CN115025163B

CN115025163B - Double golden camellia traditional Chinese medicine composition and preparation method and application thereof

Info

Publication number: CN115025163B
Application number: CN202210858905.7A
Authority: CN
Inventors: 王捷; 阳洁; 叶勇; 刘丽敏; 韦凯; 黄秋菊
Original assignee: Guangxi Medical University
Current assignee: Guangxi Medical University
Priority date: 2022-07-21
Filing date: 2022-07-21
Publication date: 2023-06-16
Anticipated expiration: 2042-07-21
Also published as: CN115025163A

Abstract

The invention discloses a Chinese medicinal composition of honeysuckle tea, which is prepared from the following raw materials in parts by weight: 50-100 parts of golden flower tea, 10-20 parts of golden honeysuckle, 10-20 parts of chrysanthemum, 10-20 parts of bitter orange, 10-20 parts of pagodatree flower, 5-15 parts of jasmine, 5-15 parts of kudzuvine root, 20-40 parts of medlar, 20-40 parts of poria cocos, 10-20 parts of astragalus membranaceus, 10-20 parts of radix pseudostellariae, 10-20 parts of codonopsis pilosula, 10-20 parts of angelica sinensis and 5-15 parts of liquorice. The Chinese medicinal composition of the honeysuckle tea is used for preparing medicaments for treating diabetic kidney injury and preparing medicaments for inhibiting kidney swelling and pain.

Description

Double golden camellia traditional Chinese medicine composition and preparation method and application thereof

Technical Field

The invention relates to the technical field of medicines. More specifically, the invention relates to a Chinese medicinal composition of honeysuckle tea, a preparation method thereof and a protective effect on streptozotocin-induced diabetic kidney injury.

Background

With the increasing level of modern life, the incidence of diabetes is also increasing, and in the long-term complications of diabetes, diabetic nephropathy (diabetic nephropathy, DN) has become the second leading cause of chronic renal failure. Various chemical synthesis medicines are generated on the market, but long-term administration of the chemical synthesis medicines has invisible threat to life health, so that continuous research on the traditional Chinese medicine composition is needed, and theoretical basis is provided for subsequent development and utilization.

Disclosure of Invention

The invention provides a double golden camellia traditional Chinese medicine composition and application thereof in medicines for treating diabetes kidney injury induced by streptozotocin, and provides theoretical basis for further research and development and utilization of the double golden camellia traditional Chinese medicine composition in the follow-up.

In order to achieve the purposes and other advantages according to the present invention, there is provided a Chinese herbal medicine composition of honeysuckle tea, comprising the following raw materials by weight: 50-100 parts of golden flower tea, 10-20 parts of golden flower, 20-40 parts of medlar, 20-40 parts of poria cocos, 10-20 parts of astragalus membranaceus, 10-20 parts of chrysanthemum, 10-20 parts of bitter orange, 10-20 parts of sophora flower, 5-15 parts of jasmine, 5-15 parts of kudzuvine root, 10-20 parts of radix pseudostellariae, 10-20 parts of codonopsis pilosula, 10-20 parts of angelica sinensis and 5-15 parts of liquorice.

The invention also provides a preparation method of the Chinese medicinal composition of the honeysuckle tea, which comprises the following steps of: mixing the raw materials, extracting with water for 2-3 times, each time with water 10-20 times of the total weight of the raw materials, decocting for 30-90 min, collecting extractive solution, filtering, concentrating the filtrate to fluid extract with relative density of 1.2-1.6 at 50-60deg.C.

Preferably, the step water and ethanol combined extraction method: the material comprises the following raw materials in parts by weight: mixing the raw materials, extracting with water for 2-3 times, each time with water 10-20 times of the total weight of the raw materials, decocting for 30-90 min, collecting extractive solution, filtering, concentrating the filtrate to obtain fluid extract A with relative density of 1.2-1.6 at 50-60deg.C; extracting the residues with 10 times of 30% ethanol solution under reduced pressure for 2-3 times each time for 30-90 min, collecting extractive solution, filtering, and concentrating the filtrate to obtain fluid extract B with relative density of 1.2-1.6 at 50-60deg.C; wherein, resin adsorption materials are adopted for adsorption, elution, filtration and impurity removal;

or extracting the fluid extract A and the fluid extract B by adding ultrasonic vibration.

Preferably, the preparation method is used for preparing a medicament containing the Chinese herbal composition of the honeysuckle flower tea of claim 2, wherein the medicament contains the Chinese herbal composition of the honeysuckle flower tea and a pharmaceutically acceptable carrier, and the content of the Chinese herbal composition of the honeysuckle flower tea in the medicament is not less than 55 percent.

Preferably, the pharmaceutically acceptable carrier includes diluents, wetting agents and binders, disintegrants, lubricants, cosolvents, flavoring agents, preservatives.

Preferably the medicament is formulated into a pharmaceutically acceptable dosage form.

Preferably, the dosage forms comprise tablets, capsules, syrups, mixture, oral liquid, granules and powder.

Preferably, the medicine administration dosage of the Chinese medicinal composition for preparing the honeysuckle tea is not less than 1.5g/kg.

Preferably, the medicament is for use in protecting streptozotocin-induced diabetic kidney injury.

The invention at least comprises the following beneficial effects:

the invention utilizes the establishment of a streptozotocin-induced diabetic kidney injury mouse model to discuss the protective effect and possible mechanism of the double golden camellia traditional Chinese medicine composition on the diabetic kidney injury, and the action mechanism is to play the role of protecting the kidney function by alleviating oxidative stress injury, improving the SOD activity of the kidney antioxidant enzyme, improving the glomerular filtration rate function, reducing blood sugar, creatinine, urea nitrogen and the like, thereby improving the pathological conditions of kidney tissues.

The golden camellia leaves have the effects of clearing kidney, expelling toxin and reducing blood sugar, but have weaker efficacy, and have adverse effects on patients with low blood images, weak constitution, weak intestines and stomach, poor spleen and stomach, multiple infection and liver hypofunction after long-term administration, and the traditional seven-medicine combination of the golden camellia leaves, the golden honeysuckle flowers, the bitter orange flowers, the jasmine flowers and the kudzuvine roots has certain effects of invigorating stomach, regulating qi and promoting absorption, harmonizing medicine property and bias, and the golden honeysuckle flowers and the chrysanthemum flowers have the effects of clearing lung toxin, clearing liver and purging heart fire, so that the seven-medicine combination of the golden camellia leaves, the golden honeysuckle flowers, the chrysanthemum flowers, the sophora flowers, the bitter orange flowers, the jasmine flowers and the kudzuvine roots has the effect of protecting liver injury. The invention is characterized in that medlar for invigorating qi, moistening lung and nourishing kidney, astragalus membranaceus for tonifying qi, strengthening exterior, and codonopsis pilosula for nourishing body fluid, nourishing blood and producing blood, radix pseudostellariae and angelica are added into the medicinal components with liver protection to condition the organism, strengthen vital qi, facilitate toxin expelling of the organism, and then the functions of promoting urination and strengthening spleen of the poria cocos serving as a monarch drug and the functions of further harmonizing drug property and bias of liquorice are combined to play a role in improving the SOD activity of kidney antioxidant enzyme, improving the glomerular filtration rate, reducing blood sugar, creatinine, urea nitrogen and the like, so that a plurality of mechanical targets are formed to promote organism urination and toxin expelling, the effect of clearing kidney, protecting liver and strengthening spleen is improved, the bias of golden camellia leaves is overcome, and the kidney injury protection effect is excellent.

Also, although golden camellia leaves have weak antibacterial, antiviral and hypoglycemic effects. The invention adds honeysuckle (or lonicera japonica), astragalus and the like, enhances the antibacterial and antiviral capacity, increases the antibacterial spectrum, increases the antiviral spectrum, enhances the kidney infection resistance and kidney injury resistance of organism organs, enhances the lung infection resistance and lung injury resistance, and obviously reduces blood fat and blood sugar, thereby promoting the toxin expelling of diabetic kidney and lung, and improving diabetic nephropathy patients with multiple infections.

The traditional Chinese medicine composition can be prepared into various preparations, is easy to absorb, has high bioavailability, and is convenient for patients meeting different conditions to carry and take.

Additional advantages, objects, and features of the invention will be set forth in part in the description which follows and in part will become apparent to those having ordinary skill in the art upon examination of the following or may be learned from practice of the invention.

Drawings

FIG. 1 is a graph comparing SOD activity of serum of each group of mice;

FIG. 2 is a bar graph comparing the MDA content of serum of mice in each group;

FIG. 3 is a microscopic view (HE, ×100) of pathological changes of kidney tissue of each group of mice, wherein A is a normal control group, B is a model group, C is a positive group, D is a low-dose group of double camellia nitidissima particles, and E is a high-dose group of double camellia nitidissima particles; wherein the figure retains a color view illustration for better viewing;

FIG. 4 is a schematic diagram of FeSO in FRAP ₄ Standard curves of absorbance values for different concentrations of standard solution;

fig. 5 is a preparation process diagram of a nano-medicament of a Chinese medicinal composition of honeysuckle tea.

Detailed Description

The present invention is described in further detail below with reference to the drawings to enable those skilled in the art to practice the invention by referring to the description.

It will be understood that terms, such as "having," "including," and "comprising," as used herein, do not preclude the presence or addition of one or more other elements or groups thereof.

The experimental methods described in the following embodiments are conventional methods unless otherwise indicated, and the reagents and materials are commercially available. The Chinese medicinal composition of the honeysuckle tea is prepared from the following raw materials in parts by weight: 50-100 parts of golden flower tea, 10-20 parts of golden flower, 20-40 parts of medlar, 20-40 parts of poria cocos, 10-20 parts of astragalus membranaceus, 10-20 parts of chrysanthemum, 10-20 parts of bitter orange, 10-20 parts of sophora flower, 5-15 parts of jasmine, 5-15 parts of kudzuvine root, 10-20 parts of radix pseudostellariae, 10-20 parts of codonopsis pilosula, 10-20 parts of angelica sinensis and 5-15 parts of liquorice. The compatibility of the Chinese medicinal composition of the honeysuckle tea is as follows: jinhua tea leaves are good at expelling toxin and clearing kidney, and are monarch drugs; fructus Lycii, fructus Lycii is good for replenishing kidney essence, moistening lung, nourishing liver, improving eyesight, and is a monarch drug; huang Qi is good at tonifying qi and consolidating superficial resistance, expelling toxin and pus, promoting urination and promoting tissue regeneration, and is a monarch drug. Fu Ling is a monarch drug for its action of promoting diuresis and removing dampness, strengthening spleen and calming heart. Honeysuckle flower, flos Lonicerae, which has effects of relieving lung toxicity, strengthening heart, promoting blood circulation and removing blood stasis, is used as ministerial drug; the bitter orange is good in clearing spleen, invigorating stomach and regulating qi and is ministerial drug; the pagodatree flower is good for cooling blood and stopping, and clearing liver and purging intestinal fire, and is used as ministerial drug; chrysanthemum flower, flos Chrysanthemi, is a ministerial drug for clearing heat, removing liver-fire and purging heart fire; radix pseudostellariae is good in replenishing qi to invigorate the spleen, promoting fluid production to moisten the lung and is used as a ministerial drug; the dangshen is good for strengthening the middle warmer, tonifying qi and promoting the production of body fluid, and is used as a ministerial drug; dang Gui is good at replenishing blood and activating blood, regulating menstruation and relieving pain, and relaxing bowel, and is a ministerial drug. Jasmine flower, flos Jasmini sambac, has effects of regulating qi-flowing, relieving pain, and removing dirt and resolving stagnation, and is used as adjuvant drug; the kudzuvine root is rich in kudzuvine root Huang Tongfen and the like, promotes the human body to absorb microelements such as calcium and zinc, nourishes heart vessels, harmonizes the properties and bias of various medicines, and is an adjuvant and guiding drug. Glycyrrhrizae radix is adjuvant drug for regulating property and bias of various drugs.

The preparation of the active ingredients of the Chinese medicinal composition of the honeysuckle tea comprises the following steps of: mixing the raw materials, extracting with water for 2-3 times, each time with water 10-20 times of the total weight of the raw materials, decocting for 30-90 min, collecting extractive solution, filtering, concentrating the filtrate to fluid extract with relative density of 1.2-1.6 at 50-60deg.C. When the active ingredients of the Chinese herbal composition of the invention are prepared into tablets, capsules, syrups, mixture, oral liquid, granules and powder, pharmaceutically acceptable carriers or nano targeting carriers are added into the active ingredients of the Chinese herbal composition of the invention, and the Chinese herbal composition is prepared by a conventional production method.

Pharmaceutically acceptable carriers of the invention include, but are not limited to, the following:

a diluent: starch, dextrin, powdered sugar, inorganic salts, lactose, microcrystalline cellulose, sugar alcohols, and the like.

Wetting agent and binder: purified water, polyethylene glycol, gelatin, ethanol, cellulose derivatives, and the like.

Disintegrating agent: sodium carboxymethyl starch, cellulose derivatives, crospovidone, and the like.

And (3) a lubricant: silica gel micropowder, pulvis Talci, magnesium stearate, polyethylene glycol, etc.

Cosolvent: water, glycerin, liquid paraffin, ethanol, propylene glycol, vegetable oil, etc.

Flavoring agent: monosaccharides, sucrose, fragrances, and the like.

Preservative: benzoic acid, ethyl ester, methyl ester, sorbic acid, propyl ester, and the like.

Nanoscale targeting vectors: polylactic acid-glycolic acid copolymer.

Example 1: preparation of Chinese medicinal composition granule of honeysuckle tea

Taking 50kg of golden camellia leaves, 10kg of honeysuckle, 20kg of medlar, 20kg of poria cocos, 10kg of astragalus, 10kg of chrysanthemum, 10kg of bitter orange, 10kg of pagodatree flower, 5kg of jasmine flowers, 5kg of kudzuvine roots, 10kg of radix pseudostellariae, 10kg of codonopsis pilosula, 10kg of angelica and 5kg of liquorice;

mixing flos Lonicerae tea, flos Lonicerae, fructus Lycii, poria, radix astragali, flos Chrysanthemi, bitter orange, flos Sophorae Immaturus, flos Jasmini sambac, radix Puerariae, radix Pseudostellariae, radix Codonopsis, radix Angelicae sinensis and Glycyrrhrizae radix, adding water 10 times, 10 times and 10 times of total weight of the medicinal materials, extracting for 3 times, decocting, boiling for 30 min each time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.6 at 50deg.C. Grinding corn starch, sodium carboxymethyl starch, dextrin and glucose excipient into powder according to conventional production method, sieving with 1000 mesh sieve, mixing with fluid extract, adding adjuvants such as lactose, gelatin, starch and microcrystalline cellulose, granulating, drying, and grading to obtain granule. Wherein, corn starch in the excipient: sodium carboxymethyl starch: dextrin: the mass ratio of glucose is 1:1:1:1, and lactose is contained in auxiliary materials: gelatin: starch: microcrystalline cellulose with a mass ratio of 1:1:1:1, and the clear paste: excipient: the mass ratio of the auxiliary materials is 7:2:1.

example 2: preparation of Chinese medicinal composition granule of honeysuckle tea

Taking golden camellia leaf 100 kg, honeysuckle 20kg, medlar 40 kg, poria 40 kg, astragalus 20kg, chrysanthemum 20kg, bitter orange 20kg, pagodatree flower 20kg, jasmine 15 kg, kudzuvine root 15 kg, radix pseudostellariae 20kg, codonopsis pilosula 20kg, angelica 20kg and liquorice 15 kg;

mixing flos Lonicerae tea, flos Lonicerae, fructus Lycii, poria, radix astragali, flos Chrysanthemi, bitter orange, flos Sophorae Immaturus, flos Jasmini sambac, radix Puerariae, radix Pseudostellariae, radix Codonopsis, radix Angelicae sinensis and Glycyrrhrizae radix, adding water 10 times, 10 times and 10 times of total weight of the medicinal materials, extracting for 3 times, decocting, boiling for 30 min each time, mixing the extractive solutions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.6 at 50deg.C. Grinding corn starch, sodium carboxymethyl starch, dextrin, glucose and other excipients into powder according to a conventional production method, sieving with a 1000-mesh sieve, mixing with the fluid extract uniformly, adding auxiliary materials such as lactose, gelatin, starch and microcrystalline cellulose, granulating, drying, and granulating to obtain granules. Wherein, corn starch in the excipient: sodium carboxymethyl starch: dextrin: the mass ratio of glucose is 1:1:1:1, and lactose is contained in auxiliary materials: gelatin: starch: microcrystalline cellulose with a mass ratio of 1:1:1:1, and the clear paste: excipient: the mass ratio of the auxiliary materials is 7:2:1.

example 3: nanometer medicinal preparation for preparing Chinese medicinal composition of honeysuckle tea

the preparation process is shown in figure 5, mixing flos Lonicerae tea, flos Lonicerae, fructus Lycii, poria, radix astragali, flos Chrysanthemi, bitter orange, flos Sophorae Immaturus, flos Jasmini sambac, radix Puerariae, radix Pseudostellariae, radix Codonopsis, radix Angelicae sinensis and Glycyrrhrizae radix, adding water with water content 10 times, 10 times and 10 times of total weight of the raw materials, extracting for 3 times, decocting, boiling for 30 min each time, mixing the extractive solutions, filtering with macroporous adsorbent resin, filtering, concentrating the filtrate to obtain fluid extract A with relative density of 1.6 at 50deg.C; extracting the residue with 10 times of 30% ethanol solution under reduced pressure for 3 times, collecting extractive solution, filtering with macroporous adsorbent resin, removing impurities, concentrating the filtrate to obtain fluid extract B with relative density of 1.2-1.6 at 50deg.C. The polylactic acid-glycolic acid copolymer is taken as a carrier material according to the weight ratio of 1: and 1, encapsulating the clear paste A and the clear paste B to obtain the nano medicament. The test package comprises the following specific steps: 10g of each of the fluid extract A and the fluid extract B and 100g of the carrier material polylactic acid-glycolic acid copolymer (PLGA) were weighed and dissolved in 200mL of ethanol together, and the mixture was completely dissolved by ultrasonic wave to obtain an organic phase. Soil temperature 80 at a concentration of 1% was formulated as an aqueous phase. The organic phase was added rapidly to the aqueous phase, sonicated for 30 minutes. Stirring at low speed at room temperature, volatilizing to remove organic solvent, and obtaining PLGA nano medicament for encapsulating the Chinese medicinal composition of the honeysuckle tea. The preparation has high absorptivity, reduced adverse reaction, reduced adverse side effect, and improved main targeting to kidney and glomerulus.

1. Materials and methods

1.1 Material

1.1.1 laboratory apparatus

Instrument name: an electronic balance of ten parts per million, a trinoantinuous blood glucose meter, blood glucose test paper and a continuous spectrum scanning type enzyme-labeled instrument.

1.1.2 Experimental reagents and drugs

Reagent name: streptozotocin (STZ), irbesartan, physiological saline, granules prepared in the embodiment 1 of the invention, SOD kit (WST-1 method), MDA determination kit (TBA method), total antioxidant capacity (FRAP method) and detection kit.

1.1.3 laboratory animals

Male C57BL/6 mice with 6 weeks of age have body mass of 18-20 g and the raising environment is SPF-grade environment.

1.2 Experimental methods

1.2.1 establishment of mouse model for diabetic nephropathy

After one week of adaptive feeding, the mice were subjected to model and experimental groupsMice were all continuously injected with streptozotocin 100 mg.kg intraperitoneally for 2 days ^-1 STZ solution was formulated in 0.1mmol/L citric acid buffer (pH 4.5). The normal control group was intraperitoneally injected with the same dose of pH 4.5 citrate buffer. Random blood glucose was measured on days 6, 7, and 8 after intraperitoneal injection of STZ. If the blood sugar values are higher than 16.7 mmol.L for 3 continuous days ^-1 And if the DN model is successfully established, rejecting the unsuccessful.

1.2.2 Grouping and administration of animals

35 mice with successful modeling were randomly divided into a normal control group, a model group and a positive control group (Irbesartan 0.18 g.kg) ^-1 ) High dose group of honeysuckle particles (5 g.kg) ^-1 ) Double golden flower granule low dose group (1.5 g.kg) ^-1 ). Corresponding medicine for stomach infusion in morning is dissolved in the daily dosage of ml.kg ^-1 Normal control group and model control group were given equal volumes of physiological saline 1 time/d for 5 weeks. All mice were free to ingest water throughout the experiment without insulin and hypoglycemic agents.

1.2.3 sample collection

After 5 weeks of drug intervention, mice were weighed and assayed for fasting blood glucose and anesthetized with 10% chloral hydrate by intraperitoneal injection. Placing the orbit in a centrifuge tube after blood is taken out, standing for 1 h,3500 r.min ^-1 Centrifuging for 10min, separating serum, and preserving at-20deg.C. After blood collection, the cervical vertebra is deblurred to kill the mice, the mice are rapidly dissected, double kidneys are extracted, and one side of the kidneys are fixed in 4% paraformaldehyde solution for pathological detection; the kidney on the other side is placed in a refrigerator at the temperature of minus 80 ℃ for freezing preservation.

1.3 detection index

1.3.1 general State, blood sugar and physical Mass observations

Mice were observed daily for mental state, body shape, hair color, urine volume, etc., and body mass was recorded weekly during the experiment. Mice blood glucose was measured at week five using a trinoantinude glucometer and a blood glucose test paper.

1.3.2 calculation of kidney index

Kidney index was calculated according to the formula relative to kidney mass (KW/BW), KW/bw= [ left side kidney mass (g) +right side kidney mass (g) ]/2 x body mass (g).

1.3.3 serum index detection

Mouse serum is taken, and SOD activity and MDA content are detected strictly according to the instruction manual of the kit.

1.3.4 renal pathology examination

After kidney tissue was removed, 24 h was fixed with 4% paraformaldehyde, paraffin embedded, HE stained and observed under a microscope for histopathological changes.

1.3.5 Determination of the Total antioxidant Capacity of the granules according to the invention by the FRAP method

Under acidic conditions the antioxidant can reduce Fe to blue ²⁺ TPTZ followed by determination of blue Fe at 593nm ²⁺ TPTZ gives the total antioxidant capacity in the sample, determined with reference to the instructions for the total antioxidant capacity test kit (FRAP method).

1.4 statistical method

SPSS 24.0 statistical software is adopted to process data, and average number + -standard deviation is used for metering data

S) represents, the comparison between groups was performed using one-way ANOVA.PA difference of < 0.05 is statistically significant.

2. Results

2.1 general State viewing

Normal mice are active in mental state, smooth in hair, normal in diet and urine, stable in weight change, and free from abnormality in experiments. The number of activities of mice during the model group and the administration group modeling period is obviously reduced, and the hair is loose and rough, and the weight is changed and disturbed.

2.2 effects of the granules of the invention on blood sugar and body Mass

Watch (watch)

Blood glucose change in each group of mice was compared at week 5 (++>

±s）（n=7）

Note that: compared with the normal control groupP<0.01; in contrast to the set of models, ^## P＜0.01。

as can be seen from Table 1, after STZ injection, blood glucose was significantly increased in the model group at week 5 compared with the normal control groupP<0.01 Meeting the diagnostic criteria for diabetes; compared with the positive medicine group, the granule administration group has better curative effect than the positive medicine groupP<0.01). The granule provided by the invention can effectively reduce the blood sugar level of a diabetic nephropathy mouse.

Watch (watch)

Comparison of body weight values of mice of each group with time (++>

±s）（n=7）

Note that: compared with normal control groupP<0.05，**P<0.01; in contrast to the set of models, ^# P<0.05， ^## P＜0.01。

as can be seen from Table 2, after the 4 th week of administration, the model group had significantly reduced body weight as compared with the normal control groupP<0.05). After week 5, the weight of both the positive drug group and the granule administration group of the invention was increased as compared with the model groupP<0.05 The weight loss of the diabetic nephropathy mice is inhibited by the granule administration groupP<0.01 Is beneficial to the normal development of body weight and keeps healthy.

2.3 Effect of the granules of the invention on kidney index

Watch (watch)

Kidney index comparison of mice of each group (++>

±s）（n=7）

recent studies have shown that the kidney index (kidney weight/body mass ratio) can be used as a simple index for evaluating renal hypertrophy. As can be seen from Table 3 and FIG. 1, the kidney index of the model group was significantly increased as compared with that of the normal control groupP<0.01). Compared with the model group, the kidney indexes of the positive drug group and the granule administration group are obviously reduced, wherein the kidney indexes of the positive drug group and the granule administration group are most obvious in the high-dose groupP<0.01 The granule has the effects of inhibiting early renal hypertrophy of the diabetic nephropathy mice and recovering damage of the diabetic nephropathy to the kidneys of the mice to a certain extent.

2.41 determination of SOD Activity and MDA content in serum

Table 4 comparison of serum SOD Activity and MDA content of mice of each group

±s）（n=7）T

as can be seen from Table 4 and FIG. 2, the MDA content in the serum of mice in the model group is significantly increased compared with that in the normal control groupPLess than 0.05), the SOD activity is obviously reducedP< 0.05), indicating that diabetic nephropathy mice are in an oxidative stress state. Compared with the model group, the MDA content of the granule administration group is obviously reduced, and the high dosage group is most obvious' wellP< 0.05); the SOD activity is obviously increased, and the SOD activity is most obvious in low dosage groupP< 0.05), the granules have a certain antioxidant stress effect.

The measurement of creatinine and blood urea nitrogen in serum of 2.42 shows that the serum creatinine and blood urea nitrogen content of mice in the double golden flower granule gastric lavage group of the invention is obviously reduced, and the effect is superior to that of a positive control group.

2.5 pathological changes of renal tissue

Comparing kidney pathological sections of different groups in fig. 3, the normal group mice are found to have clear capsule cavity outline, normal basement membrane, no hyperplasia, increased glomerular gap of the model group kidneys, increased endocytosis and obvious thickening and fusion of the basement membrane. Compared with the model group, the kidney tissue pathological changes of mice in each administration group of the double golden camellia particles are relieved, the kidney glomerular shape is recovered, the number of inner cells is increased, and the basal lamina hyperplasia is relieved.

2.6 The total antioxidant capacity (FRAP method) of the granule of the invention is measured

In FeSO ₄ The standard solution concentration is 0.15-1.5mM on the abscissa, the absorbance A with the wavelength of 593nm at 10min is taken as the ordinate, the measurement result is shown in Table 5, and the standard curve is drawn according to the measurement result and shown in FIG. 4.

TABLE 5 FeSO in FRAP Process ₄ Absorbance values for different concentrations of standard solution

Pipe number	1	2	3	4	5	6
							FeSO ₄ Concentration (mM) of solution	0.15	0.3	0.6	0.9	1.2	1.5
Absorbance A ₅₉₃	0.105	0.144	0.230	0.305	0.410	0.483

From FeSO ₄ The standard curve shows that the linear relation between 0.15 and 0.9mmol/L is good, the regression equation is Y=0.2837X+0.0597 (r=0.9990), and the antioxidation capability of the sample is expressed as FRAP value, namely 1 FRAP unit=1 mmol/L FeSO ₄ I.e. the antioxidant capacity of the sample corresponds to FeSO ₄ mmol/L. The FRAP value of the total antioxidant capacity of the double golden camellia particles is calculated to be 0.632 by measuring the total antioxidant capacity of the double golden camellia particles, which indicates that the double golden camellia particles have a certain antioxidant effect.

Typical cases: wang Mou before administration, 10 years of diabetes history, the male aged 70 years have seen symptoms of mild swelling and pain of kidney, little urine, frequent insomnia, etc. After 5 weeks of administration, the swelling and pain feeling disappears, and under the condition of normal water intake, the daily urination volume reaches about 1500ml, and the sleep is improved.

3. Discussion of the invention

Diabetic nephropathy (diabetic nephropathy, DN) is one of the most important microvascular complications of diabetes, the fundamental causative factor of which is the structural damage of glomeruli caused by hyperglycemia due to disorder of glycometabolism, and pathological changes are mainly manifested by renal hypertrophy, thickening of glomeruli and tubular basement membrane, extracellular matrix accumulation, glomerulosclerosis, etc. Therefore, effective control of renal hypertrophy in diabetic patients and regulation of blood glucose concentration in the body are potential means for protecting glomeruli of diabetic nephropathy.

Recent studies have found that the pathogenesis of diabetic nephropathy is related to tissue damage caused by oxidative stress. Under the hyperglycemic state, the body can cause a large amount of active oxygen release through various ways, so that the oxidative stress level of kidney tissues is increased, a large amount of lipid peroxide is generated, and the wide free radical damage is caused. SOD is an important antioxidant enzyme in organisms, and its serum concentration reflects the antioxidant capacity of the organism. MDA is a lipid peroxidation metabolic end product, and the content of MDA can reflect the damage degree of tissues and is an index for reflecting the peroxidation degree and oxidative stress degree of body lipid.

The experiment shows that the blood sugar and the weight of mice are improved to different degrees under the treatment of each dose of the granule, and the granule is also further beneficial to slowing down the kidney damage of diabetic nephropathy. The granule of the invention has the advantages that the kidney index is obviously reduced and the kidney tissue lesion is obviously improved in each dosage group, wherein the high dosage curative effect is optimal, which indicates that the granule of the invention has a protective effect on the kidney function of diabetic nephropathy mice in early stage. Thus, the granule can effectively improve the metabolism of diabetic nephropathy mice in vivo, effectively improve the renal function of the mice and slow down the kidney damage.

The total antioxidant capacity of the granule disclosed by the invention is measured by an FRAP method, and the granule is found to have a certain antioxidant effect. Experimental results show that the kidney function of the mice in the model group is obviously impaired, and meanwhile, the SOD activity of the kidney antioxidant enzyme is low, and the MDA content of the lipid peroxidation metabolite is increased. After the granule of the invention is used for treatment, SOD activity is enhanced, and MDA content is reduced, which shows that the granule of the invention can relieve oxidative stress injury and has a delay effect on the development of diabetic nephropathy.

Although embodiments of the present invention have been disclosed above, it is not limited to the details and embodiments shown and described, it is well suited to various fields of use for which the invention would be readily apparent to those skilled in the art, and accordingly, the invention is not limited to the specific details and illustrations shown and described herein, without departing from the general concepts defined in the claims and their equivalents.

Claims

1. The Chinese medicinal composition of the honeysuckle tea is characterized by being used for preparing a medicament for treating diabetic kidney injury, and comprises the following raw materials in parts by weight: 50-100 parts of golden flower tea, 10-20 parts of golden honeysuckle, 10-20 parts of chrysanthemum, 10-20 parts of bitter orange, 10-20 parts of pagodatree flower, 5-15 parts of jasmine flower, 5-15 parts of kudzuvine root, 20-40 parts of medlar, 20-40 parts of poria cocos, 10-20 parts of astragalus membranaceus, 10-20 parts of radix pseudostellariae, 10-20 parts of codonopsis pilosula, 10-20 parts of angelica sinensis and 5-15 parts of liquorice.

2. The preparation method of the Chinese medicinal composition of the honeysuckle tea is characterized by comprising the following steps of: the method comprises the following raw materials in parts by weight according to claim 1: mixing the raw materials, extracting with water for 2-3 times, each time with water 10-20 times of the total weight of the raw materials, decocting for 30-90 min, collecting extractive solution, filtering, concentrating the filtrate to fluid extract with relative density of 1.2-1.6 at 50-60deg.C.

3. The preparation method of the Chinese medicinal composition of the honeysuckle tea is characterized by comprising the following steps of water and ethanol combined extraction: the method comprises the following raw materials in parts by weight according to claim 1: mixing the raw materials, extracting with water for 2-3 times, each time with water 10-20 times of the total weight of the raw materials, decocting for 30-90 min, collecting extractive solution, filtering, concentrating filtrate to obtain fluid extract A with relative density of 1.2-1.6 at 50-60deg.C; extracting the residues with 10 times of 30% ethanol solution under reduced pressure for 2-3 times each time for 30-90 min, collecting extractive solution, filtering, and concentrating the filtrate to obtain fluid extract B with relative density of 1.2-1.6 at 50-60deg.C; wherein, resin adsorption materials are adopted for adsorption, elution, filtration and impurity removal;

4. The application of the Chinese herbal medicine composition of the honeysuckle flower is characterized in that the Chinese herbal medicine composition of the honeysuckle flower is used for preparing a medicine containing the Chinese herbal medicine composition of the honeysuckle flower of claim 2 or 3, wherein the medicine contains the Chinese herbal medicine composition of the honeysuckle flower and a pharmaceutically acceptable carrier or a nano targeting carrier, and the content of the Chinese herbal medicine composition of the honeysuckle flower in the medicine is not lower than 55%.

5. The use according to claim 4, wherein the pharmaceutically acceptable carrier comprises diluents, wetting agents and binders, disintegrants, lubricants, co-solvents, flavouring agents, preservatives.

6. The use according to claim 5, wherein the medicament is formulated into a pharmaceutically acceptable dosage form.

7. The use of claim 6, wherein the dosage form comprises a tablet, a capsule, a syrup, a mixture, a granule, a powder.

8. The use according to any one of claims 5 to 7, wherein the pharmaceutical dosage of the chinese herbal composition for preparing honeysuckle flower tea is not less than 1.5g/kg.

9. The use of claim 8, wherein the Chinese herbal composition of camellia nitidissima is used for preparing a medicament for treating diabetic kidney injury.