CN1065759C - Application of tea pigments in preparation of medicine for cor pulmonale - Google Patents

Application of tea pigments in preparation of medicine for cor pulmonale Download PDF

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CN1065759C
CN1065759C CN 97116818 CN97116818A CN1065759C CN 1065759 C CN1065759 C CN 1065759C CN 97116818 CN97116818 CN 97116818 CN 97116818 A CN97116818 A CN 97116818A CN 1065759 C CN1065759 C CN 1065759C
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treatment
tea pigment
examples
pulmonary
group
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CN1210008A (en
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孙刘根
王光耀
王志革
蒋学仁
方伟
王志刚
吕静波
阎长青
王舒眉
白雪垠
李雅莉
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JIANGXI PROV GREEN INDUSTRY GROUP CORP
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Abstract

The present invention discloses the new medicinal application of tea pigment, namely the application of tea pigment in preparing medicines for treating pneumocardial disease. The tea pigment used for treating pneumocardial diseases can obviously treat congestive heart failure and respiratory failure of a patient and can relieve symptoms.

Description

The application of tea pigment in the medicine of preparation treatment pulmonary heart disease
The present invention relates to the new medicine use of tea pigment, be specifically related to the application of tea pigment in the medicine of preparation treatment pulmonary heart disease, belong to the field of Chinese medicines.
Tea pigment is the natural plant pigment that extracts from Folium Camelliae sinensis, is a kind of active pigment complex that catechin forms through peroxidating in the tea polyphenols.Tea pigment is made up of theaflavin, thearubigins and abrownin.For the existing bibliographical information of the research of tea pigment.CN1074618A discloses tea pigment and production method thereof.This production process is, Folium Camelliae sinensis is to decoct extracting juice, and alkalization concentrates, and acidify adds alcohol reflux, and alcohol reflux liquid alkalizes and obtains tea pigment crystallization product, through vacuum drying, promptly obtains this tea pigment.Theaflavin, thearubigins and abrownin three have constant ratio in the tea pigment that makes with this method, can be used as medicinal.Medical value report for tea pigment may be summarized to be reduction blood viscosity, blood fat reducing, cholesterol reducing, prevention and treatment cardiovascular disease.But up to the present, the relevant tea pigment of Shang Weijian is used for the treatment of the report of pulmonary heart disease.
A kind of new pharmaceutical applications that the purpose of this invention is to provide tea pigment, promptly tea pigment is in the application of the medicine of preparation treatment pulmonary heart disease.
Pulmonary heart disease is one of modal heart disease of old people, is only second to coronary heart disease and hypertensive heart disease.The Pathophysiology of pulmonary heart disease is a pulmonary hypertension.It is a kind of on severe chronic pulmonary disease basis based on the infringement of the right heart whole-heartedly so that systemic disease, often because of the acute pulmonary infection feelings deterioration of causing a disease, generation respiratory failure, the infringement of heart failure and even liver, kidney, digestive tract and blood system.Tea pigment is used for the treatment of pulmonary heart disease, has obtained excellent curative.
The extracting method of tea pigment of the present invention can extract according to known extraction process, preferably the tea pigment that extracts according to following method:
(1), with Folium Camelliae sinensis by 1: after 15-30 multiple proportions example added water, through once or the decoction extracting juice once, fried liquid is used in the aqueous solution can produce OH -Ionic chemical compound alkalizes, and regulates PH8-10, at the 1/4-1/10 that heats concentrated this alkaline solution to the original volume amount down less than 70 ℃, gets concentrated solution then; (2) concentrated solution transfers to PH3-6 with acid, and acidifying solution adds ethanol 1-10 volume doubly to be measured, and backflow 0.5-2 hour, gets alcohol reflux liquid; (3) alcohol reflux liquid is used in aqueous solution and can produces OH -Ionic chemical compound is regulated PH7-10, and post precipitation filters, and gets the tea pigment crystallization, and tea pigment crystallization vacuum drying promptly gets the tea pigment product.
Tea pigment of the present invention is a kind of active constituents of medicine, preparation process according to routine, can be main active constituent with tea pigment, add excipient substances such as conventional excipient, flavoring agent, disintegrating agent, antiseptic, lubricant, wetting agent, binding agent, solvent, thickening agent, solubilizing agent, make any dosage form that is suitable for using clinically, as tablet, capsule, granule, oral liquid, injection etc.
Because the present invention discloses the pharmacologic action of tea pigment treatment pulmonary heart disease first, therefore, tea pigment cooperated separately or with other active constituents or adjuvant make medicament, so long as this medicament is used for the treatment of pulmonary heart disease, all belong to protection scope of the present invention.
Tea pigment of the present invention all has the effect of treatment pulmonary heart disease when making any dosage form.Any medicament; if contain tea pigment in its component or only prepare patent medicine with the tea pigment single component; on signs such as its packing or description or on other any propaganda materials, need only effect dated or that prompting has the treatment pulmonary heart disease, then fall within protection scope of the present invention.
Tea pigment of the present invention is the natural plants Folium Camelliae sinensis that derives from medicine-food two-purpose.Therefore, also tea pigment can be made health food or health care medicine.Health food or health care medicine with tea pigment is made have the effect for the treatment of pulmonary heart disease if indicate or point out on signs such as its packing or description, also fall within protection scope of the present invention.
Embodiment 1
Prescription
Tea pigment 125 grams
Medical starch 875 grams
Above-mentioned component is gone into blender, and fully stirring and evenly mixing is encapsulated with capsule machine, and every filling 1 gram makes 1000 of tea pigment capsules, and every capsules contains 125 milligrams of tea pigments.
Embodiment 2
Tea pigment 250 grams
2000 milliliters of distilled water
Stevioside 1 gram
Tea pigment is dissolved in the distilled water, and fully mixing adds stevioside, and stirring and evenly mixing is once more packed in the vial with can packing machine, and every bottled 10 milliliters, sterilization makes the tea pigment oral liquid.
The 64 routine clinical observations of experimental example 1 tea pigment treatment chronic cardiopulmonary disease
1, object and method
1.1 the whole cases of object are inpatient, diagnosis meets the diagnostic criteria of national pulmonary heart disease specialized conference revision in 1980.Be divided into two groups after being admitted to hospital at random, 64 examples are organized in treatment, male 38 examples, and women 26 examples, the age is 47 years old-78 years old, average 62 ± 5 years old.Wherein merge I ° heart failure 18 examples, II ° heart failure 31 examples, III ° heart failure 11 examples merge respiratory failure type 61 examples.Matched group 53 examples, male 33 examples, women 20 examples in age 45-72 year, average 60 ± 4 years old, wherein merge I ° heart failure 15 examples, II ° heart failure 25 examples, III ° heart failure 9 examples.Merge respiratory failure type 51 examples, two groups of case sexes, age and heart failures, breathing degree there are no significant difference (P>0.05) has comparability.
1.2 method
1.2.1 the medication matched group gives conventional oxygen therapy, infection, reduces phlegm, improves ventilation and be interrupted diuretic therapy, 4 weeks of the course of treatment.The treatment group gives the tea pigment treatment on the basis of above-mentioned conventional Comprehensive Treatment.Tea pigment is provided by the green pharmaceutical Co. Ltd in Chinese-foreign joint Jiangxi, every day 2 times, each 250mg, 4 weeks of the course of treatment.All cases all detect hemorheology index and blood gas analysis before and after treatment, carry out curative effect relatively.
1.2.2 efficacy determination hepatomegaly, edema, oliguria and symptom such as breathe hard disappear substantially or disappear is heart failure treatment produce effects, symptom obviously is improved as effectively, no significant change or increase the weight of to invalid.PaO 2And PaCO 2Basic recovery is the treatment of respiratory failure produce effects normally; PaO 2And PaCO 2Before be clearly better, but reach normal effective PO that is 2And PaCO 2It is invalid that nothing obviously is improved as.
1.2.3 the statistical procedures statistical data represents that with X ± S mean difference adopts the t check.
2, result
2.1 after curative effect was relatively treated end, treatment group heart failure was corrected 24 examples, 33 examples that take a turn for the better, total effective rate 95% (57/60).11 examples are corrected in respiratory failure, 44 examples that are clearly better, total effective rate 87% (55/61).The matched group heart failure is corrected 15 examples, 23 examples that are clearly better, total effective rate 77.6% (38/49).3 examples are corrected in respiratory failure, 32 examples that are clearly better, total effective rate 68.6% (35/51).Two groups of heart failures and respiratory failure curative effect are compared all has significant difference (P>0.05).
2.2 hemorheology is learned and the blood gas analysis variation before and after two groups of treatments
See Table 1.
Hemorheology is learned and the blood gas analysis change list before and after the table 1 liang group treatment
Figure 9711681800051
Annotate: 1) compare P<0.01,2 with matched group) compare P<0.05,3 with matched group) compare P>0.05 with matched group
2.3 after tea pigment is taken in side effect, do not see apparent side effect, do not find hepatic and renal function injure.
Experimental example 2 tea pigments treatment pulmonary heart disease 30 routine observation of curative effect
1, material and method
1.1 the object of observation is divided into two groups at random with 60 routine pulmonary heart diseases, high blood viscosity patient; Treatment group (tea pigment) 30 examples, male 18 examples, women 12 examples, in age 43-78 year (average 60.3 ± 11.2 years old), pulmonary heart disease course of disease 10-32 (average 15.6 ± 2.1 years) merges heart failure 9 examples, pulmonary encephalopathy 3 examples.Matched group 30 examples, male 20 examples, women 10 examples, in age 45-76 year (average 61.2 ± 10.7 years old), pulmonary heart disease course of disease 11-30 (average 15.1 ± 2.6 years old) merges heart failure 8 examples, pulmonary encephalopathy 2 examples.All case all meets the chronic cardiopulmonary disease diagnostic criteria that nineteen eighty-three whole nation pulmonary heart disease meeting is formulated.Treat preceding two groups of patient's sexes, age, severity extent, hemorheology index etc. and learn by statistics to handle and all do not have significant difference (P>0.05), have comparability.
1.2 the Therapeutic Method matched group is taked composite treatment, comprises the low discharge oxygen uptake, unobstructed air flue, and control infection is kept water, electrolyte and acid-base balance, suitably uses heart tonifying, diuretic etc. according to the state of an illness.The treatment group is taken tea pigment 250mg every day 3 times on above-mentioned composite treatment basis, be 15 days two groups of courses of treatment.Tea pigment capsule provides lot number by the green pharmaceutical Co. Ltd in Chinese-foreign joint Jiangxi: medicine standard (1994) 139-1 is defended in Jiangxi, and every contains tea pigment 125mg.
1.3 two groups of patients of observation index are before treatment, treat have a blood test respectively after 15 days, urine, stool routine, go out clotting time, platelet count, hepatic and renal function, hemorheology, variations such as clinical observation cough, expectoration, dyspnea, pulmonary rale, right heart failure sign, the record toxic and side effects.
1.4 efficacy evaluation produce effects: cough after finishing the course of treatment, expectoration, dyspnea obviously alleviate, and the dried moist rale of pulmonary reduces or disappears, heart failure control, and hemorheology is learned index and is transferred to normally.Effectively: cough, expectoration, dyspnea alleviate, and the dried moist rale of pulmonary reduces, the heart failure basic controlling, and hemorheology is learned index and is not reached normally, but before the treatment improvement is arranged.Invalid: cough, expectoration, dyspnea do not have alleviate, the dried moist rale of pulmonary do not have minimizing, heart failure is not controlled, hemorheology is learned the index progress, sb.'s illness took a turn for the worse or dead.
1.5 statistical method measurement data data are represented with X ± S, adopt the t check, enumeration data adopts X 2Check.
2, result
2.1 two groups of curative effects compare (seeing Table 1) treatment group and obviously are better than matched group, the former total effective rate is 93.3%, and obvious effective rate is 53.5%, latter's total effective rate is 76.7%, obvious effective rate is 33.3%, learns by statistics and handles, and two groups relatively have significant difference (P<0.05).
Table 1 treatment group and matched group curative effect are relatively
Figure 9711681800071
Annotate: 1) compare P<0.05 with matched group
2.2 every index all was significantly improved (P<0.01) after hemorheology compared the treatment of (seeing Table 2) tea pigment group before and after two groups of treatments, and the improvement degree significantly is better than matched group (P<0.01)
A hemorheology changes relatively (X ± S) before and after the treatment of table 2 liang group
Annotate: compare after the treatment of (1) treatment group and before the treatment and after the treatment of control group; (2) compare after the treatment of control group with before the treatment; 1): P<0.05 2): P<0.01 3): P>0.05
2.3 no hemorrhage before and after the toxic and side effects treatment, the conscience kidney is without any side effects, does not also see gastrointestinal reaction.
Experimental example 3 tea pigments and heparin contrast therapy pulmonary heart disease heart failure 100 routine observation of curative effect
1 material and method
1.1 the whole cases of treatment target are all made a definite diagnosis the patient that smelting is in hospital treated by the diagnostic criteria of national pulmonary heart disease specialized conference formulation in 1980.92 examples more than the heart failure II ° merge respiratory failure 22 examples in 100 examples, merge pulmonary encephalopathy 11 examples.
1.2 general situation tea pigment group 50 examples, wherein male 29 examples, women 21 examples; Heparin group 50 examples, wherein male 31 examples, women 19 examples.Two groups of 25~74 years old ages (45 years old mean age).Matched group 30 examples; Age, sex and treatment group are similar.
1.3 Therapeutic Method tea pigment group is composite treatment+tea pigment treatment, tea pigment 250mg/ time, and every day 3 times, oral 7 days was 1 course of treatment; Heparin group is Comprehensive Treatment+heparin therapy, heparin 100mg+10% glucose 500ml, and every day 1 time, intravenous drip, 7 days was 1 course of treatment.Matched group is composite treatment, i.e. heart tonifying, diuresis, oxygen uptake, improve ventilatory function, control infection, symptomatic treatment etc.
1.4 efficacy determination produce effects: cardiopalmus, breathe hard, symptom such as cyanosis, pulmonary rale, disturbance of consciousness, hepatomegaly, edema of pair of lower extremities obviously alleviates or disappear.Effectively: above-mentioned symptom, sign take a turn for the better than before.Invalid: as not have before and after symptom, the sign treatment and improve or death.
2 results
Tea pigment and heparin therapy pulmonary heart disease heart failure, respiratory failure, pulmonary encephalopathy, total effective rate is respectively 91% and 88%, sees Table 1.
Table 1 tea pigment and heparin therapy effect are relatively
Figure 9711681800081
As seen from the table, tea pigment group and heparin group total effects be there was no significant difference (P>0.05) relatively, and two groups relatively have significant difference (P<0.01) with matched group, and tea pigment group side effect incidence rate is lower than heparin group.
3 discuss
Heparin is used for the treatment of pulmonary heart disease and appears in the newspapers repeatly, still belongs to rarely and tea pigment is used for the treatment of pulmonary heart disease heart failure, respiratory failure, pulmonary encephalopathy.This result of study shows, uses tea pigment treatment pulmonary heart disease therapeutic equivalence in heparin, and total effective rate is 92%.Compare there was no significant difference (P>0.05) with heparin group, significant difference (P<0.01) is relatively arranged with matched group.
Experimental example 4 tea pigments and phentolamine contrast therapy pulmonary heart disease heart failure 30 routine observation of curative effect
1, data and method
1.1 case selects whole cases all to make a definite diagnosis pulmonary heart disease heart failure 60 examples by the diagnostic criteria of national pulmonary heart disease specialized conference formulation in 1980.Above person's 54 examples of heart failure two degree in 60 examples.Male's 58 examples, women's 2 examples, age 50-80 year (65.8 years old mean age), average course of disease 17.1 years.
1.2 general situation tea pigment group 30 examples, male's 29 examples, women's 1 example (tea pigment capsule is that the green pharmaceutical Co. Ltd in Chinese-foreign joint Jiangxi produces) phentolamine group 30 examples, male's 29 examples, women's 1 example, matched group 30 examples, age, sex and treatment group are similar substantially.
1.3 being Comprehensive Treatment, Therapeutic Method tea pigment group adds tea pigment, the each 125mg of tea pigment, every day three times, oral 15 days is a course of treatment, and the phentolamine group is that Comprehensive Treatment adds phentolamine treatment, phentolamine 10mg+10% glucose 100ml, once a day, quiet 15 days be a course of treatment.Matched group is a Comprehensive Treatment, i.e. ventilatory function, control infection, symptomatic treatment etc. are propped up, improve in heart tonifying, diuresis, oxygen uptake, expansion.
1.4 efficacy determination produce effects: cardiopalmus, breathe hard, symptom such as cyanosis, pulmonary rale, hepatomegaly, edema of pair of lower extremities obviously alleviates or disappear, i.e. the cardiac function person that improves the secondary.Effectively: above-mentioned symptom, the more preceding improvement of Signs, promptly cardiac function improves one-level person.Invalid: as not have before and after symptom, the Signs treatment and improve or the person of increasing the weight of.
2, result
Tea pigment and phentolamine treatment pulmonary heart disease heart failure, total effective rate is respectively 90% and 86.7% (seeing attached list one).
Tea pigment group and phentolamine group total effects rate relatively do not have significant difference (P>0.05) as seen from the table, two groups with matched group relatively there were significant differences (P<O.01), and tea pigment group side effect incidence rate is lower than the phentolamine group.Tea pigment and phentolamine therapeutic effect be (seeing attached list one) relatively
3, discuss
Pulmonary heart disease people is because long term hypoxia, the ventilation dysfunction of ventilation, the pulmonary capillary bed destroys, the blood vessel area reduces, anoxia and respiratory acidosis cause the lung arteriolospasm, the lung arteriolospasm often increases the weight of with acidosic existence, even slight hypoxia also can make pulmonary artery pressure obviously increase when acidosis.Erythrocytosis also has certain influence to pulmonary artery pressure simultaneously, because secondary polycythemia causes packed cell volume to increase.Resistance of blood flow increases and forms the viscous flow state.
Phentolamine is used for the treatment of the pulmonary heart disease heart failure and appears in the newspapers repeatly, and being used for the treatment of the pulmonary heart disease heart failure, tea pigment still belongs to rarely, tea pigment is the effective ingredient that extracts from green tea, contain multiple bioactive substance, and the stimulating central nervous system systemic effect is arranged, can strengthen myocardial contraction, skin expansion blood vessel, arteria coronaria, kidney blood vessel have the effect of diuresis and releasing bronchial muscular spasm.Tea pigment is by blood viscosity lowering, and microcirculation improvement has alleviated the organ pipe anaerobic state, makes medicine performance therapeutical effect.
In a word, tea pigment is a kind of new drug that curative effect is good, easy to use, safe, effective, side effect is little for the treatment of the pulmonary heart disease heart failure, for the treatment of clinical critical illness provides a kind of new method.
Table one tea pigment and phentolamine therapeutic effect are relatively
Figure 9711681800101
The clinical observation that experimental example 5 patients with cor pulmonale are taken tea pigment
One, clinical data
1, male's 38 examples in the object of observation 56 examples, women's 18 examples in age 43-87 year, average 62 years old, wherein merge respiratory failure 35 examples, with heart failure person 27 examples.Underlying diseases has chronic bronchitis, bronchiectasis, bronchial asthma, chronic fibro cavernous pulmonary tuberculosis etc., course of disease 3.5-32, average 15 years.This organizes the diagnostic criteria that all cases all meet national pulmonary heart disease specialized conference revision in 1980.
2, administrated method is taken medicine and is organized totally 55 examples, with the 20 routine patients with cor pulmonale of not taking tea pigment as matched group, two groups base therapy is identical, give treatments such as oxygen uptake, antiinflammatory, expansion bronchus and heart tonifying diuresis, record cardinal symptom such as serious cough with asthma before the treatment, uncomfortable in chest, out of breath, cardiopalmus, breathe hard, edema etc., and check arterial blood gas analysis, routine blood test etc.Experimental group adds tea pigment capsule, each 2 times, every day secondary, 45 days is a course of treatment.
Two, result
1, takes medicine that symptom integral changes (seeing Table 1) before and after the group treatment
Symptom integral changed before and after table 1 was taken medicine and organized treatment
2, symptom integral changes (seeing Table 2) before and after the treatment of control group
Symptom integral changes before and after table 2 treatment of control group
Figure 9711681800111
Symptom score (can only select one): asymptomatic=0 minute, mild=1 minute, moderate symptom=2 minute, severe symptom=3 minute.
3, the variation (seeing Table 3) of blood gas analysis and Hb before and after the medication
By table 3 as seen, take Hb and Paco behind the tea pigment 2Reduction and Sao 2And PaO 2Rising than matched group obvious (P<0.05).

Claims (3)

1, the application of tea pigment in the medicine of preparation treatment pulmonary heart disease.
2, the application of tea pigment in the medicine of preparation treatment patients with cor pulmonale heart failure.
3, the application of tea pigment in the medicine of preparation treatment patients with cor pulmonale respiratory failure.
CN 97116818 1997-08-18 1997-08-28 Application of tea pigments in preparation of medicine for cor pulmonale Expired - Fee Related CN1065759C (en)

Priority Applications (2)

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CN 97116818 CN1065759C (en) 1997-08-28 1997-08-28 Application of tea pigments in preparation of medicine for cor pulmonale
PCT/CN1998/000167 WO1999008674A1 (en) 1997-08-18 1998-08-18 New uses of tea pigment

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CN1065759C true CN1065759C (en) 2001-05-16

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