A traditional Chinese medicine composition for removing phlegm and resolving turbidity based on pathogenesis of phlegm accumulation in the interior and its preparation method and application

Abstract

The application discloses a traditional Chinese medicine composition for removing phlegm and resolving turbidity based on turbidity accumulation mechanism, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines, and comprises the following component raw materials: 6-12 parts of Bletilla striata, 0.1-0.3 parts of in-vitro cultured ox gall, 3-9 parts of rhubarb, 3-9 parts of Coptis chinensis, 10-20 parts of Alisma orientalis, 2-5 parts of Cinnamomum cassia, 6-12 parts of Curcuma zedoaria, 3-9 parts of dried tangerine or orange peel, and 3-9 parts of fried licorice root. The traditional Chinese medicine composition is targeted intervention by reasonable compatibility: through removing turbidity by purgation, promoting intestinal peristalsis and repairing intestinal mucosal barrier, and blocking LPS and other toxins into blood, so as to reduce systemic and neuroinflammation; through warming yang and resolving turbidity, the intestinal temperature is improved to create a suitable growth environment for beneficial bacteria (such as bifidobacterium); through consolidating the root and cultivating the origin, the intestinal barrier repair effect is consolidated, the mitochondrial energy metabolism is improved, the blood-brain barrier is protected, and the neuron repair is promoted.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a phlegm-resolving and turbidity-clearing traditional Chinese medicine composition based on the pathogenesis of internal accumulation of turbid toxins, its preparation method, and its application. Background Technology

[0002] The internal accumulation of turbid toxins is a core pathogenesis of modern chronic metabolic diseases and some encephalopathy. It originates from dietary changes and an imbalance in the gut microbiota, leading to the accumulation of metabolic products layer by layer, forming a pathological evolution chain of dampness → phlegm → blood stasis → heat toxins, with phlegm being the core carrier. Clinically, it is commonly seen as low abdominal temperature (<36.8℃), sticky stools, and a thick, greasy white tongue coating (indicating internal retention of kidney turbidity). Turbid toxins combined with wind-phlegm can disturb the clear orifices, leading to symptoms of wind-phlegm obstructing the orifices, as seen in encephalopathy such as autism spectrum disorder (ASD) and depression.

[0003] ASD is a neurodevelopmental disorder that occurs in early childhood and often lasts a lifetime. Its incidence rate in my country is approximately 1%, affecting over ten million people. Diagnosis of ASD remains challenging, especially since symptoms in children aged 2-3 years are often atypical and easily confused with ADHD, intellectual disability, and other conditions. Western medicine primarily uses behavioral interventions, supplemented by atypical antipsychotics (such as risperidone) or physical therapy (such as transcranial direct current stimulation), but all these methods have significant side effects, and there is no specific cure.

[0004] Although ancient Chinese medical texts do not use the term "autism," the symptoms described in the "Five Delays and Five Deficiencies" (insomnia, loneliness, social withdrawal, silence, talking to oneself, bizarre behavior, and developmental delays) closely match those of ASD. Traditional Chinese medicine believes that its cause is congenital deficiency and kidney essence depletion, with the disease location in the brain and related to the heart, liver, and kidneys. Treatment focuses on tonifying the liver and kidneys, strengthening the spleen, and nourishing the heart. However, in addition to congenital factors, factors such as abnormal pregnancy, difficult labor, and improper postpartum care can lead to phlegm, blood stasis, and toxins obstructing the body, preventing the flow of qi and blood to nourish the brain, which is also an important cause of marrow deficiency. Currently, although compound formulas such as Zuogui Yin and Er Chen Tang are used clinically, there is still no systemic Chinese medicine composition specifically for ASD.

[0005] The Sanhuang Xiexin Decoction (rhubarb, coptis, and scutellaria) originates from the *Synopsis of Prescriptions of the Golden Chamber* and is a classic formula for purging fire, primarily used to treat internal heat excess. However, it has significant limitations in treating chronic diseases caused by internal accumulation of turbid toxins and encephalopathy caused by wind-phlegm obstructing the orifices: ① It focuses on clearing the surface layer of "heat toxins" and cannot remove the core "phlegm turbidity"; ② It lacks medicines to purge kidney turbidity, making it difficult to clear the thick, greasy white coating on the tongue root; ③ Its purely cold nature leads to a decrease in abdominal temperature, making it even more difficult for the intestines to recover; ④ It lacks ingredients to remove blood stasis, thus failing to resolve the stagnation caused by prolonged illness.

[0006] In summary, there is currently no existing Chinese medicine composition that can target the complete pathological chain of internal accumulation of turbid toxins (warming the intestines to expel turbidity, draining the kidneys to expel turbidity, and resolving blood stasis and unblocking the meridians), while also addressing the "wind-phlegm obstructing the orifices" syndrome of encephalopathy, and is safe for early intervention. Therefore, there is an urgent need for a Chinese medicine composition that takes phlegm-resolving and turbidity-expelling as its core function, while also possessing the functions of warming the intestines to expel turbidity, draining the kidneys to expel turbidity, and resolving blood stasis and unblocking the meridians, for the systemic treatment of chronic diseases caused by internal accumulation of turbid toxins. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for resolving phlegm and eliminating turbidity based on the pathogenesis of internal accumulation of turbid toxins. With resolving phlegm and eliminating turbidity as the core, it also has the functions of warming the intestines to expel turbidity, purging kidney turbidity, removing blood stasis and unblocking collaterals, and purging heart and stomach fire. It is used for the systemic treatment of chronic diseases with internal accumulation of turbid toxins.

[0008] A traditional Chinese medicine composition for resolving phlegm and clearing turbidity based on the pathogenesis of internal accumulation of turbid toxins, is composed of the following raw materials in parts by weight: 6-12 parts of Arisaema cum Bile, 0.1-0.3 parts of in vitro cultured bezoar, 3-9 parts of rhubarb, 3-9 parts of Coptis chinensis, 10-20 parts of Alisma plantago-aquatica, 2-5 parts of cinnamon, 6-12 parts of Curcuma zedoaria, 3-9 parts of tangerine peel, and 3-9 parts of prepared licorice root.

[0009] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 9 parts of Arisaema cum Bile, 0.3 parts of in vitro cultured bezoar, 6 parts of rhubarb, 6 parts of Coptis chinensis, 15 parts of Alisma plantago-aquatica, 3 parts of cinnamon, 9 parts of Curcuma zedoaria, 6 parts of tangerine peel, and 6 parts of prepared licorice root.

[0010] The Chinese medicine composition described above is available in the form of decoction, granules, pills, capsules, or tablets.

[0011] The formulation principle of the traditional Chinese medicine composition in this application is as follows: This invention takes the internal accumulation of turbid toxins as its core pathogenesis, and treats it primarily by eliminating phlegm and clearing turbidity, supplemented by warming the intestines and expelling turbidity, according to the principles of monarch, minister, assistant, and guide in formulating the prescription: The principal herb, Arisaema cum Bile, clears heat, resolves phlegm, calms wind, and relieves convulsions. Arisaema cum Bile replaces rhubarb, the original principal herb in the Sanhuang Xiexin Decoction, shifting the treatment principle from "purging fire" to "eliminating phlegm and clearing turbidity." The wind-calming and convulsion-relieving effects of Arisaema cum Bile have a unique efficacy against "wind-phlegm obstructing the orifices" (autism, depression) caused by turbid toxins damaging the brain, an effect not present in the original formula.

[0012] The primary ingredient is bezoar (cultured in vitro), which clears the heart and resolves phlegm, opens the orifices and cools the liver, and calms wind and detoxifies. Cultured bezoar in vitro and Arisaema cum Bile are a classic medicinal pair, working synergistically to resolve phlegm and open the orifices, significantly enhancing their phlegm-resolving and orifice-opening effects on diseases caused by turbid toxins damaging the brain. Cultured bezoar in vitro is taken orally and not used in decoctions.

[0013] Assistant herb: Rhubarb, which purges stagnation and eliminates toxins. It has been downgraded from the principal herb in Sanhuang Xiexin Decoction to an assistant herb, retaining its function of purging toxins and providing an outlet for them. Adding rhubarb later preserves its effective purgative components.

[0014] Assistant herb: Coptis chinensis, which clears heat, dries dampness, and drains fire from the heart and stomach. It retains the core function of the Sanhuang Xiexin Decoction—"draining the heart means draining the stomach"—and Coptis chinensis' ability to drain fire from the heart and stomach is the irreplaceable essence of the original formula.

[0015] Adjuvant herb: Alisma plantago-aquatica, which promotes diuresis, eliminates dampness, and drains kidney turbidity. Patients with internal accumulation of turbid toxins often have a thick, greasy white coating on the root of the tongue, indicating the accumulation of cold dampness and turbidity in the liver and kidneys. Alisma plantago-aquatica enters the kidney meridian, and its unique function is to drain kidney turbidity; other diuretic herbs (such as Poria cocos and Coix lacryma-jobi) do not have this effect.

[0016] The adjuvant ingredient, cinnamon, warms the yang, transforms qi, and guides fire back to its source. The original formula is purely cold in nature; the addition of cinnamon achieves a balance of warming and cooling properties, embodying the treatment principle of "warming the intestines to expel turbidity." The warming yang properties of cinnamon can counteract the cold nature of Alisma plantago-aquatica, ensuring that the expulsion of turbidity does not harm the yang.

[0017] Adjuvant herb: Curcuma zedoaria, which promotes qi circulation, breaks up blood stasis, eliminates stagnation, and relieves pain. Prolonged accumulation of toxins inevitably leads to blood stasis; Curcuma zedoaria breaks up blood stasis and eliminates stagnation, thus resolving the blood stasis caused by toxins.

[0018] Adjuvant ingredient: Dried tangerine peel, which regulates qi, strengthens the spleen, dries dampness, and resolves phlegm. It assists Arisaema cum Bile in regulating qi and resolving phlegm, so that when qi flows smoothly, phlegm disappears, thus supplementing the qi-regulating deficiency of the purging formula.

[0019] The guiding herb is roasted licorice root, which harmonizes the effects of other herbs, warms the middle jiao (spleen and stomach), and protects the spleen. It warms the middle jiao, replenishes qi, and prevents cold and dampness from damaging the middle jiao.

[0020] The core logic of the formulation of this drug composition is as follows: Traditional Chinese medicine's concept of "phlegm and turbidity" is mapped to intestinal flora imbalance and endotoxin accumulation; "regulating the spleen and stomach" is mapped to restoring intestinal barrier function and flora homeostasis; and "eliminating phlegm and turbidity" is mapped to clearing enterogenic toxins and blocking the "intestinal leakage-inflammation-brain damage" pathway. The composition is as follows: Phlegm-eliminating and turbidity-resolving (chief), phlegm-clearing and orifice-opening (assistant), bowel-clearing and turbidity-purging + heart and stomach fire (assistant), kidney turbidity-purging + warming the intestines and eliminating turbidity + blood stasis-removing and collateral-clearing + qi-regulating and phlegm-resolving (adjuvant), and harmonizing and protecting the middle (guide).

[0021] The "brain-gut axis" (where the gut microbiota communicates bidirectionally with the central nervous system via immune, metabolic, and neural pathways), as confirmed by modern neuroscience, is highly consistent in mechanism with the "spleen-stomach-mind" theory in Traditional Chinese Medicine (TCM). TCM's concept of "spleen governing transformation and transportation" corresponds to the intestinal barrier function and microbiota metabolism; "phlegm and turbidity" corresponds to gut microbiota dysbiosis and endotoxin (LPS) accumulation; and "turbid toxins disturbing the clear orifices" precisely corresponds to neuroinflammation caused by enterogenic toxins entering the bloodstream. The "interference between clear and turbid qi" (failure of clear yang to ascend and turbid qi to descend) resulting from gut microbiota imbalance is a crucial pathogenesis in the development of mental disorders such as autism and depression.

[0022] Studies indicate that patients with autism and depression commonly exhibit reduced gut microbiota diversity, enrichment of opportunistic pathogens, and impaired intestinal barrier (leaky gut). Children with ASD typically present with the following issues: significantly reduced gut microbiota diversity, decreased abundance of beneficial bacteria (Bifidobacteria, Lactobacillus); increased proportion of opportunistic pathogens, enrichment of LPS-producing bacteria; impaired intestinal barrier function, persistent leaky gut; elevated plasma LPS levels, systemic low-grade inflammation; and abnormal metabolism of neurotransmitter precursors (tryptophan, tyrosine).

[0023] This disorder leads to the entry of toxins such as LPS into the bloodstream, causing neuroinflammation; it also interferes with the metabolism of precursors such as tryptophan, resulting in a decrease in the synthesis of neurotransmitters such as serotonin. Therefore, the TCM treatment method of regulating the spleen and stomach and eliminating phlegm and turbidity manifests at the modern biological level as repairing the intestinal barrier, reshaping the gut microbiota homeostasis, clearing LPS, and restoring normal neurotransmitter metabolism.

[0024] This invention provides a method for preparing a decoction of traditional Chinese medicine composition, comprising the following steps: S1. Weigh out the following herbs according to the prescription: Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis (processed with honey) and decoct with water. S2. Add rhubarb and cinnamon 3-8 minutes before the end of decoction, and collect the concentrated medicinal liquid; S3. Grind in vitro cultured bezoar into a fine powder and take it with the medicine solution or mix it with the concentrated solution.

[0025] This invention also provides a method for preparing granules of a traditional Chinese medicine composition, comprising the following steps: R1. Weigh out the following herbs according to the prescription: Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis (processed with honey), and decoct with water. R2. Combine and concentrate the decoctions, add ethanol, stir and let stand. R3. Take the supernatant and concentrate it to obtain a thick paste; R4. Weigh out rhubarb according to the drug formula, add water, decoct and concentrate to obtain rhubarb extract; R5. Weigh out the volatile oil from cinnamon according to the drug formula. Boil the residue after extracting the volatile oil with water to obtain cinnamon extract. R6. In vitro cultured bezoar is ground into a fine powder; R7. Mix the thick paste, rhubarb extract, cinnamon extract, bezoar powder and appropriate excipients, granulate, dry, then spray in cinnamon volatile oil, and package to obtain the final product.

[0026] In the preparation method described above, in step R2, the decoction is concentrated to a relative density of 1.20-1.25 at 60°C, and ethanol is added to make the ethanol content in the mixture 50-60%. The volatile oil of cinnamon is extracted by steam distillation. The pharmaceutical excipients are selected from one or more of fillers, wetting binders, disintegrants, and flavoring agents.

[0027] In the preparation method described above, the filler is at least one of dextrin, lactose, corn starch, and microcrystalline cellulose; the wetting and binding agent is 70%–95% ethanol by volume; the disintegrant is at least one of sodium carboxymethyl starch and crospovidone; and the flavoring agent is at least one of sucrose, erythritol, and steviol glycosides.

[0028] This invention also provides a method for preparing a traditional Chinese medicine composition pill, comprising the following steps: weighing Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, Glycyrrhiza uralensis (processed), Rheum palmatum, and Cinnamomum cassia according to the drug formula, grinding them into fine powder and sieving them, mixing them evenly to obtain a mixed drug powder, mixing finely ground bezoar cultured in vitro with the mixed drug powder to obtain a mixed powder, and adding refined honey to the mixed powder to make large honey pills.

[0029] In the preparation method described above, the sieving is performed through a 100-mesh sieve, and 100-120g of refined honey is added for every 100g of mixed powder.

[0030] This invention also provides an application of a traditional Chinese medicine composition for resolving phlegm and eliminating turbidity based on the pathogenesis of internal accumulation of turbid toxins, used to prepare drugs for treating chronic diseases of the internal accumulation of turbid toxins type.

[0031] As described above, the chronic diseases characterized by the accumulation of toxins include autism, depression, diabetes, hyperuricemia, and constipation.

[0032] Due to the adoption of the above technical solution, the technical effects achieved by the present invention are as follows: This invention establishes "the accumulation of turbid toxins originating in the intestines" as the core pathogenesis of autism and depression, and constructs a systematic intervention system based on this, namely the traditional Chinese medicine composition of this application. It precisely targets three key nodes of the brain-gut axis—the intestinal barrier, gut microbiota, and neuroinflammation. It innovatively proposes a three-step progressive treatment method: "clearing the bowels and eliminating turbidity—warming yang and resolving turbidity—draining turbidity and protecting the kidneys." This strategy forms a complete biological effect chain from improving the gut microbiota to stabilizing nerve function, filling the gap in existing technologies regarding the closed loop of "pathogenesis-target-treatment-prescription."

[0033] Based on research, this application proposes that the core pathogenesis of brain disorders such as autism spectrum disorder (ASD) and depression is "the accumulation of turbid toxins originating in the intestines." Therefore, this application provides the aforementioned traditional Chinese medicine composition for targeted intervention: by clearing the bowels and eliminating turbidity, it promotes intestinal peristalsis and repairs the intestinal mucosal barrier, blocking the entry of toxins such as LPS into the bloodstream, thereby reducing systemic and neurological inflammation; by warming the yang and resolving turbidity, it raises intestinal temperature to create a suitable growth environment for beneficial bacteria (such as Bifidobacteria), restores the production of short-chain fatty acids (SCFAs), and thus maintains the integrity of the intestinal barrier and regulates central neurotransmitters; by strengthening the body's foundation and nourishing its vital energy, it consolidates the intestinal barrier repair effect, improves mitochondrial energy metabolism, protects the blood-brain barrier, promotes neuronal repair, and blocks the vicious cycle of the "microbiota-gut-brain axis."

[0034] The present invention is used for the systematic treatment of chronic diseases of internal accumulation of turbidity toxin type (autism, depression, diabetes, high uric acid, constipation, etc.). Through clinical treatment, the symptoms of multiple patients with autism and depression have been significantly improved. It has a remarkable effect on joint redness, swelling, burning and severe pain in patients with high uric acid. Brief Description of the Drawings

[0035] Figure 1 is a logical diagram of the formulation of the Turbidity-Resolving and Stasis-Transforming Decoction of the present invention; Figure 2 is a comparison diagram of the therapeutic principles between the Turbidity-Resolving and Stasis-Transforming Decoction and the Sanhuang Xiexin Decoction; Figure 3 is a corresponding diagram of the pathological levels of internal accumulation of turbidity toxin and the prescriptions. Detailed Description of the Embodiments

[0036] To enable those skilled in the art to better understand the solution of the present invention, the present invention is further described in detail below. The specific embodiments listed below are only for describing the principles and features of the present invention, and the illustrated examples are only used to explain the present invention, not to limit the scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by a person of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0037] A traditional Chinese medicine composition for resolving phlegm and turbidity based on the pathogenesis of internal accumulation of turbidity toxin, comprising the following raw materials in parts by weight: 6-12 parts of Arisaema cum Bile, 0.1-0.3 parts of In-vitro Cultivated Calculus Bovis, 3-9 parts of Rhei Radix et Rhizoma, 3-9 parts of Coptidis Rhizoma, 10-20 parts of Alismatis Rhizoma, 2-5 parts of Cinnamomi Cortex, 6-12 parts of Curcumae Rhizoma, 3-9 parts of Citri Reticulatae Pericarpium, and 3-9 parts of Glycyrrhizae Radix cum Praeparata.

[0038] The preferred ratio is: 9 parts of Arisaema cum Bile, 0.3 parts of In-vitro Cultivated Calculus Bovis, 6 parts of Rhei Radix et Rhizoma, 6 parts of Coptidis Rhizoma, 15 parts of Alismatis Rhizoma, 3 parts of Cinnamomi Cortex, 9 parts of Curcumae Rhizoma, 6 parts of Citri Reticulatae Pericarpium, and 6 parts of Glycyrrhizae Radix cum Praeparata.

[0039] As shown Figure 1 in the figure, it is the logical diagram of the formulation of the Turbidity-Resolving and Stasis-Transforming Decoction of the present invention.

[0040] In the present invention, Arisaema cum Bile is used to replace Rhei Radix et Rhizoma which is the monarch drug of Sanhuang Xiexin Decoction, so that the therapeutic principle is changed from "purging fire" to "resolving phlegm and turbidity"; Arisaema cum Bile combined with In-vitro Cultivated Calculus Bovis serves as a paired drug for eliminating phlegm and resuscitation, which has effects on diseases of turbidity toxin damaging brain type that the original prescription does not have; Alismatis Rhizoma is used to drain renal turbidity to solve the problem of white, thick and greasy tongue coating at the root of the tongue; Cinnamomi Cortex is used to warm the intestine and expel turbidity to realize the simultaneous application of cold and warm natured drugs; Curcumae Rhizoma is used to transform stasis and dredge collaterals to solve the problem of stasis caused by turbidity toxin; Citri Reticulatae Pericarpium is used to regulate qi and resolve phlegm to assist Arisaema cum Bile. As Figure 2 shown in the figure, it is a comparison diagram of the therapeutic principles between the Turbidity-Resolving and Stasis-Transforming Decoction and the Sanhuang Xiexin Decoction. The present invention is used for the systematic treatment of chronic diseases of internal accumulation of turbidity toxin type (autism, depression, diabetes, high uric acid, constipation, etc.). Through clinical treatment, multiple patients with autism and depression have been significantly improved. As Figure 3The diagram shown is a correlation diagram between the pathological levels of internal accumulation of turbid toxins and the corresponding prescriptions.

[0041] Example 1: A decoction of traditional Chinese medicine composition for phlegm removal and turbidity elimination based on the pathogenesis of internal accumulation of turbid toxins. Weigh out 9g of Arisaema cum Bile, 6g of Rhubarb, 6g of Coptis chinensis, 15g of Alisma plantago-aquatica, 3g of Cinnamomum cassia, 9g of Curcuma zedoaria, 6g of Citrus reticulata peel, and 6g of Glycyrrhiza uralensis (processed). Soak the Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis in 800mL of water for 30 minutes. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Add Rhubarb and Cinnamomum cassia 5 minutes before the end of the simmering process. After simmering, filter the liquid to obtain approximately 400mL of decoction. Grind 0.3g of cultured bezoar into a fine powder and mix with the decoction for oral administration. Take one dose daily, divided into two warm doses, morning and evening.

[0042] Example 2: A traditional Chinese medicine composition granule for relieving phlegm and clearing turbidity based on the pathogenesis of internal accumulation of turbid toxins. Arisaema cum Bile 18-36 parts, in vitro cultured bezoar 0.3-0.9 parts, rhubarb 9-27 parts, coptis chinensis 9-27 parts, alisma plantago-aquatica 30-60 parts, cinnamon 6-15 parts, turmeric 18-36 parts, tangerine peel 9-27 parts, prepared licorice root 9-27 parts Weigh out the raw materials according to the prescription ratio. Weigh out Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis (processed). Add water and decoct twice. Combine the decoctions and concentrate to a relative density of 1.20-1.25 (60℃). Add ethanol to make the ethanol content in the mixture reach 60%. Stir and let stand for 24 hours. Collect the supernatant to recover the ethanol and concentrate to a thick paste. Weigh out the rhubarb according to the prescription and decoct for 10 minutes. Collect the decoction separately and concentrate to obtain rhubarb extract. Weigh out the cinnamon according to the prescription and extract the volatile oil using steam distillation. Add water to the residue after volatile oil extraction and decoct to obtain cinnamon extract. Grind the cultured bezoar into a fine powder. Mix the thick paste, rhubarb extract, cinnamon extract, bezoar powder, and appropriate excipients. Granulate, dry, and then spray with cinnamon volatile oil. Package to obtain the final product.

[0043] The excipients are 100-150 parts dextrin, 50-80 parts lactose, 30-50 parts microcrystalline cellulose, 10-20 parts sodium carboxymethyl starch, and 1-2 parts steviol glycosides.

[0044] Example 3: A traditional Chinese medicine composition pill for eliminating phlegm and clearing turbidity based on the pathogenesis of internal accumulation of turbid toxins. According to the prescription, weigh out the following raw materials: 9 parts Arisaema cum Bile, 6 parts Rhubarb, 0.3 parts Coptis chinensis, 15 parts Alisma plantago-aquatica, 3 parts Cinnamomum cassia, 9 parts Curcuma zedoaria, 6 parts Citrus reticulata peel, and 6 parts Glycyrrhiza uralensis (processed). Grind the herbs into a fine powder, pass through a 100-mesh sieve, and mix thoroughly. Grind the cultured bezoar into a fine powder and mix it thoroughly with the other powders to obtain a mixed powder. Add 100-120g of refined honey to every 100g of powder to make large honey pills, each weighing 9g. Take one pill orally twice a day.

[0045] The formula of Wenchang Jiangzhuo Decoction used in each case in Example 4 below is as follows: 15 parts prepared aconite, 9 parts dried ginger, 5 parts cinnamon, 9 parts bupleurum, 9 parts immature bitter orange, 15 parts white peony root, 15 parts atractylodes macrocephala, 15 parts codonopsis, and 9 parts prepared licorice root.

[0046] The preparation method is as follows: the prepared aconite root is decocted for 45-60 minutes; dried ginger, bupleurum, immature bitter orange, white peony root, atractylodes macrocephala, codonopsis, and prepared licorice are added, water is added and decocted, and the decoction is collected; cinnamon is added 3-8 minutes before the end of the decoction, and the decoction containing cinnamon is collected.

[0047] The decoction used is the phlegm-removing and turbidity-resolving Chinese herbal composition decoction of Example 1 of this application.

[0048] Example 4 Case 1: A 13.5-year-old male patient was diagnosed with autism. His abdominal temperature was 35.6℃, and he had bowel movements every 3-4 days, which were sticky, difficult to pass, and consisted of large, grayish-brown particles. His tongue was white with a thick, greasy coating at the base and the body was enlarged. His Zig-Induced Toxin Index (ZI) was 12 points (severe Zig-Induced Toxin). He was treated with a combination of the Zig-Expelling and Blood-Stasis-Removing Decoction and the Wenchang-Jiang-Turbidity Decoction (both taken concurrently). After 3 days, his bowel movements became once daily, formed and smooth, and his abdominal temperature rose to 36.4℃. The thick, greasy tongue coating lessened. After 3 days of smooth bowel movements, the Zig-Expelling and Blood-Stasis-Removing Decoction was discontinued, and only the Wenchang-Jiang-Turbidity Decoction was administered. After 2 months of treatment, his Zig-Induced Toxin Index (ZI) dropped to 4 points, his repetitive behaviors decreased, and his interactive communication abilities improved.

[0049] By monitoring changes in tongue coating and stool characteristics, this patient's tongue was white with a thin coating before medication. During medication, the tongue gradually became reddish and the coating became moist. After three days of medication, the tongue coating was thin and white. After two months of medication, the tongue gradually became reddish and the tongue coating was thin and white. Before treatment, the stool was large, undigested brown particles. After three days of medication, the dark brown stool turned golden yellow, the stool became finer, and the quantity increased. After two months of medication, the stool was basically stable and golden yellow. Stereotyped movements gradually disappeared, and speech became richer. This indicates that with the effect of the medication, the intestinal environment improved, toxins were gradually excreted from the body, and no new toxins were formed.

[0050] This application uses the ZI turbidity index as a quantitative evaluation tool for the degree of turbidity. The index is constructed based on the three-dimensional acquisition system of form-qi-spirit of the form-spirit evidence-based school, as shown in Table 1.

[0051] Table 1. Scoring Criteria for ZI Toxicity Index

[0052] Note: The full score for the tongue body and sublingual veins is 2 points each, the full score for accompanying signs is 2 points, and the full score for the other dimensions is 3 points.

[0053] The scoring details are as follows: Grading standards: mild (1-5 points), moderate (6-9 points), severe (10-15 points).

[0054] Case 2: A 16-year-old female patient with depression. Her abdominal temperature was 35.9℃, she had bowel movements every 2-3 days with a feeling of incomplete evacuation, and her tongue root was thick and greasy. Her ZigBody Indication (ZI) was 9 (moderate toxicity). She was given a combination of a decoction for clearing turbidity and removing blood stasis, and a decoction for warming the intestines and reducing turbidity. After 2 days, her bowel movements became regular, and her abdominal temperature rose to 36.3℃. Three days after the regular bowel movements, the decoction for clearing turbidity and removing blood stasis was discontinued, and she continued taking the decoction for warming the intestines and reducing turbidity. After one month, her ZI score dropped to 3, her mood improved significantly, and she gradually participated in more social activities. After three months of adjustment, she resumed her studies.

[0055] By monitoring changes in tongue coating and stool characteristics, this patient's tongue coating was thick and greasy at the root before medication; it gradually thinned during medication; and after two months of medication, the tongue was rosy with a thin white coating. Before treatment, the patient had a bowel movement every three to four days, with difficulty passing stool. After three days of medication, the stool changed from dark brown to golden yellow, still unformed, and the quantity increased. After two months of medication, the patient had one bowel movement daily, formed, and approaching golden yellow.

[0056] Case 3: The patient was a 14-year-old male, diagnosed with autism. His abdominal temperature was 35.4℃, he had small bowel movements every 2-3 days with a feeling of incomplete evacuation, and his tongue was thick and greasy with a white coating. His Zig-I (Zero Toxin Index) was 10 (severe). He was given a combination of a decoction to clear turbidity and remove blood stasis, along with a decoction to warm the intestines and reduce turbidity. After 3 days, his bowel movements became regular, and his abdominal temperature rose to 36.4℃. The decoction to clear turbidity and remove blood stasis was discontinued after 3 days, and he continued to take the decoction to warm the intestines and reduce turbidity. After one month, his Zig-I score dropped to 3, his repetitive behaviors decreased, his unconscious hyperactivity decreased, and he no longer needed his parents to accompany him to school.

[0057] By monitoring changes in tongue coating and stool characteristics, this patient's tongue coating was thick and greasy before medication; it gradually thinned during medication; after three days of medication, the thick and greasy coating lessened, and bowel movements became regular; after two months of medication, the tongue coating was thin and white. Before treatment, stool occurred once every three to four days; after three days of medication, the dark brown stool turned golden yellow, became finer, increased in quantity, and was basically formed; after two months of medication, bowel movements occurred once daily, were formed, and tended to be golden yellow.

[0058] Case 4: A 50-year-old male patient with a 10-year history of hyperuricemia. His abdominal temperature was 36.0℃, stools were sticky, and his tongue had a thick, greasy white coating at the root and a yellow, greasy coating. His ZigBet index was 8. He initially took the original Sanhuang Xiexin Decoction for two weeks, but his abdominal temperature decreased to 35.7℃, his stools remained sticky, and his tongue coating showed no improvement. He then switched to Paizhuo Huayu Decoction combined with Wenchang Jiangzhuo Decoction. After three days, his bowel movements became regular, his abdominal temperature rose to 36.5℃, and the thick, greasy white coating on his tongue significantly decreased. After four weeks, his uric acid level dropped from 590 umol / L to 360 umol / L, and the redness, swelling, and pain in his heels and big toes disappeared.

[0059] Case 5: The patient was an 8-year-old male, diagnosed with autism. His abdominal temperature was 35.7℃, and he had small, hard stools every 3-5 days. His tongue was thick and greasy with a white coating. His ZigBody Indication (ZI) score was 11. He was given expectorant and turbidity-resolving granules plus a warming intestinal and turbidity-reducing decoction. After 4 days, his bowel movements became regular, and his abdominal temperature rose to 36.4℃. Three days after the regular bowel movements, the expectorant and turbidity-resolving granules were discontinued, and he continued taking the warming intestinal and turbidity-reducing decoction. Two months later, his ZigBody Indication score dropped to 5, his stereotyped behaviors decreased, his impulsive behaviors decreased, his emotional and behavioral changes significantly improved, and his hitting and screaming decreased.

[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for resolving phlegm and clearing turbidity based on the pathogenesis of internal accumulation of turbid toxins, characterized in that: The ingredients include the following components: 6-12 parts of Arisaema cum Bile, 0.1-0.3 parts of in vitro cultured bezoar, 3-9 parts of rhubarb, 3-9 parts of Coptis chinensis, 10-20 parts of Alisma plantago-aquatica, 2-5 parts of cinnamon, 6-12 parts of Curcuma zedoaria, 3-9 parts of dried tangerine peel, and 3-9 parts of prepared licorice root.

2. The traditional Chinese medicine composition for resolving phlegm and clearing turbidity based on the pathogenesis of internal accumulation of turbid toxins according to claim 1, characterized in that: Nine parts of Arisaema cum Bile, 0.3 parts of in vitro cultured bezoar, 6 parts of rhubarb, 6 parts of Coptis chinensis, 15 parts of Alisma plantago-aquatica, 3 parts of cinnamon, 9 parts of Curcuma zedoaria, 6 parts of dried tangerine peel, and 6 parts of prepared licorice root.

3. The traditional Chinese medicine composition according to any one of claims 1 or 2, characterized in that: The dosage form of the traditional Chinese medicine composition is decoction, granules, pills, capsules or tablets.

4. A method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is a decoction, and its preparation method includes the following steps: S1. Weigh out the following herbs according to the prescription: Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis (processed with honey) and decoct with water. S2. Add rhubarb and cinnamon 3-8 minutes before the end of decoction, and collect the concentrated medicinal liquid; S3. Grind in vitro cultured bezoar into a fine powder and take it with the medicine solution or mix it with the concentrated solution.

5. A method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is in granule form, and its preparation method includes the following steps: R1. Weigh out the following herbs according to the prescription: Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, and Glycyrrhiza uralensis (processed with honey), and decoct with water. R2. Combine and concentrate the decoctions, add ethanol, stir and let stand. R3. Take the supernatant and concentrate it to obtain a thick paste; R4. Weigh out rhubarb according to the drug formula, add water, decoct and concentrate to obtain rhubarb extract; R5. Weigh out the volatile oil from cinnamon according to the drug formula. Boil the residue after extracting the volatile oil with water to obtain cinnamon extract. R6. In vitro cultured bezoar is ground into a fine powder; R7. Mix the thick paste, rhubarb extract, cinnamon extract, bezoar powder and appropriate excipients, granulate, dry, then spray in cinnamon volatile oil, and package to obtain the final product.

6. The preparation method according to claim 5, characterized in that: In step R2, the decoction is concentrated to a relative density of 1.20-1.25 at 60°C, and ethanol is added to make the ethanol content in the mixture 50-60%. The volatile oil of cinnamon is extracted by steam distillation. The pharmaceutical excipients are selected from one or more of fillers, wetting binders, disintegrants, and flavoring agents.

7. A method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The traditional Chinese medicine composition is a pill, and the preparation method includes the following steps: weigh out Arisaema cum Bile, Coptis chinensis, Alisma plantago-aquatica, Curcuma zedoaria, Citrus reticulata peel, Glycyrrhiza uralensis (processed), Rheum palmatum, and Cinnamomum cassia according to the drug formula, grind them into fine powder, sieve them, mix them evenly to obtain mixed powder, grind fine powder of in vitro cultured bezoar and mix it evenly with the mixed powder to obtain mixed powder, add refined honey to the mixed powder to make large honey pills.

8. The preparation method according to claim 7, characterized in that: The sieving process involves passing the powder through a 100-mesh sieve, and 100-120g of refined honey is added for every 100g of mixed powder.

9. The application of the phlegm-resolving and turbidity-clearing traditional Chinese medicine composition based on the pathogenesis of internal accumulation of turbid toxins as described in any one of claims 1 and 2, characterized in that: Used to prepare drugs for treating chronic diseases caused by the accumulation of toxins in the body.

10. The application according to claim 9, characterized in that: The chronic diseases characterized by the accumulation of toxins include autism, depression, diabetes, hyperuricemia, and constipation.

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