, and the filtrates are combined. The filtrate is concentrated under reduced pressure to a thick paste, mixed with the above-mentioned mixed fine powder and ethanol extract, vacuum dried below 60°C, and pulverized into a fine powder.

[0048] Example 2: Prescription and preparation method of the traditional Chinese medicine composition

[0049] 80-90g of Acorus tatarinowii, 170-190g of Curcuma zedoaria, 170-190g of Cuscuta chinensis, 140-150g of calcined oyster shell, 230-240g of Verbena officinalis, 150-160g of Schisandra chinensis, 170-190g of Poria cocos, 310g of Dioscorea hypoglauca, 50-60g of Glycyrrhiza uralensis, and 60-70g of Indigo naturalis.

[0050] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder. Mix them with Indigo naturalis to obtain a mixed fine powder, and pass it through a No. 5 sieve for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 5 times the amount of 95% v / v ethanol and soak for 40 hours, heat under reflux for 2.5 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 6 times the amount of water for 3 hours, decoct once, each time for 1.5 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind it into a fine powder.

[0051] Example 3: Prescription and preparation method of the traditional Chinese medicine composition

[0052] 80-90g of Acorus tatarinowii, 170-190g of Curcuma zedoaria, 170-190g of Cuscuta chinensis, 140-150g of calcined oyster shell, 230g of Verbena officinalis, 150-160g of Schisandra chinensis, 170-190g of Poria cocos, 310g of Dioscorea hypoglauca, 50-60g of Glycyrrhiza uralensis, and 60-70g of Indigo naturalis.

[0053] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder. Mix them with Indigo naturalis to obtain a mixed fine powder, and pass it through a No. 5 sieve for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 10 times the amount of 95% v / v ethanol and soak for 60 hours, heat under reflux for 3.5 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 10 times the amount of water for 3 hours, decoct 3 times, each time for 3 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind it into a fine powder.

[0054] Example 4: Prescription and preparation method of the traditional Chinese medicine composition

[0055] 80-90g of Acorus tatarinowii, 170-190g of Curcuma zedoaria, 170-190g of Cuscuta chinensis, 140-150g of calcined oyster shell, 270g of Verbena officinalis, 150-160g of Schisandra chinensis, 170-190g of Poria cocos, 310g of Dioscorea hypoglauca, 50-60g of Glycyrrhiza uralensis, and 60-70g of Indigo naturalis.

[0056] One-third of the dosage of Acorus tatarinowii in the prescription is taken separately from Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria. They are mixed and pulverized into fine powder. This powder is then mixed with Indigo naturalis to obtain a mixed fine powder, which is then sieved through a No. 5 sieve for later use. The remaining Acorus tatarinowii and Curcuma zedoaria are appropriately crushed, soaked in 6 times the amount of 95% v / v ethanol for 48 hours, heated under reflux for 3 hours, cooled, and the alcohol extract is filtered. The ethanol is recovered under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. The alcohol extract residue and the remaining herbs are soaked in 12 times the amount of water for 3 hours, decocted twice, each time for 3 hours, filtered, and the filtrates are combined. The filtrate is concentrated under reduced pressure to a thick paste, mixed with the above mixed fine powder and alcohol extract, vacuum dried below 60°C, and pulverized into fine powder.

[0057] Example 5: Prescription and preparation method of the traditional Chinese medicine composition

[0058] 80g of Acorus tatarinowii, 170g of Curcuma zedoaria, 170g of Cuscuta chinensis, 140g of calcined oyster shell, 240g of Verbena officinalis, 150g of Schisandra chinensis, 170g of Poria cocos, 310g of Dioscorea hypoglauca, 50g of Glycyrrhiza uralensis, and 60g of Indigo naturalis.

[0059] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into fine powder. Mix them with Indigo naturalis to obtain a mixed fine powder, and pass it through a No. 5 sieve for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 6 times the amount of 95% ethanol and soak for 48 hours, heat under reflux for 3 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 12 times the amount of water for 3 hours, decoct twice, each time for 3 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind it into fine powder.

[0060] Example 6: Prescription and preparation method of the traditional Chinese medicine composition

[0061] 100g of Acorus tatarinowii, 190g of Curcuma zedoaria, 190g of Cuscuta chinensis, 130g of calcined oyster shell, 250g of Verbena officinalis, 160g of Schisandra chinensis, 190g of Poria cocos, 290g of Dioscorea hypoglauca, 60g of Glycyrrhiza uralensis, and 70g of Indigo naturalis.

[0062] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into fine powder. Mix them with Indigo naturalis to obtain a mixed fine powder, and pass it through a No. 5 sieve for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 6 times the amount of 95% ethanol and soak for 48 hours, heat under reflux for 3 hours, cool, filter to obtain the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 10 times the amount of water for 2 hours, decoct twice, each time for 3 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind it into fine powder.

[0063] Example 7: Prescription and preparation method of the traditional Chinese medicine composition

[0064] 80g of Acorus tatarinowii, 190g of Curcuma zedoaria, 170g of Cuscuta chinensis, 150g of calcined oyster shell, 230g of Verbena officinalis, 160g of Schisandra chinensis, 190g of Poria cocos, 300g of Dioscorea hypoglauca, 50g of Glycyrrhiza uralensis, and 70g of Indigo naturalis.

[0065] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder (passing through an 80-mesh sieve). Mix them with Indigo Naturalis to obtain a mixed fine powder for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 8 times the amount of 95% v / v ethanol and soak for 48 hours, heat under reflux for 3 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 8 times the amount of water for 2 hours, then decoct twice, each time for 1.5 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind into a fine powder.

[0066] Example 8: Prescription and preparation method of the traditional Chinese medicine composition

[0067] 100g of Acorus tatarinowii, 170g of Curcuma zedoaria, 190g of Cuscuta chinensis, 130g of calcined oyster shell, 250g of Verbena officinalis, 140g of Schisandra chinensis, 170g of Poria cocos, 300g of Dioscorea hypoglauca, 40g of Glycyrrhiza uralensis, and 80g of Indigo naturalis.

[0068] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder (passing through an 80-mesh sieve). Mix them with Indigo Naturalis to obtain a mixed fine powder for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 8 times the amount of 95% v / v ethanol and soak for 48 hours, heat under reflux for 3 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 8 times the amount of water for 2 hours, then decoct twice, each time for 1.5 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind into a fine powder.

[0069] Example 9: Formula and preparation method of comparative traditional Chinese medicine composition

[0070] 60g of Acorus tatarinowii, 170g of Curcuma zedoaria, 300g of Cuscuta chinensis, 300g of calcined oyster shell, 230g of Verbena officinalis, 150g of Schisandra chinensis, 170g of Poria cocos, 300g of Dioscorea hypoglauca, 30g of Glycyrrhiza uralensis, and 60g of Indigo naturalis.

[0071] Take one-third of the dosage of Acorus tatarinowii in the prescription, separately take Acorus tatarinowii, calcined oyster shell, Poria cocos, and Curcuma zedoaria, mix them, and grind them into a fine powder (passing through an 80-mesh sieve). Mix them with Indigo Naturalis to obtain a mixed fine powder for later use. Crush the remaining Acorus tatarinowii and Curcuma zedoaria appropriately, add 8 times the amount of 95% v / v ethanol and soak for 48 hours, heat under reflux for 3 hours, cool, filter the alcohol extract, and recover the ethanol under reduced pressure to an appropriate amount to obtain the alcohol extract and alcohol extract residue for later use. Soak the alcohol extract residue and the remaining herbs in 8 times the amount of water for 2 hours, then decoct twice, each time for 1.5 hours, filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, mix it with the above mixed fine powder and alcohol extract, vacuum dry below 60°C, and grind into a fine powder.

[0072] Example 10: Prescription and preparation method of the traditional Chinese medicine composition

[0073] 80g of Acorus tatarinowii, 190g of Curcuma zedoaria, 170g of Cuscuta chinensis, 150g of calcined oyster shell, 230g of Verbena officinalis, 160g of Schisandra chinensis, 190g of Poria cocos, 300g of Dioscorea hypoglauca, 50g of Glycyrrhiza uralensis, and 70g of Indigo naturalis.

[0074] Take the medicinal ingredients, soak them in 8 times the amount of water for 2 hours, then decoct twice, each time for 1.5 hours. Filter, combine the filtrates, concentrate the filtrate under reduced pressure to a thick paste, dry it under vacuum below 60°C, and pulverize it into a fine powder.

[0075] [Effective Case] ​​Treatment effect on prostatitis

[0076] 1. Laboratory animals

[0077] Forty SPF-grade male SD rats, weighing 230-260g, were housed in an SPF-grade animal laboratory at a room temperature of 22-26℃ and a relative humidity of 45%-65%, with a 12h / 12h light-dark cycle. The animal experiments were approved by the Animal Experiment Center of Jiangsu Suzhong Pharmaceutical Group Biopharmaceutical Co., Ltd. (ethics number SZSW-2023022001).

[0078] 2. Medicines and reagents

[0079] The main experimental drugs and reagents are shown in Table 2.

[0080] Table 2. Information on Drugs and Reagents

[0081] 3. Model establishment and animal grouping

[0082] Thirty-five rats were randomly selected, and references were consulted. 1 This report describes the establishment of a rat model of prostatitis. Under aseptic conditions, 100 μL of 1 wt% carrageenan saline solution was injected into the prostate of anesthetized rats, 100 μL each into the left and right ventral lobes. The remaining 5 rats served as a blank control group. One week after modeling, the rats were randomly divided into 5 groups to begin drug administration: the model group, the positive control group (Prostyrax tablets group, 126.6 mg / kg). -1 ) and the sample group of Example 7 (equivalent to 2.58 g·kg of raw medicinal materials) -1 Eight sample groups (equivalent to 2.58 g / kg of raw medicinal materials) were implemented. -1 Example 9 - Comparative Sample Group (equivalent to 2.58 g / kg of raw medicinal material) -1 Five animals were placed in each group, and 63 ml of purified water was used to prepare the solution. The blank control group and the model group were given the same amount of solvent by gavage once a day for one week.

[0083] literature 1 Chen Jing, Bai Ming, Miao Mingsan. Application analysis of animal model of chronic nonbacterial prostatitis based on data mining [J]. Chinese Materia Medica Pharmacology and Clinics, 2021, 37(03):183-190.

[0084] 4. Sample collection

[0085] After administration, rats were anesthetized by intraperitoneal injection of 10% chloral hydrate solution (0.4 mL / 100 g), and blood was collected from the abdominal aorta. The prostate tissue was dissected, washed with physiological saline, and the tissue of the left ventral lobe of the prostate was photographed and recorded before being stored in 10% formalin; the tissue of the right ventral lobe of the prostate was flash-frozen in liquid nitrogen and stored at -80°C.

[0086] 4.1 Detection of TNF-α, IL-1β, and IL-6 levels in prostate tissue using ELISA.

[0087] Frozen specimens were taken in liquid nitrogen, weighed, and then added to a quantitative PBS (pH 7.4) buffer. After tissue homogenization, the samples were centrifuged at 4°C and 3000 rpm for 20 minutes. The supernatant was collected, and the levels of TNF-α, IL-1β, and IL-6 in the prostate tissue of rats in each group were detected.

[0088] 4.2 HE staining for observation of prostate tissue pathological morphology

[0089] The overall appearance, size, texture, color, and presence of necrosis of the prostate tissue are observed with the naked eye. The fixed prostate tissue is then removed and subjected to a series of procedures including fixation, dehydration, paraffin embedding, sectioning, dewaxing, and staining. The pathological changes of the prostate tissue are then observed under a microscope.

[0090] 4.3 Western blot analysis of p-AKT, p-JUN, and p-MAPK3 protein expression in prostate tissue

[0091] Total protein was extracted from tissues of each group using RIPA lysis buffer, and protein concentration was measured. Equal amounts of protein samples from each group were subjected to electrophoresis, membrane transfer, and skim milk blocking. Rabbit anti-rat primary antibodies (p-AKT, p-JUN, p-MAPK3) were added and incubated overnight at 4°C. Goat anti-rabbit secondary antibody was then added. The gray values ​​of each protein band were analyzed using IPWIN60 software, with β-actin antibody used as an internal control.

[0092] 5. Statistical Analysis

[0093] Data was processed using GraphPad Prism 9.4.1 software, and the experimental data are presented in the format of... This indicates that one-way ANOVA was used for comparisons among multiple groups. P < 0.05 indicates that the difference is statistically significant.

[0094] 6. Experimental Results

[0095] 6.1 Prostate Index

[0096] Compared with the blank control group, the prostate index of rats in the model group was significantly increased (P<0.01), indicating successful model establishment. Compared with the model group, the prostate index of the positive control group, the sample group of Example 8, and the sample group of Example 7 showed extremely significant differences (P<0.01), and the comparative sample showed significant differences (P<0.05). All showed significant improvement in the prostate index. The prostate index of the sample groups of Example 8 and Example 7 was significantly better than that of the comparative sample.

[0097] Table 3. Changes in prostate index in each group

[0098] Note: Compared with the blank group, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01; compared with the comparative sample, $ P<0.05.

[0099] 6.2 Effects on the morphology of rat prostate tissue

[0100] Macroscopic examination of the prostate tissue revealed edema in the model group compared to the blank control group, with white nodules and tissue adhesions on the surface. Microscopic observation showed that the prostate gland structure in the blank control group was intact, with no obvious inflammatory changes in the interstitium and only a small amount of fibrous tissue visible. The model group showed a large number of interstitial mononuclear cells and inflammatory cell infiltration, papillary projections within the acini, and significant epithelial cell proliferation. Compared to the model group, inflammatory cell infiltration in all treatment groups was reduced, and acinar epithelial hyperplasia and papillary projections were decreased. In terms of improving the pathological effects of prostate tissue, the improvement effects of the comparative sample group, the sample group of Example 8, and the sample group of Example 7 increased sequentially. The improvement effect of the sample group of Example 7 was comparable to that of the positive control group and significantly better than that of the comparative sample group.

[0101] 6.3 Effects on TNF-α, IL-6, and IL-1β levels in rat prostate tissue

[0102] Compared with the blank control group, the levels of inflammatory factors TNF-α, IL-6, and IL-1β in the prostate tissue of rats in the model group were increased (P<0.01). Compared with the model group, the levels of inflammatory factors TNF-α, IL-6, and IL-1β in the prostate tissue of rats in the positive control group and the sample group of Example 7 were significantly decreased (P<0.01).

[0103] Furthermore, the IL-6 levels of the sample groups in Examples 8 and 7 were significantly different from those in the sample group in Comparative Example 1 (P < 0.05), indicating that the traditional Chinese medicine compositions prepared in Examples 8 and 7 of this invention have better anti-inflammatory effects than those in the sample group in Comparative Example 1.

[0104] Table 4. Effects of TNF-α, IL-6, and IL-1β levels in rat prostate tissue.

[0105] Note: Compared with the blank control group, ## P<0.01; compared with the model group, * P<0.05, ** P<0.01; compared with the comparative sample, $ P<0.05.

[0106] In summary, the technical solutions of Embodiments 7 and 8 provided by the present invention, compared with the technical solution of Comparative Example 1, achieve better anti-inflammatory effects by optimizing and increasing the dosage of dodder seed and oyster.

[0107] [Example of Results] Osteoporosis Exploration Experiment

[0108] Model establishment: Sixty SPF-grade female SD rats, 3 months old and weighing 200–220g, were used. Ten rats were selected for grouping and preparation, and were subjected to experiments after one week of acclimatization. Except for the sham-operated group, all other rats were anesthetized by intraperitoneal injection of 10% chloral hydrate, and both ovaries were removed to replicate the postmenopausal osteoporosis model; in the sham-operated group, only a portion of the surrounding adipose tissue was removed. Postoperatively, each rat was injected with 80,000 units of veterinary penicillin to prevent infection. Starting one week postoperatively, the appropriate drugs were administered by gavage daily for 12 consecutive weeks.

[0109] Grouping and administration: Animals were randomly divided into four groups: sham surgery group, ovariectomy group, positive control group, drug A group, and drug B group, with 10 animals in each group. The positive control group received estradiol valerate tablets (0.09 mg / kg). Drug A group was prepared according to the method in Example 7 (equivalent to 2.58 g / kg of raw medicinal material). -1 Drug B was prepared according to the method in Example 10 (equivalent to 2.58 g / kg of raw medicinal material). -1 The drug was prepared in 63ml of purified water, and the same amount of solvent was administered by gavage to the sham surgery group and the ovarian removal group.

[0110] After 12 weeks of drug administration, serum alkaline phosphatase (ALP), calcium (Ca), and osteocalcin (OC), a bone metabolism marker, were measured. The results are shown in Table 5.

[0111] Table 5 Data for Relevant Indicators

[0112] Compared with the sham surgery group, # P<0.05; compared with the oophorectomy group, * P<0.05

[0113] The experimental results showed that both the positive control group and the drug group reduced ALP and OC levels and increased Ca levels. Compared with the ovariectomy group, the drug group and the positive control group significantly reduced ALP and OC levels and increased Ca levels.

[0114] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 7-13 parts, Curcuma zedoary 14-22 parts, Semen falcatum 14-22 parts, Ostrea gigas 11-19 parts, Verbena officinalis 18-30 parts, Schisandra chinensis 12-19 parts, Poria cocos 14-22 parts, Alisma orientale 24-37 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 4-9 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or 3. A method for preparing a traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or 4. The production method according to claim 3, characterized by, The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or The traditional Chinese medicine composition is made of the following raw materials by weight: Acorus gramineus 9-11 parts, Curcuma zedoary 16-20 parts, Semen falcatum 16-20 parts, Ostrea gigas 13-17 parts, Verbena officinalis 21-25 parts, Schisandra chinensis 14-17 parts, Poria cocos 16-20 parts, Alisma orientale 27-33 parts, Glycyrrhiza 4-8 parts, and Indigo naturalis 5-8 parts; or Atractylodes 8-10 parts, Curcuma 17-19 parts, Semen Falcatariae 16-19 parts, Oyster 13-16 parts, Verbena 23-25 parts, Schisandra 14-16 parts, Poria 17-19 parts, Alisma 29-31 parts, Licorice 4-6 parts, and Indigo 6-8 parts; or Atractylodes 8-10 parts, Curcuma 17-19 parts, Semen Falcatariae 16-19 parts, Oyster 13-16 parts, Verbena 23-25 parts, Schisandra 14-16 parts, Poria 17-19 parts, Alisma 30 parts, Licorice 4-6 parts, and Indigo 6-8 parts.

5. The preparation method according to any one of claims 3-4, characterized in that it comprises the following steps: taking Atractylodes, Oyster, Poria, and Curcuma in an amount of one third of the prescribed amount of Atractylodes, mixing them, and crushing them into fine powder, mixing the fine powder with Indigo to obtain a mixture of fine powder for standby; crushing the remaining Atractylodes and Curcuma, immersing them in 5-10 times of 95% v / v ethanol for 40-60 hours, heating and refluxing for 2.5-3.5 hours, cooling, filtering the ethanol extract, recovering ethanol under reduced pressure, and obtaining an ethanol extract, and using the residue for standby; immersing the ethanol extract residue and the remaining herbs in 6-12 times of water, and decocting them 1-3 times, each time for 1.5-3 hours, filtering, combining the filtrates, concentrating the filtrates under reduced pressure to obtain a thick paste, mixing the thick paste with the mixture of fine powder and the ethanol extract, and vacuum drying and crushing into fine powder.

6. The production method according to claim 5, wherein The fine powder is at least passed through a 40-mesh sieve, preferably a 60-mesh sieve, and further preferably an 80-mesh sieve.

7. A traditional Chinese medicine composition, characterized in that Prepared by the preparation method according to any one of claims 3-6.

8. The traditional Chinese medicine composition of any one of claims 1-2, 7, characterized in that, The traditional Chinese medicine composition is used for tonifying the kidney and consolidating essence; further, the traditional Chinese medicine composition can be used for treating prostatitis.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-2 and 7 in the preparation of a medicine for tonifying the kidney and consolidating essence, and further in the preparation of a medicine for treating osteoporosis or prostatitis.

10. Use according to claim 8, characterized in that, The prostatitis is chronic prostatitis, further kidney deficiency, essence chamber not fixed, damp-heat downward, and turbid essence type chronic prostatitis, and its symptoms include frequent urination, urgent urination, painful urination, burning sensation, white discharge from the urethra during urination or defecation, hypogastric pain, lumbosacral pain, testicular pain, yellow and greasy fur, and slippery and rapid pulse; or dizziness, fatigue, soreness of the waist, cold knees, impotence, premature ejaculation, and even white discharge from the urethra after slight labor, pale and swollen tongue, white fur, and deep and fine pulse.

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