CN113332410A

CN113332410A - Buccal tablet formula beneficial to reducing damage of smoking to respiratory organs and preparation method

Info

Publication number: CN113332410A
Application number: CN202110640778.9A
Authority: CN
Inventors: 李怡君; 张立伟; 田青; 王芝钰; 王肸钰; 李河笃
Original assignee: Yuekang Medical Biotechnology Co ltd
Current assignee: Yuekang Medical Biotechnology Co ltd
Priority date: 2021-06-09
Filing date: 2021-06-09
Publication date: 2021-09-03

Abstract

The invention discloses a buccal tablet formula and a preparation method which are helpful for reducing the damage of smoking to respiratory organs, wherein the formula comprises astragalus, lily, weeping forsythia leaves, houttuynia cordata, red tangerine peel, momordica grosvenori, dried ginger, liquorice and sweet osmanthus, and the preparation process comprises the steps of material selection and proportioning, pure water soaking, ultrasonic cell wall breaking treatment, vacuum low-temperature extraction, particle spray drying, proportioning, granulation, tabletting, split charging and warehousing; the lily and the weeping forsythia leaves are ministerial drugs, and have the effects of clearing lung heat and removing toxicity, and have the effects of resisting inflammation, resisting oxidation and improving immunity; the adjuvant drugs of the heartleaf houttuynia herb, the exocarpium citri rubrum and the grosvenor momordica fruit have the effects of clearing heat, moistening lung, relieving sore throat, relieving cough and eliminating phlegm, can relieve bronchitis, reduce secretion and have the effect of preventing pulmonary fibrosis; the dried ginger is used for neutralizing the cold property of the medicine, so that side effects are avoided, and the dried ginger is beneficial to long-time taking; the liquorice is a guiding drug and has the effects of neutralizing the drugs, resisting inflammation and resisting allergy.

Description

Buccal tablet formula beneficial to reducing damage of smoking to respiratory organs and preparation method

Technical Field

The invention relates to the field of medicines and functional foods, in particular to a buccal tablet formula for alleviating the damage of smoking to respiratory organs and a preparation method thereof.

Background

Chronic Obstructive Pulmonary Disease (COPD) is a chronic bronchitis and/or emphysema characterized by airflow obstruction that can further progress to the common chronic diseases of pulmonary heart disease and respiratory failure. The occurrence of the disease is related to abnormal inflammatory reaction caused by long-term inhalation of harmful gas and harmful particles, the disability rate and the fatality rate are high, the disease is frequently encountered and commonly encountered worldwide, 10 percent of adults over 40 years old are involved, and about 300 million people die each year. COPD is the first cause of death of rural population in China, and patients often develop pulmonary heart disease and even respiratory failure, which poses serious threats to life health. There is no effective control method for this disease so far. Studies have suggested that long-term smoking results in an imbalance of the protease/antipain system in lung tissue, one of its major factors, with elastase playing an extremely important role in the development of emphysema. Therefore, the development of a product capable of preventing or delaying the occurrence of chronic obstructive pulmonary disease has great significance for enhancing the national physique and improving the economic benefit of enterprises.

The chronic obstructive pulmonary disease in western medicine is similar to the clinical characteristics of lung distension in traditional Chinese medicine, and therefore, the lung obstructive pulmonary disease is used as a reference for treatment based on syndrome differentiation. The traditional Chinese medicine considers that the occurrence of the disease is the lung deficiency caused by long-term illness, such as chronic lung diseases of internal injury, chronic cough, watery phlegm, asthma, tuberculosis and the like, the delayed treatment, the retention of turbid phlegm and the obstruction of lung qi, the abnormal qi output and admission, and the lung deficiency caused by long-term occurrence among the lungs become the basis of the disease. The theory of disease origin and climate of cough, the upper climate of cough, recorded as "cough due to lung deficiency with slight cold, cough with accumulation of qi in the lung and lung distension". Secondly, the patient feels exogenous pathogenic factors, has chronic lung deficiency, and the defensive exterior is not fixed, so that the exogenous pathogenic factors of six excesses are easy to attack each other, which induces the attack of the disease and makes the disease increasingly worse. The 'exterior secret essences' state that the cough caused by the weak cold of lung origin, qi still gathers in the lung and the lung expands, which is the conflict between the adverse rising of cough and qi and the healthy qi, the healthy qi can not be conducted, but the adverse rising of qi between throats, the pathogenic factors staying in the throat can lead to the calm of the qi, and the pathogenic factors moving can lead to the rising of the qi. In the course of pathogenesis evolution, there are two aspects of principal deficiency and secondary excess all the time, and the principle of early prevention and treatment of lung distension should be lung depurating, body resistance strengthening, heat clearing and phlegm eliminating.

Modern medicine considers that the occurrence of COPD is a slow and evolving process, and the basic measures should be to enhance body resistance, prevent and treat bronchitis, inhibit elastase activity, and protect lung tissues, thereby preventing the development of chronic inflammation and the weakening of alveolar tension to form pulmonary emphysema or pulmonary fibrosis.

Disclosure of Invention

In order to solve the technical problems, the technical scheme provided by the invention is as follows: a buccal tablet formula for alleviating damage of smoking to respiratory organs is composed of the following raw material medicines in parts by mass: 15-25 parts of astragalus membranaceus, 10-20 parts of forsythia suspense leaves, 10-20 parts of lily, 10-20 parts of houttuynia cordata, 5-15 parts of red tangerine peel, 5-15 parts of momordica grosvenori, 2-8 parts of dried ginger, 2-8 parts of liquorice and 2-8 parts of sweet osmanthus.

Preferably, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by mass: 20 parts of astragalus membranaceus, 15 parts of forsythia suspense leaves, 15 parts of lily, 15 parts of houttuynia cordata, 10 parts of exocarpium citri rubrum, 10 parts of momordica grosvenori, 5 parts of dried ginger, 5 parts of liquorice and 5 parts of sweet osmanthus.

Preferably, the preparation method comprises the following steps:

(1) selecting raw material medicines according to a formula, putting the raw material medicines according to the formula into a cooking cloth bag, putting the cooking cloth bag into a container, adding purified water until the raw material is completely submerged, and soaking for 30 minutes;

(2) putting the soaked raw materials with the immersion liquid into a container of an ultrasonic cell disruption instrument, enabling an ultrasonic probe to be 1.5 cm deep into the liquid, and carrying out ultrasonic operation for 30 minutes according to the standard requirement;

(3) placing the raw materials and liquid treated by ultrasonic wave into a vacuum low-temperature decoction concentrator, adding purified water to 10 times of the amount of the materials, decocting for 1 hour, and taking out the liquid medicine;

adding purified water to 6 times of the material amount, decocting for 40 minutes, and taking out the raw material medicaments;

mixing the two decoctions, transferring into a vacuum pan, concentrating to 2-3 times of the amount of the corresponding material, taking out the medicinal liquid, and measuring the density and recording;

(4) adding maltodextrin in an amount which is 10 percent of the concentrated solution, stirring until the maltodextrin is completely dissolved, spraying the maltodextrin into powder by using an ultrafine powder spray dryer, wherein the temperature of the ultrafine powder spray dryer is set to be 150 ℃, the induced air frequency is 50Hz, and the rotating speed of a feeding peristaltic pump is 20RPM, so as to obtain fine powder, weighing and calculating the equivalent amount of each gram of powder to the original medicine, and filling the powder into a sealing bag for later use;

(5) preparing materials and preparing tablets: the main material is a powdery material prepared according to a formula, and the material consumption is calculated according to the condition that each tablet contains 1.5 g of equivalent original medicine;

(6) adding adjuvants according to physical properties of the main material, wherein the adjuvants include starch, magnesium stearate, sucrose, Mentholum, and toner, mixing the materials and adjuvants uniformly, granulating by wet method, oven drying at low temperature, calculating according to net weight of each tablet of 1.0 g, pressing into tablet, and packaging.

In the invention:

1. astragalus root: sweet taste and warm nature; entering lung and spleen meridians; has the functions of invigorating qi, consolidating superficial resistance, promoting urination, expelling pus and promoting granulation; can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, spontaneous perspiration, edema, carbuncle, cellulitis, intractable ulcer, blood deficiency, sallow complexion, internal heat, and diabetes; proteinuria due to chronic nephritis, diabetes;

the main pharmacological action is as follows: (1) the diuretic effect is: the astragalus crude drug or the extract has a remarkable diuretic effect on the experimental animals or the human body; human body tests prove that the astragalus has moderate diuretic effect and can increase urine volume and chloride excretion; can enhance metabolism and improve the nutrition state of the whole body;

(2) effect on myocardium: the astragalus has the effect of increasing the contraction of the normal heart, and has more remarkable cardiotonic effect on the heart which is damaged by poisoning or fatigue; the ethanol extract of radix astragali can enhance the heart contraction of in vitro frog or Bufo siccus, and increase amplitude; inhibition occurs at high doses;

(3) modulation of the immune system: the product can improve immunity;

(4) antioxidation and anti-aging effects: the astragalus polysaccharide has better antioxidation, thereby playing a role in resisting aging;

(5) radiation resistance: the astragalus can promote the lymphocyte transformation rate, the astragalus protective group has significant difference (P is less than 0.01) compared with the irradiation model group, and can reverse the reduction of SOD activity, eliminate free radicals generated by radiation so as to reduce the content of MDA, improve the body prevention capability and provide basis for the protection application of radiologists;

(6) antithrombotic effect: the astragalus can obviously inhibit the increase of the content of MDA in cerebral ischemia reperfusion rat brain tissue and improve SOD activity, and can clear away oxygen free radicals, and the ultramicro structure proves that the astragalus has a certain protection effect on membranous structures; the astragaloside can remarkably prolong the time of electrically stimulating the common carotid artery of a rat to form thrombus and can inhibit platelet aggregation;

(7) liver protection: astragalus can also inhibit lipoxygenase, reduce the generation of lipopolysaccharide, improve the glutathione content of the liver, resist free radicals, regulate metabolism, protect mitochondria and the like;

(8) effects on the central nervous system: the astragalus injection is injected into acupuncture points to improve the memory, and the influence on the memory is probably related to the central choline nervous system, because the central choline nervous system is closely related to the functions of learning and memory;

(9) antibacterial and virus-inhibiting effects: radix astragali has inhibitory effect on dysentery bacillus, Diplococcus pneumoniae, hemolytic streptococcus A, B, C, golden yellow, fructus Citri Limoniae, and white staphylococcus; the astragalus root also has certain inhibition effect on pathogenic effects of oral cavity virus and influenza Sendai BB1 virus, but has no direct fire extinguishing effect;

(10) protection of the lungs: the astragalus can inhibit the expression of lung tissue macrophages and neutrophil IL-1BmRNA and has a protective effect on endotoxin acute lung injury;

2. lily: sweet and cold; heart and lung meridian entered; has effects in nourishing yin, moistening lung, clearing away heart-fire, and tranquilizing mind; can be used for treating yin deficiency, dry cough, hemoptysis, dysphoria, insomnia, dreaminess, absentmindedness;

the main pharmacological action is as follows: (1) the lily water extract has cough relieving effect, can eliminate phlegm by increasing tracheal secretion, and can resist asthma caused by histamine;

(2) the anti-stress injury function is that the normal mice are drenched with the lily water extract solution of 10g/kg, which can obviously prolong the swimming time of the animal load (5%);

(3) the sedative effect is that the mouse is irrigated with 20g/kg of lily aqueous extract, so that the sleep time of the sodium pentobarbital can be obviously prolonged, the sleep rate of the subthreshold sodium pentobarbital is obviously improved, and the lily aqueous extract has the effect of clearing away the heart fire and tranquilizing the mind;

(4) the lily polysaccharide has obvious effect of promoting and enhancing mitosis caused by pokeweed mitogen and lipopolysaccharide; the lily polysaccharide can also remarkably improve the phagocytic percentage and the phagocytic index of abdominal macrophages of immunocompromised mice, promote the formation of hemolysin and hemolytic plaques and promote the lymphocyte transformation;

(5) the colchicine contained in the lily can inhibit the proliferation of cancer cells, the action mechanism of the colchicine is to inhibit the spindle body of tumor cells, so that the colchicine stays in metaphase, can not carry out effective mitosis, and particularly has good inhibition effect on breast cancer;

(6) the polysaccharide in the lily has the function of reducing blood sugar, and the two lily polysaccharide monomers obtained by separation and purification are used for carrying out research on the function of reducing blood sugar of a hyperglycemic white mouse caused by alloxan, and the result shows that the lily polysaccharide has an obvious function of reducing blood sugar and is positively correlated with the concentration;

3. and (3) forsythia suspense leaves: bitter and slightly cold; it enters lung, heart and small intestine meridians; can clear away heat and toxic materials, relieve swelling, dissipate stagnation, and disperse wind-heat; can be used for superficial infection, sore, common cold, warm disease, hyperpyrexia, polydipsia, coma, and speckle;

the main pharmacological action is as follows: has inhibitory effect on various bacteria; has remarkable effects of relieving fever, relieving vomiting and protecting liver; the forsythoside A has obvious effect of inhibiting the activity of elastase, and is beneficial to protecting lung tissues from emphysema or pulmonary fibrosis;

4. houttuynia cordata: pungent, cold and cool and entering lung meridian; has effects in clearing away heat and toxic materials, relieving swelling, treating sore, promoting urination, removing dampness, clearing away heat, relieving dysentery, invigorating stomach, and promoting digestion;

the main pharmacological action is as follows: (1) the water-soluble polysaccharide has the capability of removing hydroxyl radicals and superoxide anion radicals in vitro, and has obvious effect of removing the hydroxyl radicals;

(2) the volatile oil has the inhibition effect on 6 bacteria (Escherichia coli, common modified bacillus, pseudomonas aeruginosa, enterococcus faecalis, sarcina and staphylococcus aureus), and the houttuynia cordata volatile oil has a strong antibacterial effect on gram-negative bacteria;

(3) the anti-inflammatory action exerted on the body is mainly based on the following regulation: 1) for inflammatory cytokines, such as: influence of prostaglandins, Nitric Oxide (NO), chemokines, and the like; 2) affect the binding activity of nuclear factors; 3) regulating cytokine mRNA expression; 4) the effect on cyclooxygenase;

(4) immunoenhancement ChengBaohui et al [34] extract a pectic houttuynia cordata extract from houttuynia cordata to stimulate mouse lymphocyte proliferation, increase the proportion of CD4+ and CD8+ cells, and increase the secretion of IL-2 and IL-10 by mouse spleen lymphocytes, which can enhance the immunity of the organism;

5. orange peel: pungent, bitter and warm in nature; entering lung and spleen meridians; can regulate qi, relieve epigastric distention, eliminate dampness, reduce phlegm, dissipate stagnation and diminish inflammation;

the main pharmacological action is as follows: (1) phlegm reducing and cough relieving are the main effects of the citrus red fruit, can relieve cough, clear away lung heat, dilute sputum and accelerate the discharge of the sputum; (2) diminishing inflammation and relieving asthma; (3) regulating the spleen and stomach; (4) the harm of tobacco and wine is reduced;

6. momordica grosvenori: sweet and cool; entering lung and large intestine meridians; has effects in clearing away heat, moistening lung, relieving sore throat, relieving constipation;

the main pharmacological action is as follows: fructus Siraitiae Grosvenorii extract has effects of relieving cough, relieving asthma, eliminating phlegm, relaxing bowels, and relieving spasm; the polysaccharide component of the momordica grosvenori can obviously increase the weight of immune organs such as thymus and spleen of a mouse and the percentage and phagocytosis index of chicken red blood cells phagocytosed by macrophages in abdominal cavity of the mouse, improve the level of serum hemolysin, increase the lymphocyte transformation rate and improve the immune function;

7. dried ginger: pungent and hot, entering spleen and stomach meridians, heart and kidney meridians; has effects in warming spleen and stomach, dispelling cold, restoring yang, dredging collaterals, warming lung, and eliminating fluid retention;

8. licorice root: sweet in taste and neutral in nature; entering heart, lung, spleen and stomach meridians; has effects in invigorating spleen, invigorating qi, clearing away heat and toxic materials, expelling phlegm, relieving cough, relieving spasm, alleviating pain, and harmonizing the drugs; can be used for treating weakness of spleen and stomach, asthenia, cough, excessive phlegm, and relieving drug toxicity and pungency;

the main pharmacological action is as follows: (1) the antiviral effect is as follows: glycyrrhizic acid has effect in inhibiting proliferation of AIDS virus, glycyrrhizic acid monoammonium salt (4mg/ml) can directly kill AIDS virus, and Glycyrrhrizae radix isoflavone compound also has effect in inhibiting proliferation of AIDS virus; the glycyrrhiza polysaccharide can inhibit vesicular stomatitis virus, adenovirus and I type II herpes simplex virus in vitro;

(2) the antibacterial effect is as follows: the glycyrrhiza alcohol extract and sodium glycyrrhetate can inhibit staphylococcus aureus, tubercle bacillus, escherichia coli, amoeba protozoon and trichomonas in vitro;

(3) corticoid-like effects: glycyrrhizic acid (600mg/kg) is injected into abdominal cavity to cause thymus gland atrophy and adrenal gland weight increase of rat, which indicates that the glycyrrhizic acid has corticotropin-like effect; in addition, the hay powder, the licorice extract, the glycyrrhizic acid and the glycyrrhetinic acid all have the deoxycorticosterone-like effect, so that the urine volume and the sodium discharge volume of various animals are reduced, and the potassium discharge is increased;

(4) anti-inflammatory action: the licorice has obvious anti-inflammatory effect, and the anti-inflammatory components of the licorice mainly comprise glycyrrhizic acid, glycyrrhetinic acid and licoflavone;

(5) impact on the immune system: glycyrrhizic acid can nonspecifically enhance the phagocytic function of macrophages, enhance ConA to induce lymphocytes to secrete interleukin 2, and enhance the activity of natural killer cells in livers; the crude extract of licorice can inhibit the generation of allergic rat antibody, so as to prevent and treat penicillin anaphylactic shock; glycyrrhizin has strong complement inhibition activity, and the effective concentration of glycyrrhizin for inhibiting the total activity of serum complement is 1 mmol/L;

(6) cough relieving and phlegm eliminating effects: the glycyrrhiza extract, the licoflavone and the glycyrrhetinic acid have the effect of eliminating phlegm, and the action strength is licoflavone, the glycyrrhiza extract and the glycyrrhetinic acid;

(7) detoxification function: the licorice and its various single and compound preparations have certain detoxifying effect on various drug poisoning, metabolite poisoning, bacterial toxin poisoning, pesticide poisoning, food poisoning and the like, and the effective component of the licorice is glycyrrhizic acid.

After the scheme is adopted, the invention has the following advantages: according to the invention, the traditional Chinese medicine theory and the modern medicine theory are combined, the medicine-food homologous raw material formula is adopted, and the buccal tablet is prepared by the modern scientific extraction and processing technology, wherein the astragalus is used as a monarch drug in the formula, is the king for tonifying qi, and can tonify lung qi and tonify qi, and healthy qi cannot dry out while being vigorous and pathogenic factors, and the modern pharmacological test has the effects of enhancing the immunity of the organism and resisting pulmonary fibrosis; the lily and the forsythia suspense leaves are ministerial drugs, and have the effects of clearing lung, clearing heat and removing toxicity, and have the effects of resisting inflammation, resisting oxidation and improving immunity. Forsythoside A has remarkable effect of inhibiting elastase activity, and can be used for preventing emphysema; the adjuvant drugs of the heartleaf houttuynia herb, the exocarpium citri rubrum and the grosvenor momordica fruit have the effects of clearing heat, moistening lung, relieving sore throat, relieving cough and eliminating phlegm, can relieve bronchitis, reduce secretion and have the effect of preventing pulmonary fibrosis. The dried ginger is used for neutralizing the cold property of the medicine, so that side effects are avoided, and the dried ginger is beneficial to long-time taking; the liquorice is a guiding drug, has anti-inflammatory and anti-allergic effects, can guide the drug into lung channels, and can improve the fragrance and the taste of the drugs.

Detailed Description

Example one

A buccal tablet formula for alleviating damage of smoking to respiratory organs is composed of the following raw material medicines in parts by mass: 15 parts of astragalus membranaceus, 10 parts of forsythia suspense leaves, 10 parts of lily, 10 parts of houttuynia cordata, 5 parts of exocarpium citri rubrum, 5 parts of momordica grosvenori, 2 parts of dried ginger, 2 parts of liquorice and 2 parts of sweet osmanthus.

Example two

A buccal tablet formula for alleviating damage of smoking to respiratory organs is composed of the following raw material medicines in parts by mass: 25 parts of astragalus membranaceus, 20 parts of forsythia suspense leaves, 20 parts of lily, 20 parts of houttuynia cordata, 15 parts of exocarpium citri rubrum, 15 parts of momordica grosvenori, 8 parts of dried ginger, 8 parts of liquorice and 8 parts of sweet osmanthus.

EXAMPLE III

A buccal tablet formula for alleviating damage of smoking to respiratory organs is composed of the following raw material medicines in parts by mass: 20 parts of astragalus membranaceus, 15 parts of forsythia suspense leaves, 15 parts of lily, 15 parts of houttuynia cordata, 10 parts of exocarpium citri rubrum, 10 parts of momordica grosvenori, 5 parts of dried ginger, 5 parts of liquorice and 5 parts of sweet osmanthus.

The invention relates to a preparation method of a buccal tablet formula for alleviating the damage of smoking to respiratory organs, which comprises the following steps:

Firstly, the taking method comprises the following steps:

one tablet at a time, the oral cavity is buccal, and the total amount of the tablets taken per day is not more than 6.

Second, efficacy experiment

1. Laboratory efficacy experiments

1.1 agar plate diffusion method

(a) Agar plate preparation

Preparing 0.05mol/L, p7.4tris-HC buffer solution, pouring agarose into a triangular flask containing Tris-hCl buffer solution, boiling for 10 minutes, pouring elastin, sodium dodecyl sulfate and sodium azide which are mixed and dissolved in the Tris-HCl buffer solution into agarose liquid when the temperature is cooled to about 80 ℃, slightly shaking to ensure that the elastin is uniformly distributed (the prepared solution contains 1 percent of agarose, 0.08 percent of elastin, 0.02 percent of sodium dodecyl sulfate and 0.05 percent of sodium azide), sucking 10ml of the solution into a plate with the diameter of 6cm, condensing after cooling, placing the plate in a refrigerator with the temperature of 4 ℃ for 12 hours, and punching holes (the diameter is 4mm) before use.

(b) Drawing of standard curve

The elastase was prepared into an enzyme solution of 0.065, 0.125, 0.25, 0.5, 1.0mg/ml using Tris-HC1 buffer, and applied to an agarose plate at 20. mu.1. mu.l, and a standard curve was plotted with the negative logarithm of the enzyme concentration as the horizontal axis and the diameter of the elastin hydrolysis loop as the vertical axis.

(c) Inhibition of enzyme Activity assay

Mixing the effective components of the extracts of different concentrations or the tea bag extract with equivalent elastase solution, adding 20 μ 1 of the enzyme with concentration of 0.25mg/mlo into the sample well of agarose plate, incubating at 37 deg.C for 24 hr, measuring diameter of ring of elastin solution, and repeating number of 6, and performing statistical treatment. While distilled water was used as a blank.

(d) The experimental results are as follows:

TABLE 1 inhibition of elastase by chlorogenic acid and forsythiaside at different concentrations (n ═ 6)

Note: the enzyme activity is as follows: 14.3 S.U/mg; indicates that there are very significant differences

From the above table it can be seen that: fructus forsythiae has certain inhibitory action on elastase, forsythoside has stronger inhibitory action on elastase with the increase of concentration, and the diameter of an elastin hydrolysis ring is reduced. Statistical treatment shows that the forsythoside A has a remarkable inhibitory effect on elastase when the concentration of the forsythoside A is 1.64 mg/ml.

1.2 enzyme activity assay

(a) Drawing of standard curve

Taking 6 test tubes, respectively adding 5mg, 10 mg, 15 mg, 20mg, 25mg and 12.5mg of precisely-weighed Congo red-elastin, respectively adding 5m1 of excess enzyme solution into each tube 1-5, adding 5ml of pH8.8 boric acid buffer solution (for blank measurement) into the 6 th tube, carrying out heat preservation at 37 ℃ until the bottom of each tube is completely hydrolyzed, respectively adding 5ml of pH6.0 phosphoric acid buffer solution, carrying out centrifugal precipitation in the blank tube to remove a substrate, respectively and precisely sucking out 4ml of supernatant from each tube, respectively adding 1ml of pH8.8 boric acid buffer solution and 5ml of pH6.0 phosphoric acid buffer solution, shaking uniformly, measuring absorbance at 495nm, and drawing a standard curve by taking the amount of the substrate in the colorimetric process of each tube as a horizontal axis and the absorbance as a vertical axis.

(b) Inhibition of enzyme Activity assay

Taking 3 test tubes, respectively adding 20mg of precisely weighed Congo red-elastin, adding 3m1 of boric acid buffer solution with pH of 8.8, placing the test tubes in a water bath to preheat to 37 ℃, adding 2m of test solution preheated to 37 ℃ into the sample tubes, adding 2m of boric acid buffer solution into blank tubes, placing the test tubes in the water bath at 37 ℃ to fully oscillate, accurately preserving the temperature for 20min, then adding 5ml of phosphate buffer solution into each tube, centrifuging for 15min, taking supernatant, and measuring the absorbance at 495 nm. The inhibition was calculated according to equation I ═ 1-a/a) ]. 100.

(c) The experimental results are as follows:

TABLE 2 Effect of drugs on Experimental emphysema RV/LV + S in rats

Note: # P < 0.01; p < 0.05; # compare to normal group; comparing with the modeling group;

from the above table, it can be seen that: the experimental emphysema model of the rat can be successfully copied by injecting porcine pancreatic elastase into the trachea of the rat. The traditional Chinese medicine compound extract is administrated by intragastric administration once a day for 30 days continuously, can relieve pulmonary hypertension and right ventricular hypertrophy caused by experimental emphysema models of rats, can effectively prevent pathological histological change, and has a certain effect of resisting experimental emphysema formation of rats.

2. Experiment of group efficacy

2.1 Experimental methods:

20 persons with smoking addiction, 20 persons with chronic tracheitis, mild and moderate emphysema or chronic interstitial pulmonary inflammation are randomly selected, and the persons voluntarily serve as volunteers to set up an experimental group, and detailed medical history and symptom records and chest radiographs are made before the experiment. The experimental period is all taking experimental samples, and smokers smoke one tablet after smoking each time, and the daily dose is not more than 6 tablets; the non-smokers take the dose of 2 tablets in the morning and evening. Making medical history inquiry and chest radiography examination every 10 days, setting observation period at 30 days, making three times of medical history acquisition and chest radiography examination, and making evaluation by means of statistical analysis of examination result.

TABLE 3 Experimental observation results of the efficacy of the population

According to the statistical analysis of the data in the table, the subjective symptom improvement effect is more obvious, and comprises 30/40 halitosis reduction, 29/40 pharyngeal dryness symptom improvement, 29/40 cough symptom reduction, 22/40 expectoration reduction and 27/40 breath unsmooth improvement. The chest radiograph is not obviously changed, and is considered to be related to a shorter observation period.

In conclusion, the experimental evaluation: the laboratory test samples have a relatively obvious inhibiting effect on the activity of elastase, and can delay or prevent emphysema and pulmonary fibrosis; clinical observation preliminarily proves that the sample has the effects of improving and relieving symptoms such as halitosis, dry throat, cough and sputum caused by smoking.

The present invention and the embodiments thereof have been described above without limitation, and it should be understood by those skilled in the art that the present invention is not limited thereto, and that the present invention is not limited to the embodiments and the embodiments without inventive design without departing from the spirit of the present invention.

Claims

1. The buccal tablet formula for alleviating the damage of smoking to respiratory organs is characterized by comprising the following raw medicinal materials in parts by mass: 15-25 parts of astragalus membranaceus, 10-20 parts of forsythia suspense leaves, 10-20 parts of lily, 10-20 parts of houttuynia cordata, 5-15 parts of red tangerine peel, 5-15 parts of momordica grosvenori, 2-8 parts of dried ginger, 2-8 parts of liquorice and 2-8 parts of sweet osmanthus.

2. The buccal tablet formula for alleviating the damage of smoking to the respiratory organ according to claim 1 is characterized by comprising the following raw medicinal materials in parts by mass: 20 parts of astragalus membranaceus, 15 parts of forsythia suspense leaves, 15 parts of lily, 15 parts of houttuynia cordata, 10 parts of exocarpium citri rubrum, 10 parts of momordica grosvenori, 5 parts of dried ginger, 5 parts of liquorice and 5 parts of sweet osmanthus.

3. The buccal tablet formulation of claim 1, wherein the buccal tablet formulation is prepared to help reduce the damage of smoking to respiratory organs, comprising the steps of: