CN118045141A

CN118045141A - A Chinese medicinal composition for treating diabetes, and its preparation method

Info

Publication number: CN118045141A
Application number: CN202410346150.1A
Authority: CN
Inventors: 林日胜
Original assignee: Guangzhou South China Diabetes Medical Research Institute
Current assignee: Guangzhou South China Diabetes Medical Research Institute
Priority date: 2024-03-25
Filing date: 2024-03-25
Publication date: 2024-05-17

Abstract

The invention discloses a traditional Chinese medicine composition for treating diabetes and a preparation method thereof, which belong to the technical field of traditional Chinese medicines and comprise the following raw materials in parts by weight: 3 to 9 parts of sea horse, 3 to 9 parts of sea dragon, 9 to 30 parts of astragalus, 9 to 15 parts of rhizoma polygonati, 6 to 10 parts of epimedium, 15 to 30 parts of Chinese yam, 3 to 9 parts of ginseng, 10 to 30 parts of prepared rhizome of rehmannia, 2 to 6 parts of shizandra berry, 5 to 10 parts of earthworm, 1 to 3 parts of leech, 3 to 6 parts of scorpion, 5 to 10 parts of stiff silkworm, 10 to 15 parts of poria cocos, 3 to 10 parts of eupatorium, 3 to 9 parts of pinellia tuber and 2 to 10 parts of liquorice. The whole prescription has the effects of replenishing qi to invigorate the spleen, warming yang and tonifying kidney to treat the root, resolving phlegm and dredging collaterals, activating blood and promoting diuresis to treat the root, can improve insulin resistance, bidirectionally regulate blood fat and obviously reduce CRP level, lighten vascular inflammatory reaction, protect vascular endothelial function, obviously reduce fibrinogen level, inhibit platelet aggregation, improve microcirculation, prevent the occurrence of thrombus diseases, and is safe and free of side effects.

Description

A Chinese medicinal composition for treating diabetes, and its preparation method

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating diabetes and a preparation method thereof.

Background

Diabetes is a global chronic metabolic disease, mainly manifested by hyperglycemia, and long-term hyperglycemic states can damage various organs of the body, especially the eyes, kidneys, heart, blood vessels, and nervous system. With changes in lifestyle and an increasing trend of aging population, the incidence of diabetes has risen year by year, and has become one of the main diseases threatening human health.

Currently, the treatment methods of diabetes mainly include drug therapy, diet control, exercise therapy, and the like. Among them, drug therapy is an important means for controlling blood glucose levels and preventing complications. However, although the existing chemical synthetic drugs can control blood sugar to a certain extent, long-term use is often accompanied by a series of side effects such as hypoglycemia, gastrointestinal tract reaction, liver and kidney function damage and the like. Therefore, finding a safe, effective and less-side-effect therapeutic method has been the focus of research in the medical community.

Diabetes belongs to the category of diabetes in traditional Chinese medicine, and the root cause of diabetes is diuresis and urine sugar, which causes yang deficiency to lose in retention and preservation, and further causes loss of body fluid and essence. As described in "Xiaokexiaozhongmen Shenxiao" in the secret key of the foreign table: for diabetes, it is started, and this is caused by kidney deficiency, and urine is sweet in every hair. Meanwhile, "kidney is deficient cold, but can not be evaporated to dryness, and cereal qi is the same as urine, so the sweet taste is unchanged. "furthermore," Jingyue full book, jiuqiang "also explicitly indicates: the yang failing to transform qi will lead to water essence failing to distribute, and the water failing to get fire will lead to ascending or descending, so it goes straight into the bladder, while the two … … drinks will lead to the deficiency of true yang and the fire will lead to the failure of fire. It follows that kidney yang deficiency is one of the important pathogenesis of diabetes. Ancient medical books are also discussed in terms of spleen deficiency causing the elimination. As mentioned in "treating of class syndrome and sanxiaojie: for people with bad smell and sweet taste, spleen qi is the most serious symptom. "the" Zhengzhi Hui Bu-Xiaoke "indicates that: spleen and stomach qi failing to treat water and fire, and transforming body fluids to thirst. This suggests that spleen deficiency is also an important pathogenesis of diabetes. Kidneys are congenital origin, spleen is acquired origin, and both are mutually physiological and pathological, and influence each other and cause each other. Therefore, in the development process of diabetes, the deficiency of the spleen and the kidney often exists at the same time, and the occurrence and the development of the diabetes are promoted together. In summary, yang deficiency is the pathogenic cause of diabetes, while yang deficiency and qi deficiency are unfavorable, which leads to body fluid imbalance and thirst. Meanwhile, spleen failing to move its body fluids and stomach fire is excessive, which can promote digestion and hunger. Sugar, namely yin essence, can cause deficiency of yin essence and yin deficiency helps dryness-heat after long-term urinary sugar loss, so the symptoms of yin deficiency and dryness-heat are clinically manifested. With the progress of diseases or due to improper treatment, excessive use of cold and cool and greasy drugs, improper diet, overstrain, prolonged western medicines, improper sexual intercourse, high annual situation and the like, the diseases can consume spleen and kidney yang qi, finally cause yang qi deficiency, weak five zang organs, excessive healthy qi and deficiency evil, and become the symptoms come out one after another. This is especially evident in the middle and late stages of diabetes, with aggravated spleen-kidney yang deficiency symptoms, and impaired yang qi warming, qi transformation and pushing functions, which lead to unfavorable blood vessels, water retention, qi movement obstruction, and further cause the breeding of pathogenic factors such as turbid phlegm, blood stasis, water retention, damp toxin, etc., thus becoming a hundred-degree syndrome. In the late stage, yang deficiency fails to transform yin, and essence substances such as urine sugar and urine protein are continuously lost, so that the symptoms of yin-yang deficiency often appear.

The traditional Chinese medicine has unique advantages in the treatment of diabetes due to the unique theoretical system and abundant medicine resources. Many traditional Chinese medicines have multiple effects of reducing blood sugar, improving insulin resistance, protecting islet cells, regulating glycolipid metabolism and the like, and have relatively small side effects.

Disclosure of Invention

In order to overcome the defects of the prior art, one of the purposes of the invention is to provide a traditional Chinese medicine composition for treating diabetes, which can effectively improve the symptoms of diabetes and reduce and prevent adverse reactions.

The second object of the present invention is to provide a method for preparing a Chinese medicinal composition for treating diabetes, which has simple steps.

One of the purposes of the invention is realized by adopting the following technical scheme:

The traditional Chinese medicine composition for treating diabetes is characterized by comprising the following raw materials in parts by weight: 3 to 9 parts of sea horse, 3 to 9 parts of sea dragon, 9 to 30 parts of astragalus, 9 to 15 parts of rhizoma polygonati, 6 to 10 parts of epimedium, 15 to 30 parts of Chinese yam, 3 to 9 parts of ginseng, 10 to 30 parts of prepared rhizome of rehmannia, 2 to 6 parts of shizandra berry, 5 to 10 parts of earthworm, 1 to 3 parts of leech, 3 to 6 parts of scorpion, 5 to 10 parts of stiff silkworm, 10 to 15 parts of poria cocos, 3 to 10 parts of eupatorium, 3 to 9 parts of pinellia tuber and 2 to 10 parts of liquorice.

Further, the raw materials according to the weight parts are preferably as follows: 6 parts of sea horse, 6 parts of sea dragon, 18 parts of astragalus, 12 parts of rhizoma polygonati, 8 parts of epimedium, 23 parts of Chinese yam, 6 parts of ginseng, 20 parts of prepared rhizome of rehmannia, 4 parts of Chinese magnoliavine, 8 parts of earthworm, 2 parts of leech, 5 parts of scorpion, 8 parts of stiff silkworm, 12 parts of poria cocos, 7 parts of eupatorium, 6 parts of pinellia ternate and 6 parts of liquorice.

Hippocampus japonicus: sex taste and meridian tropism: sweet, salty, warm. It enters liver and kidney meridians. Function and main indications: warming kidney, strengthening yang, resolving hard mass and detumescence. Can be used for treating sexual impotence, enuresis, kidney deficiency, asthma, cancer scar accumulation, and traumatic injury; it is indicated for carbuncle and swelling and sore.

Sea dragon: sex taste and meridian tropism: sweet, salty, warm. It enters liver and kidney meridians. Function and main indications: warming kidney, strengthening yang, resolving hard mass and detumescence. Can be used for treating kidney yang deficiency, yang phlegm spermatorrhea, cancer scar accumulation, arthralgia phlegm core, traumatic injury; it is indicated for carbuncle and swelling and sore.

Radix astragali: sex taste and meridian tropism: sweet and warm; enter lung meridian and spleen meridian. Function and main indications: tonify qi, strengthen superficies, induce diuresis, expel toxin, expel pus, heal wound and promote tissue regeneration. Can be used for treating qi deficiency debilitation, loose stool, depression of middle-jiao, chronic diarrhea, rectocele, metrorrhagia, spontaneous perspiration, qi deficiency edema, carbuncle, ulcer, blood deficiency, sallow complexion, internal heat, and diabetes; chronic nephritis proteinuria and diabetes.

Rhizoma polygonati: sex taste and meridian tropism: sweet and flat. Enter spleen, lung and kidney meridians. Function and main indications: tonifying qi and yin, strengthening spleen, moistening lung and tonifying kidney. Can be used for treating qi deficiency of spleen and stomach, tiredness, debilitation, stomach yin deficiency, dry mouth, anorexia, cough due to lung deficiency, cough due to fatigue, hemoptysis, essence and blood deficiency, soreness of waist and knees, premature graying of hair, and internal heat diabetes.

Herba epimedii: sex taste and meridian tropism: pungent, sweet and warm. It enters liver and kidney meridians. Function and main indications: kidney yang, strengthening tendons and bones, and dispelling pathogenic wind. Can be used for treating deficiency of kidney-yang, sexual impotence, spermatorrhea, flaccidity of tendons and bones, rheumatalgia, numbness and contracture.

Chinese yam: sex taste and meridian tropism: sweet and flat. Enter spleen, lung and kidney meridians. Function and main indications: spleen and stomach tonifying, body fluid generating, lung nourishing, kidney tonifying and seminal emission astringing. Can be used for treating spleen deficiency, anorexia, chronic diarrhea, lung deficiency, asthma, cough, kidney deficiency, spermatorrhea, leukorrhagia, frequent urination, and deficiency heat diabetes. The stir-fried Chinese yam can tonify spleen and stomach. Can be used for treating spleen deficiency, anorexia, diarrhea, constipation, leukorrhagia.

Ginseng: sex taste and meridian tropism: sweet, slightly bitter and slightly warm. It enters spleen, lung, heart and kidney meridians. Function and main indications: the medicine has the functions of invigorating primordial qi, restoring pulse, strengthening spleen, benefiting lung, promoting fluid production, nourishing blood, tranquilizing mind and improving intelligence. Can be used for treating asthenia, listlessness, cold limbs, weak pulse, spleen deficiency, anorexia, lung deficiency, asthma and cough, body fluid consumption, thirst, internal heat, thirst, deficiency of qi and blood, deficiency of long-term illness, palpitation, insomnia, yang phlegm, and cold uterus.

Prepared rehmannia root: sex taste and meridian tropism: sweet and warm; it enters liver and kidney meridians. Function and main indications: nourishing yin and replenishing blood, replenishing essence and replenishing marrow. Can be used for treating deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever due to bone steaming, night sweat, spermatorrhea, internal heat, diabetes, blood deficiency, sallow complexion, palpitation, menoxenia, metrorrhagia, blood stasis, dizziness, tinnitus, and premature graying of hair and beard.

Chinese magnoliavine fruit: sex taste and meridian tropism: acid, sweet, warm. It enters lung, heart and kidney meridians. Function and main indications: astringe and astringe, replenish qi and promote the production of body fluid, tonify kidney and calm heart. Can be used for treating cough, asthma, nocturnal emission, enuresis, frequent urination, chronic diarrhea, spontaneous perspiration, night sweat, body fluid deficiency, thirst, internal heat, diabetes, palpitation, and insomnia.

Earthworm: sex taste and meridian tropism: salty and cold. Enter liver, spleen and bladder meridians. Function and main indications: clear heat and arrest convulsion, dredge collaterals, relieve asthma and induce diuresis. Can be used for treating hyperpyrexia, unconsciousness, convulsion, arthralgia, numbness of limbs, hemiplegia, cough due to lung heat, edema, and oliguria.

Leech: sex taste and meridian tropism: salty, bitter, flat; it is slightly toxic. Enter liver meridian. Function and main indications: break blood and promote menstruation, and dispel fatigue and cancer. Can be used for treating amenorrhea due to blood stasis, cancer, sore, apoplexy, hemiplegia, and traumatic injury.

Scorpion: sex taste and meridian tropism: pungent and flat; is toxic. Enter liver meridian. Function and main indications: wind-extinguishing and spasm-relieving, vein-relaxing and pain-relieving, toxin-eliminating and stagnation-dissipating. Can be used for treating internal motion of liver wind, spasm, infantile convulsion, apoplexy, hemiplegia, tetanus, rheumatism, migraine, suppurative headache, pyocutaneous disease, and monkey disease.

Stiff silkworm: sex taste and meridian tropism: salty, pungent and flat. It enters liver, lung and stomach meridians. Function and main indications: wind-extinguishing and spasm-stopping, wind-dispelling and pain-relieving, phlegm-resolving and mass-resolving. Can be used for treating liver wind, phlegm, convulsion, infantile acute convulsion, tetanus, apoplexy, headache due to wind heat, conjunctival congestion, pharyngalgia, rubella, pain and itch, and parotitis.

Poria cocos: sex taste and meridian tropism: sweet, light, flat; heart meridian; spleen meridian; lung meridian; kidney meridian function and indications: excrete dampness and promote diuresis, benefit spleen and stomach, calm heart and tranquilize mind. For dysuria, edema, phlegm-fluid retention, cough, vomiting, diarrhea, spermatorrhea, stranguria with turbid urine, palpitation and amnesia.

Eupatorium: sex taste and meridian tropism: pungent and flat. Enter spleen, stomach and lung meridians. Function and main indications: fragrant, damp-resolving, spleen-enlivening, appetite-stimulating, summer-heat relieving. Can be used for treating damp obstruction, wrist hemorrhoid, emesis, and malignant vomiting, sweet and greasy taste in mouth, halitosis, excessive salivation, summer-heat and dampness exterior syndrome, early stage of damp-heat, listlessness, chest distress, and discomfort.

Pinellia ternate: sex taste and meridian tropism: pungent and warm; is toxic. Enter spleen, stomach and lung meridians. Function and main indications: dry dampness and resolve phlegm, reduce adverse qi and arrest vomiting, resolve carbuncles and dissipate nodulation. Can be used for treating damp phlegm, cold phlegm, cough, asthma, excessive phlegm, phlegm retention, dizziness, headache, emesis, regurgitation, chest hemorrhoid, and globus hystericus; it is indicated for carbuncle and swelling of phlegm.

Licorice root: sex taste and meridian tropism: sweet and flat; it enters heart, lung, spleen and stomach meridians. Function and main indications: invigorating spleen, replenishing qi, clearing away heat and toxic materials, eliminating phlegm, relieving cough, and relieving pain. Blending the medicines; can be used for treating weakness of spleen and stomach, listlessness, debilitation, palpitation, and short breath. Relieving toxicity and intensity of the medicine.

The second purpose of the invention is realized by adopting the following technical scheme:

the invention provides a method for preparing a traditional Chinese medicine composition for treating diabetes, which comprises the following steps:

S1, taking 17 raw medicinal materials of Hippocampus, syngnathus, radix astragali, rhizoma Polygonati, herba Epimedii, rhizoma Dioscoreae, radix Ginseng, radix rehmanniae Preparata, fructus Schisandrae chinensis, lumbricus, hirudo, scorpio, bombyx Batryticatus, poria, herba Eupatorii, rhizoma Pinelliae and radix Glycyrrhrizae according to the formula, cleaning, respectively coarsely pulverizing to obtain coarse granule;

s2, soaking coarse medicinal material particles of the sea horse, the sea dragon, the astragalus, the rhizoma polygonati, the epimedium, the Chinese yam, the ginseng, the prepared rehmannia root and the Chinese magnoliavine fruit obtained in the step S1 in cold water for 30-60 min to obtain a first medicament to be decocted for later use;

S3, boiling the first medicament to be decocted obtained in the step S2 with strong fire, then decocting with slow fire for 40-60 min, and stirring for 2-3 times to obtain decoction; meanwhile, taking crude medicinal material particles of earthworm, leech, scorpion, stiff silkworm, poria cocos, eupatorium, pinellia ternate and liquorice obtained in the step S1, and soaking the crude medicinal material particles in cold water for 30-60 min to obtain a second medicament to be decocted;

S4, putting the second medicament to be decocted obtained in the step S3 into the decoction obtained in the step S3, decocting for 20-30 min after boiling, and stirring for 2-3 times to obtain the traditional Chinese medicine composition for treating diabetes.

Further, the application of the traditional Chinese medicine composition for treating diabetes in preparing the medicine for treating diabetes.

Compared with the prior art, the invention has the beneficial effects that:

In the traditional Chinese medicine composition for treating diabetes, sea horse and sea dragon are Wen Weigan, salty, kidney warming, yang strengthening, stagnation eliminating and detumescence; astragalus Wen Weigan, which has the effects of invigorating qi, raising yang, inducing diuresis to alleviate edema, and rhizoma Polygonati, which has the effects of relieving stuffiness, tonifying qi, nourishing yin, strengthening spleen, moistening lung and tonifying kidney; hippocampus, syngnathus, radix astragali, and rhizoma Polygonati are all monarch drugs, and have effects of invigorating qi and spleen, warming yang and invigorating kidney, strengthening body resistance, and resisting exogenous evil, and can be used for preventing and treating diabetic complications. The epimedium Wen Weixin and the Chinese yam have the effects of tonifying kidney yang, strengthening tendons and bones, dispelling wind-dampness, calming the flavor of Chinese yam, tonifying kidney yang, strengthening tendons and bones, dispelling wind-dampness, strengthening spleen and Chinese yam, and can strengthen the effects of the monarch drug of replenishing qi to invigorate spleen and warming yang to tonify kidney; ginseng is a key medicine for tonifying qi and strengthening body, has strong tonifying qi effect but insufficient nourishing yin, and is matched with prepared rehmannia root with sweet nature and warm nature for nourishing yin and supplementing blood so as to obtain better effects of tonifying qi and nourishing yin and promoting fluid production; fructus Schisandrae chinensis astringes and has astringents, and has effects of invigorating qi and promoting salivation; the three medicines are combined together, and the medicine has the effects of tonifying, astringing, moistening, supplementing qi, nourishing yin, assisting the principal medicine in strengthening body resistance and consolidating constitution; herba Epimedii, rhizoma Dioscoreae, ginseng radix, radix rehmanniae Preparata, and fructus Schisandrae are all ministerial drugs, and assist and supplement with principal drugs, and can be used for invigorating qi and spleen, warming yang and invigorating kidney to treat the root cause. Lumbricus is salty in nature and cold in nature, leech is salty and bitter in nature, scorpion is spicy in nature and stiff silkworm is salty and spicy in nature, and the four are all worms with strong channeling ability, so that wind and collaterals are well removed, and blood circulation is promoted and stasis is removed; poria cocos is sweet and bland in taste, excretes dampness and promotes diuresis, benefits spleen and stomach, calms heart and calms nerves; eupatorium nature is pungent in taste, aromatic in nature, damp-resolving, spleen-enlivening and appetite-stimulating; pinellia tuber Wen Weixin has the characteristics of drying dampness and resolving phlegm, calming adverse-rising energy and relieving vomiting, and resolving carbuncles and resolving masses; the seven patients are ministerial drugs together, and the traditional Chinese medicines are used for resolving phlegm, dredging collaterals, promoting blood circulation and removing dampness to take the principal aspect. Licorice root, radix Glycyrrhizae is the guiding drug, and is used for regulating the action of the other drugs, mainly and slowly, and tonifying the stomach. The whole prescription has the effects of replenishing qi to invigorate the spleen, warming yang and tonifying kidney to treat the root cause, reducing phlegm and dredging collaterals, promoting blood circulation and removing dampness to take care of the symptoms.

Clinical experiments show that the traditional Chinese medicine composition for treating diabetes has the effect of protecting renal function, has definite curative effect of treating diabetes and chronic complications thereof, can obviously improve clinical symptoms of patients, effectively prevent the occurrence of chronic complications of diabetes, delay disease processes, improve insulin resistance, have bidirectional regulation effect on blood fat, and can obviously reduce CRP (common-point protein) level, thereby reducing vascular inflammatory reaction, protecting vascular endothelial function, obviously reducing fibrinogen level, inhibiting platelet aggregation, improving microcirculation, preventing thrombosis diseases and being safe and free of side effects in clinical application.

Detailed Description

The present invention will be further described with reference to specific embodiments, and it should be noted that, on the premise of no conflict, new embodiments may be formed by any combination of the embodiments or technical features described below.

Example 1

The traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following raw materials in parts by weight: 3 parts of sea horse, 9 parts of sea dragon, 30 parts of astragalus, 9 parts of rhizoma polygonati, 6 parts of epimedium, 30 parts of Chinese yam, 3 parts of ginseng, 10 parts of prepared rhizome of rehmannia, 6 parts of Chinese magnoliavine, 5 parts of earthworm, 3 parts of leech, 6 parts of scorpion, 5 parts of stiff silkworm, 10 parts of poria cocos, 10 parts of eupatorium, 3 parts of pinellia ternate and 10 parts of liquorice.

The preparation method of the traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following steps:

Example 2

The traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following raw materials in parts by weight: 9 parts of sea horse, 3 parts of sea dragon, 9 parts of astragalus, 15 parts of rhizoma polygonati, 10 parts of epimedium, 15 parts of Chinese yam, 9 parts of ginseng, 30 parts of prepared rhizome of rehmannia, 2 parts of Chinese magnoliavine, 10 parts of earthworm, 1 part of leech, 3 parts of scorpion, 10 parts of stiff silkworm, 15 parts of poria cocos, 3 parts of eupatorium, 9 parts of pinellia ternate and 2 parts of liquorice.

Example 3

The traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following raw materials in parts by weight: 6 parts of sea horse, 6 parts of sea dragon, 18 parts of astragalus, 12 parts of rhizoma polygonati, 8 parts of epimedium, 23 parts of Chinese yam, 6 parts of ginseng, 20 parts of prepared rhizome of rehmannia, 4 parts of Chinese magnoliavine, 8 parts of earthworm, 2 parts of leech, 5 parts of scorpion, 8 parts of stiff silkworm, 12 parts of poria cocos, 7 parts of eupatorium, 6 parts of pinellia ternate and 6 parts of liquorice.

Example 4

The traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following raw materials in parts by weight: 5 parts of sea horse, 5 parts of sea dragon, 27 parts of astragalus, 12 parts of rhizoma polygonati, 7 parts of epimedium, 20 parts of Chinese yam, 8 parts of ginseng, 28 parts of prepared rhizome of rehmannia, 3 parts of Chinese magnoliavine, 9 parts of earthworm, 2 parts of leech, 4 parts of scorpion, 6 parts of stiff silkworm, 11 parts of poria cocos, 9 parts of eupatorium, 8 parts of pinellia ternate and 4 parts of liquorice.

Example 5

The traditional Chinese medicine composition for treating diabetes provided by the embodiment comprises the following raw materials in parts by weight: 7 parts of sea horse, 7 parts of sea dragon, 17 parts of astragalus, 14 parts of rhizoma polygonati, 9 parts of epimedium, 26 parts of Chinese yam, 5 parts of ginseng, 18 parts of prepared rhizome of rehmannia, 5 parts of Chinese magnoliavine, 7 parts of earthworm, 2 parts of leech, 5 parts of scorpion, 9 parts of stiff silkworm, 14 parts of poria cocos, 5 parts of eupatorium, 5 parts of pinellia ternate and 8 parts of liquorice.

Experimental example

Clinical observation test

1.1 General data

60 Patients diagnosed with diabetes mellitus, admitted to the medical institute of diabetes mellitus, south China, during the period of 12 months 2022 to 10 months 2023, were selected as subjects.

Inclusion criteria: meets the Western diagnosis standard of diabetes mellitus and is a patient suffering from spleen-kidney yang deficiency by dialectical symptoms of traditional Chinese medicine; age 30-75 years old; the compliance is good.

Exclusion criteria: those which do not meet the above criteria; the patients can not judge the influence of the curative effect or the safety due to the incomplete curative effect or the incomplete data without the prescribed medication; acute complications of diabetes and severe infections; pregnant and lactating women are intolerant or allergic to the drug of choice for this study; complications such as severe cardiovascular and cerebrovascular diseases, liver diseases, renal diseases, hematopoietic diseases, etc. are complicated, or other serious primary diseases are complicated.

1.2 Diagnostic criteria

1.2.1 Western diagnostic criteria

The Western diagnosis standard of diabetes is mainly based on diabetes diagnosis standard published by WHO world health organization in 1999. The following are specific diagnostic criteria:

1. fasting blood glucose (FPG) is more than or equal to 7.0mmol/L (126 mg/dl).

2. Random blood sugar is more than or equal to 11.1mmol/L (200 mg/dl).

3. The blood sugar in the oral glucose tolerance test (OGTT 75g glucose) for 2 hours is more than or equal to 11.1mmol/L (200 mg/dl).

Among the above criteria, diabetes can be diagnosed if the patient has diabetes, polydipsia, diuresis, unoccupied weight loss, etc. that are in compliance with the condition of diabetes and any of the above conditions.

1.2.1 Diagnostic and diagnostic criteria for TCM

Reference edition of Chinese medicine New drug clinical study guidelines (trial) and clinical establishment of spleen and kidney yang deficiency diagnosis criteria are as follows:

Cold limbs, listlessness, less qi and no desire to speak, pale complexion, soreness of waist and knees, dry mouth and thirst, chest distress, abdominal distension, numbness and pain of hands and feet, irregular stool, clear and long urine, pale and dark tongue, tooth trace on the side, thin and white or greasy tongue coating, deep, thready and weak pulse.

1.3 Methods of treatment

1.3.1 Therapeutic Agents

The Chinese medicinal composition for treating diabetes prepared in example 1.

1.3.2 Methods of treatment

The method for taking the medicine comprises the following steps: the Chinese medicine is decocted with water to obtain 300ml decoction, and is taken separately in the morning and evening 2 times a day. The medicine is taken before breakfast and after supper, and the medicine is taken after breakfast, and is fasted with pungent and spicy food, fresh, cool and sticky food and other foods.

Treatment course: the medicine is continuously taken for 4 weeks. The review was 1 time per week, with an observation time of 1 month and follow-up after 2 months. The method comprises the steps of observing the general state of a patient before treatment and after treatment, recording clinical data of the patient, evaluating clinical symptoms and treatment effects of the patient, focusing on the change condition of safety indexes, and carrying out statistical treatment and evaluation through the recording, arrangement, follow-up and final analysis of clinical cases.

1.4 Observations index

1.4.1 Observations of symptoms in TCM

The following symptom changes were observed: cold limbs, listlessness, less qi and no desire to speak, soreness of the waist and knees, dry mouth and thirst, chest distress and abdomen fullness, numbness and pain of hands and feet, irregular stool, clear urine, long-term urine, tongue appearance, pulse condition and the like. The semi-quantitative grade scoring evaluation method is adopted, and scoring registration is carried out respectively before treatment and after treatment according to four grades of 0, 2,4 and 6 and the integral change before treatment and after treatment is observed according to the grade of none, light, medium and heavy by referring to the traditional Chinese medicine and western medicine combined diabetes diagnosis and treatment standard draft "traditional Chinese medicine symptom grading standard" and the traditional Chinese medicine new medicine clinical research guiding principle (trial) "symptom grading quantification standard". The Chinese medicine symptom scoring criteria are shown in the table 1 below.

Exterior 1 Chinese medical science of diabetes

1.4.2 Observations of efficacy index

Biochemical indexes: triglyceride (TG), total Cholesterol (TC), low Density Lipoprotein (LDL), high Density Lipoprotein (HDL), fasting (FBG), 2 hours postprandial blood glucose (P2 hBG), C-reactive protein (CRP), fibrinogen (FIB), glycosylated hemoglobin (HbAlc) were each measured 1 time before/after the end of treatment.

1.4.3 Security observations

General physical examination of blood, urine and feces; liver and kidney functions. Adverse reactions possibly occurring and abnormal changes of related detection indexes are observed at one time in each examination before and after treatment.

1.5 Therapeutic efficacy criterion

1.5.1 Total treatment efficacy criterion for diseases

Reference edition "guidelines for clinical study of New Chinese medicine (trial)", judges:

The effect is shown: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the integral value of the symptoms is reduced by more than 70%; fasting blood glucose and postprandial blood glucose fall to normal ranges for 2 hours; or fasting blood glucose and postprandial blood glucose decrease by more than 40% before treatment; the glycosylated hemoglobin value drops below 6.2% or drops above 30% prior to treatment.

The method is effective: the total integral value of the improvement of clinical symptoms and physical signs of the traditional Chinese medicine is reduced by more than 30 percent; the blood sugar drop of fasting blood sugar and postprandial for 2 hours exceeds 20% before treatment, and the glycosylated hemoglobin value is more than before treatment, but does not reach the obvious effect standard.

Invalidation: fasting blood glucose, no blood glucose drop after 2 hours after meal; or a drop that does not meet the effective criteria.

1.5.2 Criteria for determining efficacy of treatment of Chinese Condition

The preparation method is formulated by referring to the traditional Chinese medicine disease diagnosis curative effect standard (2012):

Clinical cure: a decrease in syndrome value of > 90%; the effect is shown: 70% -90% of the integral value of the symptoms is reduced; the method is effective: the integral value of the symptoms is reduced by 30 to 70 percent; invalidation: the decrease of the syndrome value is less than 30%.

1.5.3 Laboratory index efficacy assessment criteria

the effect is shown: symptoms basically disappear after treatment, fasting blood glucose or postprandial blood glucose of 2h is reduced to a normal range; or fasting blood glucose and postprandial blood glucose decrease of more than 40% before treatment; glycosylated hemoglobin drops to normal or drops by more than 30% prior to treatment.

The method is effective: the symptoms are obviously improved after treatment, the fasting blood glucose is less than 8.3mmol/L, and the postprandial blood glucose is less than 10mmol/L for 2 h; or the fasting blood sugar and postprandial blood sugar are reduced by more than or equal to 20 percent before treatment, and the glycosylated hemoglobin is reduced by 7.0 percent <8 percent after treatment or more than 10 percent before treatment.

Invalidation: the blood sugar and glycosylated hemoglobin decrease in 2h after fasting and postprandial treatment does not meet the above criteria.

1.6 Statistical methods

Statistical analysis data using SPSS26.0 statistical software, and measurement data using mean.+ -. Standard deviationRepresenting, using t-test; the count data is expressed in percent and tested in χ ². The difference of P <0.05 is statistically significant.

1.7 Results

Table 2 comparison of clinical comprehensive efficacy [ example (%) ]

Number of examples	Has obvious effect	Effective and effective	Invalidation of	Total effective rate
					60	23(38.3)	47(78.3)	2(3.3)	58(96.6)

60 Cases of clinical comprehensive curative effects after treatment are 23 persons, 47 persons are effective, 2 persons are ineffective, and the total effective rate of the clinical comprehensive curative effects is 96.6%, so that the clinical comprehensive curative effects of the traditional Chinese medicine composition for treating diabetes are obvious.

Table 3 comparative efficacy of symptoms in TCM [ example (%) ]

Number of examples	Clinical cure	Has obvious effect	Effective and effective	Invalidation of	Total effective rate
						60	14(23.3)	26(43.3)	18(30.0)	2(3.3)	58(96.6)

The total effective rate of the clinical comprehensive curative effect of the 60 cases of 14 patients with clinical cure of the traditional Chinese medicine symptoms after treatment, 26 patients with obvious effect, 18 patients with effective effect, 2 patients with ineffective effect and 96.6% shows that the traditional Chinese medicine composition has obvious curative effect on diabetes.

TABLE 4 integral comparison of symptoms before and after treatment

Sign of symptoms	Before treatment	After treatment
			Cold limbs	4.42±0.73	2.53±0.52
Mental fatigue	5.63±0.83	4.23±0.92
			Soreness and weakness of waist and knees	4.52±0.88	2.12±1.12
Dry mouth and desire to drink	5.35±0.93	1.49±0.42
			Chest distress and pain	4.27±0.75	2.16±0.31
Epigastric fullness and distention	4.31±0.79	1.46±0.42
			Numbness and pain of limbs	5.38±0.83	3.92±1.02
Frequent urination at night	4.51±0.80	3.66±0.72
			Unconditioning of stool	3.95±0.47	1.74±0.36
Tongue and pulse condition	3.53±0.35	1.37±0.47
			Total integral	45.87±10.62	24±6.7

After treatment, the integral of each symptom of the patient is obviously improved (P is less than 0.01), wherein the symptoms such as cold limbs, listlessness, soreness of waist and knees, dry mouth and desire to drink, chest distress and chest pain, epigastric fullness and oppression, limb numbness and pain, frequent night urination, irregular stool, tongue appearance, pulse condition and the like have statistical significance compared with the difference before treatment, and the difference has statistical significance (P is less than 0.05), so that the composition can obviously improve the symptom signs of diabetics.

TABLE 5 sugar metabolism changes before and after treatment

Index (I)	Before treatment	After treatment
			FBG(mmol/L)	10.23±3.01	6.38±1.64
P2hBG(mmol/L)	16.28±3.75	9.24±3.71
			HbAlc(％)	8.93±2.11	6.72±1.96

After treatment, FBG, P2hBG, hbAlc were all reduced in the patient compared to pre-treatment, and the differences compared to pre-treatment were statistically significant (P < 0.01). The traditional Chinese medicine composition has obvious blood sugar recovery effect.

TABLE 6 blood lipid changes before and after treatment

Index (I)	Before treatment	After treatment
			TC(mmol/L)	5.54±1.63	4.25±0.65
TG(mmol/L)	2.43±0.89	1.65±0.73
			LDL(mmol/L)	3.67±0.82	2.49±0.74
HDL(mmol/L)	0.81±0.35	1.10±0.33

After treatment, TC, TG, LDL, HDL of the patients were all reduced compared to pre-treatment, and the differences compared to pre-treatment were statistically significant (P < 0.01). The traditional Chinese medicine composition has the function of obviously recovering blood fat.

TABLE 7 FIB and CRP comparison before and after treatment

Index (I)	Before treatment	After treatment
			FIB(g/L)	7.89±0.97	4.80±0.83
CRP(mg/L)	6.47±1.03	4.62±1.01

After treatment, both FIB and CRP were reduced in the patient compared to pre-treatment, and the differences compared to pre-treatment were statistically significant (P < 0.01). The traditional Chinese medicine composition has obvious effect on improving microcirculation and reducing inflammation.

Table 8 comparison of liver and kidney before and after treatment

Index (I)	Before treatment	After treatment
			ALT	22.35±12.63	21.74±11.34
BUN	6.83±2.83	6.72±3.04
			Scr	108.27±18.35	84.23±13.45

Patients who are incorporated in the test have chronic complications and are mostly accompanied with kidney damage with different degrees, before treatment, the Scr of the patients is higher than the normal value range, the Scr of the patients is reduced after treatment compared with that before treatment, and the difference has obvious statistical significance (P is less than 0.01) compared with that before treatment, so that the traditional Chinese medicine composition has better obvious curative effect in the aspect of protecting kidney function.

The 60 patients are subjected to routine blood, urine and stool examination before and after treatment, the liver function and kidney function results are not found to be obvious abnormal before and after treatment, and adverse reaction events are not found in the treatment period, so that the traditional Chinese medicine composition is safe and has no side effect in clinical application.

In conclusion, the traditional Chinese medicine composition for treating diabetes has the effect of protecting kidney functions, has definite curative effects on treating diabetes and chronic complications thereof, can obviously improve clinical symptoms of patients, effectively prevent the occurrence of chronic complications of diabetes, delay disease processes, improve insulin resistance, have bidirectional regulation effect on blood fat, and can obviously reduce CRP (common-point protein) level, thereby reducing vascular inflammatory reaction, protecting vascular endothelial functions, obviously reducing fibrinogen level, inhibiting platelet aggregation, improving microcirculation, preventing thrombosis diseases and being safe and free of side effects in clinical application.

The above embodiments are only preferred embodiments of the present invention, and the scope of the present invention is not limited thereto, but any insubstantial changes and substitutions made by those skilled in the art on the basis of the present invention are intended to be within the scope of the present invention as claimed.

Claims

1. The traditional Chinese medicine composition for treating diabetes is characterized by comprising the following raw materials in parts by weight: 3 to 9 parts of sea horse, 3 to 9 parts of sea dragon, 9 to 30 parts of astragalus, 9 to 15 parts of rhizoma polygonati, 6 to 10 parts of epimedium, 15 to 30 parts of Chinese yam, 3 to 9 parts of ginseng, 10 to 30 parts of prepared rhizome of rehmannia, 2 to 6 parts of shizandra berry, 5 to 10 parts of earthworm, 1 to 3 parts of leech, 3 to 6 parts of scorpion, 5 to 10 parts of stiff silkworm, 10 to 15 parts of poria cocos, 3 to 10 parts of eupatorium, 3 to 9 parts of pinellia tuber and 2 to 10 parts of liquorice.

2. The traditional Chinese medicine composition for treating diabetes according to claim 1, wherein the raw materials according to parts by weight are preferably: 6 parts of sea horse, 6 parts of sea dragon, 18 parts of astragalus, 12 parts of rhizoma polygonati, 8 parts of epimedium, 23 parts of Chinese yam, 6 parts of ginseng, 20 parts of prepared rhizome of rehmannia, 4 parts of Chinese magnoliavine, 8 parts of earthworm, 2 parts of leech, 5 parts of scorpion, 8 parts of stiff silkworm, 12 parts of poria cocos, 7 parts of eupatorium, 6 parts of pinellia ternate and 6 parts of liquorice.

3. The method for preparing the traditional Chinese medicine composition for treating diabetes according to claim 1 or 2, which is characterized by comprising the following steps:

4. The use of a Chinese medicinal composition for treating diabetes as claimed in claim 1 or 2 in the preparation of a medicament for treating diabetes.