CN113813335B

CN113813335B - Traditional Chinese medicine composition for treating radiation injury and preparation method thereof

Info

Publication number: CN113813335B
Application number: CN202111149294.0A
Authority: CN
Inventors: 曲政海; 于壮; 张业玲; 关永霞; 李蕾
Original assignee: Affiliated Hospital of University of Qingdao
Current assignee: Affiliated Hospital of University of Qingdao
Priority date: 2021-09-29
Filing date: 2021-09-29
Publication date: 2022-08-19
Anticipated expiration: 2041-09-29
Also published as: CN113813335A

Abstract

The invention relates to a traditional Chinese medicine composition for treating radiation injury and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from 15 raw medicinal materials of radix rehmanniae, radix ophiopogonis, radix scrophulariae, codonopsis pilosula, scutellaria baicalensis, thunberg fritillary bulb, blackberry lily, pinellia ternate, radix paeoniae alba, salvia miltiorrhiza, moutan bark, mangnolia officinalis, poria cocos, mint and coptis chinensis. The composition has mild medicine property, precise and appropriate compatibility and synergistic effect, has the functions of clearing away heat and toxic material, promoting blood circulation to remove blood stasis, nourishing lung and kidney, and replenishing qi to invigorate the spleen, and is suitable for diseases such as dry mouth, pharyngalgia, toothache, dry cough, chronic rhinitis and the like caused by acute and chronic radiation injury and radiotherapy. Pharmacodynamic tests show that the composition has exact therapeutic effect on radioactive lung injury and radioactive intestinal injury.

Description

Traditional Chinese medicine composition for treating radiation injury and preparation method thereof

Technical Field

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

Background

Radiation Therapy (RT) is a local treatment method for treating tumors by using radiation, about 70% of cancer patients need radiation therapy in the process of treating cancer, and about 40% of cancers can be cured radically by using radiation therapy, so that radiation therapy has become one of the main means for treating various malignant tumors. Although radiation therapy can kill tumor cells, it inevitably causes damage to normal tissues, destroys the immune function of the body, and produces a series of radiation injuries. The clinical manifestations of patients with radiation injury are characterized by the damage of multiple systems and multiple organs, especially the symptoms of nervous system, blood system, endocrine system, cardiovascular system and digestive system, and mainly appear as follows: red swelling and pain of skin, mental fatigue, hypodynamia, dysphoria, dry mouth, thirst, aphtha of the mouth and tongue, dysphagia, burning pain, cough, little phlegm, loose stool, frequent micturition, urgent micturition, and tongue with purple and petechia. With the increase of the radiation dose or the continuous progress of the radiation therapy, the radiation injury gradually worsens, if the intervention treatment is not performed in time, the treatment effect is not obvious, and the condition of the patient is aggravated, so that the life quality of the patient is seriously influenced. Therefore, radiation damage is one of the main bottlenecks limiting the increase of the tumor targeted irradiation dose and restricting the effect of radiotherapy.

The pathophysiological basis of radiation injury is inflammatory reaction, and tissue and organ injury of a radiotherapy target area caused by radiation-induced inflammation. At present, systemic treatment is lacked for radioactive injuries, a clinically common treatment scheme is single, and a mode of treating by adopting a large dose of antibiotics and glucocorticoid is mostly adopted. Through the treatment of antioxidant injury, the inflammatory edema caused by radioactive injury is relieved, and the injury of free radicals to tissues is eliminated, and amino acids required by tissue repair are supplemented, so that the repair of the damaged tissues is accelerated. However, the existing treatment methods have long treatment period, strong drug dependence, large side effect and unsatisfactory curative effect, so that the development of drugs capable of avoiding or reducing radiation injury becomes a key point of research.

From the point of traditional Chinese medicine, the radioactive rays have fire, heat and toxin, the heat energy is transformed into fire, and the fire and the heat can burn and consume the yin essence of the human body to cause diseases. According to the clinical manifestations and pathogenic characteristics of radiation injury, the etiology of radiation injury can be classified as "fire-toxin". The pathogenic fire-toxin attacks the human body, burns the skin, damages blood collaterals and internally attacks viscera; fire is pathogenic yang, which causes yin fluid, body fluid deficiency, and qi and blood deficiency; blood vessels are damaged and overflow outside the vessels to block in the vessels, forming blood stasis and blood stasis-heat binding. Therefore, the traditional Chinese medicine considers that the radiation injury is caused by excessive toxic heat, yin impairment and qi consumption, qi deficiency and blood deficiency, spleen and stomach disharmony and liver and kidney deficiency, and the treatment principle of the radiation injury is mainly to clear away heat and toxic materials, promote the production of body fluid and replenish fluid, replenish qi and enrich blood, cool blood and remove blood stasis, strengthen spleen and stomach, nourish liver and kidney, and strengthen body resistance and consolidate constitution.

Disclosure of Invention

The invention aims to provide a Chinese medicinal composition for treating radiation injury, namely 'Qingdi mixture', which is prepared from 15 Chinese medicinal materials of radix rehmanniae recen, radix ophiopogonis, radix scrophulariae, codonopsis pilosula, scutellaria baicalensis, thunberg fritillary bulb, blackberry lily, pinellia ternate (roasted), radix paeoniae alba, salvia miltiorrhiza, moutan bark, magnolia officinalis, poria cocos, mint and coptis chinensis.

The invention relates to a traditional Chinese medicine composition for treating radiation injury, which is prepared from the following traditional Chinese medicine components:

40-80 parts of radix rehmanniae; 35-60 parts of radix ophiopogonis; 20-60 parts of radix scrophulariae;

20-60 parts of codonopsis pilosula; 20-60 parts of scutellaria baicalensis; 20-60 parts of thunberg fritillary bulb;

20-60 parts of blackberrykiky rhizome; 20-60 parts of pinellia ternata; 20-60 parts of white peony root;

15-45 parts of salvia miltiorrhiza; 20-60 parts of moutan bark; 20-45 parts of magnolia officinalis;

20-60 parts of poria cocos; 10-30 parts of mint; 10-30 parts of coptis chinensis.

The traditional Chinese medicine composition comprises the following raw materials in a preferable weight ratio:

55-65 parts of dried rehmannia root; 42-54 parts of radix ophiopogonis; 35-45 parts of figwort;

35-45 parts of codonopsis pilosula; 35-45 parts of scutellaria baicalensis; 35-45 parts of thunberg fritillary bulb;

35-45 parts of blackberrykiky rhizome; 35-45 parts of pinellia ternata; 35-45 parts of white peony root;

25-35 parts of salvia miltiorrhiza; 35-45 parts of moutan bark; 26-38 parts of magnolia officinalis;

35-45 parts of poria cocos; 15-25 parts of mint; 15-25 parts of coptis chinensis.

The optimal weight ratio of the raw materials of the traditional Chinese medicine composition is as follows:

60 parts of dried rehmannia root; 48 parts of radix ophiopogonis; 40 parts of radix scrophulariae;

40 parts of codonopsis pilosula; 40 parts of scutellaria baicalensis; 40 parts of thunberg fritillary bulb;

40 parts of blackberrykiky rhizome; 40 parts of pinellia ternata; 40 parts of white peony root;

30 parts of salvia miltiorrhiza; 40 parts of moutan bark; 32 parts of magnolia officinalis;

40 parts of poria cocos; 20 parts of mint; 20 parts of coptis chinensis.

Preferably, the pinellia ternate is processed pinellia ternate.

In the formula of the Qingdi mixture, the dried rehmannia root has sweet taste and cold property, enters heart, liver and kidney channels, has the effects of cooling, stopping bleeding, nourishing yin and promoting the production of body fluid and is good at nourishing kidney yin, and the formula of the Qingdi mixture is 'blood cooling, blood enriching, kidney tonifying and water true yin deficiency' stated in the prescription of the medicine legal system; li Shizhen evaluates Sheng Di Huang in Ben Cao gang mu: the whooping face of the garment is like peach blossom, and the body is light and not old in three years. Ophiopogon japonicus is sweet in taste, slightly bitter in nature and slightly cold in nature, has the effects of nourishing yin, promoting the production of body fluid, moistening lung and clearing heart, and is good at nourishing lung yin, and is recorded in Shen nong Ben Cao Jing, wherein the symptoms of heart and abdomen stagnation, impairment in middle energizer , exhaustion of stomach meridian, weight reduction and shortness of breath, and long-term taking, light weight, no aging and no hunger. Sheng Di Huang and Mai Dong are the monarch drugs with synergistic effect to enhance the action of nourishing yin and promoting the production of body fluid.

Scrophularia ningpoensis, radix scrophulariae is sweet, bitter, salty, and slightly cold in nature, enters lung, stomach, and kidney meridians, has the effects of clearing heat and cooling blood, nourishing yin to lessen fire, and removing toxicity and dissipating nodulation, and is recorded in the book from materia medica justice that the property of radix scrophulariae from essence to yin, which is specialized in heat diseases, and bitter in flavor, which can descend, so it can be indicated for the syndrome of visceral heat accumulation. Scutellaria baicalensis is bitter in taste and cold in nature, enters lung, gallbladder, spleen, large intestine and small intestine channels, has the functions of clearing heat and drying dampness, and purging intense heat and removing toxicity, and is recorded in compendium of materia Medica in the treatment of wind-heat damp-heat headache, dolphin heat pain, fire cough, flaccidity of lung, fishy smell of throat and blood loss. Zhejiang fritillaria bulb is bitter in taste and cold in nature, enters lung and heart channels, clears heat, reduces phlegm, relieves cough, detoxifies, eliminates stagnation and eliminates carbuncle, and is listed as one of Zhejiang eight flavors. The blackberry lily is bitter in taste and cold in nature, enters lung channel, and has the effects of clearing away heat and toxic materials, eliminating phlegm and relieving sore throat, and dissipating blood and diminishing swelling. Coptis root, rhizoma Coptidis, being bitter in taste and cold in nature, enters heart, spleen, stomach, liver, gallbladder and large intestine meridians, and also has the actions of clearing heat and drying dampness, purging fire and removing toxicity. The 5 medicines are mutually reinforced to play the role of clearing heat and detoxicating, and the assistant monarch medicine can better play the role of nourishing yin and promoting the production of body fluid and is used as a ministerial medicine.

Radix Codonopsis is sweet in taste and neutral in nature, has effects of invigorating spleen and lung, nourishing blood and promoting fluid production, and can be used for treating spleen and stomach weakness, deficiency of both qi and blood, listlessness, asthenia, diarrhea, rectocele, etc. Poria has sweet and light taste and neutral nature, has effects of benefiting dampness, promoting diuresis, invigorating spleen and calming heart, and can be used together with radix Codonopsis to exert effects of invigorating spleen and replenishing qi, and can be used as adjuvant drug for treating spleen obstruction due to nourishing and greasiness of the above materials.

Salvia miltiorrhiza, bitter in taste and slightly cold in nature, has the functions of activating blood and dissolving stasis, stimulating the menstrual flow and relieving pain, clearing heart and relieving restlessness, cooling blood and eliminating carbuncle by entering the heart and liver meridians, and is recorded in Ben Cao gang mu for treating hernia pain by activating blood and clearing heart fire. Cortex moutan is bitter in taste and slightly cold in pungent and warm properties, and has the effects of clearing heat, cooling blood, promoting blood circulation and removing blood stasis after entering heart, liver and kidney meridians, and the records of Shen nong's herbal are recorded in the records of the main treatment of cold and heat, stroke, convulsive epilepsy, pathogenic qi, hard mass, blood stasis and retention of intestines and stomach, five internal organs and carbuncle and sore. The mint is pungent in flavor and cool in nature, enters lung and liver channels, and has the effects of dispelling wind and heat, clearing head and eyes, relieving sore throat, promoting eruption, soothing liver and promoting qi circulation. The 3 medicines are combined to be used as guiding medicines for promoting blood circulation to remove blood stasis, expanding blood vessels, improving circulation and promoting absorption.

The above 15 traditional Chinese medicines such as radix rehmanniae, radix ophiopogonis and the like are combined according to the compatibility theory of monarch, minister, assistant and guide and drug pair in the traditional Chinese medicine, the medicines are combined and have synergistic effect, the effects of clearing heat and removing toxicity, promoting blood circulation and removing blood stasis, nourishing lung and kidney and tonifying qi and spleen are achieved, both the symptoms and root causes are treated, the acute and chronic injury caused by radioactive rays is relieved, the radiotherapy sensitivity is increased to a certain extent, the local control rate is improved, and each good effect is achieved for treating the radioactive injury caused by fire toxin invasion.

The invention also aims to provide a preparation method of an oral preparation containing the traditional Chinese medicine composition, wherein the traditional Chinese medicine oral preparation is one of granules, oral liquid, capsules and tablets.

Preferably, the preparation method of the oral liquid comprises the following steps:

A. weighing 15 raw material medicines of radix rehmanniae, radix ophiopogonis, radix scrophulariae, codonopsis pilosula, scutellaria baicalensis, thunberg fritillary bulb, blackberry lily, pinellia ternate, white paeony root, salvia miltiorrhiza, moutan bark, mangnolia officinalis, poria cocos, mint and coptis chinensis, cleaning and slicing the radix rehmanniae, the codonopsis pilosula, the thunberg fritillary bulb, the salvia miltiorrhiza and the poria cocos, cleaning and slicing the radix scrophulariae, the scutellaria baicalensis, the blackberry lily, the radix paeoniae alba, the moutan bark and the coptis chinensis, cleaning and slicing the mangnolia officinalis, cutting the mangnolia officinalis into shreds, cleaning and slicing the mint, cleaning and processing the pinellia ternate into processed pinellia ternate, cleaning and selecting the radix ophiopogonis, flattening and drying the processed pinellia ternate for later use;

B. decocting the above 15 materials with 6-10 times of water for 2-3 times, each for 1-3 hr, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.25 at 50-60 deg.C, adding ethanol to ethanol content of 50-70%, standing for cold precipitation for 12-24 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.05-1.20 at 50-60 deg.C, adding purified water, stirring, standing, and filtering to obtain filtrate;

C. and C, adding 1.5-2.8% of activated carbon into the filtrate obtained in the step B, heating, filtering to remove carbon, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the product.

Preferably, step B is decocted with 8 times of water for 2 times, 2 hours for the first time and 1 hour for the second time.

Preferably, step B is left to cool for 12 hours.

In order to verify the efficacy of the traditional Chinese medicine composition in treating radiation injury, the inventor carries out pharmacodynamic test research. It should be noted that the selected drugs for pharmacodynamic test and research are representative formulations and the drugs obtained by the preparation method of the present invention. The other formulations and methods of preparation of the present invention are not intended to be exhaustive, and the tests and results thereof are not intended to be limiting.

Test example 1 Effect on rat Radioactive Lung injury model

1 materials of the experiment

1.1 experimental animals 60 male healthy SPF grade SD rats of 6 weeks old, body weight (200 ± 20) g, provided by runan pharmaceutical group, inc, license number: SYXK (lu) 20180008. Animals are raised in cages in a special laboratory, and are raised adaptively for 1 week before the experiment, the room temperature is 20-25 ℃, the relative humidity is 40% -60%, the animals are naturally illuminated, and the animals can eat and drink water freely.

1.2 Instrument, reagents and drug AG285 model electronic analytical balance (Mettler-Toledo, Switzerland), Thermo Scientific Medifuge Mini desk centrifuge (Sammerfoil, USA), Varian 23EX medical Linear Accelerator (supplied by southern Hospital radiotherapist); ELISA kit (MDA, SOD, TNF-alpha, TGF-beta 1) (Sigma, USA), chloral hydrate (Qingdaoyuan seaweed, Inc.); the test drug was an oral liquid sample prepared according to the formulation and preparation method of example 3; the positive control drug is dexamethasone tablet (specification: 0.75 mg/tablet, batch number: 191203), Guangdong south China pharmaceutical industry group Co., Ltd.

2 method of experiment

2.1 groups of healthy SD rats are modeled and randomly divided into 6 groups, namely a normal control group, a model control group, a dexamethasone positive control group (called a 'positive control group' for short), a test high-dose group, a test medium-dose group and a test low-dose group, wherein each group comprises 10 rats. Except for a normal control group, the rest groups are anesthetized by intraperitoneal injection by using 10% chloral hydrate according to the dose of 0.4g/kg body mass, the anesthetized rats are placed in a self-made mouse cage, the neck and the tail of each rat are fixed to enable the rat to lie on the back on a self-made fixed frame, the chest is fully exposed in the radiation field, a lead plate with the thickness of about 5cm is used for shielding the parts except the lung, a linear accelerator is used for carrying out whole chest single irradiation by using 6MV-X rays, the single irradiation dose is 20Gy, the absorption dose rate is 300cGy/min, the source skin distance is set to be 1m, the size of the irradiation field is determined to be 4.5cm multiplied by 4cm according to the size of the rat and the possibility of considering related errors, and the size of the irradiation field is vertical single irradiation. Rats in the normal control group were anesthetized and then were mock-irradiated.

2.2 after 2 hours of radiation treatment, each test group was administered by gavage, and dose was converted according to the dose conversion factor of different animals in the appendix of the guidelines for clinical study on New drug, wherein the positive control group was administered dexamethasone 1mg

The test drugs are sequentially administrated in a test high dose group, a test middle dose group and a test low dose group according to the equivalent dose of crude drugs of 7.125g/kg, 14.25g/kg and 28.50g/kg for 0.5 time, 1 time and 2 times, and normal control group and model control group are administrated by normal saline with equal volume and are administrated 1 time a day for 8 weeks.

2.3 detection index and method

(1) During the trial, the rats in each group were observed for modeling and for behavioral changes after treatment with drug.

(2) After the rat is subjected to the last administration, 10% chloral hydrate is subjected to intraperitoneal injection anesthesia, 5mL of rat blood is left through the heart and kept stand for 30min, the rat blood is centrifuged for 20min at 4 ℃ at 3000r/min, supernate is taken, and the contents of MDA, TNF-alpha and TGF-beta 1 and SOD activity in the rat blood serum are detected by adopting an ELISA method.

2.4 statistical methods SPSS19.0 statistical software was used for analytical processing. Experimental data by mean ± standard deviation (

) "Format representation, comparison of differences between groups by one-way analysis of variance toP< 0.05 indicated that the difference was statistically significant.

3 results of the experiment

(1) After irradiation, the rats were observed daily for 8 weeks for mental state, appearance, diet, drinking water, and excretion. The normal control group rats have good mental status, bright and smooth back hair, normal diet, drinking water, excrement and urine excretion status; the rest 5 model groups of rats continuously suffered from symptoms of listlessness, slow movement, thin hair loss on the back, less diet and drinking water, and reduced excretion of urine and feces after irradiation. After 2 weeks of administration, the hair and mental status of the rats in the dexamethasone positive control group and each test group are slightly improved compared with the model group, but the activity is slow, and the diet and water intake are still less; as the treatment time is prolonged, the symptoms gradually alleviate; after 8 weeks of administration, the hair loss on the back of rats in the dexamethasone positive control group and each test group is gradually improved, the skin is restored, the food intake and the activity are increased compared with the former rats, and the hair loss is obviously lighter than that in the model control group.

(2) Compared with the normal control group, the contents of MDA, TNF-alpha and TGF-beta 1 in the serum of the rat of the model control group are obviously increased, the SOD activity level is obviously reduced, and the difference has statistical significance ((P< 0.05), which indicates the success of molding in this experiment. Compared with a model control group, the positive control group and the experimental high, medium and low dose groups have the statistical significance that the contents of MDA, TNF-alpha and TGF-beta 1 in the rat serum are obviously reduced, the SOD activity level is obviously improved, and the difference hasP< 0.05); compared with a positive control group, the contents of MDA, TNF-alpha and TGF-beta 1 in the serum of rats in the experimental high-dose group and the experimental medium-dose group are obviously reduced, and the SOD activity level is obviously improvedHigh, the difference is statistically significant: (P< 0.05). The results show that the Qingdi mixture can reduce the MDA content in serum, enhance the SOD activity and enhance the oxidation resistance of lung tissues, and simultaneously reduce the contents of cytokines such as TNF-alpha, TGF-beta 1 and the like in the serum to relieve the radioactive pulmonary alveolus inflammatory reaction and inhibit the pulmonary fibrosis process, thereby playing a definite treatment effect on the radioactive lung injury. The results are shown in Table 1.

TABLE 1 Effect of test drugs on the rat Radioactive Lung injury model

Note: compared with the normal control group:P< 0.05 indicated with "+"; compared with the model control group:P< 0.05 use " ^▲ "means; compared with the positive control group, the compound preparation,P< 0.05 indicated by "#".

Test example 2 Effect on rat Radioactive intestinal injury model

1 test materials

1.1 Experimental animals were the same as in Experimental example 1.

1.2 Instrument, reagents and drug AG285 model electronic analytical balance (Mettler-Toledo, Switzerland), Thermo Scientific Mediffue mini-bench centrifuge (Sammerfoil, USA), Olympus optical microscope (Olympus, Inc., Japan), Varian 23EX medical linear accelerator (supplied by southern Hospital's radiotherapist); ELISA kits (NO, MDA, SOD) (Sigma, usa), chloral hydrate (Qingdao Yulong seaweed, ltd); the test drug was an oral liquid sample prepared according to the formulation and preparation method of example 3; the positive control drug was norfloxacin tablets (specification: 0.1 g/tablet, batch No. 191101), Jilin Hengjin pharmaceutical industry GmbH.

2 method of experiment

2.1 groups of healthy SD rats were obtained by modeling, and were randomly divided into 6 groups, i.e., a normal control group, a model control group, a norfloxacin positive control group (referred to as "positive control group"), a test high dose group, a test medium dose group, and a test low dose group, each of which contained 10 rats. Except for a normal control group, the rest groups are subjected to intraperitoneal injection of anesthetized rats by 10% chloral hydrate according to the dose of 3.5ml/kg, the anesthetized rats are fixed on a special organic glass plate, the abdomen is fully exposed in a radiation field, a lead plate with the thickness of about 5cm is used for shielding the part except the abdomen, a linear accelerator is used for carrying out single irradiation on the abdomen by using 6MV-X rays, the single irradiation dose is 10Gy, the absorption dose rate is 200cGy/min, the source skin distance is set to be 1m, the size of the irradiation field is determined to be 8.5cm multiplied by 5.5cm according to the size of the rats and the possibility of considering related errors, and the vertical single irradiation is carried out. Rats in the normal control group were anesthetized and then were mock-irradiated.

2.2 after 2 hours of radiation treatment, each test group was administered by gavage, and the dose was converted according to the dose conversion factor of different animals in the appendix of the guidelines for clinical study on New drug of traditional Chinese medicine, wherein the positive control group was administered norfloxacin 0.1 g/ion

And kg, the tested medicines are respectively filled into the test high-dose group, the test middle-dose group and the test low-dose group in sequence according to crude drugs, wherein the crude drugs are respectively 28.50g/kg (2 times of human dosage), 14.25g/kg (1 time of human dosage) and 7.125g/kg (1/2 times of human dosage), equivalent to 0.5 time of human equivalent dosage for 2 times and 1 time of human, and the normal control group and the model control group are filled with equal-volume normal saline, are respectively filled for 1 time every day and are continuously filled for 7 days.

2.3 detection index and method

(1) During the test period, the general conditions of body weight, hair, activity, etc. of each group of rats after modeling and administration of treatment were observed.

(2) On the 8 th day of experiment, the rats of each experimental group are sacrificed after fasting for 8 hours, the terminal ileum with the length of 5cm is taken out after being dissected along the abdominal midline for scraping off the mucous membrane, the rats are washed by precooled normal saline, filter paper is sucked dry and weighed, the rats are placed in an ice water bath, the rats are rapidly sheared into pieces by ophthalmic scissors and ground into 10 percent homogenate, the rats are centrifuged at 4000r/min for 10min, 2ml of supernatant is taken and stored in a refrigerator at 4 ℃ for standby application, and the NO, the MDA content and the SOD activity are respectively determined according to NO, SOD and MDA kit instructions; another 2cm long terminal ileum was fixed with 10% formaldehyde and the average villus height was measured under a light microscope.

2.4 statistical methods Using SPSS19.0 statistical software analysisAnd (6) processing. Experimental data by mean ± standard deviation (

3 results of the experiment

(1) The body mass and state of each group of rats after 1 day of irradiation have no obvious change compared with those before irradiation. On the 2 nd day after irradiation, compared with the normal control group, the model control group has bad diet, slight diarrhea and reduced body constitution; compared with the model control group, the positive control group and the test high, medium and low dose groups have less diarrhea. On the 3 rd day after irradiation, the rats in the model control group showed listlessness, dullness of fur, severe diarrhea, and decreased body mass, compared with the normal control group; compared with the model control group, the positive control group and the experimental high, medium and low dose groups have lighter diarrhea, wherein the experimental high dose group has the lightest diarrhea. On day 7 after irradiation, the positive control group and the experimental high, medium and low dose groups showed good condition, smooth skin and hair, and recovery of body mass, compared with the model control group.

(2) Compared with the normal control group, the average villus height and SOD activity of the small intestine of the rat in the model control group are obviously reduced, the NO concentration and the MDA content are obviously increased, and the difference has statistical significance: (PLess than 0.05), which indicates that the molding of the experiment is successful. Compared with the model control group, the average villus height and SOD activity of the small intestine of rats in the positive control group and the experimental high, medium and low dose groups are obviously increased, the NO concentration and MDA content are obviously reduced, and the difference has statistical significance: (P< 0.05); compared with a positive control group, the average villus height and SOD activity of the small intestine of rats in a high-dose test group and a medium-dose test group are obviously improved, the NO concentration and the MDA content are obviously reduced, and the difference has statistical significance: (P< 0.05). The results show that the Qingdi mixture has the functions of protecting the intestinal injury induced by radiation and promoting the regeneration of mucous membrane, can inhibit the generation of a large amount of NO, simultaneously can reduce the MDA content in serum, enhance the SOD activity and enhance the oxidation resistance of tissues, thereby playing a role in protecting the intestinal injury induced by radiationThe treatment effect is definite, and a development thought is provided for the subsequent radioactive injury treatment design. The results are shown in Table 2.

TABLE 2 Effect of test drugs on the model of Radioactive bowel injury in rats

Detailed Description

The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.

EXAMPLE 1 preparation of oral liquid

Dried rehmannia root, radix Ophiopogonis 40g, radix scrophulariae 35g, radix scrophulariae 20g

Codonopsis pilosula 60g scutellaria root 60g thunberg fritillary bulb 60g

Blackberry lily 20g pinellia tuber 20g white peony root 20g

Salvia miltiorrhiza 45g and moutan bark 60g and magnolia officinalis 45g

Poria 20g peppermint 10g coptis 10g

A. Weighing 15 raw material medicines of radix rehmanniae, radix ophiopogonis, radix scrophulariae, radix codonopsis, scutellaria baicalensis, thunberg fritillary bulb, blackberry lily, pinellia ternate, white paeony root, red-rooted salvia root, tree peony bark, mangnolia officinalis, poria cocos, mint and coptis chinensis, cleaning and slicing the radix rehmanniae, the radix codonopsis, the thunberg fritillary bulb, the red-rooted salvia root and the poria cocos, cleaning and slicing the radix scrophulariae, the scutellaria baicalensis, the blackberry lily, the white paeony root, the tree peony bark and the coptis chinensis, cleaning and slicing the mangnolia officinalis, cleaning and slicing the mint, cleaning and processing the pinellia ternate into processed pinellia ternate, cleaning and sorting the radix ophiopogonis, flattening and drying for later use;

B. decocting the 15 medicinal decoction pieces with 9 times of water for 2 times, the first time for 3 hr, the second time for 2 hr, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.18 at 50-60 deg.C, adding ethanol to make ethanol content reach 60%, standing, cold precipitating for 24 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.05 at 50-60 deg.C, adding purified water, stirring, standing, and filtering to obtain filtrate;

C. and C, adding activated carbon accounting for 1.5% of the filtrate in the filtrate B, heating, filtering to remove carbon, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the finished product.

EXAMPLE 2 preparation of granules

Dried rehmannia root, radix rehmanniae 65g, ophiopogon root, figwort 45g

Codonopsis pilosula 35g scutellaria root 35g thunberg fritillary bulb 35g

Blackberry lily 45g pinellia 45g white peony root 45g

25g of salvia miltiorrhiza, 35g of moutan bark, 26g of magnolia officinalis

Poria cocos, wolf berry, herba Menthae, Coptis chinensis, Poria cocos, herba Menthae and Coptis chinensis, 25g

B. decocting the 15 medicinal decoction pieces with 2 times of water for 2 times, 2 hr for the first time and 2 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.16 at 50-60 deg.C, adding ethanol to make ethanol content reach 70%, standing, cold precipitating for 12 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.17 at 50-60 deg.C, and keeping;

C. and (C) taking the extract in the step (B), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding 0.25% of aspartame and dextrin, mixing uniformly, adding 90% of ethanol to prepare a soft material, granulating, drying and finishing to obtain the finished product.

EXAMPLE 3 preparation of oral liquid

Dried rehmannia root, radix rehmanniae 60g, ophiopogon root, figwort root, radix scrophulariae 40g

Codonopsis pilosula 40g, scutellaria root 40g, thunberg fritillary bulb 40g

Blackberry lily 40g pinellia tuber 40g white peony root 40g

Salvia miltiorrhiza 30g and moutan bark 40g and magnolia officinalis 32g

Poria cocos 40g peppermint 20g coptis root 20g

B. decocting the 15 medicinal decoction pieces with 8 times of water for 2 times, the first time for 2 hours, the second time for 1 hour, mixing the decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.21 at 50-60 deg.C, adding ethanol to ethanol content of 60%, standing for cold precipitation for 12 hours, filtering, recovering ethanol from the filtrate to obtain fluid extract with relative density of 1.08 at 50-60 deg.C, adding purified water, stirring, standing, and filtering to obtain filtrate;

C. and C, adding activated carbon accounting for 2.0% of the mass of the filtrate into the filtrate obtained in the step B, heating, filtering to remove carbon, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the finished product.

EXAMPLE 4 preparation of capsules

Dried rehmannia root, radix Ophiopogonis 80g, figwort 60g

Radix Codonopsis 20g Scutellariae 20g Fritillaria thunbergii 20g

Blackberry lily 60g pinellia tuber 60g white peony root 60g

Root of red rooted saliva 15g moutan bark 20g magnolia bark 20g

Poria cocos wolf 60g, peppermint 30g, coptis root 30g

B. decocting the 15 medicinal decoction pieces with 7 times of water for 2 times, 3 hr for the first time, 1 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15 at 50-60 deg.C, adding ethanol to make ethanol content reach 50%, standing, cold precipitating for 24 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.20 at 50-60 deg.C, and keeping;

D. and C, taking the extract obtained in the step B, carrying out belt vacuum drying under the conditions that the vacuum degree is-0.08 MPa to-0.10 MPa and the drying temperature is 62 ℃, crushing into fine powder, sieving, adding the starch, the silica gel micropowder and the low-substituted hydroxypropyl cellulose (the weight ratio is 5: 1: 1.5) in the formula ratio, mixing uniformly, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the compound soft capsule.

EXAMPLE 5 preparation of tablets

Dried rehmannia root, radix Ophiopogonis 80g, ophiopogon root, radix scrophulariae 35g, radix scrophulariae 60g

Radix Codonopsis 20g Scutellariae radix 60g Bulbus Fritillariae Thunbergii 20g

Blackberry lily 60g pinellia tuber 20g white peony root 60g

Salvia miltiorrhiza 15g and moutan bark 60g and magnolia officinalis 20g

Tuckahoe 60g mint 10g coptis root 30g

B. decocting the 15 medicinal decoction pieces with 8 times of water for 3 times, 2 hr for the first time, 1 hr for the second time, and 1 hr for the third time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.25 at 50-60 deg.C, adding ethanol to make ethanol content reach 70%, standing, cold precipitating for 12 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.10 at 50-60 deg.C;

C. and (C) taking the extract obtained in the step (B), adding a proper amount of starch, uniformly mixing, drying to obtain a dry extract, crushing the dry extract, adding 85% ethanol solution to prepare a soft material, granulating, drying, granulating, adding a proper amount of 0.5% magnesium stearate, mixing, and tabletting to obtain tablets.

EXAMPLE 6 preparation of oral liquid

Dried rehmannia root, radix rehmanniae 55g, ophiopogon root, 42g and figwort 35g

Codonopsis pilosula 45g scutellaria root 45g thunberg fritillary bulb 45g

Blackberry lily 35g pinellia tuber 35g white peony root 35g

Salvia miltiorrhiza 35g moutan bark 45g magnolia officinalis 38g

Poria cocos 35g, peppermint 15g, coptis root 15g

B. decocting the 15 medicinal decoction pieces with 10 times of water for 2 times, the first time for 3 hr, the second time for 1 hr, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.24 at 50-60 deg.C, adding ethanol to make ethanol content reach 50%, standing, cold precipitating for 24 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.10 at 50-60 deg.C, adding purified water, stirring, standing, and filtering to obtain filtrate;

C. and C, adding activated carbon accounting for 2.8 percent of the mass of the filtrate into the filtrate obtained in the step B, heating, filtering to remove carbon, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the finished product.

EXAMPLE 7 preparation of granules

58g of dried rehmannia root, 47g of dwarf lilyturf tuber and 38g of figwort root

Codonopsis pilosula 42g baikal skullcap root 42g thunberg fritillary bulb 36g

Blackberrykiky rhizome 38g, pinellia tuber 38g, white peony root 36g

Salvia miltiorrhiza 28g moutan bark 45g Magnolia officinalis 35g

Poria cocos 38g, peppermint 18g, coptis root 22g

B. decocting the 15 medicinal decoction pieces with 9 times of water for 3 times, 1 hr for the first time, 1 hr for the second time, and 1 hr for the third time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.22 at 50-60 deg.C, adding ethanol to ethanol content of 60%, standing, cold precipitating for 12 hr, filtering, and recovering ethanol from the filtrate to obtain extract with relative density of 1.16 at 50-60 deg.C;

C. and (C) soaking in the step (B), performing belt vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 65 ℃, crushing into fine powder, sieving, adding 0.20% of trichloro-dextrin, mixing uniformly, adding 75% of ethanol to prepare a soft material, granulating, drying and finishing to obtain the finished product.

EXAMPLE 8 preparation of tablets

Dried rehmannia root, radix rehmanniae 40g, ophiopogon root, figwort 20g

Codonopsis pilosula 60g baikal skullcap root 20g thunberg fritillary bulb 60g

Blackberry lily 20g pinellia tuber 60g white peony root 20g

Salvia miltiorrhiza 45g, moutan bark 20g, magnolia officinalis 45g

Poria cocos 20g, peppermint 30g, coptis root 10g

B. decocting the 15 medicinal decoction pieces with 8 times of water for 3 times, 2 hr for the first time, 1 hr for the second time, and 2 hr for the third time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.20 at 50-60 deg.C, adding ethanol to ethanol content of 70%, standing, cold precipitating for 24 hr, filtering, and recovering ethanol from the filtrate to obtain fluid extract with relative density of 1.18 at 50-60 deg.C;

C. and (C) taking the extract in the step (B), adding a proper amount of starch, uniformly mixing, drying to obtain a dry extract, crushing the dry extract, adding a 90% ethanol solution to prepare a soft material, granulating, drying, finishing granules, adding a proper amount of 0.3% magnesium stearate and 0.1% talcum powder, mixing, and tabletting to obtain tablets.

EXAMPLE 9 preparation of capsules

62g of radix rehmanniae, 51g of radix ophiopogonis and 46g of radix scrophulariae

Codonopsis pilosula 37g scutellaria baicalensis 32g thunberg fritillary bulb 36g

Blackberry lily 42g pinellia tuber 39g white peony root 38g

Salvia miltiorrhiza 38g moutan bark 37g Magnolia officinalis 28g

Poria cocos wolf 43g, peppermint 22g, coptis root 21g

B. decocting the 15 medicinal decoction pieces with 9 times of water for 2 times, 3 hr for the first time, 1 hr for the second time, mixing decoctions, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.17 at 50-60 deg.C, adding ethanol to make ethanol content reach 60%, standing, cold precipitating for 12 hr, filtering, recovering ethanol from the filtrate to obtain extract with relative density of 1.16 at 50-60 deg.C, and keeping;

D. and (3) taking the extract obtained in the step (B), carrying out belt vacuum drying under the conditions that the vacuum degree is-0.09 MPa to-0.10 MPa and the drying temperature is 65 ℃, crushing into fine powder, sieving, adding the starch and the microcrystalline cellulose (the weight ratio is 5: 1) according to the formula amount, mixing uniformly, granulating, drying, granulating, filling, polishing in a polishing machine, and removing damaged capsules to obtain the compound.

Claims

1. A traditional Chinese medicine composition for treating radiation injury is characterized by being prepared from the following traditional Chinese medicine components:

55-65 parts of dried rehmannia root; 42-54 parts of radix ophiopogonis; 35-45 parts of radix scrophulariae;

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following traditional Chinese medicine components:

40 parts of blackberrykiky rhizome; 40 parts of pinellia ternate; 40 parts of white peony root;

40 parts of poria cocos; 20 parts of mint; 20 parts of coptis chinensis.

3. The traditional Chinese medicine composition according to any one of claims 1-2, wherein the pinellia ternate is processed pinellia ternate.

4. The traditional Chinese medicine composition according to any one of claims 1-2, wherein the traditional Chinese medicine composition is an oral pharmaceutical preparation.

5. The traditional Chinese medicine composition of claim 4, wherein the oral pharmaceutical preparation is one of granules, oral liquid, capsules and tablets.

6. The traditional Chinese medicine composition of claim 5, wherein the preparation method of the oral liquid comprises the following steps:

B. taking the above 15 raw material medicines, adding 6-10 times of water, decocting for 2-3 times, each time for 1-3 hours, mixing decoctions, filtering, concentrating the filtrate to obtain a clear paste with a relative density of 1.15-1.25 at 50-60 ℃, adding ethanol to make the ethanol content reach 50% -70%, standing, performing cold precipitation for 12-24 hours, filtering, recovering ethanol from the filtrate to obtain an extract with a relative density of 1.05-1.20 at 50-60 ℃, adding purified water, stirring uniformly, standing, filtering to obtain a filtrate for later use;

C. and C, adding 1.5-2.8% of activated carbon in parts by mass into the filtrate obtained in the step B, heating, filtering to remove carbon, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the finished product.

7. The Chinese medicinal composition according to claim 6, wherein in the step B, 8 times of water is added for decoction for 2 times, 2 hours for the first time and 1 hour for the second time.

8. The Chinese medicinal composition according to claim 6, wherein the step B is carried out by standing and cold-precipitating for 12 hours.