CN104587145A - Application of qi regulating and blood activating preparation in preparation of drug for prevention and treatment of acute coronary syndrome - Google Patents
Application of qi regulating and blood activating preparation in preparation of drug for prevention and treatment of acute coronary syndrome Download PDFInfo
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Abstract
Belonging to the field of medicine, the invention relates to application of a qi regulating and blood activating preparation in preparation of a drug for prevention and treatment of acute coronary syndrome. The qi regulating and blood activating preparation is prepared from 350-600 parts of Cinnamomum migao, 4-15 parts of borneol, 250-500 parts of Ligusticum wallichii, 25-50 parts of Allium macrostemon as the raw materials. Clinical experiments investigate patient angina pectoris, traditional Chinese medicine syndrome scoring, inflammatory indicators and other indexes, and experimental data show that the qi regulating and blood activating preparation can protect blood vessel injury, control inflammatory reaction and alleviate plaque formation and rupture, can significantly improve acute myocardial infarction caused by acute myocardial ischemia, unstable angina and other symptoms. Thus, the qi regulating and blood activating preparation can be used as an ideal drug for prevention and treatment of acute coronary syndrome.
Description
Technical field:
The invention belongs to field of medicaments, be specifically related to the application of vital energy regualting and blood circulation-promoting preparation in preparation control acute coronary syndrome medicine.
Background technology:
Acute coronary syndrome (ACS) is rotten to the corn with Coronary Atherosclerotic Plaque or breaks, complete or the incomplete occluding thrombus of secondary, become one group of clinical syndrome caused by acute myocardial ischemia, comprise acute myocardial infarction (AMI) and unstable angina pectoris (UA), wherein AMI comprises ST section elevation myocardial infarction, Non-ST Elevation Acute type myocardial infarction; A kind of great, common disease of serious harm human health.Coagulation function activates and vulnerable plaque inflammatory reaction playing an important role at ACS, is two central pathological links.There is atheromatous plaque in coronary artery is the basic reason causing acute coronary syndrome, and plaque rupture is the immediate cause causing acute coronary syndrome.
At present clinically by aspirin, clopidogrel Antiplatelet therapy, the application of heparin anticoagulant therapy and other ischemia resisting medicine, makes prognosis improve.Aspirin is cox-2 inhibitors, hinders arachidonic acid development for TXA2, has irreversible inhibitory action to the platelet aggregation of TXA2 induction; Clopidogrel is the medicine of special suppression ADP activated blood platelet, has special powerful inhibitory action, and be irreversible reaction to the platelet aggregation of ADP induction.But aspirin, clopidogrel they in platelet activation approach can only be stoped respectively to carry out anticoagulant, and the activation of hematoblastic activation, coagulation function is also undertaken by other approach; In addition, at present the reaction that controls inflammation, stablize vulnerable plaque treatment on still lack effective means.
The traditional Chinese medical science is thought, acute coronary syndrome is Primary Asthenia-Secondary Sthenia Syndrome, and clinical main manifestations is these deficiency syndrome of the deficiency of vital energy, yang deficiency, the deficiency of YIN and deficiency of both QI and YIN or gas sun two void, the mark excess syndrome of the stagnation of QI, blood stasis, stagnation of phlegm, cold coagulation, and blood stasis is ubiquitous pathological characteristic, can through the overall process of coronary heart disease.Acute coronary syndrome is common mostly is heart blood silt, therefore Chinese medicine reaches the drug treatment of effect of coronary circulation-promoting pain-relieving based on activating blood and removing stasis Method.Current Chinese medicine has shown huge potentiality in the treatment of acute coronary syndrome.
Fructus cinnamomi camphorae has another name called Cinnamomum Migao H.W.Li., is the dry fruit of Lauraceae cinnamon, its volatile oil having content higher, and its chemical composition is mainly monoterpene or sesquiterpenoids; This property of medicine taste: Xin Wen, nontoxic; There is expelling cold and dampness, promoting the circulation of QI to relieve pain effect.Modern pharmacology research demonstrates Cinnamomum Migao H.W.Li. energy relaxing smooth muscle; increase coronary flow; reduce myocardial oxygen consumption, improve hemodynamics, On Antagonizing Experimental Arrhythmia, anti-bacteria and anti-virus, anti-inflammation detumescence ease pain, have the effects such as good protection to cat acute experimental myocardial ischemia and infraction.
Rhizoma Chuanxiong is the rhizome of Umbelliferae Ligustrum plant Rhizoma Chuanxiong, warm in nature, acrid in the mouth, micro-hardship, is the Chinese medicine that blood circulation promoting and blood stasis dispelling is conventional; Its contain volatile oil, alkaloid, phenolic substance, organic acid, Phthalide lactone and other etc. composition; There is effect of blood-activating and qi-promoting, wind-expelling pain-stopping.Clinical pharmacology research shows: Rhizoma Chuanxiong has relaxing smooth muscle, increases hat flow, reduces myocardial oxygen consumption, improves myocardial metabolism, expands peripheral blood vessel, anti-platelet aggregation, antithrombus formation, increase blood flow and improves the effect such as microcirculation and sedation and analgesia.
Bulbus Allii Macrostemonis is Chinese medicine traditional simply, is the dry bulb of Liliaceae allium Allium macrostemon AlliummacmstemonBge. or Chinese onion Allium chinensis G.Don.Nature and flavor acrid, bitter, warm, has warming middle-JIAO to activate yang, the chest stuffiness relieving of regulating the flow of vital energy, effect of activating YANG and eliminating stagnation.Bulbus Allii Macrostemonis is clinical is usually used in the thoracic obstruction, chest pain radiating to the back etc.Containing more than 10 kind of steroid saponins such as Bulbus Allii Macrostemonis glycoside A-I in the polar component of Bulbus Allii Macrostemonis, and the nitrogen-containing compound such as adenosine, thymidine.Mainly sulfur-containing compound in volatile ingredient, wherein containing methacrylic trithioether platelet aggregation being had to strong inhibition effect.In addition abundant aminoacid and the element of multiple needed by human body is also contained in Bulbus Allii Macrostemonis.Current clinical research shows: Bulbus Allii Macrostemonis has anticoagulant, blood fat reducing and control atherosclerosis, and antibacterial antioxidation, anticancer, spasmolytic is relievingd asthma, the effects such as analgesia and anoxia enduring.
Borneolum Syntheticum is the processed goods of Spore density Borneolum Syntheticum resin, or the crystallization that feverfew Herba Blumeae Balsamiferae leaf extracts, or is the highly finished product that raw material synthesizes through chemical method with Oleum Terebinthinae, Camphora etc.The main component of borneol is dextro Borneolum Syntheticum, and Blumeae preparatum Tabellae is mainly L-Borneol, and Borneolum Syntheticum is pungent, bitter, be slightly cold.GUIXIN, spleen, lung meridian, have the function of refreshment of having one's ideas straightened out, clearing away heat to alleviate pain.Modern pharmacology research demonstrates the existing effect resisted myocardial ischemia of Borneolum Syntheticum, and coronary flow can be made obviously to increase; In addition, Borneolum Syntheticum can also increase the permeability of blood brain barrier, strengthens medicine across barrier ability.
The vital energy regualting and blood circulation-promoting drop pill gone on the market is the pure Chinese medicinal preparation formed for raw material with Cinnamoman Migao H.W.Li, Bulbus Allii Macrostemonis, Rhizoma Chuanxiong, Borneolum Syntheticum, there is effect of aromatic herbs activating YANG, regulating QI to relieve pain, clinical in the obstruction of qi in the chest and cardialgia (angina pectoris) caused by prophylactic treatment deficiency of heart-YANG, stagnation of heart-blood, disease is seen uncomfortable in chest, chest pain, cardiopalmus, is breathed hard, fear of cold, very then chest pain radiating to the back, the cold pain of sense are very, hypopnea etc.As mentioned above, vital energy regualting and blood circulation-promoting preparation is good to angina pectoris action effect, but about vital energy regualting and blood circulation-promoting preparation has no report in the effect for the treatment of acute coronary syndrome, therefore study the disease such as acute myocardial infarction, unstable angina that vital energy regualting and blood circulation-promoting preparation shows at treatment acute coronary syndrome significant.
Summary of the invention:
The object of this invention is to provide the application of vital energy regualting and blood circulation-promoting preparation in preparation treatment acute coronary syndrome medicine.
Another object of the present invention is to provide vital energy regualting and blood circulation-promoting preparation at treatment acute coronary syndrome relevant disease as the application in unstable angina, acute myocardial infarction, sudden death etc.
Vital energy regualting and blood circulation-promoting preparation of the present invention is the preparation of the various dosage forms be prepared from as raw material by Cinnamomum Migao H.W.Li., Rhizoma Chuanxiong, Bulbus Allii Macrostemonis, Borneolum Syntheticum four taste Chinese medicine.
Vital energy regualting and blood circulation-promoting preparation of the present invention, according to listed as parts by weight, is prepared from by following raw material medicaments: Cinnamomum Migao H.W.Li. 350 ~ 600 parts, Borneolum Syntheticum 4 ~ 15 parts, Rhizoma Chuanxiong 250 ~ 500 parts, Bulbus Allii Macrostemonis 25 ~ 50 parts.
Say accurately, according to listed as parts by weight, be prepared from by following raw material medicaments: Cinnamomum Migao H.W.Li. 450 parts, Borneolum Syntheticum 9 parts, Rhizoma Chuanxiong 360 parts, Bulbus Allii Macrostemonis 36 parts.
Preparation method of the present invention first crude drug is become active constituents of medicine through processing extraction purification, then is prepared into pharmaceutical preparation further; Its preparation method belongs to prior art, can obtain from file disclosed in existing patent, or technical literature and drug standard preparation disclosed in other.
Vital energy regualting and blood circulation-promoting preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, buccal tablet, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, spray, drop pill, patch.
Vital energy regualting and blood circulation-promoting preparation of the present invention, its preparation can containing conventional excipient, such as binding agent, filler, tablet agent, diluent, wetting agent, disintegrating agent, coloring agent, flavoring agent, wetting agent and medicinal carrier material.
The preferred vital energy regualting and blood circulation-promoting drop pill of vital energy regualting and blood circulation-promoting preparation of the present invention.
Vital energy regualting and blood circulation-promoting preparation of the present invention is in use according to the situation determination usage and dosage of patient.The vital energy regualting and blood circulation-promoting drop pill produced by Guizhou National Pharmaceutical Co., Ltd such as gone on the market, the heavy 25mg of every ball, usage and dosage is oral, every day 3 times, each 10.
Acute coronary syndrome comprises unstable angina pectoris, non-ST elevation myocardial infarction, ST elevation myocardial infarction etc., it is a kind of specific type in coronary heart disease, sb.'s sickness becomes critical, think this kind of disease at present, have common pathomechanism, namely on atherosclerotic basis, Plaque instability increases, show as that plaque surface occurs slight crack, breaks, thrombosis, finally cause blood vessel not exclusively or entirely shut.Think at present, cause and promote that the reason that speckle instability increases mainly contains inflammatory reaction, in ACS patient body, the inflammatory reaction of Showed Very Brisk causes speckle by stablizing the main cause changed to instability.And CRP, IL-6, TNF-α is the important pro-inflammatory factor of inflammatory reaction, at present, the struvite index of clinical research is based on CRP, IL-6, TNF-α.
For probing into the application of vital energy regualting and blood circulation-promoting preparation at treatment acute coronary syndrome, the present invention selects 90 routine clinical definites to be the patient of acute coronary syndrome, is divided into matched group and vital energy regualting and blood circulation-promoting treatment group at random; After treatment cycle terminates, to observe curative effect to treat angina pectoris, ECG curative effect, to comprise dead Western medicine colligation curative effect, Chinese medicine syndrome integral as clinical efficacy indexes, detect c reactive protein (CRP), interleukin 8-6 (IF-6) and tumor necrosis factor (TNF-α) level before and after treatment simultaneously.Result show: treatment after two groups of inflammation index CRP, IF-6, TNF-α all obviously decline, and treatment group comparatively matched group decline more obvious; Treatment group curative effect to treat angina pectoris, ECG curative effect, comprise dead Western medicine colligation curative effect, Chinese medicine syndrome integral is more all better than matched group, indicate vital energy regualting and blood circulation-promoting preparation, to prophylactic treatment acute coronary syndrome, there is significant curative effect, may be used for prophylactic treatment acute coronary syndrome and relevant disease thereof.
Detailed description of the invention:
For a better understanding of the present invention, adopt following experimental example, its novelty teabag in pharmaceutical field is described.Following experiment is intended to the present invention is described but not limitation of the present invention.
Experimental example:
1, clinical data all cases all derives from Guiyang Medical College inpatient between in April ,-2013 in January, 2012, through being diagnosed as acute coronary syndrome, totally 160 examples, are divided into treatment 1 group (routine of western medicine+vital energy regualting and blood circulation-promoting) at random, treat 2 groups (routine of western medicine+fast-acting heart disease curings), treat 3 groups (heart protected by routine of western medicine+Moschus), each 40 examples of matched group (routine of western medicine); Wherein treatment group: male 70 people, women 50 people, mean age is (60.25 ± 10.56) year, ill-distribution is unstable angina pectoris (UA) is 87 examples, ST section elevation myocardial infarction (STEMI) 18 example, Non-ST Elevation Acute type myocardial infarction (NSTEMI) 15 example, be divided into three treatment groups again, every group 40 example, no significant difference; Matched group: male 23 people, women 17 people, the mean age (62.37 ± 7.89) year, ill-distribution to be unstable angina pectoris (UA) be 29 examples, ST section elevation myocardial infarction (STEMI) 6 example, Non-ST Elevation Acute type myocardial infarction (NSTEMI) 5 example.Each group in sex, age, the course of disease and ill-distribution etc. through statistical test no significant difference.
2, Therapeutic Method: treat 1 group: give vital energy regualting and blood circulation-promoting drop pill on western medicine routine treatment basis, every day 3 times, each 10, the course for the treatment of is 2 weeks; Treat 2 groups: on western medicine routine treatment basis, give SUXIAO JIUXIN WAN, each 7 balls (the heavy 40mg of every ball), 3 times on the one; Treat 3 groups: on western medicine routine treatment basis, give Heart pill of Musk, each 2 balls (the heavy 22.5mg of every ball), 3 times on the one; Matched group: for western medicine routine treatment standard is treated.
Western medicine routine treatment comprises monitoring, calmness, analgesia, oxygen uptake, antiplatelet, anticoagulant, coronary artery dilating, tune fat, blood pressure lowering etc.The medicines such as aspirin, receptor blocking agent, angiotensin converting enzyme inhibitor, calcium antagonist are all allowed to use.
3, observation index: a, safety indexes: three large routine, rabat, hepatic and renal functions.B, curative effect index: the cardinal symptoms such as angina pectoris and electrocardiogram before the treatment after change; Tcm syndrome curative effect: chest pain, uncomfortable in chest, cardiopalmus etc.C, inflammation index: CRP Concentration Testing, IF-6 detect, TNF-alpha levels detects.
4, efficacy assessment standard
4.1 angina pectoriss, ECG curative effect evaluation criteria: " angina pectoris and the ECG curative effect evaluation criteria " worked out with reference to Angina Pectoris from Coronary Artery Disease with Therapy of Combination of TCM with Western Medicines in 1979 and arrhythmia forum.
4.2 Comprehensive Clinical efficacy assessment standards: work out with reference to method in " the new Chinese medicine treatment thoracic obstruction (coronary heart disease angor) guideline of clinical investigations " and " angina pectoris and ECG curative effect evaluation criteria " of Ministry of Public Health formulation in 1993.
4.3 tcm syndrome efficacy assessment standards: tcm syndrome score standard and tcm syndrome efficacy assessment standard, with reference to " traditional Chinese medical science cardiopathia Standardization of diagnosis and curative effect and the medication specification " of Shen Shaogong.
5, experimental result
5.1 clinical efficacy
5.1.1 curative effect to treat angina pectoris compares, and the results are shown in following table 1:
Table 1: curative effect to treat angina pectoris compares: N/ example (P/%)
| Group | N | Effective | Effectively | Invalid | Increase the weight of | Dead | Total effective rate |
| Treatment 1(vital energy regualting and blood circulation-promoting) | 40 | 19（47.5） | 17（42.5） | 2（5.0） | 1（2.5） | 1（2.5） | 90.0% |
| Treatment 2(fast-acting heart disease curing) | 40 | 17（42.5） | 17（42.5） | 3（7.5） | 2（5.0） | 1（2.5） | 85.0% |
| The heart protected by treatment 3(Moschus) | 40 | 17（42.5） | 16（40.0） | 3（7.5） | 3（7.5） | 1（2.5） | 82.5% |
| Matched group | 40 | 14（35.0） | 11（27.5） | 7（17.5） | 5（12.5） | 3（7.5） | 62.5% |
Upper table display: comparitive study between treatment group and matched group after treatment, analyze through Ridit, P<0.05, difference has significant, illustrates that treatment group more can improve angina pectoris symptom effectively than matched group; Compare between each treatment group, vital energy regualting and blood circulation-promoting drop pill group is better than other treatment group, shows that vital energy regualting and blood circulation-promoting preparation is more excellent to improvement anginal during acute attack.
5.1.2 ECG curative effect compares, and the results are shown in following table 2:
Table 2: ECG curative effect compares: N/ example (P/%)
| Group | N | Effective | Effectively | Invalid | Increase the weight of | Total effective rate |
| Treatment 1(vital energy regualting and blood circulation-promoting) | 40 | 16（40.0） | 14（35.0） | 6（15.0） | 3（7.5） | 75.0% |
| Treatment 2(fast-acting heart disease curing) | 40 | 13（32.5） | 13（32.5） | 7（17.5） | 6（15.0） | 65.0% |
| The heart protected by treatment 3(Moschus) | 40 | 13（32.5） | 12（30.0） | 8（20.0） | 6（15.0） | 62.5% |
| Matched group | 40 | 10（25.0） | 7（17.5） | 12（30.0） | 8（20.0） | 42.5% |
Upper table display: comparitive study between treatment group and matched group after treatment, analyze through Ridit, P<0.05, difference has significant, illustrates that treatment group more can improve ECG curative effect effectively than matched group; Compare between each treatment group, vital energy regualting and blood circulation-promoting drop pill group is better than other treatment group, shows that vital energy regualting and blood circulation-promoting preparation is more excellent to improvement Electrocardiographic during acute attack.
5.1.3 Western medicine colligation treatment comparative result sees the following form 3:
The treatment of table 3 Western medicine colligation is compared: N/ example (P/%)
| Group | N | Effective | Effectively | Invalid | Increase the weight of | Dead | Total effective rate |
| Treatment 1(vital energy regualting and blood circulation-promoting) | 40 | 18（45.0） | 17（42.5） | 3（7.5） | 1（2.5） | 1（2.5） | 87.5 |
| Treatment 2(fast-acting heart disease curing) | 40 | 16（40.0） | 17（42.5） | 3（7.5） | 2（5.0） | 2（5.0） | 82.5 |
| The heart protected by treatment 3(Moschus) | 40 | 16（40.0） | 17（42.5） | 2（5.0） | 3（7.5） | 2（5.0） | 82.5 |
| Matched group | 40 | 14（37.5） | 11（27.5） | 8（20.0） | 5（12.5） | 3（7.5） | 62.5 |
Upper table display: analyze through Ridit, P<0.05, difference has significant, and treatment group can improve the Comprehensive Clinical curative effect comprising death effectively; Compare between each treatment group, difference is without remarkable objection, but vital energy regualting and blood circulation-promoting drop pill group is slightly better than other treatment group, shows that vital energy regualting and blood circulation-promoting preparation is better to the improvement of Comprehensive Clinical symptom during acute attack.
5.1.4 Chinese medicine syndrome integral compares, and the results are shown in following table 4:
Table 4: Chinese medicine syndrome integral compares
| Group | N | Before treatment | After treatment | Difference before and after treatment |
| Treatment 1(vital energy regualting and blood circulation-promoting) | 40 | 8.34±1.45 | 3.43±0.78 | 4.91±1.27 |
| Treatment 2(fast-acting heart disease curing) | 40 | 8.45±1.23 | 3.77±0.86 | 4.68±1.34 |
| The heart protected by treatment 3(Moschus) | 40 | 8.21±1.56 | 3.61±1.04 | 4.60±1.42 |
| Matched group | 40 | 8.16±1.33 | 4.59±1.15 | 3.57±1.19 |
Upper table display: experimental data is through statistical procedures, and before treatment, between group, syndrome integral compares, no significant difference (P>0.05); After treatment, treatment group compares with matched group syndrome integral, and difference has significant (P<0.05), illustrates that treatment group is better than matched group in the improvement of tcm clinical practice symptom; Compare between each treatment group, vital energy regualting and blood circulation-promoting drop pill group is better than other treatment group, shows that vital energy regualting and blood circulation-promoting preparation is more excellent to the improvement of tcm clinical practice symptom during acute attack.
5.2 Testing index changes:
5.2.1 inflammation index change, the results are shown in following table 5:
Inflammation index change before and after table 5 liang group patient treatment
The display of upper table: experimental data through statistical procedures, CRP, IL-6, TNF-α comparing difference there are no significant meaning (P>0.05) before two groups of treatments; After treatment, treatment group indices is all lower than matched group (P<0.05), illustrates that treatment group more can reduce the inflammatory reaction of acute coronary syndrome effectively compared with matched group; Compare between each treatment group, vital energy regualting and blood circulation-promoting drop pill group is better than other treatment group, shows that the improvement of vital energy regualting and blood circulation-promoting preparation to inflammation is more excellent.
Above-mentioned experimental example shows: the angina pectoris that vital energy regualting and blood circulation-promoting drop pill of the present invention causes acute myocardial infarction, electrocardiogram and to comprise dead Western medicine colligation curative effect all excellent compared with matched group, and difference has significant (P<0.05); Meanwhile, treatment after Syndrome in TCM marquis integration and treatment before and after integration differential relatively in, vital energy regualting and blood circulation-promoting treatment group is better than matched group; In inflammation index is affected, treatment after treatment group inflammation index CRP, IL-6, TNF-α all obviously decline, and vital energy regualting and blood circulation-promoting treatment group comparatively matched group decline more obvious, difference has significant (P<0.05).To treat with Heart pill of Musk with treatment 2,3 groups i.e. doctor trained in Western medicine basis adopting SUXIAO JIUXIN WAN and compare, there is obvious advantage, illustrate that acute myocardial infarction, unstable angina etc. that vital energy regualting and blood circulation-promoting preparation of the present invention causes acute myocardial ischemia are acute and rescue heart effect comparatively SUXIAO JIUXIN WAN, Heart pill of Musk are good.In sum: show that vital energy regualting and blood circulation-promoting drop pill has the therapeutic effect of affirmative to acute coronary syndrome, moderately can reduce the recent mortality rate of acute coronary syndrome, demonstrate it and may be used for prevention and therapy acute coronary syndrome and relevant disease thereof.
Claims (7)
1. the application of vital energy regualting and blood circulation-promoting preparation in preparation control acute coronary syndrome medicine.
2. apply as claimed in claim 1, it is characterized in that described acute coronary syndrome is the coronary artery relevant disease that acute myocardial ischemia causes.
3. apply as claimed in claim 2, it is characterized in that described relevant disease is acute myocardial infarction (AMI) and unstable angina pectoris (UA).
4. apply as claimed in claim 3, it is characterized in that described acute myocardial infarction (AMI) comprises ST section elevation myocardial infarction, Non-ST Elevation Acute type myocardial infarction.
5. the application as described in as arbitrary in claim 1-4, is characterized in that described vital energy regualting and blood circulation-promoting preparation, according to listed as parts by weight, is prepared from by following raw material medicaments: Cinnamomum Migao H.W.Li. 350 ~ 600 parts, Borneolum Syntheticum 4 ~ 15 parts, Rhizoma Chuanxiong 250 ~ 500 parts, Bulbus Allii Macrostemonis 25 ~ 50 parts.
6. apply as claimed in claim 5, described vital energy regualting and blood circulation-promoting preparation is vital energy regualting and blood circulation-promoting drop pill.
7. apply as claimed in claim 6, described vital energy regualting and blood circulation-promoting drop pill, its preparation method belongs to prior art, can obtain, or prepare according to the disclosed national drug standards from existing patent or non-patent publication.
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Application publication date: 20150506 |