CN102961383A - Application of tanshinone IIA or pharmaceutically acceptable salt thereof in improving exercise tolerance of pulmonary vascular disease patients - Google Patents
Application of tanshinone IIA or pharmaceutically acceptable salt thereof in improving exercise tolerance of pulmonary vascular disease patients Download PDFInfo
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- CN102961383A CN102961383A CN2012104628010A CN201210462801A CN102961383A CN 102961383 A CN102961383 A CN 102961383A CN 2012104628010 A CN2012104628010 A CN 2012104628010A CN 201210462801 A CN201210462801 A CN 201210462801A CN 102961383 A CN102961383 A CN 102961383A
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Abstract
The invention discloses application of tanshinone IIA or a pharmaceutically acceptable salt thereof in preparing a medicament for improving the exercise tolerance of pulmonary vascular disease patients. The tanshinone IIA or the pharmaceutically acceptable salt thereof can be used for preparing the medicament for improving the exercise tolerance of the pulmonary vascular disease patients; the tanshinone IIA or the pharmaceutically acceptable salts thereof can be combined with common medicaments for treating the pulmonary vascular diseases clinically at present; and the tanshinone IIA or the pharmaceutically acceptable salt thereof is safe and effective and low in price, and has bright market prospect.
Description
Technical field
The present invention relates to the new application of tanshinone IIA, especially relate to the application of acceptable salt in improving pulmonary vascular disease patient activity tolerance on tanshinone IIA or its materia medica.
Background technology
Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Radix Salvia Miltiorrhiza bge., begins to be stated from Shennong's Herbal, bitter in the mouth, cold nature, have broken disease except abdominal mass, end stuffy sensation with restlessness, the effects such as QI invigorating, classify as top grade, GUIXIN, liver two warps, the successive dynasties book on Chinese herbal medicine all records.
Tanshinone IIA is the effective monomer that extracts from salviamiltiorrhizabung, and its molecular formula is C
19H
18O
3, the clinical Cardiovarscular aspect that is mainly used in has atherosclerosis, suppresses the effects such as left ventricular hypertrophy, arrhythmia at present.
Pulmonary vascular disease refers to the general name of disease of pulmonary circulation, refers to because pulmonary artery, pulmonary vein and the dysfunction of pulmonary capillary and the disease that pathological change causes comprise the diseases such as pulmonary hypertension, pulmonary venous hypertension and pulmonary infarction.Pulmonary hypertension has the advantages that cause of disease complexity, sickness rate are high, misdiagnosis rate is high, hazardness is strong, mortality rate is high, and its main clinical manifestation is that average pulmonary artery is more than or equal to 25mmHg.Pulmonary vascular disease comprises that kinds of Diseases are many, and the cause of disease is complicated, but often has similar disease to send out process and prognosis of disease.But degradation symptom under out of breath, weak, dyspnea, limitation of activity or the activity tolerance how can occur, affect patient's prognosis and quality of life.Be a difficult point for pulmonary vascular treatment clinically at present, it is few and curative effect is limited to can be used for the medicament categories of lung vascular treatment.Therefore be badly in need of clinically a kind of safe, effectively can improve pulmonary vascular disease patient activity tolerance, improve the medicine of patients ' life quality and prognosis.
Summary of the invention
The object of the present invention is to provide the new purposes of acceptable salt on tanshinone IIA or its materia medica, i.e. tanshinone IIA and derivant thereof the new application in pharmacy.
Particularly, the object of the invention is to provide the application in acceptable salt on tanshinone IIA or its materia medica can improve pulmonary vascular disease patient activity tolerance as preparation the medicine.
In fact, the present invention relates to acceptable salt on tanshinone IIA or its materia medica and improve application in the pulmonary vascular disease patient activity tolerance medicine as preparation.
Relate to acceptable salt on tanshinone IIA or its materia medica and improve application in the pulmonary hypertension patient activity tolerance medicine as preparation.
Relate to the application in acceptable salt on tanshinone IIA or its materia medica improves pulmonary venous hypertension Disease activity tolerance as preparation the medicine.
Relate to the application in acceptable salt on tanshinone IIA or its materia medica improves Pulmonary Embolism Patients (chronic thromboembolia type patients with pulmonary hypertension) activity tolerance as preparation the medicine.
Relate to the application in acceptable salt on tanshinone IIA or its materia medica improves the right heart failure patient activity tolerance that pulmonary vascular disease causes as preparation the medicine.
Acceptable salt can use separately or use with the form of pharmaceutical composition on tanshinone IIA of the present invention or its materia medica, and described pharmaceutical composition comprises acceptable salt and pharmaceutical carrier on active component tanshinone IIA or its materia medica.The drug regimen that can also comprise the treatment pulmonary vascular disease of one or more compositions in acceptable salt on tanshinone IIA or its materia medica and pharmaceutical carrier and prostacyclin and analog (such as epoprostenol), endothelin 1 receptor antagonists (such as bosentan), phosphodiesterase inhibitor (such as sldenafil) and the anticoagulant (such as Low molecular heparin) in the described pharmaceutical composition.
The treatment effective dose of acceptable salt is the dosage that improves lung blood vessel patient activity tolerance, improves its quality of life isoreactivity effect for producing after the individual administration on described tanshinone IIA or its materia medica.And when giving individual single dose or multiple dose, dosage comprises the effect of pharmacokinetic property, route of administration, what characteristic (sex, age, body weight, health condition, build) of patient's situation, symptom degree and the treatment of depositing, therapeutic frequency and the expectation of acceptable salt on tanshinone IIA or its materia medica according to many factors and difference.
Generally, the independent medication of acceptable salt can reach the effect for the treatment of on described tanshinone IIA or its materia medica.Described tanshinone IIA or derivatives thereof is for each dosage of the active component of individuality 40 ~ 80 mg/ time, and once a day, treatment cycle was 4 ~ 8 weeks, just can reach the activity tolerance that significantly improves patient, effective therapeutic effect of the quality of making the life better.When the medicine of tanshinone IIA or derivatives thereof and other treatment pulmonary vascular disease share, the each dosage that share dosage and usage and be 1. tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, the iloprost inhalation dose is 2.5 ~ 5.0ug/ time, one day 6 ~ 9 times, each medication is interval two hours at least.In 4 ~ 8 weeks for the treatment of cycle, 2. each dosage of tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, bosentan one day 2 times, each 62.5mg continued for 4 weeks, increased to subsequently maintenance dose 125mg.Treatment cycle is 4-12 week.3. each dosage of tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, and sldenafil, 20 ~ 80mg/ days, one day three times.Treatment cycle was 8 ~ 12 weeks.Because anticoagulant using dosage meter usage is very complicated clinically, when recommendation is share with the tanshinone IIA or derivatives thereof, set the scheme of share with clinical specific targets.Share of acceptable salt and other drug is not limited to the scheme of share that lists herein on tanshinone IIA or its materia medica, is not limited to two kinds of drug combinations, has three medicines of evidence-based medical and multiple medicines to share also in the protection domain of this patent.
Acceptable salt can carry out individual administration by number of ways on described tanshinone IIA and the materia medica thereof, and that route of administration comprises is oral, intravenous injection etc.Correspondingly, described tanshinone IIA or derivatives thereof can be prepared into oral formulations and injection with pharmaceutically suitable carrier.Wherein, oral formulations comprises tablet, capsule, microcapsule, soft capsule, granule, drop pill, oral liquid and powder.Injection comprises intravenous injection and injectable powder.Can also different pharmaceutically suitable carrier can be equipped with according to the dosage form needs, antioxidant, emulsifying agent, stabilizing agent and antifungus agent can be added simultaneously.
Beneficial effect of the present invention is as follows:
1. the present invention has excavated new medical application to acceptable salt on known compound tanshinone IIA or its materia medica, has opened up a new application.
2. acceptable salt can improve the medicine of pulmonary vascular disease patient activity tolerance safely and effectively on tanshinone IIA or its materia medica, and acceptable salt can share with the present clinically common drug for the treatment of pulmonary vascular disease commonly used on tanshinone IIA and the materia medica thereof, safe and effective, low price has market prospect.
Description of drawings
Fig. 1 is that rear average six minutes walking distances of patients with pulmonary hypertension obviously increase around the sodium tashinone II A sulfonate injection treatment, and there is statistical significance P＜0.01.Different straight lines represents the variation of the six minutes walking distances in different patient front and back, N=10 among the figure.
Fig. 2 significantly improves with rear patients with pulmonary hypertension Borg scoring around the sodium tashinone II A sulfonate injection treatment, and there is statistical significance P＜0.01.
Fig. 3 is that rear average six minutes walking distances of chronic thromboembolia type patients with pulmonary hypertension obviously increase around the sodium tashinone II A sulfonate injection treatment, and there is statistical significance P＜0.05.Different straight lines represents the variation of the six minutes walking distances in different patient front and back, N=3 among the figure.
Fig. 4 is that rear average six minutes walking distances of patients with pulmonary hypertension obviously increase around the treatment of sodium tashinone II A sulfonate injection associating sldenafil, and there is statistical significance P＜0.01.Different straight lines represents the variation of the six minutes walking distances in different patient front and back, N=5 among the figure.
The specific embodiment
Describe by the following examples the new purposes of acceptable salt in field of medicaments on tanshinone IIA or its materia medica, but following examples only purpose of the present invention do not limit protection scope of the present invention for illustrating.
Among the present invention on tanshinone IIA or its materia medica independent medication of acceptable salt can reach the effect for the treatment of.Described tanshinone IIA or derivatives thereof is for each dosage of the active component of individuality 40 ~ 80 mg/ time, and once a day, treatment cycle was 4 ~ 8 weeks, just can reach the activity tolerance that significantly improves patient, effective therapeutic effect of the quality of making the life better.When the medicine of tanshinone IIA or derivatives thereof and other treatment pulmonary vascular disease share, share dosage and usage is: 1. each dosage of tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, the iloprost inhalation dose is 2.5-5.0ug/ time, one day 6 ~ 9 times, each medication is interval two hours at least.Treatment cycle 4-8 week, 2. each dosage of tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, bosentan one day 2 times, each 62.5mg in lasting 4 weeks, increases to maintenance dose 125mg subsequently.Treatment cycle is 4-12 week.3. each dosage of tanshinone IIA active component is 40 ~ 80 mg/ time, once a day, and sldenafil, 20 ~ 80mg/ days, one day three times.Treatment cycle was 8 ~ 12 weeks.Because anticoagulant using dosage meter usage is very complicated clinically, when recommendation is share with the tanshinone IIA or derivatives thereof, set the scheme of share with clinical specific targets.Share of acceptable salt and other drug is not limited to the scheme of share that lists herein on tanshinone IIA or its materia medica, is not limited to two kinds of drug combinations, has three medicines of evidence-based medical and multiple medicines to share also in the protection domain of this patent.
Acceptable salt can carry out individual administration by number of ways on tanshinone IIA and the materia medica thereof, and that route of administration comprises is oral, intravenous injection etc.Correspondingly, described tanshinone IIA or derivatives thereof can be prepared into oral formulations and injection with pharmaceutically suitable carrier.Wherein, oral formulations comprises tablet, capsule, microcapsule, soft capsule, granule, drop pill, oral liquid and powder.Injection comprises intravenous injection and injectable powder.Can also different pharmaceutically suitable carrier can be equipped with according to the dosage form needs, antioxidant, emulsifying agent, stabilizing agent and antifungus agent can be added simultaneously.
Embodiment one: can significantly increase average six minutes walking distances of patients with pulmonary hypertension after around the tanshinone IIA treatment
One, patient information
Patient is totally 10 examples, male's 4 examples wherein, women's 6 examples, 17 ~ 62 years old age.
Two, enter the group standard
All enter to organize patient and be diagnosed as patients with pulmonary hypertension according to " ESC2009 pulmonary hypertension diagnosis and treatment treatment guide ", all the front echocardiography pulmonary arterial systolic pressure of patient is all greater than 40mmHg.
Three, experimental program
Patient carries out walking in six minutes experiment (6MWT) after entering group, average six minutes walking distances before the record experiment, then carry out conventional therapy according to the state of an illness, and give and sodium tashinone II A sulfonate injection 1mg/Kg body weight, add 5% glucose injection, intravenous drip, once a day, treatment cycle was 4 weeks.Carry out again walking in six minutes experiment, average six minutes walking distances after the record treatment.
Result of the test: as shown in Figure 1, the front patient's for the treatment of average six minutes walking distances are 260 ± 45m, and patient's average six minutes walking distances are 424 ± 31m after the treatment, and there is statistical significance P＜0.01.
Conclusion:Can significantly improve six minutes walking distances of pulmonary hypertension patient around the tanshinone IIA treatment, obviously improve the patient activity ability.
Embodiment two: can significantly improve patients with pulmonary hypertension dyspnea and tired scoring after around the tanshinone IIA treatment
One, patient information
Patient is totally 10 examples, male's 4 examples wherein, women's 6 examples, 17 ~ 62 years old age.
Two, enter the group standard
All enter to organize patient and be diagnosed as patients with pulmonary hypertension according to " ESC2009 pulmonary hypertension diagnosis and treatment treatment guide ", all the front echocardiography pulmonary arterial systolic pressure of patient is all greater than 40mmHg.
Three, experimental program
Patient enters to organize the relief patient and utilizes Borg dyspnea and tired grade form to carry out dyspnea and tired scoring (Borg scoring), score value before the record experiment, then carry out conventional therapy according to the state of an illness, and give and sodium tashinone II A sulfonate injection 1mg/Kg body weight, add 5% glucose injection, intravenous drip, once a day, treatment cycle was 4 weeks.Carry out again dyspnea and tired scoring, record its score value.
Result of the test: as shown in Figure 2, the front patient's for the treatment of dyspnea is 4.9 ± 0.8m with tired scoring, and patient's patient's dyspnea is 1.1 ± 0.4m with tired scoring after the treatment, and there is statistical significance P＜0.01.
Conclusion:Can significantly improve pulmonary hypertension patient dyspnea and tired scoring (Borg scoring) around the tanshinone IIA treatment, obviously improve the patient activity ability, improve quality of life of patients.
Embodiment three: can significantly increase average six minutes walking distances of chronic thromboembolia type patients with pulmonary hypertension after around the tanshinone IIA treatment
One, patient information
Patient is totally 3 examples, is the women, age 46-62 year.
Two, enter the group standard
All enter to organize patient and be diagnosed as chronic thromboembolia type patients with pulmonary hypertension according to " ESC2009 pulmonary hypertension diagnosis and treatment treatment guide ", all the front echocardiography pulmonary arterial systolic pressure of patient is all greater than 40mmHg.
Three, experimental program
Patient carries out walking in six minutes experiment (6MWT) after entering group, average six minutes walking distances before the record experiment, then carry out conventional therapy according to the state of an illness, and give and sodium tashinone II A sulfonate injection 1mg/Kg body weight, add 5% glucose injection, intravenous drip, once a day, treatment cycle was 4 weeks.Carry out again walking in six minutes experiment, average six minutes walking distances after the record treatment.
Result of the test: as shown in Figure 3, the front patient's for the treatment of average six minutes walking distances are 128 ± 25m, and patient's average six minutes walking distances are 408 ± 16m after the treatment, and there is statistical significance P＜0.01.
Conclusion:Can significantly improve six minutes walking distances of pulmonary hypertension patient around the tanshinone IIA treatment, obviously improve the patient activity ability.
Embodiment four: can significantly increase average six minutes walking distances of patients with pulmonary hypertension after around the treatment of tanshinone IIA associating sldenafil
One, patient information
Patient is totally 5 examples, 2 of male, 3 of women, 18 ~ 51 years old age.
Two, enter the group standard
All enter to organize patient and be diagnosed as patients with pulmonary hypertension according to " ESC2009 pulmonary hypertension diagnosis and treatment treatment guide ", all the front echocardiography pulmonary arterial systolic pressure of patient is all greater than 40mmHg.
Three, experimental program
Patient carries out walking in six minutes experiment (6MWT) after entering group, and then average six minutes walking distances before the record experiment carry out conventional therapy according to the state of an illness, and give and sodium tashinone II A sulfonate injection 1mg/Kg body weight, add 5% glucose injection, intravenous drip, once a day.Share sldenafil 25mg/ time, one day three times, treatment cycle was 4 weeks.Carry out again walking in six minutes experiment, average six minutes walking distances after the record treatment.Rear patient's adverse effect is share in observation.
Result of the test: as shown in Figure 3, the front patient's for the treatment of average six minutes walking distances are 161 ± 36m, and patient's average six minutes walking distances are 415 ± 11m after the treatment, and there is statistical significance P＜0.01.Patient is without ADR.
Conclusion:Can significantly improve six minutes walking distances of pulmonary hypertension patient around the treatment of tanshinone IIA associating sldenafil, obviously improve the patient activity ability.Without obvious adverse reaction.
Claims (10)
1. acceptable salt can improve application in the medicine of pulmonary vascular disease patient activity tolerance as preparation on tanshinone IIA or its materia medica.
2. acceptable salt improves application in the pulmonary vascular disease patient activity tolerance medicine as preparation on tanshinone IIA or its materia medica.
3. acceptable salt improves application in the pulmonary hypertension patient activity tolerance medicine as preparation on tanshinone IIA or its materia medica.
4. acceptable salt improves application in the medicine of pulmonary venous hypertension Disease activity tolerance on tanshinone IIA or its materia medica as preparation.
5. acceptable salt improves application in the medicine of Pulmonary Embolism Patients activity tolerance on tanshinone IIA or its materia medica as preparation.
6. acceptable salt improves application in the medicine of the right heart failure patient activity tolerance that pulmonary vascular disease causes on tanshinone IIA or its materia medica as preparation.
7. according to claim 1 ~ 6 described application of arbitrary claim is characterized in that, acceptable salt uses separately on described tanshinone IIA or its materia medica.
8. according to claim 1 ~ 6 described application of arbitrary claim, it is characterized in that, acceptable salt uses with the form of pharmaceutical composition on described tanshinone IIA or its materia medica, and described pharmaceutical composition comprises acceptable salt and pharmaceutical carrier on tanshinone IIA or its materia medica.
9. application according to claim 8 is characterized in that, also comprises one or more the compositions in prostacyclin, endothelin 1 receptor antagonists and phosphodiesterase inhibitor and the anticoagulant in the described pharmaceutical composition.
10. according to claim 1 ~ 6 described application of arbitrary claim is characterized in that, acceptable salt and pharmaceutically suitable carrier are prepared into oral formulations or injection on described tanshinone IIA or its materia medica.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105125554A (en) * | 2015-07-23 | 2015-12-09 | 南京赋海澳赛医药科技有限公司 | Composition and application thereof in drugs for resisting chronic obstructive pulmonary diseases |
Citations (1)
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| CN102160866A (en) * | 2011-04-13 | 2011-08-24 | 广州医学院第一附属医院 | Application of tanshinone IIA or pharmaceutically acceptable salts thereof in preparing medicines for treating or preventing pulmonary hypertension disease |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102160866A (en) * | 2011-04-13 | 2011-08-24 | 广州医学院第一附属医院 | Application of tanshinone IIA or pharmaceutically acceptable salts thereof in preparing medicines for treating or preventing pulmonary hypertension disease |
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| JING WANG ET AL.: "Tanshinone IIA modulates pulmonary vascular response to agonist and hypoxia primarily via inhibiting Ca2+ influx and release in normal and hypoxic pulmonary hypertension rats", 《CARDIOVASCULAR PHARMACOLOGY》 * |
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| 陈豫钦等: "丹参酮IIA磺酸钠抑制低氧性肺动脉高压大鼠模型IL-6的表达", 《中华医学会呼吸病学年会－2011（第十二次全国呼吸病学学术会议）论文汇编》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105125554A (en) * | 2015-07-23 | 2015-12-09 | 南京赋海澳赛医药科技有限公司 | Composition and application thereof in drugs for resisting chronic obstructive pulmonary diseases |
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Application publication date: 20130313 |