CN102755580B - Method for preparing chewable tablets of drug for treating unstable angina pectoris - Google Patents

Abstract

The invention discloses a method for preparing chewable tablets of a drug for treating unstable angina pectoris, and aims to solve the problem of treatment of unstable angina pectoris. The preparation method is characterized by comprising the steps as follows: (1), cassia twigs, long pepper, dalbergia wood and coarse galangal powder are subjected to steam distillation for extracting volatile oil for standby; (2), kudzuvine root, edible mussel and arisaema fargesii are decocted, condensed, dried and crushed to obtain cooked powder; (3), sanguis draconis is crushed to obtain fine powder for standby; (4), medicinal residue obtained in step 1 is mixed and decocted with radix codonopsitis, milk vetch, radix aconite lateralis preparata, radix salviae miltiorrhizae, corydalis tuber, red halloysite and glechoma longituba, the decoction solution is filtered and condensed to thick extractum, and the thick extractum is dried and crushed to obtain dry extractum powder; (5), the dry extractum powder, the cooked powder and the volatile oil are mixed uniformly, granulated and stabilized to obtain dry granules; and (6), the dry granules are added in the fine powder obtained in step 3, mixed uniformly and compressed into tablets. Clinical trial proves that the chewable tablets prepared with the method provided by the invention have the characteristics of good curative effect and high safety when being used for treating unstable angina pectoris, thereby being worthy of clinical application and popularization.

Description

A kind of chewable tablet preparation method for the treatment of the medicine of unstable angina pectoris

[technical field]

The present invention relates to tcm field, be specifically related to treat the chewable tablet preparation method of the medicine of unstable angina pectoris.

[background technology]

Unstable angina pectoris (Unstable Angina, UA) is the clinical manifestation between fatigue stable angina pectoris and acute myocardial infarction.Mainly comprise that onset angina pectoris, deterioration effort angina, tranquillization angina pectoris companion electrocardiogram ischemia change and To Previous Angina After Myocardial Infarction.It is characterized in that the increase of carrying out property of angina pectoris symptom, rest or the angina pectoris of property at night of new outbreak or occur that the angina pectoris persistent period extends.Compare with stable angina pectoris, the pain of unstable angina pectoris is stronger, and the persistent period is longer, and lower activity just can bring out, and during rest, also can spontaneously occur (angina decubitus), and character is carrying out property (deterioration type), and these changes can combination in any.UA is generally the prodroma of acute myocardial infarction, and in 1 year, AMI incidence rate can reach 12%-13%, and mortality rate reaches 3%-18%.The pathomechanism of UA is unstable spot skin breakage in coronary artery, with thrombosis and vasoconstriction, makes due to the minimizing of blood supply of cardiac muscle constitutional.New pathological research shows, UA remains at unstable spot lipid kernel large, inflammatory cell infiltration under fibrous tissue.Western medical treatment is many selects medicament for resisting platelet aggregation, anticoagulant, nitrate esters and beta-blocker according to the state of an illness.

Angina pectoris belongs to Chinese medicine " thoracic obstruction ", " pained " category, and Chinese medicine thinks, it is weak that the pathogenic factors of primary disease mostly is plain body, aged debility, and overstrain internal injury, the bad grade of feelings will causes the deficiency of vital energy, expectorant is turbid, blood stasis is relevant.Pathogenesis is deficiency in origin and excess in superficiality, and deficiency in origin be take the deficiency of vital energy as main, and mark is real take that expectorant is turbid, blood stasis is as main, the clinical methods of taking QI invigorating dissipating phlegm and removing blood stasis more, but still lack the medicine for this specific type of unstable angina pectoris.

Mono-kind of the patent of invention < < that applies on the same day with inventor treats in the pharmaceutical composition > > of unstable angina pectoris and discloses a kind of pharmaceutical composition, its crude drug comprises: Ramulus Cinnamomi, Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali, Radix Puerariae, Radix Salviae Miltiorrhizae, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Mytilus, Rhizoma Alpiniae Officinarum, Eriocheir sinensis seven, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, Sanguis Draxonis.This kind of pharmaceutical composition preparation method is: Ramulus Cinnamomi, Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali, Radix Puerariae, Radix Salviae Miltiorrhizae, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Mytilus, Rhizoma Alpiniae Officinarum, Eriocheir sinensis seven, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN are mixed and add 4 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, adds Sanguis Draxonis powder after standing.But 4 weeks courses for the treatment of, decocting dosage form serve on 28 days, loaded down with trivial details inconvenience, patient is difficult to adhere to.

[summary of the invention]

Technical assignment of the present invention is for above the deficiencies in the prior art, and the chewable tablet preparation method of the medicine of the sure treatment unstable angina pectoris of a kind of curative effect is provided.

The technical scheme that the present invention solves its technical problem is: a kind of chewable tablet preparation method for the treatment of the medicine of unstable angina pectoris, described medicine material medicine is by Ramulus Cinnamomi, Radix Codonopsis, Radix Aconiti Lateralis Preparata, the Radix Astragali, Radix Puerariae, Radix Salviae Miltiorrhizae, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Mytilus, Rhizoma Alpiniae Officinarum, Eriocheir sinensis seven, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, and Sanguis Draxonis is made; It is characterized in that, its preparation method comprises the following steps:

(1) use extraction by steam distillation volatile oil standby Ramulus Cinnamomi, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Rhizoma Alpiniae Officinarum coarse powder, and it is standby to collect medicinal residues;

(2) Radix Puerariae, Mytilus, Eriocheir sinensis seven coarse powder are decocted with water, concentrate drying is pulverized ripe powder;

(3) Sanguis Draxonis is pulverized to such an extent that fine powder is standby;

(4) step 1 gained medicinal residues are mixed with Radix Codonopsis, the Radix Astragali, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, decoct with water secondary, collecting decoction, filter, filtrate is condensed into thick extractum, thicker extractum drying under reduced pressure is become to dry extract, pulverizes 100 mesh sieves and obtains extract dry extract;

(5) the extract obtained dry extract of step 4, the ripe powder of step 2 gained, step 1 gained volatile oil mix homogeneously, cross 20 mesh sieves granulations, granulate, obtain dry granule;

(6) the dry granule of step 5 gained is added to step 3 gained fine powder, mix tabletting.

Wherein said:

Ramulus Cinnamomi is the withe of canella Cortex Cinnamomi Cinnamomum cassia Presl.Nature and flavor acrid, sweet, warm.Enter the heart, lung, urinary bladder channel.Merit can relieving the exterior syndrome by diaphoresis, promoting the flow of QI-blood by warming the meridian, activating YANG and prormoting functioning of QI.

Radix Codonopsis is Campanulaceae Radix Codonopsis Codonopsis pilosula(Franch.) Nannf., element flower Radix Codonopsis (RADIX CODONOPSIS PILOSULAE from Northwest of China) Codonopsis pilosula Nannf.var.modesta(Nannf.) dry root of L.T.Shen or radix codonpsis tangshen Codonopsis tangshen Oliv..Nature and flavor are sweet, flat.Return spleen, lung meridian.Merit can invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.

Radix Aconiti Lateralis Preparata is the processed goods of the daughter root of ranunculaceae plant Aconitum carmichjaelii Debx. Aconitum carmichaeli Debx..Nature and flavor are pungent, sweet, hot greatly.GUIXIN, kidney, spleen channel.Merit can recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, by wind-cold damp pathogen.

The Radix Astragali is leguminous plant Radix Astagali Astragalus membranaceus(Fisch.) Bge.var.mongholicus(Bge.) Hsiao or Radix Astragali Astragalus membranaceus(Fisch.) dry root of Bge..Nature and flavor are sweet, temperature.Return lung, spleen channel.Merit can invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.

Radix Puerariae is legume pueraria lobata Pueraria lobata(Willd.) dry root of Ohwi or Radix Puerariae rattan Pueraria thomsonii Benth..Nature and flavor are sweet, pungent, cool.Return spleen, stomach warp.Merit can expelling pathogenic factors from muscles for reducing heat, promotes the production of body fluid, and rash, yang invigorating antidiarrheal.

Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bunge..Nature and flavor are bitter, are slightly cold.GUIXIN, Liver Channel.Merit can stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, and relieving restlessness clears away heart-fire.

Fructus Piperis Longi is dry near maturation or the mature fruit cluster of Piperaceae plant Fructus Piperis Longi Piper longum L..Nature and flavor are pungent, heat.Return stomach, large intestine channel.Merit can warming spleen and stomach for dispelling cold, therapeutic method to keep the adverse QI flowing downwards pain relieving.

Lignum Dalbergiae Odoriferae is the dry duramen of leguminous plant Lignum Dalbergiae Odoriferae wingceltis Dalbergia odorifera T.Chen trunk and root.Nature and flavor are pungent, temperature.Return liver, spleen channel.Merit can promoting flow of QI and blood, pain relieving, hemostasis.

Mytilus is Mollusca lamellibranchiata Mytilidae Mytilus crassitesta Lischke Mytilus crassitesta Lischke; Mussel M.edulis L.; Perna uiridis (Linnaeus) M.(Chloromya) smaragdinus Chemnitz; Flat top clam Modiolus modiolus(L.); Philippine pushes up clam M.philippinarum Hanley partially, with meat, is used as medicine.Nature and flavor are sweet, temperature.Merit can invigorating the liver and kidney; Benefiting essence-blood; Goiter disappears; Remove irritable feverish sensation in the chest, fall borax poison.

Rhizoma Alpiniae Officinarum is the dry rhizome of zingiberaceous plant Rhizoma Alpiniae Officinarum Alpinia officinarum Hance.Nature and flavor are pungent, heat.Return spleen, stomach warp.Merit can warming stomach for dispelling cold, and pain relieving helps digestion.

Eriocheir sinensis seven, Liliaceae Smilacina plant tube flower Radix et rhizoma smilacinae japonicae Smilacina henryi(Baker) root stock and the root of Wang et Tang.Nature and flavor are sweet, temperature.Merit can temperature male wind-supplying kidney, expelling wind and removing dampness, and blood circulation promoting and blood stasis dispelling, reduces phlegm; Eliminating stagnation.

Rhizoma Corydalis is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang.Nature and flavor are pungent, bitter, temperature.Return liver, spleen channel.Merit can be invigorated blood circulation, promoting the circulation of QI, pain relieving.

Halloysitum Rubrum, is silicates mineral halloysite family halloysite, main containing hydrated aluminium silicate Al4(Si4O10) (OH) 8.4H2O].Nature and flavor are sweet, sour, puckery, temperature.Return stomach, large intestine channel.Merit can astringing intestine to stop diarrhea, hemostasis, promoting tissue regeneration and ulcer healing.

HUOXUEDAN is labiate HUOXUEDAN G.hederacea L.var.longituba Nakai; The herb of G.hederacea auct.non L..Bitter in the mouth; Pungent; Cool in nature.Return liver; Gallbladder; Urinary bladder channel.Merit is can dampness removing treating stranguria; Heat-clearing and toxic substances removing; Dissipating blood stasis for subsidence of swelling.

Sanguis Draxonis, the resin oozing out for babassu Sanguis Draxonis Daemonorops draco Blume. fruit is through being processed into.Nature and flavor are sweet, salty, flat.GUIXIN, Liver Channel.Merit can removing blood stasis and relieving pain, hemostasia and promoting granulation.

Composition principle: unstable angina pectoris belongs to a kind of of coronary heart disease, its pathogenesis is except the deficiency of vital energy, expectorant are turbid, blood stasis, the more important thing is that cold objective breast is spacious, sun does not overcome the coldness, the solidifying tears of heart arteries and veins, and < < Plain Questions is lifted pain opinion > > and is pointed out clearly: " cold enters through and checks late; tears and not all right; visitor is in arteries and veins insufficiency of blood outward, and visitor is obstructed in arteries and veins, therefore yet soldier's pain." < < Plain Questions regulating menstruation opinion > > cloud: " cold amasss in rushing down in the heart and not, does not rush down wet and goes, and cold solely stays blood clotting tears, solidifying arteries and veins is obstructed ".Its reason can be taken advantage of for weakened body resistance heresy, and the sick duke or princess under an emperor > of < < General Treatise on the Cause and Symptoms of Diseases cardiac and abdominal pain > says: " cardiac and abdominal pain person, a little less than internal organs deficiency of five ZANG-organs, therefore wind and cold visitor therebetween also." can be also prolonged illness yang-energy weakness with emaciation phlegm stagnancy, > > cloud in poor and humble family in < < Principle and Prohibition for Medical profession: " obstruction of qi in the chest and cardialgia, so always because of yang deficiency, Gu Yin must take advantage of it." treatment of UA, through cloud: " deficiency syndrome should be treated by tonifying method." this all sick method for the treatment of general rule also." vim and vigour person, happiness temperature and aversion to cold, cold blood clotting and not flowing, Wen Ze disappears and goes it ".Yang deficiency, method is when temperature compensation yang-energy, and tonify deficiency heavily activates yang, and in side of the present invention, Ramulus Cinnamomi is pungent sweet, and temperature enters heart channel, the property of the pure sun of tool, function warming the meridian for promoting the flow of YANG QI, is the key medicine of dredging the meridian, when being first-selection.Radix Codonopsis, Radix Astragali invigorating the spleen and replenishing QI, Radix Aconiti Lateralis Preparata temperature compensation kidney-Yang; Radix Puerariae yang invigorating; Select the circulation of qi promoting medicine of warm property to lead to pain relieving: the pain relieving of Fructus Piperis Longi warming spleen and stomach for dispelling cold, the pain relieving of Lignum Dalbergiae Odoriferae promoting flow of QI and blood, Rhizoma Alpiniae Officinarum warming middle-JIAO to relieve pain, the Rhizoma Corydalis promoting the circulation of QI pain relieving of invigorating blood circulation; And Radix Salviae Miltiorrhizae, Eriocheir sinensis seven, HUOXUEDAN, Sanguis Draxonis blood circulation promoting and blood stasis dispelling; In < < Tang materia medica > >, record the main the five internal organs pathogen of Sanguis Draxonis, sudden attack of pain in the chest and abdomen, can removing mass blood, pain relieving raw meat; < < Bencao Jingshu > >: " black horse Lin exhausts, sweet main benefit, salty master disappears, the key medicine of dissipating blood stasis blood, tissue regeneration promoting blood ".In addition, Halloysitum Rubrum can stop blooding to protect and holds back yang-energy; Mytilus has the merit of invigorating the liver and kidney benefiting essence-blood, can remove irritable feverish sensation in the chest, HUOXUEDAN heat-clearing and toxic substances removing, and the two all has the merit of using corrigent.Modern pharmacology is tested and is shown, HUOXUEDAN can effectively be alleviated inflammatory cell infiltration under rat UA model cardiac fibers tissue.And the active component mussel containing in Mytilus lives element (MSM) with 1.35g/(kgd more), 4.05g/(kgd), 6.75g/(kgd) dosage is given respectively rat oral gavage 21 days, at ligation arteria coronaria, cause in acute myocardial infarction of rat experiment, can obviously fall abnormal improve and the degree of S-T section in end electrocardiogram, obviously dwindle myocardial infarct size.MSM also can alleviate ischemia injury in the Rat Ecg that fast intravenous injection pituitrin causes and change, and obviously reduces myocardial ischemia positive rate.This maintenance mechanism of MSM may with reduce concentration of malondialdehyde in blood, improve copper, Cu/Zn SOD, glutathion peroxidating and enzymatic activity, prevent that myocardial cell lipid peroxidation is relevant.Oral Administration in Rats MSM1.35g/(kgd), 2.7g/(kgd), 5.4g/(kgd), continuous 8 days, the rat experiment thrombosis that rotating ring method is formed had obvious inhibitory action.After same method administration, MSM can press down the rat platelet aggregation of ADP induction, and its maximum agglutination rate is reduced, and aggregation velocity slows down.The external medication of MSM also can reduce collagen-induced Platelet Aggregation in Rabbits rate and aggregation velocity.

Compared with prior art, the present invention has following characteristics and advantage advantage:

1, dosage form is convenient, adopts chewable tablet mode, rapid-action, and stable in properties, and volume is little, and it is all convenient to store, transport, carry, take;

2, ripe powder step can be save binding agent and filler, is convenient to dwindle the volume of effective dose, is convenient to take;

3, volatile oil, dry extract, ripe powder, take respectively different extraction processing modes according to drug condition, in the hope of the effect of performance medicine maximum.

[specific embodiment]

Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.

Embodiment 1, crude drug weight proportion: 10 parts of Ramulus Cinnamomi, 6 parts of Radix Codonopsis, 3 parts of Radix Aconiti Lateralis Preparatas, 6 parts of the Radixs Astragali, 3 parts of Radix Puerariaes, 6 parts of Radix Salviae Miltiorrhizaes, 3 parts of Fructus Piperis Longi, 15 parts of Lignum Dalbergiae Odoriferaes, 15 parts of Mytilus, 6 parts of Rhizoma Alpiniae Officinarums, 75 parts of Eriocheir sinensiss, 6 parts of Rhizoma Corydalis, 6 parts of Halloysitum Rubrums, 3 parts of HUOXUEDAN, 1 part of Sanguis Draxonis.Can be prepared from by following method:

(1) use extraction by steam distillation volatile oil standby Ramulus Cinnamomi, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Rhizoma Alpiniae Officinarum coarse powder, and it is standby to collect medicinal residues;

(2) after Radix Puerariae, Mytilus, Eriocheir sinensis seven coarse powder are cleaned, add 2 times of decoctings and boil, do not stop to stir, concentrated gradually, dry, pulverize ripe powder, cross 80 mesh sieves;

(3) Sanguis Draxonis is pulverized, crossed 150 mesh sieves, obtain fine powder standby;

(4) step 1 gained medicinal residues are mixed with Radix Codonopsis, the Radix Astragali, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, decoct with water secondary, collecting decoction, filter, filtrate is condensed into thick extractum, thicker extractum drying under reduced pressure is become to dry extract, pulverizes 100 mesh sieves and obtains extract dry extract;

(5) the extract obtained dry extract of step 4, the ripe powder of step 2 gained, step 1 gained volatile oil mix homogeneously, cross 20 mesh sieves granulations, granulate, obtain dry granule;

(6) the dry granule of step 5 gained is added to step 3 gained fine powder, mix tabletting.

Embodiment 2, crude drug weight proportion: 20 parts of Ramulus Cinnamomi, 10 parts of Radix Codonopsis, 6 parts of Radix Aconiti Lateralis Preparatas, 10 parts of the Radixs Astragali, 6 parts of Radix Puerariaes, 10 parts of Radix Salviae Miltiorrhizaes, 6 parts of Fructus Piperis Longi, 20 parts of Lignum Dalbergiae Odoriferaes, 20 parts of Mytilus, 12 parts of Rhizoma Alpiniae Officinarums, 76 parts of Eriocheir sinensiss, 10 parts of Rhizoma Corydalis, 10 parts of Halloysitum Rubrums, 6 parts of HUOXUEDAN, 2 parts of Sanguis Draxonis.Can be prepared from by following method:

(1) use extraction by steam distillation volatile oil standby Ramulus Cinnamomi, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Rhizoma Alpiniae Officinarum coarse powder, and it is standby to collect medicinal residues;

(2) after Radix Puerariae, Mytilus, Eriocheir sinensis seven coarse powder are cleaned, add 2 times of decoctings and boil, do not stop to stir, concentrated gradually, dry, pulverize ripe powder, cross 100 mesh sieves;

(3) Sanguis Draxonis is pulverized, crossed 200 mesh sieves, obtain fine powder standby;

(4) step 1 gained medicinal residues are mixed with Radix Codonopsis, the Radix Astragali, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, decoct with water secondary, collecting decoction, filter, filtrate is condensed into thick extractum, thicker extractum drying under reduced pressure is become to dry extract, pulverizes 100 mesh sieves and obtains extract dry extract;

(5) the extract obtained dry extract of step 4, the ripe powder of step 2 gained, step 1 gained volatile oil mix homogeneously, cross 20 mesh sieves granulations, granulate, obtain dry granule;

(6) the dry granule of step 5 gained is added to step 3 gained fine powder, mix tabletting.

Embodiment 3, crude drug weight proportion: 30 parts of Ramulus Cinnamomi, 12 parts of Radix Codonopsis, 10 parts of Radix Aconiti Lateralis Preparatas, 12 parts of the Radixs Astragali, 10 parts of Radix Puerariaes, 12 parts of Radix Salviae Miltiorrhizaes, 10 parts of Fructus Piperis Longi, 30 parts of Lignum Dalbergiae Odoriferaes, 30 parts of Mytilus, 15 parts of Rhizoma Alpiniae Officinarums, 79 parts of Eriocheir sinensiss, 12 parts of Rhizoma Corydalis, 12 parts of Halloysitum Rubrums, 9 parts of HUOXUEDAN, 3 parts of Sanguis Draxonis.Can be prepared from by following method:

(1) use extraction by steam distillation volatile oil standby Ramulus Cinnamomi, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Rhizoma Alpiniae Officinarum coarse powder, and it is standby to collect medicinal residues;

(2) after Radix Puerariae, Mytilus, Eriocheir sinensis seven coarse powder are cleaned, add 2 times of decoctings and boil, do not stop to stir, concentrated gradually, dry, pulverize ripe powder, cross 150 mesh sieves;

(3) Sanguis Draxonis is pulverized, crossed 150 mesh sieves, obtain fine powder standby;

(4) step 1 gained medicinal residues are mixed with Radix Codonopsis, the Radix Astragali, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, decoct with water secondary, collecting decoction, filter, filtrate is condensed into thick extractum, thicker extractum drying under reduced pressure is become to dry extract, pulverizes 100 mesh sieves and obtains extract dry extract;

(5) the extract obtained dry extract of step 4, the ripe powder of step 2 gained, step 1 gained volatile oil mix homogeneously, cross 20 mesh sieves granulations, granulate, obtain dry granule;

(6) the dry granule of step 5 gained is added to step 3 gained fine powder, mix tabletting.

Embodiment 1 ~ 3 gained chewable tablet all meets the preparation requirement of < < Chinese Pharmacopoeia > > to chewable tablet, can effectively reach the object for the treatment of unstable angina pectoris, and side effect is less.The above results is that clinical data fully proves, interrelated data is as follows, and wherein drugs use is crude drug weight proportion and preparation method in embodiment 2.

1 object and method

1.1 objects: in January, 2010 to 2011 year December unstable angina pectoris patient 64 examples, the diagnostic criteria that diagnostic criteria is formulated with reference to ACC (ACC)/American Heart Association (AHA) 2002.Exclusion standard: cardiac function IV level, severe arrhythmia, as ventricular tachycardia, affect hemodynamic supraventricular tachycardia; Merge the serious primary disease such as liver, kidney, hemopoietic system.Male 49 examples wherein, female's 19 examples; 38～73 years old age; The course of disease 1 month～8 years; First hair style angina pectoris 20 examples, deterioration type angina pectoris 32 examples, spontaneous angina pectoris 4 examples, Combination 8 examples.

1.2 method

1.2.1 grouping: divide at random two groups, treatment group 31 examples, matched group 33 examples, clinical data there was no significant difference between two groups.Two groups of ages, sex, the course of disease, complication etc. are learned and are processed by statistics, and difference there are no significant meaning (P>0.05), has comparability.

1.2.2 Therapeutic Method: matched group gives the conventional western medicine of antianginal, comprises oral Imdur, bamyl (aspirin), metoprolol, simvastatin etc., the treatment of patient with severe symptoms's subcutaneous injecting of low molecular heparin.Treatment group is that on treatment of control group scheme basis, to add the embodiment of the present invention 2 gained chewable tablet oral again, and dosage 1g is each, every day 2 times, within 7 days, is 1 course for the treatment of, continuous 4 courses for the treatment of.

1.2.3 observation index: follow the tracks of and record angina pectoris attacks number of times and electrocardiogram before and after two groups of patient's medications.Two groups take medicine before and finish rear liver function, renal function, blood glucose, the blood fat of all taking a blood sample the course for the treatment of.With ultrasoundcardiogram, measure Left Ventricular Ejection Fraction; With ambulatory monitoring studies 24h average heart rate, arrhythmia episode frequency and ischemic ST-T, change.The diagnostic criteria that ischemic-type ST changes: 80ms after ST section level or force down >=1mm(J of declivity type point).Ischemia Time interval <1min is designated as ischemic episode 1 time.

1.2.4 curative effect determinate standard: angina pectoris attacks criterion of therapeutical effect: effectively reduce more than 80% for angina pectoris attacks number of times; Effectively for angina pectoris attacks number of times reduces 50%～80%; Invalid is angina pectoris attacks number of times minimizing less than 50%.ECG curative effect evaluation criteria: effective for the original ischemic ST-segment rise >=0.15mV of resting electrocardiogram or the T ripple that mainly leads shoal >=50%; Be effectively ST section recovery 0.05～0.14mV, or the T ripple that mainly leads shoal but less than 50%; Invalid is that ECG ST-T is unchanged or worsen.

1.2.5 statistical analysis: carry out statistical analysis with SPSS 13.0, P<0.05 indicates significant.

2 results

The curative effect comparisons of 2.1 liang of group cases: uncomfortable in chest, the chest pain of patient after two groups of treatments, palpitation of the heart comes on frequency and nitroglycerin consumption all significantly decline (P<0.01).Between two groups of groups, relatively show, treatment group patient's obvious effective rate and total effective rate are all apparently higher than matched group (P<0.01).See the following form.

The data comparison of 2.2 laboratorys: before and after two groups of treatments, relatively, diastolic pressure after patient treatment (P<0.05), 24h average heart rate (P<0.05), 24h premature beat number of times (P<0.01), 24h ischemic ST-T change number of times and lasting total time (P<0.01) all significantly declines.Compare with matched group, treatment group ECG curative effect obvious effective rate is apparently higher than matched group (P<0.01).See the following form.

2.3 untoward reaction: compare equal no difference of science of statistics when every biochemical indicators such as the liver function for the treatment of group, renal function, blood glucose, blood fat are followed up a case by regular visits to matched group.

3. conclusion

The demonstration of this result of study, the present invention treats unstable angina pectoris determined curative effect, safety is good, is worthy of promotion and application.

Claims (1)

1. a chewable tablet preparation method for the treatment of the medicine of unstable angina pectoris, it is characterized in that, crude drug weight proportion: 30 parts of Ramulus Cinnamomi, 12 parts of Radix Codonopsis, 10 parts of Radix Aconiti Lateralis Preparatas, 12 parts of the Radixs Astragali, 10 parts of Radix Puerariaes, 12 parts of Radix Salviae Miltiorrhizaes, 10 parts of Fructus Piperis Longi, 30 parts of Lignum Dalbergiae Odoriferaes, 30 parts of Mytilus, 15 parts of Rhizoma Alpiniae Officinarums, 79 parts of Eriocheir sinensiss, 12 parts of Rhizoma Corydalis, 12 parts of Halloysitum Rubrums, 9 parts of HUOXUEDAN, 3 parts of Sanguis Draxonis, its preparation method comprises the following steps:

(1) use extraction by steam distillation volatile oil standby Ramulus Cinnamomi, Fructus Piperis Longi, Lignum Dalbergiae Odoriferae, Rhizoma Alpiniae Officinarum coarse powder, and it is standby to collect medicinal residues;

(2) Radix Puerariae, Mytilus, Eriocheir sinensis seven coarse powder are decocted with water, concentrate drying is pulverized ripe powder;

(3) Sanguis Draxonis is pulverized to such an extent that fine powder is standby;

(4) step 1 gained medicinal residues are mixed with Radix Codonopsis, the Radix Astragali, Radix Aconiti Lateralis Preparata, Radix Salviae Miltiorrhizae, Rhizoma Corydalis, Halloysitum Rubrum, HUOXUEDAN, decoct with water secondary, collecting decoction, filter, filtrate is condensed into thick extractum, thicker extractum drying under reduced pressure is become to dry extract, pulverizes 100 mesh sieves and obtains extract dry extract;

(5) the extract obtained dry extract of step 4, the ripe powder of step 2 gained, step 1 gained volatile oil mix homogeneously, cross 20 mesh sieves granulations, granulate, obtain dry granule;

(6) the dry granule of step 5 gained is added to step 3 gained fine powder, mix tabletting.