WO2022021639A1 - Traditional chinese medicine composition for invigorating spleen and activating yang, and use thereof - Google Patents

Abstract

Disclosed are a traditional Chinese medicine composition for invigorating the spleen and activating yang, and the use thereof. The composition is composed of the following ingredients in parts by weight: 12-18 parts of Puerariae lobatae radix, 12-18 parts of Salviae miltiorrhizae radix et rhizoma, 25-35 parts of Atractylodis macrocephalae rhizoma, 25-35 parts of Codonopsis radix, 4-6 parts of Phellodendri chinensis cortex, 12-18 parts of Chuanxiong rhizoma, 8-12 parts of Panax notoginseng, 8-12 parts of Cinnamomi ramulus, 12-18 parts of Epimedii folium, 25-35 parts of Cistanche deserticola, 12-18 parts of Corni fructus, 8-12 parts of Zingiberis rhizoma and 12-18 parts of Atractylodis rhizoma. The composition is used for treating diabetes, diabetic nephropathy and chronic renal disease caused by a deficiency of yin and yang, blood stasis and sputum. The composition has obvious curative effects on the symptoms of a patient, such as xerostomia, polydipsia, fatigue, asthenia, abdominal distention, a fear of cold, cold limbs, darkish complexion, soreness and weakness of the waist and knees, limb paralysis, blurred vision, frequent micturition, increased nocturia, cloudy or oily urine, impotence, facial edema or limb edema, morning diarrhea, a pale and plump tongue, a white and dry tongue coating, and a deep, thready and forceless pulse.

Description

A kind of traditional Chinese medicine composition for strengthening spleen and activating yang and application thereof technical field

The invention relates to the field of traditional Chinese medicine formulations, in particular to a traditional Chinese medicine composition for strengthening the spleen and activating yang.

Background technique

Diabetes is a common and frequently-occurring disease in clinical practice. In 2010, Prof. Ning Guang's team surveyed the prevalence of diabetes and prediabetes among people over 18 years old in China, reaching 11.6% and 50.1%, respectively. The prevalence of diabetes in my country is increasing year by year, especially in recent years, the prevalence rate has risen sharply, the development trend is not optimistic, and the incidence has changed. Epidemiological data show that more than 80% of diabetics are obese in my country.

Diabetes, modern Chinese medicine mostly belongs to the category of "diabetes" in Chinese medicine. The related discussion of diabetes mellitus was first seen in the "Nei Jing", including "xiaoheng", "three eliminations", "diaphragm elimination", "xiaozhong" and other disease names. The explanation in "Shuowen Jiezi": "to disappear, to exhaust" means "to lose weight, dissipate, and consume". "Thirsty and desire" means "dry mouth and desire to drink". Literally, this disease name is a generalization of patients with similar symptoms. Ancient physicians formed various theories when discussing the pathogenesis of diabetes mellitus. Physicians of past dynasties have enriched and developed the pathogenesis of the disease, including the theory of yin deficiency and dryness, the theory of three eliminations, the theory of liver stagnation and qi stagnation, and the theory of blood stasis. Dispelling and other pathogenesis understanding.

At present, it is generally believed that the basic pathogenesis of the lung, stomach and kidney with multiple responsibilities of the diseased viscera is "Yin deficiency is the foundation, dryness and heat are the standard", and the treatment focuses on "nourishing yin and clearing heat".

However, today's clinical findings are different from those in ancient times in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods. In the long-term clinical practice, the applicant found that modern diabetics drink water again and again but do not quench their thirst. The water they drink cannot be transformed into body fluid and urinate frequently; Nourishing the limbs and the body is thin; modern diabetes patients are mostly obese, obese people have more phlegm, phlegm-dampness is full, dampness damages the spleen, the typical "Yin deficiency and dry-heat diabetes" patients are rare, and nourishing yin helps dampness. Spleen, clearing heat will damage spleen-yang and phlegm-dampness will be worse. Therefore, no matter "yin deficiency" or "dry heat", they are only the "marks" of diabetes, and only the symptoms of diabetes are seen, while the root of the disease is ignored.

The pathogenesis of modern diabetes has evolved from "dry heat due to yin deficiency" to "weak spleen and stomach, lack of clear yang, dampness and turbidity, and stagnation of fire." The qi, blood, and body fluids of qi, blood and body fluids are blocked, and "diabetes" is caused by not following the normal path. It should be treated by "invigorating the spleen and stomach, raising the yang, removing dampness and turbidity, and reducing yin fire".

In the later stage of modern diabetes, both yin and yang are mostly manifested as deficiency of both yin and yang. Many patients with late stage diabetes involve the kidneys, and patients with early stage diabetic nephropathy develop microalbuminuria, which is related to glomerular damage, mesangial hyperplasia and glomerular basement membrane thickening. The role of ACEI in reducing proteinuria has become a consensus. As a representative drug of angiotensin-converting enzyme inhibitor, Kaibotong can dilate blood vessels and delay the progression of the disease, but it cannot reverse the disease, and its clinical efficacy is very limited. The superiority of traditional Chinese medicine therapy in the clinical treatment of diabetic nephropathy is increasingly apparent. However, there are few Chinese patent medicines for the treatment of late stage diabetes, especially complicated diabetic nephropathy. Some focus on nourishing qi and nourishing yin, promoting blood circulation and dredging collaterals, such as Keluoxin capsule; For example, Jinhe Jiangtang Capsules, etc., there is no relevant research on the effects of spleen-kidney synchronization, yin and yang supplementation, blood circulation and blood stasis, phlegm and turbidity reduction, and there is no such variety in the market.

SUMMARY OF THE INVENTION

In order to solve the problems of the prior art, the object of the present invention is to provide a traditional Chinese medicine composition for strengthening spleen and yang yang, which has exact curative effect, and has the effects of synchronizing the spleen and kidney, tonifying yin and yang, promoting blood circulation and removing blood stasis, resolving phlegm and reducing turbidity. It can be used concurrently, well-matched, and the characteristics of the principles and methods are obvious. It is safe for patients with diabetes, diabetic nephropathy, and chronic renal insufficiency caused by evidences such as late stage diabetes, deficiency of yin and yang, mixed deficiency and excess, deficiency of lung, spleen, and kidney, phlegm, turbidity, blood stasis, etc. efficient.

Another object of the present invention is to apply the above-mentioned Chinese medicinal composition for strengthening the spleen and clearing the yang in the preparation of medicines for the treatment of diabetes, diabetic nephropathy and chronic renal insufficiency.

The object of the invention is achieved in this way: a kind of traditional Chinese medicine composition for strengthening the spleen and activating yang, is characterized in that: by weight, the formula is made up of the following components: 12-18 parts of pueraria, 12-18 parts of Salvia miltiorrhiza, 25- 35 parts, Codonopsis 25-35 parts, Treats 4-6 parts, Chuanxiong 12-18 parts, Tian Qi 8-12 parts, Guizhi 8-12 parts, Xianlingpi 12-18 parts, Cistanche deserticola 25-35 parts, Dogwood 12-18 servings, 8-12 servings of dried ginger, and 12-18 servings of Atractylodes.

Preferably, calculated in parts by weight, the formula is composed of the following components: 14-16 parts of Pueraria, 14-16 parts of Salvia, 28-32 parts of Atractylodes, 28-32 parts of Codonopsis, 4-6 parts of Treats, 14-16 parts of Chuanxiong parts, 9-11 parts of Tianqi, 9-11 parts of Guizhi, 14-16 parts of Xianlingpi, 28-32 parts of Cistanche deserticola, 14-16 parts of dogwood, 9-11 parts of dried ginger, and 14-16 parts of Atractylodes.

Most preferably, calculated in parts by weight, the formula is made up of the following components: 15 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis Radix, 5 parts of Treats, 15 parts of Chuanxiong, 10 parts of Tianqi, 10 parts of Guizhi , 15 copies of Xianlingpi, 30 copies of Cistanche, 15 copies of dogwood, 10 copies of dried ginger, and 15 copies of Atractylodes.

The application of the traditional Chinese medicine composition for strengthening spleen and activating yang in preparing medicines for treating diabetes, diabetic nephropathy and chronic renal insufficiency.

The medicine is decoction, granule, tablet, capsule, oral liquid or pill.

The medicine is a preparation prepared by using the extract of the components in the formula of the Chinese medicine composition for strengthening the spleen and removing yang as the active ingredient, and adding medicinal excipients.

The extract is a water extract.

Said diabetes is the late stage of diabetes.

The diabetes, diabetic nephropathy and chronic renal insufficiency are phlegm-type diabetes, diabetic nephropathy and chronic renal insufficiency.

The present invention is a formula for "treatment of diabetes from the spleen and stomach". Polydipsia, mental fatigue, fullness of the abdomen and abdomen, chills, cold limbs, dark complexion, weak waist and knees, limb paralysis, blurred vision, frequent urination, increased nocturnal urination, turbidity, impotence, swollen face or swollen limbs, Diarrhea, pale tongue, fat body, white and dry coating, thin and weak pulse, etc. Diabetes, diabetic nephropathy, chronic renal insufficiency, etc. have obvious curative effect after taking the medicine.

detailed description

The invention is a traditional Chinese medicine composition for strengthening the spleen and activating yang, which is characterized in that: calculated in parts by weight, the formula is composed of the following components: 12-18 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, 25-35 parts of Codonopsis Radix. 35 parts, 4-6 parts of Cork, 12-18 parts of Chuanxiong, 8-12 parts of Tianqi, 8-12 parts of Guizhi, 12-18 parts of Xianlingpi, 25-35 parts of Cistanche, 12-18 parts of dogwood, dried Ginger 8-12 parts, Atractylodes 12-18 parts. Preferably, calculated in parts by weight, the formula is composed of the following components: 14-16 parts of Pueraria, 14-16 parts of Salvia, 28-32 parts of Atractylodes, 28-32 parts of Codonopsis, 4-6 parts of Treats, 14-16 parts of Chuanxiong parts, 9-11 parts of Tianqi, 9-11 parts of Guizhi, 14-16 parts of Xianlingpi, 28-32 parts of Cistanche deserticola, 14-16 parts of dogwood, 9-11 parts of dried ginger, and 14-16 parts of Atractylodes. Most preferably, calculated in parts by weight, the formula is made up of the following components: 15 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis Radix, 5 parts of Treats, 15 parts of Chuanxiong, 10 parts of Tianqi, 10 parts of Guizhi , 15 copies of Xianlingpi, 30 copies of Cistanche, 15 copies of dogwood, 10 copies of dried ginger, and 15 copies of Atractylodes.

The application of the Chinese medicine composition for strengthening spleen and activating yang in the preparation of medicines for treating diabetes, diabetic nephropathy and chronic renal insufficiency, especially yin and yang deficiency with blood stasis, phlegm-type diabetes, diabetic nephropathy and chronic renal insufficiency. Preferably, the diabetes is the late stage of diabetes and its complications. The medicament can be in oral dosage forms such as decoction, granule, tablet, capsule, oral liquid or pill. The medicine is a corresponding preparation prepared by using the extracts of the components in the formula of the Chinese medicine composition for strengthening the spleen and removing the yang as active ingredients, and adding pharmaceutical excipients of corresponding dosage forms according to the existing general process. Preferably, the extract is a water extract.

The formula of the present invention comes from the theoretical system of the inventor's "Treatment of Diabetes from the Spleen and Stomach", and it is believed that the pathogenesis of diabetes is: "The spleen and stomach are out of balance, the things are not naturalized, the subtleties are not transported, and the organs are out of nourishment", so the treatment is to reconcile the spleen and stomach, attack and supplement both Shi is the core. In the early stage of diabetes, spleen deficiency is often manifested as stagnation and heat, and blood stasis is present. In the later stage, both yin and yang deficiency are mostly manifested.

The symptoms of diabetes mellitus are mainly consumption of more food, dry mouth and more drinking. The metabolism, transportation and transformation of diet are most closely related to the spleen and stomach. So, how is water metabolized into the human body? "Plain Questions: The Differentiation of Meridians" says: "Drinking enters the stomach, escaping the essence and qi, and transporting it upward to the spleen, dispersing the spleen, returning to the lungs, regulating the water channels, and transporting the bladder downward. Under normal circumstances, food and water grains enter the human body, decompose through the stomach, metamorphose into the subtle substances, and transport and transform through the spleen to spread the subtle substances throughout the body to support the functional activities of the whole body. When the diet is disordered and the spleen and stomach are damaged, the disease will occur. It can be seen that as early as the "Neijing" period, it was clearly proposed that the onset of diabetes is either due to overeating fat, sweet and thick taste, internal injury to the spleen and stomach, or due to accumulation of heat in the stomach, which is fundamentally in the "spleen and stomach".

(1) The spleen and stomach are out of balance, and things are not naturalized. Over time, heat, stagnation, dampness, phlegm, turbidity, and blood stasis are generated.

Fatty, sweet and thick-flavored diet damages the spleen and stomach, and cannot be transported and transformed. Thirst.

Diabetes the thirst for a long time, fat, sweet and thick taste, the change of the cream, the internal injury to the spleen and stomach, the spleen deficiency, the phlegm-dampness is endogenous, and the hair is diabetes.

Emotional depression, liver qi discomfort, stagnation of blood and heat for a long time will also lead to the pathogenesis of thirst.

(2) If the spleen fails to function properly, the subtleties are not transported, and the viscera fails to nourish, the qi and blood will be deficient, and both yin and yang will be deficient over time.

The spleen and stomach are located in the middle coke, which transports and transforms water and valleys. If the spleen fails to function properly, the spleen cannot disperse the essence, the upper essence cannot be transferred to the lungs, and the lower essence cannot be transported to the bladder, and the viscera cannot be nourished. Damage to the spleen and stomach of the middle burner, passive blood biochemistry, deficiency of qi and blood, and lack of righteousness, not only cause diabetes, but also various syndromes. Dystrophy of blood vessels, disharmony of meridians and collaterals, showing signs of paralysis of limbs; deficiency of liver and kidney yin, inability to nourish ears and eyes, showing signs of dim vision, sudden blindness, deafness, etc. And sores and boils, carbuncle.

Combined with a large number of clinical practice, the present invention believes that the syndrome of deficiency and excess is common in the clinical diagnosis of diabetes, and the combination of deficiency and excess runs through the entire course of diabetes. Deficiency syndrome is mainly qi deficiency and yin deficiency. Generally speaking, in the early stage, it is mostly manifested as spleen deficiency and lung heat, spleen deficiency and stomach deficiency, spleen deficiency and liver stagnation. , and develop into a syndrome of yin and yang deficiency or spleen deficiency and collateral obstruction. Concurrent syndromes are mostly evidence, mainly stagnation, heat, dampness, phlegm, turbidity, and blood stasis, often caused by multiple evil qi intermingled with each other, or appearing in the entire course of diabetes, or more prominent at a certain stage. Therefore, reconciling the spleen and stomach, attacking and nourishing as the core treatment method, and nourishing the spleen and strengthening the core are the core. In the process of strengthening the righteousness, attention must be paid to exorcising evil spirits.

Diabetic nephropathy is often complicated by modern diabetic patients in the later stage, which is characterized by deficiency of both yin and yang, mainly yin and yang deficiency of spleen and kidney, and pathogenic factors such as phlegm, turbidity and blood stasis. Some patients with chronic renal insufficiency also show the same syndrome. Aiming at the characteristics of such a disease, treating with the traditional Chinese medicine composition of the present invention has a certain and exact curative effect on diabetes, diabetic nephropathy and chronic renal insufficiency. In the prescription, Atractylodes Rhizoma invigorates the spleen and replenishes Qi and dries dampness, and Codonopsis pilosula tonifies the middle and invigorates Qi, so that the central axis can be transported, and they are the monarch medicine. It is combined with Xianlingpi and Cistanche to warm the kidney and help the yang, and they are the minister medicine. Unblocks the spleen and collaterals, relieves heat to produce body fluid and quenches thirst, Salvia miltiorrhiza, Chuanxiong and Tianqi promote blood circulation and remove blood stasis and clear the spleen and collaterals, Atractylodes japonica invigorates the spleen and removes dampness, resolves phlegm and removes turbidity. From the yang-warming medicine, "seeking yin in yang" is used, and Huangbai is used to clear heat and dry dampness to help the spleen to purify and reduce yin-fire. The whole formula ascends and descends and harmonizes together, combining the functions of spleen and kidney harmony, yin and yang supplementation, promoting blood circulation and removing blood stasis, resolving phlegm and reducing turbidity.

According to modern research, Atractylodes macrocephala in this recipe can promote the recovery of damaged autonomic nerve function, adjust the balance of human viscera functions, regulate gastrointestinal motility, lower blood sugar, diuresis, and enhance resistance. Codonopsis polysaccharide can reduce alloxan-induced diabetes. At the same time, it can improve insulin resistance and insulin sensitivity of the body to a certain extent; Xianlingpi has various pharmacological effects such as improving immune function, anti-aging, anti-oxidation, anti-inflammatory, hypoglycemic, and anti-depression. , Cistanche deserticola has anti-oxidation and anti-aging, neuroprotection, ischemia-reperfusion, improving immunity, protecting the liver and protecting the liver, etc.; Puerariae has the effect of lowering blood sugar. For the treatment of its complications, Salvia miltiorrhiza contains a large amount of diterpene quinone pigment, tanshinone, danshensu, diylaldehyde and other substances, which have the functions of promoting blood circulation and removing blood stasis, reducing blood viscosity, etc., and can well improve the blood viscosity of diabetic patients. , Chuanxiong has sedative and analgesic, inhibiting the release of oxygen free radicals, etc., Tianqi can dilate blood vessels, improve microcirculation disorders, lower blood lipids, scavenge free radicals, anti-inflammatory, antioxidant and other effects, improve fundus microcirculation and retinal ischemia In hypoxic state, Atractylodes Rhizoma can reduce hyperglycemia, hyperuricemia, hypertension and protect the myocardium. Cinnamon twig has anti-inflammatory, vasodilatory, antihypertensive, anticonvulsant, antiplatelet aggregation, and anticoagulant effects. Ginger has anti-inflammatory properties. It also has significant effects on the cardiovascular system and digestive system. Cornus has obvious immune regulation, hypoglycemic, anti-tumor, anti-aging and other effects. Cortex Phellodendri has various pharmacological effects, mainly including hypoglycemic, antibacterial, Anti-fungal, antitussive, antihypertensive, anti-trichomoniasis, anti-hepatitis, anti-ulcer and immunosuppressive effects.

Therefore, the prescription of the present invention can supplement Yin and Yang, promote blood circulation and remove blood stasis, resolve phlegm and reduce turbidity. Through the following clinical research data, it is proved that this prescription is especially suitable for the treatment of diabetic nephropathy caused by deficiency of yin and yang and stasis caused by phlegm in the later stage of diabetes. It is effective, safe and reliable for patients with multiple complications of diabetes and chronic renal insufficiency.

Example 1 (decoction)

The formula consists of the following components: Pueraria 15g, Salvia 15g, Atractylodes 30g, Codonopsis 30g, Phellodendron 5g, Chuanxiong 15g, Tianqi 10g, Cinnamon 10g, Xianlingpi 15g, Cistanche 30g, Cornus 15g, Ginger 10g, Atractylodes 15g . Add water and cook to a bowl.

Embodiment 2 (decoction)

The formula consists of the following components: 14g Pueraria Root, 14g Salvia miltiorrhiza, 28g Atractylodes Rhizoma, 28g Codonopsis Radix, 4g Phellodendri, 14g Chuanxiong, 9g Panax Radix, 9g Guizhi, 14g Xianlingpi, 28g Cistanche, 14g Cornel, 9g Ginger, 14g Atractylodes . Add water and cook to a bowl.

Embodiment 3 (decoction)

Each dose of the formula is composed of the following components: 16g of Pueraria Root, 16g of Salvia miltiorrhiza, 32g of Atractylodes Rhizoma, 32g of Codonopsis Radix, 6g of Treats, 16g of Rhizoma Chuanxiong, 11g of Panax Radix, 11g of Cinnamon Branch, 16g of Xianlingpi, 32g of Cistanche, 16g of Cornus, 11g of Dried Ginger, Atractylodes 16g. Add water and cook to a bowl.

Example 4 (decoction)

The formula consists of the following components: 15g Pueraria lobata, 16g Salvia miltiorrhiza, 30g Atractylodes Rhizoma, 28g Codonopsis Radix, 6g Cortex Phellodendri, 14g Chuanxiong, 11g Tianqi, 9g Guizhi, 14g Lingpi, 30g Cistanche, 16g Cornel, 9g Ginger, 14g Atractylodes . Add water and cook to a bowl.

Example 5 (tablet)

Calculated by weight, the formula is composed of the following components: 18 parts of Pueraria lobata, 18 parts of Salvia miltiorrhiza, 35 parts of Atractylodes Rhizoma, 35 parts of Codonopsis Radix, 6 parts of Treats, 18 parts of Chuanxiong, 12 parts of Tianqi, 12 parts of Guizhi, 18 parts of Xianlingpi 35 parts of Cistanche, 18 parts of dogwood, 12 parts of dried ginger, and 18 parts of Atractylodes. . Extract with water twice, add 8-10 times of water each time, decoct for 1-1.5 hours, combine the water extracts, concentrate and dry to obtain dry extract.

Take 20g of dry extract and grind it into fine powder, according to the tablet manufacturing process, add medicinal starch and micropowder silica gel, mix, granulate, dry and granulate, then add magnesium stearate, mix well, and press into 100 tablets, namely Get tablets. Each tablet weighs 0.3g.

Example 6 (capsule)

Take 20 g of the dry extract obtained in Example 5 and grind it into fine powder, according to the capsule manufacturing process, add medicinal starch and micropowder silica gel, mix, sieve, and put into capsules to make 100 capsules to obtain capsules. The content of each capsule weighs 0.2g.

Clinical comparative experiment

In order to objectively evaluate the clinical effectiveness and safety of the traditional Chinese medicine composition of the present invention, according to the requirements of the clinical research guidelines for new traditional Chinese medicines, clinical research is carried out on the medicine. The following studies were approved by the Ethics Committee of Shantou Hospital of Traditional Chinese Medicine, and all patients gave informed consent to this study.

1. Clinical research on the treatment of diabetes and diabetic nephropathy

1Clinical data

1.1 General information A total of 64 patients with type 2 diabetic nephropathy of yin and yang deficiency with blood stasis and phlegm from January 2016 to February 2018 in the Diabetes Department of Shantou Hospital of Traditional Chinese Medicine were selected and randomly divided into the control group and the observation group. , 32 cases in each group. In the control group, there were 15 males and 17 females; aged 61-72 years, mean age (66.89±5.13) years, duration of diabetes mellitus 10-20 years, mean duration (10.26±2.75) years, complications (some patients combined 2 or 2 or more complications), 3 with gastroparesis, 3 with diabetic foot, 19 with peripheral neuropathy, and 28 with retinopathy. The observation group included 18 males and 20 females, aged 60-75 years, average age (62.17±7.03) years, diabetes duration 8-21 years, mean duration (10.78±2.80) years, complications: 4 cases with gastroparesis , 2 cases with diabetic foot, 18 cases with peripheral neuropathy, 27 cases with retinopathy. There was no significant difference in general data between the two groups (P>0.05), which was comparable.

1.2 Diagnosis and differentiation criteria Western medicine diagnostic criteria: Diagnosis and classification of diabetes according to the 1999 WHO diagnostic and classification criteria. TCM Syndrome Differentiation Criteria: Dry mouth and throat, vexation and heat in the five hearts, pale complexion, mental fatigue, aversion to cold and cold limbs, swelling of the face and limbs, frequent urination, increased nocturia, turbidity as fat as ointment, and even drinking a fen yi, complexion Mucuna black, sore waist and knees, fullness in the abdomen and abdomen, poor appetite, impotence, diarrhea, pale tongue, fat body, white and dry coating, thin and weak pulse.

1.3 Inclusion criteria (1) Meet the diagnostic criteria for type 2 diabetes; (2) The main syndrome of TCM syndrome differentiation belongs to patients with yin and yang deficiency with blood stasis and phlegm that can be treated with Jianpi Tongyang prescription.

1.4 Exclusion criteria (1) Exclude hospitalized patients with myocarditis, pericardial disease, other organic heart disease, electrolyte imbalance and other heart diseases; (2) Patients with severe cardiovascular and cerebrovascular and liver damage, or recent diabetic ketosis , hyperosmotic coma; (3) pregnancy, allergies, etc. who are not suitable for this treatment plan; (4) those who are older than 75 years old; (5) major changes in lifestyle during data collection, which may affect the results of the study Analyzed patients; (6) non-cooperators.

2 methods

2.1 Treatment methods Both groups were given comprehensive diabetes treatment, namely health education, diet management, exercise management, blood glucose monitoring and management, etc., and targeted interventions were given to those with comorbidities. The control group was additionally treated with Kaibotong (National Medicine Zhunzi H31022986, Shanghai Squibb Pharmaceuticals), orally, 12.5 mg/time, 2-3 times/d. The observation group was additionally treated with the Jianpi Tongyang formula of Example 1 of the present invention, decocted in water, 1 dose a day, decocted into 400 mL, 200 mL each time, warmed twice in the morning and evening, and the treatment results were counted after 2 months of treatment.

2.2 Observation indicators

2.2.1 Safety evaluation criteria General physical examination: blood pressure, respiration, pulse, body temperature. ② Routine examination of hematuria and stool.

2.2.2 Efficacy observation Fasting and postprandial 2h blood glucose, glycosylated hemoglobin, blood pressure, 24-hour urine albumin quantification, TCM clinical symptoms and signs, before and after treatment were evaluated once.

2.3 Statistical processing Statistical software SPSS 18.0 was used for statistical processing of relevant data in this study, measurement data were expressed as mean ± standard deviation, and t-test was used; Chi-square test was used, and P<0.05 indicated a comparison of count data between groups The difference is more significant and there is statistical significance.

3 results

3.1 Comparison of blood glucose and blood pressure between the two groups before and after treatment There was no significant difference in fasting blood glucose, 2h postprandial blood glucose, HbA1c, and blood pressure (systolic blood pressure, diastolic blood pressure) between the two groups before treatment (P>0.05). After treatment, the above indexes were significantly lower than those before treatment (all P<0.05), but there was no significant difference between the two groups (all P>0.05) (Table 1). It shows that the general conditions of the two groups of patients are similar and have good comparability, and both blood sugar and blood pressure have been effectively controlled after treatment.

Table 1 Comparison of blood glucose, glycosylated hemoglobin and blood pressure between the two groups before and after treatment

Note: ^★ P<0.05 compared with before treatment.

3.2 Comparison of 24h urine protein quantitative comparison between the two groups before and after treatment There was no significant difference in urine albumin quantitative between the two groups before treatment (P>0.05). After treatment, the urine protein quantification of the two groups was significantly lower than that before treatment, and the difference was significant (P<0.01). group, the difference was statistically significant (P<0.01) (Table 2). It shows that both Jianpi Tongyang prescription and Kaibotong can effectively reduce urinary albumin excretion, but Jianpitongyang prescription is better than Kaibotong in reducing urinary protein excretion.

Table 2 Urine protein comparison between the two groups before and after treatment (mg/24h)

Note: ^★ Comparison before treatment and after treatment, P<0.01; ^● Comparison between treatment group and control group after treatment, P<0.05.

3.3 Comparison of adverse reactions of patients in the two groups There was no abnormal liver function, further aggravation of renal insufficiency, acute complications such as diabetic ketoacidosis and hypoglycemia coma in the two groups.

3. Conclusion

Diabetes belongs to the category of "diabetes" in traditional Chinese medicine, and ancient traditional Chinese medicine mostly treats it from "dryness and heat due to yin deficiency". However, the current clinical findings have changed in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods. Clinical practice shows that Jianpi Tongyang Recipe in the treatment of yin and yang deficiency with phlegm and blood stasis type diabetes not only has an exact hypoglycemic effect and is safe to use, but also has advantages over western medicine in reducing urinary protein and alleviating symptoms caused by diabetes.

2. Clinical research on the treatment of chronic renal insufficiency

1. General information and methods

1.1 Case source

A total of 60 eligible patients with chronic renal insufficiency (CRF) who were admitted to the outpatient clinic and inpatient ward of the Diabetes Department of Shantou Hospital of Traditional Chinese Medicine from January 2016 to December 2018 were randomly selected.

1.2 Case grouping

Among the diagnosed patients with chronic renal insufficiency, the selected 60 patients were randomly divided into 2 groups according to the ratio of 1:1, namely the traditional Chinese medicine group and the control group. The gender, age and other general data of the two groups were compared, and SPSS software was used to determine whether they were comparable (no significant difference P>0.05).

1.3 Diagnostic criteria for cases

1.3.1 Western medicine diagnostic criteria: referring to Internal Medicine, CRF is divided into four stages: ① renal function compensation stage: creatinine clearance (CCr) 50～80mL/min, serum creatinine (SCr) 133～177umol/L; ②Renal decompensation stage: CCr 20～50mL/min, SCr 186～442umol/L: ③ Renal failure stage: CCr 10～20mL/min, SCr 451～707umol/L; ④ Uremia stage: CCr<10mL/ min, SCr>707umo1/L.

Among them, ① to ③ are the early and middle stages.

1.3.2 TCM diagnostic criteria

The diagnostic criteria of traditional Chinese medicine refer to "Guidelines for Clinical Research of New Chinese Medicines" and "Internal Medicine of Traditional Chinese Medicine" published by the Ministry of Health of the People's Republic of China in 2002 (traditional Chinese medicine planning textbooks for general higher education).

TCM syndrome differentiation standard: TCM syndrome differentiation is yin and yang deficiency with blood stasis and phlegm syndrome. Main symptoms: chills and cold extremities, fatigue, shortness of breath, sluggishness, lack of appetite, soreness and weakness of the waist and knees. Secondary symptoms: cold pain in the waist, abdominal distention, loose stools, clear and long nocturnal urination, pale tongue with tooth marks, and weak pulse.

1.4. Inclusion and exclusion criteria of cases

1.4.1 Inclusion criteria: ① Those who meet the above-mentioned Western medicine diagnostic criteria and TCM syndrome differentiation criteria; ② No history of allergy to the drugs in this study; ③ Age 30-87 years old; ④ All patients participated voluntarily and signed the informed consent form, with good compliance.

1.4.2 Exclusion criteria: ① CRF uremic stage; ② Pregnant or lactating women; ③ Use of hormones and other immunosuppressants in the past 1 month, history of kidney transplantation; ④ Accompanied by serious primary diseases such as heart, brain, liver and hematopoietic system 5. Hemodialysis and kidney transplantation have been performed. 6. Poor compliance and unable to complete the treatment as required.

1.4.3 Elimination and dropout criteria: patients who meet the inclusion criteria and have been grouped, but have not received any treatment for various reasons, or who have not completed the treatment and control observations as required for various reasons, and who have incomplete efficacy observation records.

1.5 Research methods: The control group was given a high-quality low-protein diet. The protein intake is determined according to the creatinine clearance rate. If the dietary protein intake is insufficient, an appropriate amount of essential amino acids can be given (oral or intravenous drip). Symptomatic treatment of anti-infection, correction of acidosis, antihypertensive, correction of electrolyte imbalance, etc. was given. On the basis of the control group, the Chinese medicine group was given the Jianpi Tongyang formula of Example 1, decocted in water, 1 dose per day, decocted into 400mL, 200mL each time, warmed twice in the morning and evening, 4 weeks as a course of treatment, 2 Statistical treatment results after a course of treatment.

1.6. Observation method

1.6.1 Observation indicators

1.6.1.1 Safety Evaluation Criteria

①General physical examination: blood pressure, respiration, pulse, body temperature. ② blood, urine, liver and kidney function, serum potassium.

1.6.1.2 Observation of curative effect.

①SCr, blood urea nitrogen (BUN), cystatin C (Cys-C), urine microalbumin (UAER), 24-hour urine protein quantification, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol ( LDL-C), triglyceride (TG), total cholesterol (CHOL), etc.

②The clinical symptoms and signs of traditional Chinese medicine were evaluated once before treatment and once after 2 months of treatment.

1.7 Efficacy evaluation criteria

1.7.1 Clinical efficacy criteria

It was formulated with reference to "Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Chronic Renal Failure (Trial Scheme)" and clinical experience. Markedly effective: ① Symptoms relieved or disappeared; ② BUN decreased by ≥30%; ③ SCr decreased by ≥30%. Effective: ① symptoms relieved or disappeared; ② BUN decreased by ≥ 20%; ③ SCr decreased by ≥ 20%; the above ① items are required, and ②③ can be judged if one item is present. Stable: Symptoms improved and BUN and SCr did not worsen or decreased slightly. Ineffective: The subjective symptoms and signs did not relieve or aggravate before and after treatment, and BUN and SCr did not improve significantly or were higher than before treatment.

1.7.2 The efficacy standard of traditional Chinese medicine

It was formulated with reference to the "Guiding Principles for Clinical Research on New Chinese Medicines (Trial)". Clinical recovery: TCM symptoms disappeared or basically disappeared, and the score reduction rate was ≥95%; markedly effective: TCM symptoms were relieved, 70%≤integral reduction rate <95%; Effective: TCM symptoms were relieved, 30%≤integral reduction rate <70%; : There is no improvement in clinical symptoms, and the score reduction rate is less than 30%. Point reduction rate (%) = (points before treatment - points after treatment) ÷ points before treatment × 100%

1.8 Statistical processing The statistical software SPSS 18.0 was used for statistical processing of the relevant data in this study. The measurement data were expressed as mean ± standard deviation, and t test was used; The difference is more significant and there is statistical significance.

2 results

2.1 Comparison of renal function indexes between the two groups before and after treatment There was no significant difference in blood urea nitrogen (BUN), serum creatinine (Scr) and glomerular filtration rate (eGFR) between the two groups before treatment (P>0.05). The blood urea nitrogen (BUN), serum creatinine (BUN), serum creatinine (BUN), serum creatinine ( Scr) and glomerular filtration rate (eGFR) were significantly better than those in the control group (P<0.05), with statistical significance, see Table 3.

Table 3 Comparison of renal function indexes between the two groups before and after treatment (n=30)

Note: ★Compared with before treatment, P<0.05; ●Compared with control group, P<0.05

2.2 Before and after treatment, there was no significant difference in the quantitative comparison of postprandial urine albumin and 24-hour urine protein between the two groups before and after treatment (P>0.05). After treatment, the urinary albumin and 24-hour urine protein quantification of patients in both groups decreased, and the difference was statistically significant before and after treatment (P<0.05). The quantitative level of urinary protein was significantly better than that of the control group (P<0.05), with statistical significance, as shown in Table 4.

Table 4 Quantitative comparison of urinary albumin and 24-hour urinary protein between the two groups before and after treatment (n=30)

Note: ★Compared with before treatment, P<0.05; ●Compared with control group, P<0.05

2.3 Comparison of TCM symptom scores between the two groups After treatment, the efficacy evaluation of TCM symptoms in the Jianpi Tongyang prescription group was significantly better than that in the control group, and the difference was statistically significant (P<0.05), as shown in Table 5.

Table 5 Comparison of TCM efficacy evaluation after treatment

Note: ★Compared with the control group, P<0.05

2.4 Comparison of adverse reactions of patients in the two groups In the Jianpi Tongyang Recipe group, 3 patients had belching and acid reflux, 3 patients had sore throat, and 3 patients had constipation; Treatment can be completed after symptomatic treatment. There were no acute complications such as abnormal liver function, diabetic ketoacidosis, hypoglycemia and coma in the two groups.

3. Conclusion

Chronic renal insufficiency belongs to the categories of "guange", "consumption", "edema" and "low back pain" in traditional Chinese medicine. The pathogenesis of this disease is complex, with both the deficiency of righteousness and the inner connotation of evil. Most Chinese medicine practitioners believe that the basic pathogenesis of this disease is deficiency of yin and yang of the spleen and kidney, and blood stasis, dampness and turbidity run through the entire course of the disease.

Clinical practice shows that the Jianpi Tongyang prescription of the present invention combined with conventional symptomatic therapy has a better therapeutic effect on patients with CRF due to yin and yang deficiency and phlegm syndrome, can alleviate the patient's traditional Chinese medicine syndrome, and improve their renal function, and is effective in delaying chronic kidney disease. In terms of progress, it has more advantages than simple western medicine treatment.

Claims (9)

1. A traditional Chinese medicine composition for strengthening spleen and activating yang, characterized in that: calculated in parts by weight, the formula is composed of the following components: 12-18 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, and 25-35 parts of Codonopsis Radix , 4-6 parts of Treats, 12-18 parts of Chuanxiong, 8-12 parts of Tianqi, 8-12 parts of Guizhi, 12-18 parts of Xianlingpi, 25-35 parts of Cistanche, 12-18 parts of dogwood, 8 parts of dried ginger -12 copies, Atractylodes 12-18 copies.
2. The traditional Chinese medicine composition for strengthening the spleen and activating yang according to claim 1, is characterized in that: calculated in parts by weight, the formula is made up of the following components: 14-16 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, Codonopsis 28-32 parts, Treats 4-6 parts, Chuanxiong 14-16 parts, Tianqi 9-11 parts, Guizhi 9-11 parts, Xianlingpi 14-16 parts, Cistanche deserticola 28-32 parts, Cornus 14-16 parts servings, 9-11 servings of dried ginger, and 14-16 servings of Atractylodes. .
3. The traditional Chinese medicine composition for strengthening the spleen and activating yang according to claim 1, is characterized in that: calculated in parts by weight, the formula is made up of the following components: 15 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis Radix, 5 parts of Cork Phellodendri 15 parts of Chuanxiong, 10 parts of Tianqi, 10 parts of Guizhi, 15 parts of Xianlingpi, 30 parts of Cistanche, 15 parts of dogwood, 10 parts of dried ginger, and 15 parts of Atractylodes.
4. Application of the traditional Chinese medicine composition for strengthening spleen and yang in any one of claims 1 to 3 in the preparation of medicines for the treatment of diabetes, diabetic nephropathy and chronic renal insufficiency.
5. Application according to claim 4, is characterized in that: described medicine is decoction, granule, tablet, capsule, oral liquid or pill.
6. The application according to claim 4, wherein the medicine is a preparation prepared by adding medicinal excipients with extracts of the components in the formula of the Chinese medicine composition for strengthening spleen and yang as active ingredients.
7. The application according to claim 6, wherein the extract is a water extract.
8. The application according to claim 4, wherein the diabetes is late diabetes.
9. The application according to claim 4, wherein the diabetes, diabetic nephropathy, and chronic renal insufficiency are phlegm-type diabetes, diabetic nephropathy, and chronic renal insufficiency.