A traditional Chinese medicine compound for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for treating Sjogren's syndrome

Abstract

A traditional Chinese medicine compound for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for treating Sjogren's syndrome, belonging to the field of traditional Chinese medicine preparations for treating joint diseases. It is made from 3 - 7 parts of Nardostachys jatamansi, 10 - 20 parts of Polygonatum sibiricum, 5 - 10 parts of Poria cocos, 10 - 20 parts of Coix lacryma-jobi, 5 - 15 parts of maltose, 1 - 5 parts of Rhodiola rosea, 1 - 5 parts of Eleutherococcus senticosus, 1 - 5 parts of Gynostemma pentaphyllum, 1 - 5 parts of Anemarrhena asphodeloides, 3 - 10 parts of Schisandra chinensis, 10 - 20 parts of Rehmannia glutinosa, 2 - 8 parts of Trichosanthes kirilowii, 2 - 8 parts of raw donkey-hide gelatin, and 3 - 8 parts of Geranium wilfordii. In this formula, Polygonatum sibiricum and Rehmannia glutinosa are the monarch drugs, invigorating the spleen, replenishing qi, nourishing yin, and regulating the "acquired foundation"; raw donkey-hide gelatin, Anemarrhena asphodeloides, Schisandra chinensis, and Trichosanthes kirilowii assist Rehmannia glutinosa in nourishing yin, and Poria cocos, Coix lacryma-jobi, and Rhodiola rosea help Polygonatum sibiricum invigorate the spleen, serving as the ministerial drugs; Nardostachys jatamansi and maltose warm the middle-jiao to reinforce deficiency, disperse stagnation and awaken the spleen, can harmonize the properties of the medicine, and promote the functions of the spleen and stomach, serving as the adjuvant drugs; Eleutherococcus senticosus, Gynostemma pentaphyllum, and Geranium wilfordii are the guiding drugs, enhancing the overall effect of the formula.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine preparations for the treatment of Sjogren's syndrome, and specifically relates to a compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for the treatment of Sjogren's syndrome. Background Art

[0002] Sjogren's syndrome is a chronic inflammatory disease, which is characterized by mainly affecting exocrine glands. Patients often show attenuation of the functions of salivary and lacrimal glands, resulting in symptoms of dry mouth and eyes. Moreover, this symptom may also invade other exocrine glands and even non-glandular tissues, causing systemic damage to multiple organs.

[0003] At present, the etiology and pathogenesis of this disease are not yet fully understood. There is no radical cure in Western medicine. The main treatments are replacement and symptomatic treatments. When there is organ damage, glucocorticoids, immunosuppressants, biological agents, etc. can be used, while patients with only dry mouth and eyes mostly receive symptomatic treatments. Traditional Chinese medicine generally believes that it is related to dryness pathogens and is called "dry arthralgia". Traditional Chinese medicine also has unique advantages in the treatment of Sjogren's syndrome.

[0004] The pathogenesis of Sjogren's syndrome is complex. Most modern physicians believe that the general etiology and pathogenesis of this disease in traditional Chinese medicine are mainly deficiency of yin, qi and blood stasis, with dryness and heat as the superficial symptoms. Qi deficiency leading to failure of transportation, internal heat due to yin deficiency and blood stasis with fluid deficiency are the pathogenic factors of this disease. The formation of dryness syndrome is related to zang-fu organs such as the lung, spleen, stomach, liver and kidney. Treating from the spleen and stomach, the spleen is the source of qi and blood production. Weakness of the spleen and stomach will cause phlegm-dampness to obstruct qi movement, and body fluids cannot be distributed to nourish the whole body, resulting in the emergence of dryness symptoms. The treatment should be to invigorate the spleen and stomach and nourish yin and moisten dryness. Treating from the liver, deficiency of liver blood cannot moisten, and the liver fails to disperse and dredge, so body fluids are lost in the process of distribution and metabolism. When treating, yin should be nourished and the liver should be soothed. Treating from the lung, the lung is mainly responsible for distributing body fluids, and the lung is a delicate zang-fu organ, and dryness and heat pathogens are likely to invade the lung defense. Therefore, when treating, it is advisable to clear and nourish the lung and stomach and promote the production of body fluids and moisten dryness. Treating from the kidney, the transpiration and qi transformation function of the kidney is the key factor controlling the whole body fluid metabolism, and the treatment should be to tonify the kidney and moisten dryness. Summary of the Invention

[0005] The purpose of the present invention is to provide a compound traditional Chinese medicine for effectively treating Sjogren's syndrome, which is dialectically treated from the perspective of invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals, and has a good treatment effect.

[0006] The technical solution adopted by the present invention is as follows:

[0007] A compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for the treatment of Sjogren's syndrome, and the active ingredients of the compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals are prepared from the following Chinese medicine raw materials in parts by weight:

[0008]

[0009]

[0010] The drugs in the formula are divided into four categories: invigorating the spleen, replenishing qi, nourishing yin, and dredging collaterals, which are introduced separately below:

[0011] I. Invigorating the spleen: Nardostachys jatamansi, Polygonatum sibiricum, Poria cocos, Coix lacryma-jobi, maltose

[0012] Nardostachys jatamansi: Pungent, sweet, and warm in nature, attributing to the spleen and stomach meridians. Regulating qi and relieving pain, dispelling depression and awakening the spleen.

[0013] Traditional Chinese medicine theory: Aromatic and awakening the spleen, warm but not dry, sweet but not stagnant.

[0014] Modern research shows that various sesquiterpene components contained in Nardostachys jatamansi have hepatoprotective activity, central nervous system activity, and antioxidant activity (Pathak S, Godela R. Nardostachys jatamansi: Phytochemistry, ethnomedicinal uses, and pharmacological activities: A comprehensive review[J]. Fitoterapia, 2023:105764.)

[0015] Polygonatum sibiricum: Sweet and neutral in nature, attributing to the lung, spleen, and kidney meridians. Tonifying qi and nourishing yin, invigorating the spleen and strengthening the kidney, moistening the lung

[0016] Traditional Chinese medicine theory: Entering the spleen meridian, tonifying the spleen qi and being suitable for nourishing spleen yin, being good at treating those with spleen deficiency belonging to both qi and yin deficiency.

[0017] Modern research shows that: Polygonatum sibiricum polysaccharide has a certain scavenging effect on DPPH, hydroxyl free radicals, and superoxide anion free radicals, and has antioxidant activity (Wang S, Li G, Zhang X, et al. Structural characterization and antioxidant activity of Polygonatum sibiricum polysaccharides[J]. Carbohydrate polymers, 2022, 291:119524.) In addition, Polygonatum sibiricum polysaccharide inhibits pyroptosis through the NLRP 3 / GSDMD signal, reduces the levels of inflammatory cytokines TNF-α and IL-6, as well as the expression of cytokines IL-18 and IL-1β related to apoptosis, and significantly alleviates the histopathological damage of the liver tissue (Wang S, He F, Wu H, et al. Health-Promoting Activities and Associated Mechanisms of Polygonati Rhizoma Polysaccharides[J]. Molecules, 2023, 28(3):1350.)

[0018] Poria cocos: Sweet, light, and neutral in nature, acting on the heart, lungs, spleen, and kidneys. Promoting diuresis and percolating dampness, strengthening the spleen and calming the mind

[0019] Traditional Chinese medicine theory: Poria cocos strengthens the spleen and percolates dampness, and also has the function of replenishing qi, and can treat various syndromes of spleen deficiency.

[0020] Modern research shows that: Poria cocos polysaccharide realizes immune regulation by activating the Ca2+ / protein kinase C / P38 / NF-κB signaling pathway in macrophages (Pu Y, Liu Z, Tian H, et al. The immunomodulatory effect of Poria cocos polysaccharides is mediated by the Ca2+ / PKC / p38 / NF-κB signaling pathway in macrophages[J]. International Immunopharmacology, 2019, 72:252-257). In addition, poria cocos triterpenic acid can competitively inhibit the apical sodium-dependent bile acid transporter in the intestine and the sodium / taurocholate cotransporting polypeptide in the liver, thereby increasing the conversion of blood cholesterol to bile acid and reducing blood lipid levels (Cai H, Cheng Y, Zhu Q, et al. Identification of triterpene acids in poria cocos extract as bile acid uptake transporter inhibitors[J]. Drug metabolism and disposition, 2021, 49(5):353-360).

[0021] Coix seed: Sweet, light, and cool in nature, acting on the spleen, stomach, and lungs. Promoting diuresis and percolating dampness, strengthening the spleen and stopping diarrhea, expelling wind-dampness

[0022] Traditional Chinese medicine theory: Coix seed is sweet and light, and it does not cause greasiness when strengthening the spleen. It is advisable to stir-fry it when strengthening the spleen. Compendium of Materia Medica says: "Coix seed is a medicine for the Yangming meridian, and it can strengthen the spleen and benefit the stomach."

[0023] Modern research shows that coix seed polysaccharide has antioxidant, immunity-enhancing, blood sugar-lowering, and metabolism-regulating effects. Coix seed polysaccharide can directly eliminate free radicals in the body to achieve antioxidant stress; it can promote T lymphocyte proliferation by activating the IL-2-mediated JAK3 / STAT5 signaling pathway, thereby improving cellular immune function and promoting immune regulation (Wang Yanfang, Yang Binbin, Chen Qian, et al. In vitro and in vivo studies on coix seed polysaccharide improving cellular immune function by regulating the JAK3 / STAT5 pathway [J]. Chinese Journal of Traditional Chinese Medicine, 2021, 36(11): 6414-6417). Coixol can exert a certain anti-inflammatory effect by inhibiting the expression of pro-inflammatory mediators such as TNF-α, NO, iNOS and COX-2 in vitro (Hu Y, Zhou Q, Liu T, et al. Coixol suppresses NF-κB, MAPK pathways and NLRP3 inflammasome activation in lipopolysaccharide-induced RAW 264.7 cells[J]. Molecules, 2020, 25(4): 894)

[0024] Maltose: sweet and warm, it benefits the spleen, stomach and lungs. It warms the middle and replenishes the deficiency, moistens the lungs and relieves coughs

[0025] TCM theory: Article 13 of Synopsis of the Golden Chamber: Symptoms and Treatments of Blood Bi and Deficiency Diseases: "Deficiency symptoms such as urgency in the abdomen, palpitations, epistaxis, abdominal pain, nocturnal emission, soreness and pain in the limbs, hot hands and feet, dry throat and mouth can be treated with Xiao Jianzhong Decoction." Xiao Jianzhong Decoction uses maltose as the main ingredient. The reason why maltose can strengthen the middle burner is that it comes from grains. Xiao Jianzhong Decoction uses a lot of maltose, firstly for its effect of strengthening the middle burner and nourishing qi and blood, and secondly because sweetness can relieve spasms and relieve pain. One medicine has two functions, so it is the main ingredient.

[0026] Modern research shows that maltose can significantly increase serum SOD activity in gastric ulcer model mice, reduce MDA content, enhance gastric mucosal antioxidant capacity, inhibit free radical generation, and increase the activity of oxygen free radical scavenging system in vivo (Li Zhen, Song Huiping, Zhang Hao, et al. Comparative study on the prevention of gastric ulcer model mice by Xiaojianzhong decoction combined with different sugars [J]. Journal of Shandong University of Traditional Chinese Medicine, 2016, 40(06): 573-575+592. DOI: 10.16294 / j.cnki.1007-659x.2016.06.022.)

[0027] 2. Qi-boosting: Rhodiola rosea, Acanthopanax senticosus, Gynostemma pentaphyllum

[0028] Rhodiola rosea: sweet and bitter, enters the heart and lungs. Replenishes qi and activates blood circulation, dredges meridians and relieves asthma. Treats qi deficiency and blood stasis

[0029] Rhodiola is a traditional Chinese medicine that tonifies the kidney, replenishes qi, activates blood circulation, and clears yin deficiency heat. Its sweet taste can tonify kidney qi, and its cold nature can clear the deficiency heat of yin. At the same time, it can also activate blood circulation and nourish blood. Through the treatment of activating qi and promoting blood circulation, the abnormal qi transformation can be alleviated, stasis can be removed, and the condition of blocked collaterals can be improved.

[0030] Modern research shows that salidroside can regulate and control the multi-target effects of various synergistic pathways of oxidative stress, inflammation, mitochondria, autophagy, and cell death, as well as the AMPK signaling related to the effects that may be beneficial to metabolic diseases (Bai X L, Deng X L, Wu G J, et al. Rhodiola and salidroside in the treatment of metabolic disorders[J]. Mini Reviews in Medicinal Chemistry, 2019, 19(19): 1611 - 1626.). Salidroside can eliminate dysfunctional mitochondria by regulating the PINK1 - Parkin signaling pathway and improving mitophagy, thereby protecting spinal cord neurons after ischemia - reperfusion injury.

[0031] Acanthopanax senticosus: Pungent, slightly bitter, and warm in nature, attributing to the spleen, lungs, kidneys, and heart meridians. It replenishes qi and strengthens the spleen, tonifies the kidney and soothes the nerves. It is used to treat qi deficiency of the spleen and lungs, and deficiency of both the lungs and kidneys. Acanthopanax senticosus has the effect of tonifying deficiency and strengthening the weak, and it even exceeds ginseng in tonifying qi and strengthening the body.

[0032] Modern research shows that Acanthopanax senticosus contains a variety of saponins, polysaccharides, flavonoid compounds, etc. Modern pharmacological research shows that Acanthopanax senticosus is an "adaptogenic" drug, which can dilate blood vessels, increase the blood flow of the heart, especially the coronary artery, the brain, and other parenchymal organs such as the kidneys; promote and improve microcirculation, reduce platelet aggregation function, reduce blood viscosity; regulate the body's metabolism, reduce tissue oxygen consumption, lower tissue metabolism, and increase the body's tolerance to hypoxia; promote the synthesis of ribose and proteins, improve the body's superoxide dismutase and scavenge oxygen free radicals; improve the body's non - specific resistance to harmful stimulating factors, and has the effects of anti - fatigue, anti - stress, and anti - infection (Li Guimei. Efficacy observation of 58 cases of acute ischemic stroke treated with Acanthopanax senticosus injection combined with nimodipine[J]. Hebei Journal of Traditional Chinese Medicine, 2005(10): 778 - 779.). In addition, Acanthopanax senticosus polysaccharide can improve the condition of the analgesic and anti - inflammatory model in mice, and its mechanism of action may be to improve the immune organ index and regulate the levels of related immune cytokines. (Pan Jingzhi, Jin Sha, Liu Yajing, etc. Study on the analgesic, anti - inflammatory effects and immune regulation mechanism of Acanthopanax senticosus polysaccharide[J]. Shanghai Journal of Traditional Chinese Medicine, 2019, 53(10): 74 - 82. DOI: 10.16305 / j.1007 - 1334.2019.10.019.)

[0033] Gynostemma pentaphyllum: sweet, bitter, slightly cold, acting on the spleen and lung meridians. Tonifying qi and strengthening the spleen, resolving phlegm and relieving cough. Treating qi deficiency of the spleen and stomach, dry cough due to lung deficiency

[0034] It has the effects of clearing heat, tonifying qi, and detoxifying. (Editorial Committee of "Chinese Herbal Medicine" of the State Administration of Traditional Chinese Medicine. Chinese Herbal Medicine [M]. Volume 5. Shanghai: Shanghai Science and Technology Press, 1999: 532-539.)

[0035] Modern research shows that Gynostemma pentaphyllum has pharmacological activities such as anti-tumor, immunomodulatory, anti-inflammatory, and liver protection, and triterpenoid saponins are the main active ingredients of Gynostemma pentaphyllum (Shen Zilin, Wang Zhenbo, Hou Huifang, etc. New progress in the chemical composition, pharmacological effects and application research of Gynostemma pentaphyllum [J]. Ginseng Research, 2020, 32(5): 59-64.)

[0036] III. Nourishing Yin: Anemarrhena asphodeloides, Schisandra chinensis, Rehmannia glutinosa, Trichosanthes kirilowii Maxim., Colla Corii Asini

[0037] Anemarrhena asphodeloides: bitter, sweet and cold, acting on the lung, stomach and kidney meridians. Clearing heat and purging fire, nourishing yin and moistening dryness.

[0038] Anemarrhena asphodeloides is cold in nature. It can clear and moisten the lung, purge fire and promote fluid production in the stomach, and nourish the kidney and reduce fire. It is especially suitable for those with excessive internal heat and injured body fluid. It is advisable to use it stir-fried with salt for nourishing yin and moistening dryness.

[0039] Modern research shows that Anemarrhena asphodeloides has the effects of clearing heat, anti-inflammatory, reducing blood sugar, anti-platelet aggregation, improving learning and memory, and protecting against myocardial ischemia-reperfusion injury. Both raw Anemarrhena asphodeloides and Anemarrhena asphodeloides stir-fried with salt can reduce the contents of FT3, FT4, and urinary 17-OHCS in the serum of hyperthyroid yin-deficient rats. Both have the effect of nourishing yin, and the effect is enhanced after stir-frying with salt. (Wu Ying, Song Zebi, Xu Yue, etc. Comparison of the yin-nourishing effects of Anemarrhena asphodeloides before and after salt stir-frying [J]. Chinese Journal of Experimental Traditional Medical Formulae, 2013, 19(24): 211-214.)

[0040] Schisandra chinensis: sour, sweet and warm, acting on the heart, lung and kidney meridians. Astringing and consolidating, replenishing qi and promoting fluid production, tonifying the kidney and calming the mind.

[0041] Schisandra chinensis tastes sour and sweet. Sweet can tonify qi, and sour can promote fluid production. It has the effect of replenishing qi and promoting fluid production, and is often used for thirst due to fluid injury and consumptive thirst.

[0042] Modern research shows that Schisandra chinensis contains active ingredients such as polysaccharides and lignans, and has activities such as liver protection, anti-tumor, antioxidant, anti-inflammatory, and blood sugar improvement. Schisandra chinensis polysaccharide has a certain alleviating effect on insulin resistance in T2DM rats, possibly by activating the AMPK / Nrf2 / TXNIP pathway. (Liu Ruoke, Hu Yuanyuan, Li Wenchong, et al. Effects of Schisandra chinensis polysaccharide on insulin resistance and AMPK / Nrf2 / TXNIP pathway in type 2 diabetic rats [J]. Chinese Traditional Patent Medicine, 2024, 46(02): 635-639.). In addition, Schisandra chinensis polysaccharide can play an anti-inflammatory role by inhibiting LPS-induced TNF-α secretion and delaying neutrophil apoptosis. (Sun Xiaohong, Li Jiayi, Li Hongtao, et al. Inhibitory effect of Schisandra chinensis polysaccharide on lipopolysaccharide-induced neutrophil inflammation [J]. Journal of Jilin University (Medicine Edition), 2017, 43(05): 928-931+1073. DOI: 10.13481 / j.1671-587x.20170513.)

[0043] Rehmannia glutinosa: Sweet and cold in nature, attributing to the heart, liver and kidney meridians. Clearing heat and cooling blood, nourishing yin and promoting the production of body fluid.

[0044] Rehmannia glutinosa is sweet in taste and cold in nature, with a moist texture, entering the nutrient and blood aspects. It nourishes yin and promotes the production of body fluid to quench thirst, being used for polydipsia due to vexation-heat and internal heat diabetes. Also, it nourishes yin and moistens dryness, nourishes the kidney and reduces fire, being used for yin deficiency with internal heat and hectic fever.

[0045] Modern research shows that catalpol, the main active ingredient in Rehmannia glutinosa, downregulates the COX-2 / NLRP3 signaling pathway to inhibit neuronal damage. (Wu Xiaohui, Wang Junming, Qin Lingyu, et al. Exploration of the antidepressant effect of Rehmannia glutinosa assisted by the efficacy of nourishing yin and clearing heat [J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2023, 38(05): 2340-2349.)

[0046] Trichosanthes kirilowii: Sweet, slightly bitter and slightly cold in nature, attributing to the lung and stomach meridians. Clearing heat and purging fire, promoting the production of body fluid to quench thirst.

[0047] Trichosanthes kirilowii is sweet, bitter and cold. Its bitter and cold nature can clear heat and purge fire, and its sweet and cold nature can promote the production of body fluid and moisten dryness. Entering the lung and stomach meridians, it can nourish the body fluids of the lung and stomach, being good at moistening the lung dryness and generating the body fluid of the stomach.

[0048] Modern research shows that trichosanthin polysaccharide may have an analgesic effect while exerting its medicinal effects. (Lv Hang, Wang Ziyi, Fu Libo, et al. Study on the analgesic effect of trichosanthin polysaccharide on normal rats [J]. Journal of Changchun Normal University, 2023, 42(12): 98-101.) Additionally, the active components of trichosanthin, cactosterol and spinasterol, may improve insulin resistance by acting on the T2DM target PPARγ. (Hu Bin, Wang Bin, Zhu Xiaochuan, et al. Exploring the interaction between the active components of trichosanthin and type 2 diabetes targets based on molecular docking technology [J]. Journal of Shanxi Medical University, 2023, 54(11): 1508-1514. DOI: 10.13753 / j.issn.1007-6611.2023.11.012.)

[0049] Raw donkey-hide gelatin: Sweet and neutral, acts on the lung, liver and kidney meridians. Tonifies blood, nourishes yin, moistens dryness and stops bleeding.

[0050] Raw donkey-hide gelatin is sweet and neutral, with a moist texture. It enters the lung to moisten dryness and nourishes yin to replenish kidney water, being especially suitable for those with yin deficiency and blood deficiency.

[0051] Modern research shows that the components with a molecular weight > 10 kDa in the active components of raw donkey-hide gelatin have stronger immune regulation and antioxidant abilities, contributing to the development of health foods based on CCA. (Zhang G, Guo F, Zeng M, et al. The immune-enhancing effect and in vitro antioxidant ability of different fractions separated from Colla corii asini [J]. Journal of Food Biochemistry, 2022, 46(11): e14174.)

[0052] IV. Promoting blood circulation to dredge collaterals: Geranium wilfordii Maxim.

[0053] Geranium wilfordii Maxim.: Pungent, bitter and neutral, acts on the liver, spleen and kidney meridians. Expels wind-dampness, dredges collaterals, stops diarrhea.

[0054] Modern research has proven that Geranium wilfordii Maxim. has effects such as anti-tumor, blood sugar lowering, and blood pressure raising. Its main chemical components are tannins, flavonoids, organic acids, volatile oils, etc. Geraniin may play an obvious protective role against myocardial ischemia-reperfusion injury by activating the Nrf2 signaling pathway and inhibiting excessive autophagy of cardiomyocytes (Peng Cailiang, Cui Xuan, Jiang Ning, et al. The effect and mechanism of geraniin on myocardial ischemia-reperfusion injury in rats [J]. Jilin Journal of Traditional Chinese Medicine, 2023, 43(09): 1063-1067. DOI: 10.13463 / j.cnki.jlzyy.2023.09.018.)

[0055] The compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for treating Sjogren's syndrome proposed by the present invention uses polygonatum sibiricum and rehmannia glutinosa as the monarch drugs to invigorate the spleen, replenish qi, nourish yin and care for the "foundation of acquired constitution"; raw donkey-hide gelatin, anemarrhena asphodeloides, schisandra chinensis and trichosanthes kirilowii assist rehmannia glutinosa in nourishing yin, and poria cocos, coix lacryma-jobi and rhodiola rosea help polygonatum sibiricum in invigorating the spleen, serving as the ministerial drugs; nardostachys jatamansi and maltose warm the middle-jiao to replenish deficiency, relieve depression and arouse the spleen, can harmonize the properties of the drugs and promote the function of the spleen and stomach, serving as the adjuvant drugs; acanthopanax senticosus, gynostemma pentaphyllum and geranium wilfordii are used as the guiding drugs to enhance the overall effect of the prescription.

[0056] As a preferred technical solution of the compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for treating Sjogren's syndrome of the present invention, its active ingredients are prepared from the following Chinese medicine raw materials in parts by weight:

[0057]

[0058] The present invention also proposes a preparation method of the compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals, and the steps are as follows:

[0059] (1) First, weigh each Chinese medicine component in the prescription according to the amount.

[0060] (2) Break up the raw donkey-hide gelatin and set it aside together with the maltose for later use.

[0061] (3) Mix rehmannia glutinosa, polygonatum sibiricum, anemarrhena asphodeloides, schisandra chinensis, poria cocos, coix lacryma-jobi, rhodiola rosea, trichosanthes kirilowii, nardostachys jatamansi, acanthopanax senticosus, gynostemma pentaphyllum and geranium wilfordii, add 5 times the weight of water of the Chinese medicine, soak for 30 minutes, and then decoct for 30 minutes.

[0062] (4) Melt the maltose and the raw donkey-hide gelatin and mix them evenly into the decoction of the above 12 flavors of medicine, and store the obtained decoction in the refrigerator. Description of the Drawings

[0063] Figure 1 For monitoring the water intake of mice after administration.

[0064] Figure 2 For measuring the salivary flow rate of mice.

[0065] Figure 3 For comparing the levels of IL-17 and IL-10 in the submandibular glands of mice. Detailed Description of the Invention

[0066] The following further details a compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals for treating Sjogren's syndrome of the present invention in conjunction with the drawings and embodiments.

[0067] Example 1

[0068] The compound traditional Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and dredging collaterals is prepared as follows:

[0069] (1) First, weigh each traditional Chinese medicine ingredient in the prescription: 5 g of Nardostachyos Root, 15 g of Polygonatum Rhizome, 10 g of Poria, 15 g of Coix Seed, 10 g of Maltose, 5 g of Rhodiola Root, 5 g of Acanthopanax Senticosus, 5 g of Gynostemma Pentaphyllum, 5 g of Anemarrhena Rhizome, 5 g of Schisandra Fruit, 15 g of Rehmannia Root, 5 g of Trichosanthes Root, 5 g of Colla Corii Asini, and 5 g of Geranium Herb.

[0070] (2) Smash the Colla Corii Asini and set it aside with the Maltose for later use.

[0071] (3) Mix Rehmannia Root, Polygonatum Rhizome, Anemarrhena Rhizome, Schisandra Fruit, Poria, Coix Seed, Rhodiola Root, Trichosanthes Root, Nardostachyos Root, Acanthopanax Senticosus, Gynostemma Pentaphyllum, and Geranium Herb, add water 5 times the weight of the traditional Chinese medicine, soak for 30 min, and then decoct for 30 min.

[0072] (4) Melt the Maltose and Colla Corii Asini and mix them evenly into the decoction of the above 12 herbs, and store the obtained decoction in the refrigerator.

[0073] Animal experiment:

[0074] I. Grouping and model establishment

[0075] Select 25 NOD / ShiLtJ mice and divide them into a model group, a low-dose drug group, a medium-dose drug group, a high-dose drug group, and a positive control group, with 5 mice in each group.

[0076] The negative control group and the model group were given normal saline by gavage (dose: 20 mg / kg).

[0077] The low-, medium-, and high-dose drug groups were given the traditional Chinese medicine decoction for invigorating the spleen, replenishing qi, nourishing yin, and dredging collaterals (prepared according to the method of Example 1) by gavage in sequence, and the doses were 20, 40, and 80 mg / kg in sequence.

[0078] The positive control group was given hydroxychloroquine sulfate (100 mg / kg) by gavage once a day for 8 consecutive weeks.

[0079] II. Experimental methods

[0080] 1. Monitoring of water intake

[0081] After 2 h of the last administration, record the water volume in the water bottle (denoted as M1), and record the remaining water volume after 24 h (denoted as M2). M1 - M2 is the water intake.

[0082] 2. Determination of salivary flow rate

[0083] After measuring the water intake, anesthetize the mice, pick up a small piece of gauze strip (denoted as M1) with forceps and place it under the tongue of the mice. After 5 min, measure the mass of the gauze strip (denoted as M2). M2 - M1 is the salivary flow of the mice in 5 min. The salivary flow rate is (M2 - M1) (mg) / 100 g body weight.

[0084] 3. Detection of IL-17 and IL-10 levels in the submandibular glands of mice by ELISA

[0085] Take a part of the cryopreserved submandibular gland tissue, add pre-cooled phosphate buffer solution (1:10) to make a homogenate, and centrifuge to obtain the supernatant. Detect the levels of IL-17 and IL-10 according to the ELISA kit instructions.

[0086] III. Results

[0087] 1. Comparison of water intake and salivary flow rate of mice in each group

[0088] As Figure 1 , 2 shown, compared with the model group, the water intake and salivary flow rate of mice in the other groups decreased. Compared with the model group, the water intake and salivary flow rate of mice in each drug group increased, and with the increase of the drug dose, the water intake and salivary flow rate showed a dose-response relationship.

[0089] 2. Comparison of IL-17 and IL-10 levels in the submandibular glands of mice in each group

[0090] As Figure 3 shown, compared with the model group, the levels of IL-17 and IL-17 / IL-10 in the submandibular glands of mice in the other groups increased, and the level of IL-10 decreased; compared with the model group, the levels of IL-17 and IL-17 / IL-10 in the submandibular glands of mice in each drug group decreased, and the level of IL-10 increased, and with the increase of the drug dose, the levels of IL-17, IL-10 and IL17 / IL-10 showed a dose-response relationship.

[0091] The above content is only an example and explanation of the concept of the present invention. Those skilled in the art of this technology can make various modifications or supplements to the specific embodiments described or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined by this claim book, they should all belong to the protection scope of the present invention.

Claims

1. A Chinese medicine compound for strengthening the spleen, replenishing qi, nourishing yin and unblocking collaterals for treating Sjögren's syndrome, characterized in that: The effective ingredients of the Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and unblocking collaterals are prepared from the following Chinese medicine raw materials in parts by weight: 3-7 parts of Nardostachys grandiflora; 10-20 parts of Polygonatum sibiricum; 5-10 parts of Poria cocos; 10-20 parts of Coix seeds; 5-15 parts of maltose; 1-5 parts of Rhodiola rosea; 1-5 parts of Acanthopanax senticosus; 1-5 parts of Gynostemma pentaphyllum; 1-5 parts of Anemarrhena Rhizoma; 3-10 parts of Schisandrae Chinensis; 10-20 parts of raw Rehmannia root; 2-8 parts of Radix Trichosanthis; 2-8 parts of raw donkey hide gelatin; 3-8 portions of geranium; The preparation method steps are as follows: (1) First weigh the Chinese medicinal ingredients in the prescription according to their amount; (2) Crush the raw donkey-hide gelatin and set it aside together with the maltose; (3) Mix raw Rehmannia root, Polygonatum sibiricum, Anemarrhena asphodeloides, Schisandra chinensis, Poria cocos, Coix seeds, Rhodiola rosea, Radix Trichosanthis, Nardostachys grandiflora, Acanthopanax senticosus, Gynostemma pentaphyllum and Geranium herb, add 5 times the weight of the Chinese medicine in water, soak for 30 minutes, and then boil for 30 minutes; (4) Dissolve maltose and raw donkey-hide gelatin in the above 12 medicinal decoctions and mix evenly. The resulting decoction should be refrigerated.

2. The spleen-strengthening, qi-invigorating, yin-nourishing and collateral-dredging compound Chinese medicine according to claim 1, characterized in that: The effective ingredients of the Chinese medicine for invigorating the spleen, replenishing qi, nourishing yin and unblocking collaterals are prepared from the following Chinese medicine raw materials in parts by weight: 5 parts of Nardostachys grandiflora; 15 parts of Polygonatum sibiricum; 10 parts of Poria cocos; 15 parts of Coix seeds; 10 parts of maltose; 5 parts of Rhodiola rosea; 5 parts of Acanthopanax senticosus; 5 parts of Gynostemma pentaphyllum; 5 parts of Anemarrhena Rhizoma; 5 parts of Schisandrae Chinensis; 15 parts of raw Rehmannia root; 5 parts of Radix Trichosanthis; 5 parts of raw donkey hide gelatin; 5 portions of geranium.

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