Spleen-tonifying, phlegm-reducing and stasis-removing traditional Chinese medicine compound for treating phlegm-stasis blockage type sicca syndrome

Through the Chinese herbal compound for strengthening the spleen, resolving phlegm and removing blood stasis, the limitations of Western medicine in treating Sjögren's syndrome and the lack of Chinese herbal compound for the pathogenesis of phlegm, blood stasis and numbness have been solved, achieving the effect of significantly improving patients' symptoms and improving their quality of life.

CN120754180APending Publication Date: 2025-10-10FIRST AFFILIATED HOSPITAL OF ANHUI UNIV OF CHINESE MEDICINE +1
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Patent Information

Application Number
CN202511165584.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-08-20
Publication Date
2025-10-10

AI Technical Summary

Technical Problem

Existing Western medicine drugs for the treatment of Sjögren's syndrome have limitations, especially the lack of effective Chinese herbal compound for the phlegm, blood stasis and obstruction type of pathogenesis. Long-term use of Western medicine may cause adverse reactions, and there is a lack of precise Chinese herbal compound specifically for this pathogenesis in traditional Chinese medicine treatment.

Method used

A traditional Chinese medicine compound for strengthening the spleen, resolving phlegm and removing blood stasis, which consists of Atractylodes lancea, Salvia miltiorrhiza, Magnolia officinalis, Atractylodes macrocephala, Poria cocos, Polyporus umbellatus, Angelica sinensis, Ligusticum chuanxiong, Millettia reticulata, Crataegus pinnatifida, Euphorbia pulex, Tangerine peel, Cassia twig, Talcum, Alisma orientalis, Eupatorium fortunei and Licorice, is used. By rationally combining the traditional Chinese medicine ingredients, the compound can exert the effects of strengthening the spleen and drying dampness, promoting blood circulation and removing blood stasis, and resolving phlegm and dredging the meridians, and a decoction is made for treatment.

Benefits of technology

Significantly improve patients' symptoms, such as dry mouth, dry eyes, fatigue, and joint pain, increase saliva and tear flow rates, reduce inflammatory indicators, improve patients' quality of life, and reduce recurrence.

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Abstract

The invention discloses a spleen-tonifying, phlegm-reducing and stasis-removing traditional Chinese medicine compound for treating phlegm-stasis blockage type sicca syndrome, and belongs to the field of traditional Chinese medicine compound preparations. Although the sicca syndrome is mainly caused by yin deficiency and dryness-heat, the disease course is long, yin and body fluid loss can influence the spleen and stomach functions, dampness caused by spleen deficiency and body fluid impairment caused by dryness-heat, dampness turbidity and dryness-heat are combined, refined liquid forms phlegm, phlegm stasis blocks veins, qi and blood circulation is not smooth, heat is converted from depression, yin and body fluid is further consumed, and dryness is aggravated. Therefore, the traditional Chinese medicine compound is prepared from rhizoma atractylodis, radix salviae miltiorrhizae, cortex magnoliae officinalis, rhizoma atractylodis macrocephalae, poria cocos, polyporus umbellatus, angelica sinensis, ligusticum wallichii, caulis spatholobi, hawthorn, winged euonymus twig, pericarpium citri reticulatae, cassia twig, talc, rhizoma alismatis, herba lycopi, liquorice and the like through compatibility, has the effects of tonifying spleen, reducing phlegm and removing blood stasis, treats both symptoms and root causes through overall compatibility, and is capable of tonifying spleen to treat root causes, reducing phlegm and removing blood stasis to treat symptoms and moistening dryness. The traditional Chinese medicine thinking that qi needs to be regulated when blood stasis is treated, and qi circulation means blood circulation is embodied. The traditional Chinese medicine composition has a good treatment effect on phlegm stasis and obstruction type sicca syndrome.
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Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine compound preparation, and particularly relates to a spleen-invigorating, phlegm-resolving and stasis-removing traditional Chinese medicine compound for treating dry syndrome of phlegm and stasis. BACKGROUND

[0002] Sjogren syndrome (SS) is a chronic inflammatory autoimmune disease involving multiple exocrine glands, and its incidence has been increasing in recent years. Clinically, it mainly manifests as xerostomia and xerophthalmia, and can also involve the respiratory system and the digestive system. The prognosis is generally good when the disease is limited to the salivary glands and lacrimal glands, but some patients who do not receive timely treatment may have life-threatening conditions.

[0003] The exact cause of Sjogren syndrome is unknown, but it is generally believed to be related to genetics, infection, and environment. Its clinical manifestations are complex and diverse, including common local symptoms such as xerophthalmia, xerostomia, dry tongue, and dry skin, as well as characteristic manifestations such as rampant dental caries, parotid gland swelling and pain, and symptoms involving multiple systems such as muscles and bones, kidneys, respiratory system, digestive system, nervous system, and blood.

[0004] From the perspective of traditional Chinese medicine theory, Sjogren syndrome is generally characterized by deficiency in origin and excess in superficiality, with deficiency of yin in origin and dryness-heat in superficiality. The disease is often protracted and lingering, and long-term illness often leads to deficiency and stasis. The kidney is affected, resulting in deficiency of vital qi, which further affects the functions of generating, transporting, and absorbing body fluid, leading to abnormal distribution of body fluid. The pathogenesis of Sjogren syndrome with phlegm and stasis obstruction is mainly due to spleen deficiency and dampness stagnation, with spleen deficiency as the root and dampness stagnation and phlegm stasis as the superficiality. Spleen deficiency leads to abnormal production and distribution of qi, blood, and body fluid. On the one hand, spleen deficiency and dampness stagnation cause oral and ocular dryness, and water retention leads to phlegm. On the other hand, spleen deficiency and weak qi lead to blood stasis, and phlegm and stasis further obstruct the meridians, forming a vicious cycle.

[0005] Currently, Western medicine mainly adopts symptomatic treatment for Sjogren syndrome, such as artificial tears for xerophthalmia, and active control of disease conditions with glucocorticoids, methotrexate, cyclophosphamide, and hydroxychloroquine for patients with significant organ damage. However, Western medicine treatment has certain limitations, such as long-term use of glucocorticoids and other drugs may cause adverse reactions, and some patients may experience disease rebound when the drug dosage is reduced or stopped.

[0006] Traditional Chinese medicine has its own advantages in the treatment of Sjogren's syndrome, although the effect is relatively slow, but long-term medication, long-term effect is good, less adverse reaction or even no. Through the overall grasp, syndrome differentiation and treatment, it has a positive effect on improving the symptoms of patients, improving the quality of life and reducing recurrence. In the prescription of traditional Chinese medicine for treating phlegm and blood stasis type disease, although there are such prescriptions as Shuanghe Decoction (from Hui Chun, Vol. 4, Zhabingyuanliu Xichu, mainly for treating phlegm and blood stasis type syndrome) which has the function of resolving phlegm and removing blood stasis, but the traditional Chinese medicine compound which is specially aimed at phlegm and blood stasis type Sjogren's syndrome, and closely around its unique pathogenesis, still needs to be further developed and researched. Therefore, it has important clinical significance and broad market prospect to develop a kind of traditional Chinese medicine compound which can accurately aim at phlegm and blood stasis type Sjogren's syndrome, and can effectively improve the symptoms and improve the quality of life of patients. SUMMARY

[0007] In view of the deficiency of the existing western medicine treatment and the unique phlegm and blood stasis type pathogenesis of Sjogren's syndrome, the technical problem to be solved by the present application is to provide a traditional Chinese medicine compound for treating phlegm and blood stasis type Sjogren's syndrome.

[0008] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is:

[0009] A traditional Chinese medicine compound for treating phlegm and blood stasis type Sjogren's syndrome, the effective components of which are prepared from the following weight of traditional Chinese medicine raw materials:

[0010] Atractylodes 5~15 g; Salvia miltiorrhiza 10~20 g;

[0011] Magnolia officinalis 3~12 g; Atractylodes 6~15 g;

[0012] Poria cocos 10~20 g; Grifola 5~15 g;

[0013] Angelica 5~20 g; Chuanxiong 5~12 g;

[0014] Caulis Spatholobi 10~25 g; Crataegus 8~18 g;

[0015] Guicai 5~12 g; Pericarpium Citri Reticulatae 3~12 g;

[0016] Cassia twig 3~10 g; Gypsum 5~15 g;

[0017] Alisma 5~15 g; Alisma 8~18 g;

[0018] Glycyrrhiza 1~5 g.

[0019] In the traditional Chinese medicine compound for invigorating the spleen, resolving phlegm and removing blood stasis, the efficacy of each traditional Chinese medicine is as follows:

[0020] Atractylodes, Bistort, North Atractylodes. Bitter and warm, spleen, stomach, liver. Has the effect of dry wet spleen, dispel wind and cold, clear eyes. Mainly for wet and wet, loss of appetite, vomiting, depression, phlegm, abdominal distension and diarrhea; wet and wet, headache and body pain, dampness, joint pain. Modern pharmacological studies show that Atractylodes contains a variety of active ingredients, such as β-eudesmol and atractylodin. Promote gastrointestinal motility, liver protection, choleretic, anti-ulcer, anti-tumor, sedation, hypoglycemic and anti-viral effects.

[0021] Salvia, also known as red salvia, wood and milk. Bitter and cold. Heart, liver. Has the effect of activating blood and removing blood stasis, dredging channels and relieving pain, clearing the heart and relieving the blood and eliminating carbuncles. Mainly for chest pain, abdominal pain, mass accumulation, heat and pain, restlessness, insomnia, irregular menstruation, dysmenorrhea, and sore pain. Modern pharmacological studies show that the chemical composition of Salvia is mainly divided into liposoluble components and water-soluble components. Salvia has a wide range of complex pharmacological activities, and the main pharmacological activities of liposoluble components are anticoagulation and anti-platelet aggregation, lipid regulation, anti-inflammatory, anti-tumor; the main pharmacological activities of water-soluble components are anti-oxidation, anti-atherosclerosis, and blood pressure reduction; in addition, Salvia polysaccharide also has obvious anti-tumor and immune regulation effects.

[0022] Magnolia, also known as thick skin, heavy skin, red bark, oil bark, Sichuan bark, and purple oil bark. Warm, bitter and pungent. Spleen, stomach, lung, large intestine. Has the effect of drying wetness and eliminating phlegm, and reducing gas and eliminating fullness. Mainly for wetness in the middle, abdominal distension, food accumulation and gas retention, abdominal distension and constipation, lung qi not descending, phlegm and cough, wet and turbid, cholera and diarrhea, seven emotions, phlegm and phlegm. Modern pharmacological studies show that the chemical composition of Magnolia mainly contains lignans, alkaloids and volatile oils; the main components of lignans are magnolol, tetrahydro-magnolol, isomagnolol, and honokiol. Magnolol and isomagnolol have muscle relaxation; small doses of Magnolia decoction can stimulate intestinal smooth muscle, while large doses can have inhibitory effects. In addition, Magnolia also has anti-ulcer, central inhibition, hypotensive, anti-pathogenic microorganisms, inhibition of intracellular calcium flow, anti-platelet and anti-tumor effects.

[0023] Bai zhu, also known as Yu zhu, Dong zhu, Zhe zhu, Shan ji, Shan jing. Bitter, sweet, warm; spleen, stomach meridian with Qi, spleen, dry wet, water, stop sweating, an effect of the fetus. Treatment of spleen deficiency, poor appetite, abdominal distension and diarrhea, dizziness, edema, sweating, fetal movement instability. Modern pharmacological studies show that Bai zhu contains volatile oil, the main components of atractylone, Bai zhu lactone A, B and sugar (mainly for mannose, fructose) and other. Bai zhu lactone I have a regulatory effect on the gastrointestinal tract. Bai zhu decoction has diuretic, anti-aging effect. Bai zhu polysaccharide, Bai zhu volatile oil can enhance cellular immune function. Bai zhu alcohol extract and petroleum ether extract can inhibit uterine smooth muscle contraction in experimental animals. In addition, Bai zhu has a protective effect on the liver, gallbladder, blood sugar, antibacterial, antitumor, sedative, antitussive, expectorant and other effects.

[0024] Tremella, also known as Yu ling, Fu ling, Wan ling gui, Fu du. Sweet, mild, flat. Heart, lung, spleen, kidney meridian. Have water, wet, spleen, heart. Treatment of edema, phlegm, spleen deficiency, diarrhea, palpitations, insomnia. Modern pharmacological studies show that the product contains β-tremella polysaccharide, accounting for about 93% of the dry weight, also contains tremella acid, protein, fat, lecithin, choline, histidine, ergosterol and other. Have a protective effect on the liver and enzymes, anti-gastric ulcer, central inhibition, diuretic, enhance cellular immunity and humoral immunity, hypoglycemic, antitumor, anti-pathogenic microorganisms, promote hematopoiesis and other functions.

[0025] Polyporus, also known as wild pig feces, pig shit, Fengling, Di wutao, wild pig food, pig tremella. Sweet, mild, flat. Kidney, bladder meridian. Have water, swelling, wet. Treatment of edema, dysuria, beriberi, diarrhea, turbidity, leukorrhagia and other. Modern pharmacological studies show that pig ling mainly contains polysaccharides, such as pig ling glucan, as well as steroids, free and combined type of biotin, crude protein and other ingredients. Diuretic, liver protection, antibacterial, immune regulation.

[0026] Angelica, sweet, pungent, warm. Liver, heart, spleen meridian. Function of blood tonic, blood circulation, regulating menstruation, pain, moistening the intestines. Treatment of blood deficiency, dizziness, palpitations, irregular menstruation, amenorrhea, dysmenorrhea, cold abdominal pain, dry constipation, rheumatism, sprains, carbuncles and sores. Wine angelica blood circulation. For amenorrhea, rheumatism, sprains. Modern pharmacological research found that angelica contains volatile oil, sucrose, vitamins, fatty acids and other ingredients. Angelica polysaccharide to promote hematopoiesis (elevate the content of peripheral blood red blood cells, white blood cells, hemoglobin, etc.); angelica polysaccharide, ferulic acid enhance immunity, in addition to have the effect of inhibiting platelet aggregation, anti-thrombosis, anti-inflammatory, antibacterial, antioxidant.

[0027] Chuanxiong, also known as Shanjukong, Xionglin, Xiangguo, Maheng, Xixiong, Guanxiong, is warm in nature and pungent in taste. It belongs to the liver meridian, gallbladder meridian and pericardium meridian. It has the functions of activating blood and promoting qi, dispelling wind and relieving pain. It is mainly used for treating chest pain due to blood stasis, rib pain due to liver stagnation, chest and rib pain due to blood stasis, various headaches and rheumatic pain. Modern pharmacological studies have found that this product contains alkaloids (such as chuanxiongzine), volatile oils (mainly ligustrazine, chuanxiong, etc.), phenolic substances (such as ferulic acid), lactones and vitamins A, folic acid, sucrose, sterols, fatty oils, etc. Chuanxiongzine can improve microcirculation and inhibit platelet aggregation; water decoction has a sedative effect on the central nervous system of animals and has a significant and lasting antihypertensive effect; in addition, chuanxiong also has the effects of enhancing immunity, antihistamine and cholagogue.

[0028] Semen Sargentodoxae, also known as Xueshenteng, Jiucengfeng, Xueshenteng, Zihengteng, Xueshengteng, Daxueteng, Guoganglong, is warm in nature and bitter and sweet in taste. It belongs to the liver meridian and kidney meridian. It has the functions of promoting blood circulation, regulating menstruation and relaxing muscles and tendons. It is used for treating irregular menstruation, dysmenorrhea, amenorrhea, rheumatic pain, numbness of hands and feet, and atrophy due to blood deficiency. Modern pharmacological studies have shown that Sargentodoxae contains isoflavones such as formononetin, daidzein, triterpenoids such as epifriedelanol, friedelinone, and steroidal compounds such as β-sitosterol, carotene glycoside, brassicasterol, and sargentol. It has the effects of expanding blood vessels, anti-platelet aggregation, anti-inflammatory, immune regulation, etc.

[0029] Fructus Crataegi, also known as Shanliguo and Shanlihong, is sour and sweet in taste, slightly warm in nature, and belongs to the spleen, stomach and liver meridians. It has the functions of digesting food and resolving accumulation, promoting blood circulation and removing blood stasis. It is used for treating food accumulation, dysentery, abdominal pain, abdominal pain due to blood stasis, and dysmenorrhea. Modern pharmacological studies have found that Crataegus contains flavonoids, triterpenoid saponins, saponins, free acids, fatty acids, vitamin C, etc. It has the effects of lowering blood lipids, anti-platelet aggregation, antioxidant, enhancing immunity, diuresis, sedation, uterine contraction, antibacterial, improving cardiovascular function, etc.

[0030] Radix Aristolochiae, also known as Aristolochia, Ghost Arrow, Sixiangling, Sifengshu, Sifengji, Jianzhongxiao, is bitter and pungent in taste and cold in nature. It belongs to the liver and spleen meridians. It has the functions of breaking blood, resolving toxins, and killing insects. It is used for treating abdominal pain, amenorrhea, dysmenorrhea, postpartum abdominal pain, lochia, hernia, arthralgia, swelling, contusion pain, insect accumulation abdominal pain, scalding injury, and snake bite. Modern pharmacological studies have found that Radix Aristolochiae contains epifriedelanol, friedelin, quercetin, aristolochic acid, aristolochic acid, oleic acid, linoleic acid, linolenic acid, hexanoic acid, acetic acid, benzoic acid, etc. flavonoids. It has the effects of improving circulation, anti-thrombosis, strengthening heart, regulating blood lipids and lowering blood sugar.

[0031] Pericarpium Citri Reticulatae, also known as orange peel, Guileld, and Huangjupei. It has a bitter and acrid taste and a warm nature, and is associated with the spleen and lung meridians. It has the functions of regulating qi, invigorating the spleen, drying dampness, and reducing phlegm. It is used to treat qi stagnation in the spleen and stomach, vomiting, hiccup, damp phlegm, cold phlegm cough, and chest pain. Modern pharmacological studies have shown that pericarpium citri reticulatae contains nobiletin, hesperidin, neohesperidin, hesperetin, p-hydroxyphenylethylamine, and flavonoid compounds. The volatile oil content of pericarpium citri reticulatae is 1.5%-2.0%, and the volatile oil content of pericarpium citri reticulatae var. grandis is 1.2%-3.2%. The components include α-thujene and limonene. The decoction of this product can inhibit gastrointestinal peristalsis and improve circulation. The water-soluble total alkaloids of pericarpium citri reticulatae have the effect of raising blood pressure. Pericarpium citri reticulatae extract has the effects of scavenging oxygen free radicals and anti-lipid peroxidation. The volatile oil has a stimulating expectorant effect, and the main effective component is limonene. It also has the effects of promoting bile secretion and reducing serum cholesterol.

[0032] Cinnamomum cassia, also known as Guijian, Guizhimu, Rengui zhi, Liuguai, Guaizhi, Guaizhi, Guimu zhi, Guimu zhi, and Guangmei Jian. It has a bitter and acrid taste and a warm nature, and is associated with the heart, lung, and bladder meridians. It has the functions of sweating and relieving the skin, warming and unblocking the meridians, assisting yang and transforming qi, and descending and regulating qi. It is used to treat colds, abdominal cold pain, blood cold, joint pain, phlegm, edema, palpitations, and galloping. Modern pharmacological studies have shown that cinnamomum cassia contains a variety of chemical components, including volatile components, organic acids, and glycosides. The main components studied in domestic and foreign literature are cinnamaldehyde and cinnamic acid, which have the pharmacological effects of regulating body temperature, analgesia, antibacterial, anti-inflammatory, anti-allergic, anti-viral, promoting vasodilation, diuresis, sedation, anti-anxiety, anti-tumor, and lowering blood pressure.

[0033] Talc, also known as liquid stone, tao stone, and common stone. It has a sweet and bitter taste and a cold nature, and is associated with the bladder, lung, and stomach meridians. It has the effects of diuresis, clearing heat, and resolving dampness. It is used to treat hot and stone, urinary heat and pain, heat and thirst, and wet and hot diarrhea. It is also used to treat eczema, wet sores, and miliaria. Modern pharmacological studies have shown that talc contains magnesium silicate, aluminum oxide, and nickel oxide, and has the effects of anti-pathogenic microorganisms, protecting the mucosa, and promoting scabbing.

[0034] Alisma orientalis, also known as Shuize, Ruyihua, Chekucai, Tian'e'egon, Tian'tu, and Zizhuahua. It has a sweet and bitter taste and a cold nature, and is associated with the kidney and bladder meridians. It has the effects of diuresis, heat, and turbidity. It is used to treat dysuria, edema, diarrhea, and high blood pressure. Modern pharmacological studies have shown that alisma orientalis contains triterpenoids and sesquiterpenes. Alisma has the effects of diuresis, lowering blood pressure, and inhibiting stone formation. In addition, alisma has the effects of increasing coronary flow, anti-inflammatory, antibacterial, anti-coagulation, anti-convulsion, regulating immunity, and lowering blood sugar.

[0035] Zedoariae rhizome, also known as sweet potato seedlings, ground shoots, sweet dew seeds, and square-stemmed zedoariae, has a bitter, pungent, and slightly warm taste and enters the liver and spleen meridians. It has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncles, and promoting diuresis and reducing swelling. It is mainly used to treat irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to postpartum blood stasis, sores, carbuncles, swelling, and edema. Modern pharmacological research shows that Zedoariae rhizome contains volatile oils, glucosides, tannins, and linalin, as well as flavonoid glycosides, phenols, amino acids, organic acids, saponins, zedoariase, stachyose, galactose, and fructose. It has the effects of improving microcirculatory disorders, resisting thrombosis, and strengthening the heart.

[0036] Licorice, belonging to the Heart, Lung, Spleen, and Stomach meridians, has the effects of tonifying the spleen and replenishing Qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving acute pain, and harmonizing various medicines. It is mainly used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncles and sores, and to alleviate drug toxicity and potency. Modern pharmacological research shows that the chemical components of licorice mainly include triterpenoid saponins, flavonoids, glycyrrhizic polysaccharides, etc. The pharmacological effects of licorice mainly include anti-inflammatory, anti-tumor, antibacterial, antiviral, antioxidant, and immunomodulatory effects.

[0037] Traditional Chinese Medicine (TCM) considers the invasion of dryness, spleen deficiency and dampness stagnation, and phlegm and blood stasis blocking the meridians as the primary factors contributing to dryness and arthralgia, classifying it as "dryness and arthralgia." "Dryness is dry and astringent, easily damaging body fluids." Dryness invades the human body, easily leading to a loss of body fluids, resulting in various symptoms caused by dryness and astringency. The "Origin of Medicine" states: "Dampness stagnation prevents the distribution of body fluids and transforms into dryness." Phlegm and dampness are the primary products of impaired fluid metabolism. Phlegm and dampness block the qi and blood meridians, disrupting the distribution of body fluids and causing dryness. Prolonged loss of body fluid circulation leads to prolonged illness. Imbalances in qi, blood, yin and yang, and visceral dysfunction are the pathological basis of this condition. The "Treatise on Blood Symptoms" states: "When there is tuberculosis and blood, qi is blocked by blood and cannot ascend, and body fluids are also unable to rise with qi." This clearly demonstrates that blood stasis blocking the meridians leads to a loss of body fluid circulation, causing dryness and arthralgia. The underlying pathogenesis lies in damage to the spleen and stomach, which impairs their ability to produce blood, circulate body fluids, and regulate qi. Patients often suffer from dietary restrictions (e.g., impaired emotional well-being), or invasion of external pathogens, which damage the spleen and stomach. This leads to dysfunctional spleen and stomach function, disrupted Qi flow, and impaired fluid circulation, which accumulates and generates dampness. Furthermore, stagnant food and water transform into heat, which, over time, transforms into turbidity. Turbidity, with its heaty nature, depletes Qi and Yin over time. Qi deficiency, however, deprives blood and body fluids of their ability to circulate. Yin deficiency, on the other hand, depletes the source of nourishing nutrients, leading to blood stasis and obstruction of the meridians, resulting in a multitude of arthritis symptoms, manifesting as dryness. The clinical hallmarks of dryness and arthritis are the simultaneous presence of both dryness and arthritis. Treatment requires a clear understanding of the underlying pathogenesis, combining syndrome differentiation with pathological differentiation. In addition to strengthening the spleen and promoting Qi circulation, treatment should be combined with herbs that activate blood circulation, resolve stasis, and resolve phlegm to unclog the meridians. This is the only way to circulate body fluids, unblock joints and tendons, and restore balance to the body. Therefore, the present invention proposes a traditional Chinese medicine compound for strengthening the spleen, resolving phlegm and removing blood stasis for Sjögren's syndrome of phlegm, blood stasis and obstruction type, which is made up of atractylodes, salvia miltiorrhiza, Magnolia officinalis, Atractylodes macrocephala, Poria cocos, Polyporus umbellatus, Angelica sinensis, Chuanxiong, Millettia reticulata, hawthorn, Psoralea corylifolia, tangerine peel, cassia twig, talc, Alisma orientalis, Eupatorium fortunei and licorice, and can effectively treat Sjögren's syndrome of phlegm, blood stasis and obstruction type.

[0038] This traditional Chinese medicine compound features Atractylodes lancea and Salvia miltiorrhiza as the main ingredients. Atractylodes lancea is bitter and warm in nature, promoting spleen invigoration and dampness removal. Salvia miltiorrhiza is slightly bitter and slightly cold, relieving depression, activating blood circulation, and removing blood stasis. Together, these two herbs serve as the main ingredients: Atractylodes lancea strengthens the spleen and eliminates dampness as the primary ingredient, while Salvia miltiorrhiza promotes blood circulation and removes blood stasis as the secondary ingredient. This approach addresses both the primary and secondary symptoms, promoting the production and distribution of body fluids. Magnolia officinalis, Atractylodes macrocephala, Poria cocos, and Polyporus umbellatus are combined with Atractylodes lancea, while Angelica sinensis, Chuanxiong rhizome, Millettia spatholobi, and Psoralea corylifolia are combined with Salvia miltiorrhiza. Magnolia officinalis is pungent and warm, drying dampness and eliminating phlegm, regulating the middle burner, and assisting Atractylodes in its spleen-strengthening function. Poria cocos and Polyporus umbellatus are sweet and mild in nature, promoting spleen invigoration and diuresis. Together with Atractylodes lancea, they regulate the middle and lower burners, balancing dampness removal and dampness elimination, thereby helping to dissipate internal dampness. Atractylodes macrocephala invigorates Qi and strengthens the spleen, preventing excessive excretion and protecting vital Qi. Angelica sinensis and Millettia spatholobi are sweet and pungent and warm in nature, promoting blood tonification, regulating menstruation and relieving pain, and relaxing tendons and activating collaterals. Dryness syndrome favors soft and moist ingredients while avoiding bitter and dry ones. Both promote blood circulation and qi, nourishing the liver and moistening the joints. This also prevents chronic illness. Wood stagnation overwhelms earth, and a smooth liver leads to a soothing stomach. Chuanxiong promotes qi and blood circulation, while Psoralea corylifolia is potent in promoting blood circulation and menstruation. Together with Angelica sinensis and Millettia reticulata, and Danshen, these herbs are warming without drying, nourishing blood and menstruation, providing nourishment without greasiness, and nourishment without stagnation. Hawthorn, with its sweet and warm nature, serves as a ministerial ingredient, assisting Atractylodes macrocephala in strengthening the spleen and promoting qi, while complementing Danshen in removing blood stasis. For dryness and numbness caused by spleen deficiency and dampness stagnation, phlegm and dampness are blocked. Tangerine peel is used in combination with Atractylodes lancea and Magnolia officinalis to regulate qi and strengthen the spleen, eliminate dampness and resolve phlegm. However, the production and transfer of body fluids requires the transpiration and vaporization of yang qi, so cinnamon twig is used to warm and unblock the meridians, promoting yang and transforming qi. Alisma orientalis is sweet and cold in nature, entering the kidney and bladder meridians, promoting diuresis, dispelling dampness, and purging heat. Cinnamon twig, Alisma orientalis, and talc are used together to assist the diuretic effects of Poria cocos and Polyporus umbellatus. Unblocking the water channels naturally strengthens the spleen. For blood stasis blocking the collaterals and obstructing the meridians, Zedoaria is used in combination with herbs like Salvia miltiorrhiza and Angelica sinensis to activate blood circulation, dispel stasis, and dredge the body fluid channels. Licorice serves as a guiding herb, harmonizing all the other herbs.

[0039] The above medicines can be used together to strengthen the spleen and promote qi circulation, resolve phlegm and remove blood stasis. The overall combination takes into account both strengthening the body and eliminating pathogenic factors, so that the body's qi is strong and full of body fluids, blood stasis is removed, the meridians are unblocked, and the body fluids are distributed smoothly, thus relieving dryness and numbness.

[0040] As a preferred technical solution of the present invention, the effective ingredients of the spleen-strengthening, phlegm-resolving and blood-stasis-removing Chinese medicinal compound are preferably prepared from the following Chinese medicinal raw materials by weight:

[0041] Atractylodes lancea 8-12 g; Salvia miltiorrhiza 12-18 g;

[0042] Magnolia officinalis 5-10 g; Atractylodes macrocephala 8-12 g;

[0043] Poria 12-18 g; Polyporus 8-12 g;

[0044] Angelica sinensis 10-15 g; Ligusticum chuanxiong 6-10 g;

[0045] Millettia repens 12-18 g; Crataegus pinnatifida 10-15 g;

[0046] Radix et Rhizoma Aristolochiae 6~10 g; Pericarpium Citri Reticulatae 6~10 g;

[0047] Cinnamomi Ramulus 6~9 g; Natrii Muriatici 8~12 g;

[0048] Alismatis Rhizoma 6~12 g; Alismatis Rhizoma 10~15 g;

[0049] Glycyrrhizae Radix et Rhizoma 2~4 g.

[0050] As a further preferred technical scheme of the present application, the effective components of the spleen-invigorating, phlegm-resolving and stasis-removing traditional Chinese medicine compound are preferably prepared from the following weight of traditional Chinese medicine raw materials:

[0051] Radix et Rhizoma Atractylodis 10 g; Radix Salviae Miltiorrhizae 15 g;

[0052] Magnoliae Officinalis Cortex 8 g; Rhizoma Atractylodis Macrocephalae 10 g;

[0053] Poria Cocos 15 g; Grifola 10 g;

[0054] Angelica sinensis 12 g; Ligusticum Chuanxiong 9 g;

[0055] Caulis Spatholobi 15 g; Fructus Crataegi 12 g;

[0056] Radix et Rhizoma Aristolochiae 9 g; Pericarpium Citri Reticulatae 9 g;

[0057] Cinnamomi Ramulus 8 g; Natrii Muriatici 10 g;

[0058] Alismatis Rhizoma 10 g; Alismatis Rhizoma 12 g;

[0059] Glycyrrhizae Radix et Rhizoma 3 g.

[0060] The steps of preparing the spleen-invigorating, phlegm-resolving and stasis-removing traditional Chinese medicine compound into decoction are as follows: mixing the traditional Chinese medicines, adding water with a weight of 1~3 times that of the traditional Chinese medicines, heating and refluxing for 1~3 h, adding water with a weight of 1~2 times that of the filter residue to the filter residue again, heating and refluxing for 1~2 h, combining the two filtrates, and concentrating to obtain 350~450 mL of decoction. BRIEF DESCRIPTION OF DRAWINGS

[0061] Figure 1 is the comparison of the patient's feeling scores (dry mouth, dry eyes, fatigue, joint pain) before and after treatment.

[0062] Figure 2 is the comparison of the patient's tear flow rate and saliva flow rate before and after treatment.

[0063] Figure 3 is the comparison of the inflammatory indexes ESR (a) and CRP (b) before and after treatment.

[0064] Figure 4The ESSPRI (a) and immunological indexes (IgG, IgM, IgA) (b) before and after treatment are compared. DETAILED DESCRIPTION

[0065] The application further discloses a compound of the spleen-invigorating, phlegm-resolving and blood-stasis-removing traditional Chinese medicine for treating dry syndrome of phlegm and blood stasis, which is prepared by the following steps.

[0066] Example 1

[0067] The application further discloses a compound of the spleen-invigorating, phlegm-resolving and blood-stasis-removing traditional Chinese medicine for treating dry syndrome of phlegm and blood stasis, which is prepared by the following steps.

[0068] The atractylodes 10 g, salvia miltiorrhiza 15 g, magnolia officinalis 8 g, white atractylodes 10 g, poria cocos 15 g, polyporus 10 g, angelica 12 g, chuanxiong 9 g, caesalpinia 15 g, hawthorn 12 g, devil's arrow 9 g, tangerine peel 9 g, cassia twig 8 g, talc 10 g, alisma 10 g, lycium 12 g and licorice 3 g are mixed, 530 g of water is added, and heating reflux extraction is carried out for 2 h, then 1.5 times the weight of water of the filter residue is added again, and heating reflux extraction is carried out for 1 h; the two filtrates are combined, and concentration is carried out to obtain a decoction with a volume of 350 mL.

[0069] Example 2

[0070] The application further discloses a compound of the spleen-invigorating, phlegm-resolving and blood-stasis-removing traditional Chinese medicine for treating dry syndrome of phlegm and blood stasis, which is prepared by the following steps.

[0071] Observation index: (1) patient's clinical feeling: dry mouth, dry eyes, fatigue, joint pain, respectively, 0-10 points as the score; calculate the European anti-rheumatic disease alliance dry syndrome patient self-report index (ESSPRI); (2) determine the saliva flow rate and Schirmer test of the patients before and after treatment; (3) fasting venous blood of the two groups of patients is taken before treatment and after 8 weeks of treatment, and inflammatory indexes ESR, CRP, and immunological indexes IgA, IgM and IgG are detected.

[0072] The research results show that, compared with before treatment, the patient's feeling (including dry mouth, dry eyes, fatigue, joint pain) is significantly reduced (P<0.05) (see Figure 1 ); the tear flow rate and saliva flow rate are significantly increased (P<0.05) (see Figure 2 ); the inflammatory indexes (ESR, CRP) are significantly reduced (P<0.05) (see Figure 3); after treatment, the ESSPRI index and immunological index IgG of the patient were significantly reduced (P<0.05) (see Figure 4 )。

[0073] Therefore, the spleen-invigorating, phlegm-resolving and blood-stasis-removing traditional Chinese medicine compound can be used for treating the siccative syndrome caused by phlegm and blood stasis, and has good treatment effect.

[0074] The above is only an example and description of the concept of the present application, and those skilled in the art can make various modifications or supplements to the described specific embodiments or use similar ways to replace, as long as the concept of the present application is not deviated or the scope defined by the present claims is not exceeded, which shall belong to the protection scope of the present application.

Claims

1. A Chinese herbal formula for invigorating the spleen, resolving phlegm and removing blood stasis for treating Sjögren's syndrome of phlegm-stasis and numbness obstruction type, characterized in that: Its active ingredients are prepared from the following Chinese medicinal raw materials by weight: Atractylodes lancea 5-15 g; Salvia miltiorrhiza 10-20 g; Magnolia officinalis 3-12 g; Atractylodes macrocephala 6-15 g; Poria 10-20 g; Polyporus 5-15 g; Angelica sinensis 5-20 g; Chuanxiong 5-12 g; Millettia repens 10-25 g; Crataegus pinnatifida 8-18 g; 5-12 g of tangerine peel; 3-12 g of dried tangerine peel; Cinnamon twig 3-10 g; Talc 5-15 g; Alisma orientalis 5-15 g; Zedoariae rhizome 8-18 g; Licorice 1-5 g.

2. The spleen-strengthening, phlegm-resolving and blood-stasis-eliminating Chinese medicinal compound according to claim 1, wherein: Its active ingredients are prepared from the following Chinese medicinal raw materials by weight: Atractylodes lancea 8-12 g; Salvia miltiorrhiza 12-18 g; Magnolia officinalis 5-10 g; Atractylodes macrocephala 8-12 g; Poria 12-18 g; Polyporus 8-12 g; Angelica sinensis 10-15 g; Ligusticum chuanxiong 6-10 g; Millettia repens 12-18 g; Crataegus pinnatifida 10-15 g; 6-10 g of Psoralea corylifolia; 6-10 g of dried tangerine peel; 6-9 g of cinnamon twig; 8-12 g of talc; Alisma orientalis 6-12 g; Zedoariae rhizome 10-15 g; Licorice root 2~4 g.

3. The Chinese medicinal compound for strengthening the spleen, resolving phlegm and removing blood stasis as claimed in claim 2, characterized in that: Its active ingredients are prepared from the following Chinese medicinal raw materials by weight: Atractylodes lancea 10 g; Salvia miltiorrhiza 15 g; Magnolia officinalis 8 g; Atractylodes macrocephala 10 g; Poria 15 g; Polyporus 10 g; Angelica sinensis 12 g; Ligusticum chuanxiong 9 g; Millettia repens 15 g; Hawthorn 12 g; Ghost arrow feather 9 g; Tangerine peel 9 g; Cinnamon twig 8 g; Talc 10 g; Alisma orientalis 10 g; Zedoariae rhizome 12 g; Licorice 3 g.

4. The spleen-strengthening, phlegm-resolving and blood-stasis-eliminating Chinese medicinal compound according to claim 1, 2 or 3, wherein: The steps of preparing the spleen-strengthening, phlegm-resolving and blood-stasis-removing Chinese herbal compound into a decoction are as follows: mixing the Chinese herbs, adding 1 to 3 times the weight of water of the Chinese herbs, heating and refluxing for 1 to 3 hours, filtering, adding 1 to 2 times the weight of the filtrate residue again, heating and refluxing for 1 to 2 hours; combining the two filtrates, and concentrating to obtain 350 to 450 mL of the decoction.