CN111150794A

CN111150794A - Qi-tonifying manna granules and preparation method and application thereof

Info

Publication number: CN111150794A
Application number: CN202010045179.8A
Authority: CN
Inventors: 刘志龙
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-01-16
Filing date: 2020-01-16
Publication date: 2020-05-15

Abstract

The invention discloses a qi-tonifying and dew-eliminating granule and a preparation method and application thereof. The qi-tonifying manna granules disclosed by the invention can improve clinical symptoms of diabetic patients, effectively reduce FBG levels of the diabetic patients, have no adverse reaction phenomenon to human bodies, have no toxic or side effect, are good medicines for treating diabetes with definite curative effect and high safety, and are worthy of clinical popularization.

Description

Qi-tonifying manna granules and preparation method and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition, in particular to qi-tonifying manna granules and a preparation method and application thereof.

Background

Diabetes Mellitus (DM) is a group of metabolic diseases characterized by the increase of chronic blood glucose (blood sugar for short), and modern medicine considers that the disease is caused by the defects of insulin secretion and/or action, and can cause multiple system damages, so that chronic progressive lesions, hypofunction and failure of tissues and organs such as eyes, kidneys, nerves, hearts, blood vessels and the like can be caused, and acute severe metabolic disorders such as Diabetic Ketoacidosis (DKA) and blood sugar hypertonic states can be caused when the disease is severe. Diabetes is a common, frequently occurring chronic metabolic disease throughout the world. According to the international diabetes union, the number of the worldwide diabetics reaches 3.7 hundred million in 2011, and the number of diabetics is estimated to be close to 5.5 hundred million worldwide after 10 years. Along with the continuous development of the economy of China and the great improvement of the living standard of people in recent years, the prevalence rate of diabetes in China is remarkably increased, and the diabetes brings heavier economic burden to patients and families. A large number of researches and clinical practices prove that the traditional Chinese medicine treatment has good effects on delaying the occurrence and development of diabetes and complications thereof, improving the survival and the life quality of patients and the like.

Diabetes belongs to the category of diabetes in traditional Chinese medicine, and is recorded in the journal of the Ling Shu: "all the five zang organs are weak, so it is good for fever. Physicians in different generations believe that the cause of diabetes is related to deficiency of innate endowment, improper diet, emotional disorders and excessive desire. Understanding of the pathogenesis of diabetes mellitus, doctors of all ages stand up to the theory of yin deficiency and dryness-heat, as in cloud of clinical guideline medical record san xiao: the syndrome of three eliminations, although it has the upper, middle and lower parts, is not more than yin deficiency with yang hyperactivity and dryness with heat. This theory has a profound effect on the future generations, and physicians of all generations have the basic principles of clearing heat, tonifying qi, nourishing yin and promoting the production of body fluid. Diabetes usually involves multiple zang-fu organs, and the pathological changes have a wide scope of influence, and can cause multiple syndromes. A large number of researches show that the qi-yin deficiency syndrome is the most common syndrome type of diabetes, and the treatment method for supplementing qi, nourishing yin, clearing heat and promoting the production of body fluid can not only aim at pathogenesis, but also obviously improve clinical symptoms of patients.

The Qing Dynasty famous physicians Zhang Xi from Zhongyu Ye Tang from Yi Xue Zhong Can xi Lu indicates that the syndrome of diabetes is mostly due to the failure of ascending of original qi and the insufficiency of body fluid, so in the formula, Huang Qi is used as the monarch drug to obtain the action of ascending of original qi, while shan Yao, Zhi mu and Hua powder are used to nourish true yin to raise yang and yin, Ji Nei jin is used to transport spleen and strengthen stomach to transform sugar in the diet as body fluid, Wu Wei Zi is sour in nature to warm and strengthen kidney essence to prevent the sliding and prevent water drinking too quickly.

CN200410078814 discloses a diabetes pill and its formulation, which contains 10 g of trichosanthes root, 20 g of kudzuvine root, 30 g of potentilla discolor, 15 g of dried rehmannia root, 15 g of prepared rhizome of rehmannia, 20 g of dioscorea opposita, 10 g of cornus fruit, 10 g of anemarrhena, large-leaved gentian, 10 g of raspberry, 25 g of codonopsis pilosula, 30 g of raw astragalus root, 5g of amomum fruit and 7.5 g of salvia miltiorrhiza.

Disclosure of Invention

The invention provides qi-tonifying manna granules and a preparation method and application thereof. The qi-tonifying and dew-eliminating granules are an effective prescription for originally treating qi and yin deficiency of diabetes, are prepared by taking the yuye decoction of Zhangxi pure recorded in Zhongzhuizhong xi Lu of medicine as a basis and summarizing the experience of treating diabetes according to the traditional Chinese medicine of the inventor, and are aimed at patients with qi and yin deficiency of diabetes.

On one hand, the invention provides qi-tonifying and sweet dew granules which are characterized by comprising the raw materials of astragalus mongholicus, American ginseng, radix trichosanthis, Chinese yam, cornus officinalis, radix puerariae, potentilla discolor, dark plum fruit, endothelium corneum gigeriae galli, radix ophiopogonis and honey-fried licorice root.

Further, the raw materials of the particles are as follows: 10-20 parts of astragalus membranaceus, 2-8 parts of American ginseng, 10-20 parts of trichosanthes root, 10-20 parts of Chinese yam, 5-15 parts of dogwood fruit, 10-20 parts of kudzu root, 10-20 parts of discolor cinquefoil herb, 5-15 parts of dark plum, 5-15 parts of chicken's gizzard-membrane, 5-15 parts of radix ophiopogonis and 1-5 parts of honey-fried licorice root.

Further, the raw materials of the particles are as follows: 12-18 parts of astragalus membranaceus, 4-6 parts of American ginseng, 12-18 parts of trichosanthes root, 12-18 parts of Chinese yam, 8-12 parts of cornus officinalis, 12-18 parts of kudzu vine root, 12-18 parts of discolor cinquefoil herb, 8-12 parts of dark plum, 8-12 parts of chicken's gizzard-membrane, 8-12 parts of radix ophiopogonis and 2-4 parts of honey-fried licorice root.

Further, the raw materials of the particles are as follows: 15 parts of astragalus membranaceus, 5 parts of American ginseng, 15 parts of trichosanthes root, 15 parts of Chinese yam, 10 parts of cornus pulp, 15 parts of kudzu vine root, 15 parts of discolor cinquefoil herb, 10 parts of dark plum fruit, 10 parts of chicken's gizzard-membrane, 10 parts of radix ophiopogonis and 3 parts of honey-fried licorice root.

In a second aspect, the invention also provides a preparation method of the qi-tonifying manna granules, which is characterized in that the qi-tonifying manna granules adopt a preparation process of a conventional decoction.

Further, the preparation method comprises the following steps:

(1) weighing the raw medicinal materials according to the weight parts, removing impurities, cutting into sections or crushing, adding 5-10 times of water, heating and decocting for 1-5 hours, and filtering to obtain a decoction for later use; adding 2-6 times of water into the residue, heating and decocting for 1-3 hr, and filtering to obtain decoction; adding 1-3 times of water into the residue, decocting for 0.5-1.5 hr, and filtering to obtain decoction;

(2) mixing the three decoctions, and evaporating under reduced pressure to obtain soft extract; then adding 50% -75% ethanol with the volume of 1-3 times of the volume of the mixture, uniformly mixing, standing overnight, filtering and taking supernate for later use; adding 50% -75% ethanol with the volume of 1-3 times of the precipitate for washing, filtering and taking supernatant for later use;

(3) mixing the filtered supernatants, vacuum rotating to remove ethanol to obtain Chinese medicinal extract, drying, and pulverizing to obtain dry extract powder;

(4) adding conventional adjuvants into the dry extract powder, and making into granule.

Further, the step (1) is as follows: weighing the raw medicinal materials according to the weight parts, removing impurities, cutting into sections or crushing, adding 8 times of water, heating and decocting for 3 hours, and filtering to obtain a decoction for later use; adding 4 times of water into the residue, heating and decocting for 2 hr, filtering to obtain decoction; adding 2 times of water into the residue, decocting for 1 hr, and filtering to obtain decoction.

Further, the step (2) is as follows: mixing the three decoctions, and evaporating under reduced pressure to obtain soft extract; then adding 50% ethanol with 2 times volume, mixing uniformly, standing overnight, filtering and taking supernatant for later use; the precipitate was washed with 2 volumes of 75% ethanol, and the supernatant was filtered and collected for further use.

Further, the process for preparing the granules is selected from wet granulation or dry granulation.

Further, the conventional adjuvant is selected from diluent (such as starch, sucrose, dextrin or lactose), disintegrant (such as sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose), and binder (such as hydroxypropyl cellulose, polyvidone, ethyl cellulose or polyethylene glycol).

In a third aspect, the invention also provides application of the qi-tonifying manna granules in preparation of a medicament for treating diabetes.

Further, the medicine is selected from granules, capsules or tablets.

The theoretical basis of the qi-tonifying and blood-nourishing granule is mainly derived from the pure Zhang Xi' diabetes syndrome, which is mostly caused by the failure of original qi to rise. On the understanding of diabetes, Zhang Xi pure cloud: the syndrome of diabetes is marked by the upper, middle and lower parts of the ancient times, which means that the syndrome is all in the middle energizer and extremely in the upper and lower parts. Gong theory of upper-jiao, middle-jiao and lower-jiao all thirsty but polydipsia and diuresis, and the urine has sweet taste. Zhang Xi is considered pure and the syndrome of diabetes is mostly caused by the failure of primordial qi to rise and the failure of spleen to disperse essence. Therefore, the treatment mainly aims at strengthening the spleen, supplementing qi, nourishing yin and promoting the production of body fluid. In addition, the understanding of the pathogenesis of diabetes is based on the theory of yin deficiency and dryness-heat in doctors of all ages, and the basic principle of clearing heat and moistening dryness, nourishing yin and promoting the production of body fluid is used in the treatment. A large number of researches show that the syndrome of deficiency of both qi and yin is the most common syndrome type of diabetes, and the treatment method for supplementing qi, nourishing yin, promoting the production of body fluid and quenching thirst not only aims at pathogenesis, but also can obviously improve clinical symptoms of patients.

Radix astragali is used as principal drug for benefiting qi and promoting fluid production; american ginseng tonifies qi and nourishes yin, clears heat and promotes fluid production; trichosanthis radix is good at clearing lung-heat and stomach-heat, promoting the production of body fluid and quenching thirst; the yam is used as ministerial drugs for tonifying the spleen and reinforcing the kidney, the dogwood is used for tonifying the kidney and securing essence, and astringing yin and body fluid to reduce urination so as to prevent the essence from descending; radix Puerariae helps radix astragali to ascend the spleen and stomach and clear yang, distribute body fluid and quench thirst; herba Potentillae Discoloris and mume fructus have effects of clearing heat, promoting fluid production and quenching thirst; the dwarf lilyturf tuber nourishes yin and moistens dryness, benefits stomach and promotes fluid production; the endothelium corneum Gigeriae Galli can promote spleen function and transport and remove food essence, which are used as adjuvant drugs; prepared licorice root, radix Glycyrrhizae Praeparata, sweet in flavor and neutral in nature, acts as a guiding drug, and acts as a spleen-qi invigorating and middle-warmer-tonifying drug, and as a harmonizing drug for the other drugs. The medicines are matched to bring out the best in each other, and the effects of tonifying qi and yin, clearing heat and promoting the production of body fluid are achieved together.

The invention has the beneficial effects that:

the qi-tonifying manna granules can improve clinical symptoms of diabetics, effectively reduce FBG levels of the diabetics, have no adverse reaction phenomenon to human bodies, have no toxic or side effect, are good medicines for treating the diabetes with definite curative effect and high safety, and are worthy of clinical popularization.

Detailed Description

The technical solutions of the present invention are further illustrated by the following specific embodiments, but it is easily understood by those skilled in the art that the specific material ratios, process conditions and results thereof described in the examples are only for illustrating the present invention, and should not also limit the present invention described in detail in the claims.

By utilizing comprehensive departments integrating clinic, scientific research and teaching and specialized equipment such as a glucometer, a blood ketone instrument, an insulin pump, a dynamic blood glucose monitor, a diabetic foot diagnosis box, a nerve threshold tester, a fundus camera, a neurovascular therapeutic apparatus, a limb air pressure therapeutic apparatus and the like, the inventor takes the Chinese and western medicine combined prevention and treatment of diabetes and acute and chronic complications thereof as the development direction of the prior research field, inherits the clinical experience and academic thought of the famous old traditional Chinese medicine, integrates the modern research method for arrangement and refinement to form an innovative theory, and invents the qi-yin deficiency syndrome treating qi-yin type 2 diabetes mellitus particles.

In order to systematically verify the clinical effectiveness and safety of the qi-tonifying manna granules, a large number of preliminary clinical and experimental studies show that the formula has the effects of benefiting qi, nourishing yin, clearing heat and promoting fluid production, and has the effects of reducing blood sugar, improving clinical symptoms and delaying the development of diabetes and complications thereof. In order to further optimize and improve the clinical curative effect of the qi-tonifying manna granules, comparative clinical research is further carried out in our hospital. The clinical protocol and results were as follows:

example 1 selection of eligible subjects:

1. diagnostic criteria:

1.1 Western diagnostic criteria:

diabetes can be diagnosed by referring to the criteria set by the 2013 american Association for Diabetes (ADA) expert council, if one of the following conditions is met:

① FPG is not less than 7.0mmol/L (126mg/dL), and fasting means no heat intake for at least 8 hr;

②2hPG≥11.1mmol/L(200mg/dL)，

③ OGTT2hPG is more than or equal to 11.1mmol/L (200mg/dL), and the OGTT test adopts sugar water containing 75g of anhydrous glucose proposed by WHO as sugar load;

if one of the above conditions is satisfied, diabetes can be diagnosed.

1.2 Chinese medicine diagnosis standard:

refer to the diagnosis of diabetes in the "diagnosis of disease and symptoms of traditional Chinese medicine and treatment effect evaluation standard" made by the national traditional Chinese medicine administration in 2012.

(1) Thirst, polydipsia, polyphagia, hunger, frequent micturition and emaciation.

(2) At the beginning, the symptom of more than three can be unremarkable. Vertigo, tuberculosis, thoracic obstruction, apoplexy, bromhidrosis, sore and furuncle are often complicated with chronic diseases. Severe patients may have symptoms of polydipsia, headache, vomiting, abdominal pain, shortness of breath, or even coma and syncope.

(3) Check fasting and postprandial blood sugar 2 hours.

On the basis of meeting the diagnosis basis, the Chinese medicinal composition also meets the syndrome diagnosis standard of diabetes with syndrome of deficiency of both qi and yin (refer to the clinical research guidelines of new Chinese medicaments), and has the following symptoms: lassitude, asthenia, dry throat, thirst, anorexia, no speaking desire, feverish sensation in the chest, red tongue, little body fluid, and thready, rapid and weak pulse.

2. Inclusion criteria were:

(1) meets the diagnosis standard of the Western medicine type-2 diabetes,

(2) the traditional Chinese medicine composition is suitable for patients with syndrome differentiation of qi-yin deficiency (diabetes);

(3) infection, acidosis, electrolyte disorder, hypertension, etc. are effectively controlled, and other traditional Chinese medicines or Chinese patent medicines are not taken during the treatment period;

(4) has no other serious medical history, can be used by both men and women, and has the age more than or equal to 18 years.

3. Exclusion criteria:

(1) pregnant or lactating women;

(2) patients with serious primary diseases such as heart, brain, liver and the like, known to be allergic or intolerant to certain drugs in the research;

(3) the inability to collaborate (meaning the inability to coordinate with dietary control or to administer medication as prescribed, which affects the efficacy), and psychiatric patients;

(4) acute metabolic disorder such as diabetic ketoacidosis and the like and complicated infected patients exist in the last month.

Example 2 clinical embodiment

1. The test method comprises the following steps:

the test adopts self control before and after treatment, is included in 105 patients, and adopts 'qi-tonifying manna granules' for treatment.

2. The qi-tonifying manna granules comprise the following medicinal components in part by weight:

15 parts of astragalus membranaceus, 5 parts of American ginseng, 15 parts of trichosanthes root, 15 parts of Chinese yam, 10 parts of cornus pulp, 15 parts of kudzu vine root, 15 parts of discolor cinquefoil herb, 10 parts of dark plum fruit, 10 parts of chicken's gizzard-membrane, 10 parts of radix ophiopogonis and 3 parts of honey-fried licorice root.

(1) Weighing the raw medicinal materials according to the weight parts, removing impurities, cutting into sections or crushing, adding 8 times of water, heating and decocting for 4 hours, and filtering to obtain a decoction for later use; adding 4 times of water into the residue, heating and decocting for 2 hr, filtering to obtain decoction; adding 2 times of water into the residue, heating and decocting for 1 hr, and filtering to obtain decoction;

(2) mixing the three decoctions, and evaporating under reduced pressure to obtain soft extract; then adding 50% ethanol with 2 times volume, mixing uniformly, standing overnight, filtering and taking supernatant for later use; adding 2 times of 75% ethanol into the precipitate for washing, filtering and taking supernatant for later use;

(4) adding starch as filler and 0.5% polyvidone as binder into the dry extract powder, granulating, and packaging into bags to obtain granule.

3. Method of treatment

The qi-tonifying manna granules are added on the basis of unchanged basic treatment, one dose is taken every day, and the granules are taken twice a meal in the morning and at night, and the treatment course is more than or equal to one month.

4. Observation items and indices

4.1 safety observations:

clinically, possible adverse reaction symptoms including systemic adverse reactions and gastrointestinal adverse reactions should be closely observed, and whether stopping taking medicine or taking measures should be recorded.

4.2 observation of curative effect:

(1) major associated symptom score:

the traditional Chinese medicine composition is formulated according to a symptom grading scale of clinical research guiding principles of new traditional Chinese medicines, each symptom is divided into 3 degrees according to the severity degree, 1 point for mild integral, 2 points for moderate integral and 3 points for severe integral. The main observation symptoms were six: listlessness, asthenia, dry throat, thirst, anorexia, no speaking desire, dysphoria with smothery sensation in chest, and degree expressed by scoring method, and observed and recorded for 1 time before and after treatment;

(2) fasting Blood Glucose (FBG): the examination was recorded l times before and after treatment.

4.3 therapeutic efficacy criteria

(1) The effect is shown: the clinical symptoms of the traditional Chinese medicine are obviously improved, and the syndrome integral is reduced by more than or equal to 70 percent; lowering fasting blood glucose to a normal range; or the fasting blood sugar value is reduced by more than 40 percent before treatment.

(2) The method has the following advantages: the clinical symptoms of the traditional Chinese medicine are improved, and the syndrome integral is reduced by more than or equal to 30 percent; the fasting blood glucose value is reduced by more than 20 percent before treatment, but the fasting blood glucose value does not reach the significant effect standard.

(3) The traditional Chinese medicine clinical symptoms are not obviously improved or even aggravated, and the traditional Chinese medicine syndrome integral is reduced by less than 30 percent; the fasting blood sugar is not reduced or the reduction does not reach the effective standard.

4.4 Observation method:

① strict compliance with the protocol, such as the real record case report form;

② integral evaluation of main relevant symptoms before and after treatment;

③ before and after treatment, fasting blood glucose is checked once, and other items are selected.

Example 3 criteria for discontinuation and withdrawal of clinical trials

1. The physician participating in the clinical trial carefully records the cause of the trial discontinuation and the relationship to the clinical trial, including an assessment of the time of discontinuation.

(1) Those who cannot adhere to the treatment;

(2) non-treatment-plan performers;

(3) serious adverse reactions or adverse events occurred during the treatment and subjects should not be taken on the next day;

(4) serious combined disease occurs in the treatment process;

(5) the subject is asked to exit the clinical trial;

(6) other situations occur where the investigator deems it inappropriate to continue participation in the clinical trial.

2. Patients who were withdrawn from the clinical trial during treatment were asked to clearly record the reason and to document the assessment at the time of discontinuation.

(1) The subject proposes to withdraw from the clinical trial;

(2) when the subject does not come to the hospital for a follow-up visit, the subject should ask for a reason by telephone or letter, and investigate the subsequent course.

Example 4 clinical trial record

1. All cases were observed according to the protocol.

2. The medication of the patient is carefully recorded, and the detailed recording and explanation are carried out on all the medications, missed medications, more than half of the medications, and all the medications.

3. Clinical history and symptom score scale were used as original record and were not modified.

4. The various implementation data should be faithfully recorded.

5. Laboratory data for normal ranges should also be faithfully recorded.

Example 5 method for recording and reporting adverse events, adverse reactions

The types, degrees, occurrence times, durations, treatment measures, treatment courses and the like of adverse events and adverse reactions occurring during the test period are recorded in a case report table, and the correlation with the test drugs is evaluated on the basis of comprehensively considering complications and concomitant medication and is recorded in detail by doctors.

In addition, when an adverse event or an adverse reaction is found, the observing physician can determine whether to stop the observation according to the condition of the disease, and follow up the case in which the drug should be stopped due to the adverse event or the adverse reaction, and record the result in detail.

Example 6 evaluation criteria for therapeutic Effect

The judgment standard of the curative effect of diseases and syndromes and the evaluation of the curative effect of main symptoms refer to the clinical research guidelines for treating diabetes by using new traditional Chinese medicines.

Example 7, data management, statistical processing and summary of data:

after the clinical test is finished, all clinical data are collected and input into a computer, a database is established for data management, and SPSS 21.0 software is used for system analysis. And rechecking, recording and statistically analyzing the data according to the clinical test data initial record, the processing standard operation specification and the clinical test statistical analysis standard operation specification.

And (3) data review:

in the clinical test process, a clinical researcher performs data reexamination according to the requirements of a clinical test scheme, and checks whether the items and measurement units which are possibly missed are unified or not. If the error is recorded on the case, a manual examination problem report table is filled in, and the report table is timely returned to the clinical researchers for correction. And finally, the data processing statistical personnel further comprehensively verify and check the integrity and the accuracy of the data before data entry.

Statistical analysis:

before the statistical analysis of the clinical test data, an analyst makes a statistical analysis plan, clearly defines detailed statistical analysis steps, carefully checks and confirms the clinical test data, and performs the statistical analysis. The analysis content is the partial content of performing descriptive statistical analysis, and then performing baseline comparison, curative effect analysis, safety evaluation, elimination and drop case analysis and combined medication analysis of clinical characteristics before treatment.

The efficacy analysis comprises the comparison of the total efficacy among groups, the comparison of the scores of all scales and the like. It should also be noted that the consistency analysis of each individual index of efficacy with the overall efficacy decision.

If there are cases of loss and loss of visit, the reason for loss and loss of visit should be explained and the loss should be calculated. The proportion of the missed cases to the total observed cases, the clinical characteristics of the baseline of all shed, missed cases were analyzed and comparisons between groups were made. The influence on the truth of the clinical trial research conclusion caused by the falling off and the case of missed visit is eliminated as much as possible.

Selection of a statistical method:

based on the nature of the clinical trial data (metrology data and grade data), an appropriate statistical analysis method is selected. The comparison of the metrology data uses a paired t-test or a t-test of independent samples.

Example 8, clinical trial results:

1. index comparison

Compared with the treatment before, the clinical symptom score and the fasting blood glucose of the patient are obviously reduced after the treatment, and compared with the clinical symptom score and the fasting blood glucose, the difference is significant when the P is less than 0.01 (detailed in tables 1 and 2).

TABLE 1 integral change of clinical symptoms before and after treatment

(N＝110)

Note that: p is < 0.01 after treatment compared to before treatment.

TABLE 2 fasting blood sugar change table before and after treatment

(N＝110)

2. Comparison of clinical efficacy

After treatment, 43 cases of patients with significant efficacy accounted for 40.9%, 60 cases of patients with efficacy accounted for 57.3%, and 2 cases of patients with no efficacy accounted for 1.80% (see table 3 for details).

TABLE 3 statistical table of clinical effects

3. Case exit and culling

Patients can return to hospital for further diagnosis without withdrawal during observation.

4. Adverse reaction conditions

No adverse reactions were observed during the treatment.

The qi-tonifying and blood-nourishing granules are prepared by cutting down and reducing the raw materials based on a jade liquid soup from Zhangxi pure records of Yi Xue Zhong Can xi, have the functions of benefiting qi and nourishing yin, clearing heat and promoting the production of body fluid, reducing blood sugar, improving clinical symptoms and delaying the development of diabetes and complications thereof.

The results show that the symptom integral and FBG of the patient are obviously reduced after treatment compared with those before treatment, which indicates that the qi-tonifying manna granules can improve the clinical symptoms of the diabetic patient, effectively reduce the FBG level of the diabetic patient and further improve the clinical symptoms of the patient.

The results of clinical research and observation on diabetic patients prove that the qi-tonifying manna granules have better clinical curative effect; meanwhile, no adverse reaction phenomenon is found in the clinical practice process, and no toxic or side effect is caused; is a good medicine for treating diabetes with definite curative effect and higher safety, and is worthy of clinical popularization.

Claims

1. The qi-tonifying and sweet dew granule is characterized by being prepared from the raw materials of astragalus, American ginseng, trichosanthes root, Chinese yam, dogwood fruit, kudzuvine root, potentilla discolor, dark plum fruit, chicken's gizzard-membrane, dwarf lilyturf tuber and honey-fried licorice root.

2. The qi-replenishing mannose particle of claim 1, wherein the particles are made from the following raw materials: 10-20 parts of astragalus membranaceus, 2-8 parts of American ginseng, 10-20 parts of trichosanthes root, 10-20 parts of Chinese yam, 5-15 parts of dogwood fruit, 10-20 parts of kudzu root, 10-20 parts of discolor cinquefoil herb, 5-15 parts of dark plum, 5-15 parts of chicken's gizzard-membrane, 5-15 parts of radix ophiopogonis and 1-5 parts of honey-fried licorice root.

3. The qi-replenishing mannose particle of claim 1, wherein the particles are made from the following raw materials: 12-18 parts of astragalus membranaceus, 4-6 parts of American ginseng, 12-18 parts of trichosanthes root, 12-18 parts of Chinese yam, 8-12 parts of cornus officinalis, 12-18 parts of kudzu vine root, 12-18 parts of discolor cinquefoil herb, 8-12 parts of dark plum, 8-12 parts of chicken's gizzard-membrane, 8-12 parts of radix ophiopogonis and 2-4 parts of honey-fried licorice root.

4. The qi-replenishing mannose particle of claim 1, wherein the particles are made from the following raw materials: 15 parts of astragalus membranaceus, 5 parts of American ginseng, 15 parts of trichosanthes root, 15 parts of Chinese yam, 10 parts of cornus pulp, 15 parts of kudzu vine root, 15 parts of discolor cinquefoil herb, 10 parts of dark plum fruit, 10 parts of chicken's gizzard-membrane, 10 parts of radix ophiopogonis and 3 parts of honey-fried licorice root.

5. The method for preparing YIQIGANLU granule according to any one of claims 1-4, comprising the steps of:

6. The method for preparing Yiqimannogranule according to claim 5, wherein the step (1) is: weighing the raw medicinal materials according to the weight parts, removing impurities, cutting into sections or crushing, adding 8 times of water, heating and decocting for 3 hours, and filtering to obtain a decoction for later use; adding 4 times of water into the residue, heating and decocting for 2 hr, filtering to obtain decoction; adding 2 times of water into the residue, decocting for 1 hr, and filtering to obtain decoction.

7. The method for preparing Yiqimannogranule according to claim 5, wherein the step (2) is: mixing the three decoctions, and evaporating under reduced pressure to obtain soft extract; then adding 50% ethanol with 2 times volume, mixing uniformly, standing overnight, filtering and taking supernatant for later use; the precipitate was washed with 2 volumes of 75% ethanol, and the supernatant was filtered and collected for further use.

8. The method for preparing Yiqimannon granules according to claim 5, wherein the process for preparing into granules is selected from wet granulation or dry granulation.

9. The method for preparing qi-replenishing mannan granules according to claim 5, wherein the conventional excipients are selected from diluents (preferably starch, sucrose, dextrin or lactose), disintegrants (preferably sodium carboxymethyl starch or low substituted hydroxypropyl cellulose) and binders (preferably hydroxypropyl cellulose, povidone, ethyl cellulose or polyethylene glycol).

10. The use of the Yiqimannogranule according to any one of claims 1 to 4 for the preparation of a medicament for the treatment of diabetes.