CN115025127B

CN115025127B - Application of poecilobdella manillensis in preparation of medicine for treating chronic obstructive pulmonary disease and traditional Chinese medicine preparation

Info

Publication number: CN115025127B
Application number: CN202210953548.2A
Authority: CN
Inventors: 孙静涛; 胡田魁; 孙铱
Original assignee: Yunnan Sanjiang Materia Medica Co ltd
Current assignee: Yunnan Sanjiang Materia Medica Co ltd
Priority date: 2022-08-10
Filing date: 2022-08-10
Publication date: 2022-11-11
Anticipated expiration: 2042-08-10
Also published as: CN115025127A

Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses application of poecilobdella manillensis in preparation of a medicine for treating chronic obstructive pulmonary disease and a traditional Chinese medicine preparation. The invention provides a new application of poecilobdella manillensis in preparing a medicine for treating chronic obstructive pulmonary disease, provides a new natural medicine for treating chronic obstructive pulmonary disease, and has good treatment effect on chronic obstructive pulmonary disease and no obvious adverse reaction and toxic or side effect.

Description

Application of poecilobdella manillensis in preparation of medicine for treating chronic obstructive pulmonary disease and traditional Chinese medicine preparation

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to application of poecilobdella manillensis in preparing a medicine for treating chronic obstructive pulmonary disease and a pharmaceutical preparation.

Background

Chronic Obstructive Pulmonary Disease (COPD), an important respiratory disease that is a chronic onset, recurrent episodes that ultimately lead to chronic death, has a high prevalence and mortality worldwide, and is a major disease threatening human health. Along with the reduction of the fatality rate of cardiovascular and cerebrovascular diseases, the chronic respiratory diseases are gradually increased, and huge social and economic burden is caused.

The current treatment of COPD includes several aspects including the avoidance of exposure to risk factors, drug therapy, surgery, other treatments, the most prominent of which are drug therapy, including bronchodilators, glucocorticoids, antibiotics, mucolytics, immunomodulators, vaccines and the like. Because COPD is a compound disease caused by multiple factors, the progress of the COPD course cannot be reversed by any single active ingredient drug, and the treatment effect of the existing drug is not ideal enough. In addition, the western medicines have serious toxic and side effects. Therefore, the development of a traditional Chinese medicine with good treatment effect on COPD and no toxic or side effect has great potential and bright prospect.

Poecilobdella manillensis (Poecilobel la manillensis Lesson) is Poecilobdella manillensis of Poecilobdellida of Arecilobdellida of Ancisdellida of Anetholophylum, and has multiple pharmacological effects of softening blood vessel, resisting coagulation, resisting thrombus and dissolving thrombus, resisting platelet aggregation, reducing blood fat, promoting uric acid excretion, resisting inflammation, resisting cancer and the like. Can be used for treating carotid artery plaque, systemic arterial plaque, myocardial infarction, cerebral hemorrhage, coronary atherosclerotic heart disease, angina pectoris, atherosclerosis, gout, diabetic nephropathy, diabetic peripheral neuropathy, retinal hemorrhage, diabetes, etc. At present, no report about the application of poecilobdella manillensis in treating chronic obstructive pulmonary disease is found.

Disclosure of Invention

The invention aims to overcome the defects in the prior art and provides a new application of poecilobdella manillensis in preparing a medicament for treating chronic obstructive pulmonary disease, and the medicament has a good treatment effect and has no obvious adverse reaction and toxic or side effect.

In order to achieve the purpose, the invention provides application of poecilobdella manillensis in preparing a medicament for treating chronic obstructive pulmonary disease.

Preferably, the dosage form of the medicament is powder, capsules, tablets, granules, spray, injection or decoction.

Preferably, the medicament also contains pharmaceutically acceptable auxiliary materials.

Preferably, the adjuvant is selected from at least one of microcrystalline cellulose, lactose and dextrin.

Preferably, the oral dosage of the medicine is 0.1 to 3 g/day.

The invention provides a traditional Chinese medicine preparation for treating chronic obstructive pulmonary disease, which comprises the raw material components of poecilobdella manillensis.

Preferably, the traditional Chinese medicine preparation also contains the following raw material components: pericarpium Citri Tangerinae, rhizoma Pinelliae, rhizoma Acori Graminei, semen Armeniacae amarum, rhizoma arisaematis and Glycyrrhrizae radix.

Preferably, the weight ratio of the poecilobdella manillensis, the dried orange peel, the pinellia ternate, the rhizoma acori graminei, the almond, the rhizoma arisaematis and the liquorice is 1:4 to 20:5 to 20:4 to 18:4 to 18:4 to 18:1~6.

The invention provides a new application of poecilobdella manillensis in preparing a medicine for treating chronic obstructive pulmonary disease, provides a new natural medicine for treating chronic obstructive pulmonary disease, and has good treatment effect on chronic obstructive pulmonary disease and no obvious adverse reaction and toxic or side effect.

Detailed Description

The following describes in detail specific embodiments of the present invention. It should be understood that the detailed description and specific examples, while indicating the present invention, are given by way of illustration and explanation only, not limitation.

The endpoints of the ranges and any values disclosed herein are not limited to the precise range or value, and such ranges or values should be understood to encompass values close to those ranges or values. For ranges of values, between the endpoints of each of the ranges and the individual points, and between the individual points may be combined with each other to give one or more new ranges of values, and these ranges of values should be considered as specifically disclosed herein.

The invention provides an application of poecilobdella manillensis in preparation of a medicine for treating chronic obstructive pulmonary disease.

The active components in the poecilobdella manillensis comprise hirudin, which is the strongest natural anticoagulant substance in the world today, acts directly on thrombin, is effective on both the forming thrombus and the formed thrombus, and simultaneously has the advantage that the hirudin is not damaged when being taken orally. In addition, the poecilobdella manillensis also contains fibrinolysin, hyaluronidase and the like, and can decompose fibrin in thrombus, thereby having excellent thrombolytic and fibrinolytic effects. The medicament prepared from the poecilobdella manillensis serving as a raw material has multiple active ingredients and multiple action targets, and can effectively treat chronic obstructive pulmonary disease caused by multiple factors.

In the invention, the poecilobdella manillensis is in the form of poecilobdella manillensis or an extract thereof for preparing the medicament for treating the chronic obstructive pulmonary disease. Specifically, the Poecilobdella manillensis comprises at least one of a Poecilobdella manillensis living body, a Poecilobdella manillensis dried medicinal material and Poecilobdella manillensis freeze-dried powder; the Poecilobdella manillensis extract comprises hirudin and hirudin extracted from Poecilobdella manillensis and/or Poecilobdella manillensis saliva.

In a preferred embodiment, the dosage form of the drug is powder, capsule, tablet, granule, spray, injection or decoction, and the above drugs in various dosage forms can be prepared according to a conventional method in the pharmaceutical field, and are not particularly limited herein. In addition, the dosage form of the drug is not limited thereto, and those skilled in the art will recognize that feasible dosage forms are within the scope of the present invention.

Furthermore, the medicine also contains pharmaceutically acceptable auxiliary materials, wherein the auxiliary materials can be a flavoring agent and can also be materials used in the preparation process, such as a diluent, an excipient, a filler, an adhesive, a wetting agent, a disintegrating agent, an absorption enhancer, a surfactant, an adsorption carrier, a lubricant and the like.

Specifically, the auxiliary material is at least one selected from microcrystalline cellulose, lactose and dextrin.

In a preferred embodiment, the oral dosage of the drug is 0.1 to 3 g/day. It will be appreciated that the dose is calculated as the amount of Poecilobdella manillensis or Poecilobdella manillensis extract in the medicament.

The invention also provides a traditional Chinese medicine preparation for treating chronic obstructive pulmonary disease, which comprises the raw material components of Poecilobdella manillensis. It should be noted that, on the basis of the realization of the above embodiments, the Chinese medicine preparation can be combined with the technical solutions of the above embodiments.

In a specific embodiment, the method of preparing the chinese medicinal formulation comprises: drying in the shade, air drying, freeze drying, salting out, ultrafiltering, gel filtering, isoelectric precipitation, ion exchange chromatography, affinity chromatography, adsorption chromatography, reverse flow dissolution and enzymolysis.

In a preferred embodiment, the Chinese medicinal preparation is a Chinese medicinal compound, and specifically, the Chinese medicinal preparation comprises the following raw material components: poecilobdella manillensis, dried orange peel, pinellia ternate, rhizoma acori graminei, almond, rhizoma arisaematis and liquorice.

More preferably, the weight ratio of the poecilobdella manillensis, the dried orange peel, the pinellia ternate, the rhizoma acori graminei, the almond, the rhizoma arisaematis and the liquorice is 1:4 to 20:5 to 20:4 to 18:4 to 18:4 to 18:1~6.

The present invention will be described in detail below by way of examples, but the scope of the present invention is not limited thereto. In the following examples, the lyophilized poecilobdella manillensis powder is provided by Yunnan Sanjiang herbal medicine industry Co. In addition, the experimental methods in the following examples are all conventional in the art unless otherwise specified. The experimental materials used in the following examples are all commercially available products unless otherwise specified.

Example 1

The traditional Chinese medicine preparation is freeze-dried poecilobdella manillensis powder.

Example 2

Filling the freeze-dried poecilobdella manillensis powder in example 1 into a commercially available gelatin hollow capsule, wherein each capsule contains 0.3g of freeze-dried poecilobdella manillensis powder to obtain the poecilobdella manillensis capsule.

Example 3

And (3) mixing the freeze-dried poecilobdella manillensis powder prepared in the example 1 with microcrystalline cellulose, and tabletting to obtain 0.5g of poecilobdella manillensis tablets, wherein the weight ratio of the freeze-dried poecilobdella manillensis powder to the microcrystalline cellulose is 40.

Example 4

Shearing Poecilobdella manillensis head, pulping, extracting effective components (water soluble protein including hirudin) with water-acetone mixed solvent, lyophilizing, and adding lactose and dextrin to obtain Poecilobdella manillensis granule with anticoagulant activity of 400U per 3 g.

Example 5

Subjecting the effective components obtained in example 4 to gel chromatography, separating to obtain hirudin and other proteins, freeze drying to obtain extract powder, dispersing the extract powder in PEG400, subpackaging in containers, and pressing propellant F ₁₂ And obtaining the poecilobdella manillensis spray, wherein the weight ratio of the extract powder to the PEG400 to the propellant is 80.

Example 6

Dissolving the extract powder prepared in example 5 with sterile water for injection, sterile filtering, filling into bottles, freeze-drying, sealing, and making into sterile powder for injection to obtain Poecilobdella manillensis injection.

Example 7

3g of poecilobdella manillensis (dried medicinal material) is taken and crushed into fine powder which is divided into 2 parts; 15g of dried orange peel, 17g of pinellia ternate, 15g of rhizoma acori graminei, 15g of almond, 16g of rhizoma arisaematis and 4g of liquorice, 1500mL of water is added for each time, the decoction is decocted for 2 times and 30min for each time, the decoction is combined and concentrated to 500mL to obtain concentrated solution, the concentrated solution is divided into 2 times, and 2 parts of poecilobdella manillensis fine powder are taken, namely the weight ratio of the poecilobdella manillensis, the dried orange peel, the pinellia ternate, the rhizoma acori graminei, the almond, the rhizoma arisaematis and the liquorice is 1.5:7.5:8.5:7.5:7.5:8:2.

test example 1 pharmacodynamic experiment of drug

1. The influence of the freeze-dried poecilobdella manillensis powder provided by the embodiment 1 on airway inflammation and lung tissue pathology of a chronic obstructive pulmonary disease model rat.

1. Materials and methods

1.1 reagents and drugs

Cigarette making: the cigarette (tar content 10mg, nicotine content 1.1mg, carbon monoxide content 12 mg) is produced by Hongyun Honghe tobacco (group) limited company; lipopolysaccharide (LPS): sigma, USA; sodium pentobarbital: shanghai West Tang Biotech, inc.; switzerland dyeing liquid: qingdao Haibo Biotech Co.

1.2 instruments

5804R Low temperature ultracentrifuge (eppendorf, germany); olympus CH30 light microscope. RM2016 type rotary paraffin cut tablets (shanghai come instrument ltd); a desk type constant temperature oscillator (jin Tan city Cheng Wei testing instrument factory).

1.3 grouping and methods

Healthy SD rats, 50, female, body weight (203 + -18) g, were purchased from the university of Kunming medical laboratory animal center. Rats were randomly divided into 5 groups of 10 rats each. On days 1 and 14 of model replication, except for the normal control group, after the rats were anesthetized with sodium pentobarbital, the neck was opened, the trachea was exposed, 0.2mL each of Lipopolysaccharide (LPS) (200. Mu.g/200 mL) was injected into the trachea with a 1mL syringe, penicillin injection was dropped into the skin wound, and then the skin was sutured and aseptically handled with a cotton ball iodine tincture, and Yunyan brand cigarettes were smoked in a 75L closed box for 0.5h every 15 to 28 days on days 2 to 13 in the morning. Administration (from the third day of molding), and the normal control group is drenched with 10mL/kg of 0.9% physiological saline for 1 time/day; the model group is drenched with 0.9% normal saline 10mL/kg for 1 time/day; the freeze-dried poecilobdella manillensis powder is taken in a high-dose group (which is 10 times of the dose of clinical adults): 0.8g/kg,1 time/d; the freeze-dried poecilobdella manillensis powder is prepared by filling the freeze-dried poecilobdella manillensis powder (which is 5 times of the dose of clinical adults) into a dosage group: 0.4g/kg,1 time/d; the lyophilized poecilobdella manillensis powder is administrated by low-dose groups (equivalent to 2.5 times of clinical adult dose): 0.2g/kg,1 time/d. The 5 groups of the traditional Chinese medicine are continuously perfused for 28 days, and every index is measured on the 2 nd day after the perfusion is finished.

1.4, observation index

1.4.1 general case

The activity, sensitivity to external reaction, fur gloss, diet, drinking water, constitution and death of the rats were observed.

1.4.2 bronchoalveolar lavage fluid (BALF) inflammatory cell count

The rats were sacrificed by femoral bleeding, the right main bronchus was ligated by thoracotomy, the left lung was lavaged 2 times with 5mL of normal saline containing heparin sodium, bronchoalveolar lavage fluid was collected, BALF was mixed well, and 0.1mL was diluted by adding an equivalent amount of white blood cell count solution. Counting by using a blood cell counting plate, centrifuging the residual BALF for 10min by using a centrifuge at 2000r/min, smearing the sediment, performing Wright staining, and counting 400 white blood cells under a light microscope to perform cell classification counting.

1.4.3 blood leukocyte count and Classification

Taking femoral artery blood, smearing, performing Wright's staining, counting 400 white blood cells under a light microscope, and performing cell classification counting.

1.4.4 bronchopulmonary histomorphological Observation

After the rats were sacrificed, the left lung upper lobe position was fixed in 10% neutral formalin solution. Alcohol gradient dehydration, xylene transparent specimen, wax dipping, embedding, slicing, HE staining, and observing the change of tissue morphology under an optical microscope.

2. Results of the experiment

2.1 general case observations

The normal control group rats are active and active, smooth in fur, fat in body shape and stable in breathing; the rat model group gradually reduces the activity, atrophies the state, crouches the hunch, has sparse hair, erects hair, has no luster, reduces the appetite, moves slowly, has thin and small body, starts cough frequently from day 18, sneezes frequently, and makes the later breathing deepen and rapid, which accords with the expression of the lung-qi deficiency syndrome; the rats in the high, medium and low dose groups of the poecilobdella manillensis freeze-dried powder are between the control group and the model group.

2.2 bronchoalveolar lavage fluid (BALF) inflammatory cell count results are given in Table 1 below.

TABLE 1 nucleated cell count and class comparison (. + -. S) for each group of rats

As can be seen from Table 1, the total number of leukocytes, the number of lymphocytes and the number of neutrophils in the BALF of the model group are obviously greater than those in the normal control group, and the differences are significant (P is less than 0.01). The total number of leucocytes, the number of lymphocytes and the number of neutrophils in the high-dose, medium-dose and low-dose treatment groups BALF of the poecilobdella manillensis freeze-dried powder are obviously less than those in the model group, and the difference is significant (P is less than 0.01).

2.3 blood leukocyte counts and classification results are given in Table 2 below.

TABLE 2 nucleated cell count and classification comparisons (+ -s) for each group of rats

As can be seen from Table 2, the total number of blood leukocytes, the number of lymphocytes and the number of neutrophils in the model group are all obviously greater than those in the normal control group, and the differences are significant (P < 0.01). The total number of white blood cells, the number of lymphocytes and the number of neutrophils in the high-dose, medium-dose and low-dose treatment groups of the poecilobdella manillensis freeze-dried powder are obviously reduced compared with those in the model group, and the difference is significant (P is less than 0.05).

2.4 bronchopulmonary histomorphometry observations

The results show that the control rat has complete trachea and bronchoalveolar structure, no deformation of the bronchiolar epithelial cells, no exudate in the alveolar cavity and no thickening of the alveolar space. The lung organization pathology in the model group showed a characteristic change in COPD, with focal alveolar inflammatory manifestations in addition to the deformation of bronchiolitis. The pulmonary interstitial capillaries obviously dilate congestion, and a part of alveoli contain light eosine-stained edema fluid and focal pulmonary hemorrhage; partial alveoli collapse to form atelectasis, partial alveoli are highly expanded, the lung space is narrowed and fractured, and obvious focal emphysema is formed; part of the alveolar epithelial cells are degenerated and necrotized and shed in the alveolar cavity; necrosis and desquamation of bronchiolar epithelium, purulent exudate in the bronchial lumen, destruction of surrounding lung tissue and neutrophil infiltration. The Hirudinaria manillensis freeze-dried powder has characteristic pathological changes of COPD in high, medium and low dose groups, but is generally lighter than a model group, wherein respiratory bronchial lumen stenosis and occlusion are slightly relieved compared with the model group, congestion and edema of an indigenous layer are relieved, lymphocyte infiltration is performed on the tube wall, but the attenuation is obviously reduced compared with the model group, and the proliferation of smooth muscle and collagen fiber tissues of the bronchioles and arteriole tube walls is also obviously relieved compared with the model group. Wherein, COPD symptoms of middle and high dose groups of low dose groups of the freeze-dried poecilobdella manillensis powder are obviously reduced.

3. Conclusion

The middle and high dose groups of the lyophilized poecilobdella manillensis powder prepared in the example 1 can inhibit or reduce airway inflammatory reaction of COPD rats and reduce lung tissue injury caused by inflammation.

2. The freeze-dried poecilobdella manillensis powder prepared in the example 1 has the effect of treating chronic obstructive pulmonary disease.

1. Materials and methods

1.1 reagents and drugs

Cigarette making: the cigarette (tar 10mg, nicotine 1.1mg, carbon monoxide 12 mg) is produced by Hongyun Honghe tobacco (group) limited company; lipopolysaccharide (LPS): sigma, USA; sodium pentobarbital: shanghai West Tang Biotech, inc.

1.2 instruments

Test animal lung function analysis system (Beijing space New concept software Co., ltd.); olympis CH30 optical microscope; RM2016 model rotary paraffin cut tablets (Hipposhiica instruments Co., ltd.).

1.3 grouping and methods

Healthy SD rats, 50, female and 200 + -23 g in body weight, were purchased from the Experimental animals center of Kunming medical university. Rats were randomly divided into 5 groups, namely a normal control group, a model group and high, medium and low dose groups of Poecilobdella manillensis lyophilized powder, each group containing 10 rats. The animal modeling and the drug administration method are the same as the experiment I.

1.4 Observation index

1.4.1 bronchial morphology measurements

After the rats were sacrificed, the left lung upper lobe position was fixed in 10% neutral formalin solution. Alcohol gradient dehydration, xylene transparent specimen, wax dipping, embedding, slicing, HE dyeing, and measuring the diameter of the small bronchus, the thickness of the tube wall and the thickness of the smooth muscle layer by using an image analysis system.

The specific measurement method comprises the following steps: randomly selecting regular small bronchus in a bronchus HE section, selecting 3-6 bronchus cross-cut areas for each specimen, and calculating by adopting an image analysis system: total area of tube wall (WAt) = area enclosed by outer wall of air channel (Ao) -area of inner side of tube wall (Ai); smooth muscle layer area (WAsm) = smooth muscle layer outside area (Asmo) — smooth muscle layer inside area (Asmi). The tube wall thickness was expressed as the area of the tube wall per unit length (WAt/Pi) and the thickness of the smooth muscle layer was expressed as the area of the smooth muscle layer per unit length (WAsm/Pi) as a result of normalization with the inner circumference of the tube wall (Pi).

1.4.2 pulmonary function assay

A rat is anesthetized by pentobarbital sodium, a trachea cannula is placed in a box, 8 spontaneous respiration cycles of the rat are recorded, airway pressure (P) and volume (V) changes are obtained, and lung exhalation resistance (Re) and lung inhalation resistance (Ri) are obtained through corresponding calculation. Then, 6mL of air is rapidly injected into the rat airway through the three-way pipe to cause the rat to passively breathe deeply, and then the Forced Vital Capacity (FVC) and the forced expiratory capacity (FEV 0.3, corresponding to the FEV1 of the human) at 0.3s can be measured, and the ratio FEV0.3/FVC can be obtained.

1.5 statistical treatment

All experimental data were statistically analyzed using the SPSS11.5 software package.

2. Results of the experiment

2.1 bronchial morphology measurements the results are given in Table 3 below.

TABLE 3 bronchial morphology measurements (± s)

As can be seen from Table 3, the small bronchial walls and smooth muscle layers of the model rats are obviously thickened (P < 0.01) compared with those of the normal control group, and emphysema is generated, which indicates that COPD rats have the change of the small airway tissue structure. After treatment, the thickness of the hirudo powder in the high and medium dose groups of rats in the small bronchus wall and smooth muscle layer is obviously reduced (P is less than 0.05).

2.2 pulmonary function measurements the results are given in Table 4 below.

TABLE 4 measurement of rat Lung function (. + -. S)

As can be seen from Table 4, compared with the normal control group, the FEV0.3/FVC of the model group rats is significantly reduced (P < 0.01), and the Re and Ri are significantly increased (P < 0.01), which indicates that the model rats have airflow obstruction. Compared with the model group, the Hirudinaria manillensis freeze-dried powder of high and medium dosage group rats have significantly increased FEV0.3/FVC (P < 0.01) and significantly reduced Re and Ri (P < 0.01).

3. Conclusion

The high and medium dose groups of the freeze-dried poecilobdella manillensis powder prepared in the embodiment 1 can obviously inhibit the thickening of the small airway tube wall and smooth muscle layer of a COPD rat, increase the FEV0.3/FVC of the rat and reduce the Re and Ri of the rat. The traditional Chinese medicine is proved to be capable of improving the lung function of the COPD rats, and the medicine is suggested to have a potential therapeutic effect on the COPD.

Test example 2 clinical test

1. Clinical effect of medicament prepared from poecilobdella manillensis on treating chronic obstructive pulmonary disease

1. Data and method

1.1 diagnostic criteria

Refer to the diagnosis standard and disease grading standard of the Chinese medical society of Chronic Obstructive Pulmonary Disease (COPD) guidance in 2007.

1.2 inclusion criteria

(1) The diagnosis standard of chronic obstructive pulmonary disease is met; (2) The medicine conforms to the type of deficiency of both lung and kidney and the type of deficiency of both lung and spleen qi in the syndrome differentiation and typing standard of the traditional Chinese medicine; and (3) known informed consents.

1.3 case exclusion criteria

(1) The age is less than 18 years old or more than 85 years old; (2) Those with severe respiratory failure, acute attack and complicated infection; (3) patients with other serious organic diseases; (4) psychotic patients; (5) Patients have poor compliance, and can not take medicine and review on time and according to requirements, and patients with incomplete recorded data; (6) those allergic to the drugs used.

1.4 general data

100 patients diagnosed with COPD were randomized into 4 groups, treated 1 group of 28, of which 15 men and 13 women; age 38-71 years old; the disease course is 3-22 years, and the average disease course is 14 years; the disease was grade I in 7 cases and grade II in 15 cases. Class III, 6 examples. 2 groups of 24 patients were treated, 13 men and 11 women; age 35-71 years old; the disease course is 3-22 years, and the average disease course is 13 years; the disease degree was 6 cases in grade I and 14 cases in grade II. Class III, 4 examples. Treatment of 23 groups of patients, 11 men and 12 women; age 33-70 years old; the disease course is 3-21 years, and the average disease course is 14 years; the disease degree was 5 cases in grade I and 13 cases in grade II. Grade III 5. Control group 25, 13 male and 12 female; age 39-72 years; the disease course is 3-21 years, and the average disease course is 15 years; the disease degree was 8 cases, 14 cases, and 3 cases. The four groups have comparability in the aspects of sex constitution, age, disease course, disease condition and the like, and have no significant difference (P is more than 0.05).

1.5 methods of treatment

The control group mainly comprises bronchodilators, expectorants and oxygen therapy. The bronchodilator is mainly aminophylline (specification 0.1g × 100 tablets, manufactured by Shandong Xinhua pharmaceutical Co., ltd.), 0.1g, for oral administration, tid. The phlegm reduction is mainly ambroxol hydrochloride (Nitai Dayang pharmaceutical Co., ltd., specification 30mg X20 tablets), 30mg, oral administration, tid. Treatment 1 group of lyophilized poecilobdella manillensis powder (0.3 g/bottle), 1g, tid; for 2 groups of granules of Poecilobdella manillensis prepared in the oral example 4, 3g of Poecilobdella manillensis raw materials in the granules are taken every day; treatment 3 groups of the poecilobdella manillensis decoction prepared in example 7 are taken orally for 2 times per day (3 g of poecilobdella manillensis in the decoction taken every day), and the treatment course of the four groups is 3 months.

1.6 Observation index

Cough, expectoration, asthma symptoms and pulmonary function.

1.7 therapeutic efficacy determination

Refer to the "Chronic obstructive pulmonary disease diagnosis and treatment guidelines" for the standardization of diagnosis and treatment of chronic obstructive pulmonary disease. And (3) clinical control: cough, expectoration and asthma symptoms basically disappear, and lung function is normal; the effect is shown: cough, expectoration and asthma symptoms are obviously relieved, and lung function is relieved by 2 grades; the method has the following advantages: the symptoms of cough, expectoration and asthma are relieved, and the lung function is relieved by 1 level; and (4) invalidation: cough, expectoration, asthma symptoms and no change or deterioration of lung function.

2. Results

2.1 comparison of Total therapeutic Effect

The results of the four groups of total therapeutic effects after 3 months of treatment are shown in Table 5 below.

TABLE 5

From the above table, it can be seen that all of the 4 cases can be used for treating chronic obstructive pulmonary disease, and the total effective rate of the treatment has no significant difference.

2.2 The results of the comparison of the individual symptom therapeutic effects are shown in tables 6 to 8 below.

TABLE 6 comparison of the efficacy of the individual symptoms (cough)

TABLE 7 comparison of therapeutic effects of individual symptoms (expectoration)

TABLE 8 comparison of the therapeutic effects of the individual symptoms (asthma)

As can be seen from tables 6 to 8, there was no significant difference in improvement in expectoration symptoms between the treated group and the control group (P > 0.05). The treatment group is remarkably improved in relieving and improving cough and asthma compared with the control group (P is less than 0.05).

2.3 adverse reactions were as follows:

in the observation process, patients in the treatment group have no subjective discomfort, and have no abnormal changes in liver and kidney functions, electrocardiogram and the like. While the control group had many adverse reactions such as nausea, vomiting, headache, palpitation, etc.

In conclusion, the medicament prepared from the poecilobdella manillensis provided by the invention has a good treatment effect on chronic obstructive pulmonary disease, and has no obvious adverse reaction and toxic or side effect. The invention provides a new natural medicine for treating chronic obstructive pulmonary disease, and exploits a new application of poecilobdella manillensis.

The preferred embodiments of the present invention have been described above in detail, but the present invention is not limited thereto. Within the scope of the technical idea of the invention, many simple modifications can be made to the technical solution of the invention, including combinations of various technical features in any other suitable way, and these simple modifications and combinations should also be regarded as the disclosure of the invention, and all fall within the scope of the invention.

Claims

1. A traditional Chinese medicine preparation for treating chronic obstructive pulmonary disease is characterized in that raw material components of the traditional Chinese medicine preparation comprise Poecilobdella manillensis, dried orange peel, pinellia ternate, rhizoma acori graminei, almond, rhizoma arisaematis and liquorice;

wherein the weight ratio of the poecilobdella manillensis, the dried orange peel, the pinellia ternate, the rhizoma acori graminei, the almond, the rhizoma arisaematis and the liquorice is 1:4 to 20:5 to 20:4 to 18:4 to 18:4 to 18:1~6.