CN1296080C - Liver clearing blood pressure lowering capsule nd its preparation method - Google Patents
Liver clearing blood pressure lowering capsule nd its preparation method Download PDFInfo
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- CN1296080C CN1296080C CNB2004101014949A CN200410101494A CN1296080C CN 1296080 C CN1296080 C CN 1296080C CN B2004101014949 A CNB2004101014949 A CN B2004101014949A CN 200410101494 A CN200410101494 A CN 200410101494A CN 1296080 C CN1296080 C CN 1296080C
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Abstract
The present invention relates to a new Chinese medicine for treating hypertension by using medicinal plants as raw material, more specifically a capsule for removing heat from livers and lowering blood pressure. The present invention is mainly prepared from spica prunellae, fleece-flower root, pagodatree flower, mistletoe, pueraria root, red sage root, rhizoma alismatis, herba cirsii, polygala root and cyathula root. A method for preparing the present invention comprises the following steps: extracting the fleece-flower root, the pueraria roots, the rhizoma alismatis and the cyathula root in the ten medicines by using 50 to 70% ethanol; extracting the spica prunellae and the red sage root by using 60 to 95% ethanol; extracting the dregs of the spica prunellae and the red sage roots, the pagodatree flower, the mistletoe, the herba cirsii and the polygala root by using water; concentrating the three kinds of extracting liquid into thick paste, and combining and uniformly mixing the thick paste; preparing the capsule for removing heat from livers and lowering blood pressure by decompression drying, pulverization, granulation and filling. The present invention has obvious and stable curative effect on hypertension, and is characterized in that the blood reducing function to elevated diastolic pressure is superior to the present common Chinese medicines. The present invention has the advantages of safe administration, no adverse reaction and no toxic and side effect.
Description
Affiliated technical field
The present invention is to be the new Chinese medicine of the treatment hypertension that develops of raw material with the medicinal plants.
Background technology
The survey showed that for the morbidity pathogenesis of hypertension and clinical symptoms thereof, and hypertension is multifactor causing, and overabundant liver-fire, the hepatic and renal YIN deficiency can appear in the tcm clinical practice syndrome; Narrow and the pathological changes of arteries etc. can appear in the blood of human body blood circulation.The traditional Chinese medical science usually was simple the emphasis with cold and cool Chinese medicine suppressing the hyperactive liver and subsiding YANG aspect the medication treatment of hypertension in the past; Doctor trained in Western medicine is then mainly used the chemical synthetic drug expanding cardiovascular.
At present, the medicine of treatment hypertension is in clinical practice, and majority all has certain untoward reaction or toxic and side effects.For example, the Chinese medicine Bezoar pill for lowering blood pressure, the property of medicine is cold and cool partially, belongs to calm depressor, because sedation is stronger, often causes drowsinessly, because of main component is artificial Calculus Bovis, Cornu Saigae Tataricae, Margarita etc., takes for a long time to cause diarrhoea.Chinese medicine SONGLING XUEMAIKANG and for example, the property of medicine is salty-cold partially, and taking for a long time also to influence digestive system, untoward reaction such as diarrhoea, gastral cavilty distension occur.Though energy blood pressure lowerings such as chemical synthetic drug captopril, Norvasc for another example, but there are many untoward reaction such as dizzy, headache, cardiopalmus, the pain over the chest and back, angioedema and blood supply insufficiency after taking, take for a long time not only and can damage liver and kidney, and hypertension itself dizziness, headache, the cardiopalmus that occur symptom such as be insomnia also can not get basic improvement.
Summary of the invention
The present invention adopts the liver and kidney tonifying method according to the understanding of the traditional Chinese medical science to the pathogenic characteristic of hypertension " liver-fire is easily prosperous, kidney yin easily lose "; And, cause myocardium di for avoiding expanding cardiovascular according to the analysis of modern medicine to cardiovascular and cerebrovascular disease, according to the new approaches treatment hypertension of expansion heart periphery and distal vessels, with Ji protection target organ; Realize treating both the principal and secondary aspects of a disease and develop capsule for clearing liver and reducing blood pressure.According to traditional Chinese medical science liver, the homologous theory of kidney, to hypertension adopt the liver heat removing sun with nourishing kidney-yin, tonifying kidney-yin with the research of writing out a prescription of suppressing the hyperactive liver fire.Capsule for clearing liver and reducing blood pressure is had in mind from conditioning liver, kidney two are dirty, and with the liver heat removing and kidney replenishing legislation, liver, kidney are also controlled; Adopt the blood pressure lowering approach medication of expansion heart periphery and distal vessels simultaneously, reducing heart periphery blood supply resistance, thereby reach the purpose for the treatment of both the principal and secondary aspects of a disease.
One, prescription and preparation method
1. fill a prescription
Spica Prunellae 150～350g, Radix Polygoni Multiflori 120～400g, Flos Sophorae 100～300g, Herba Taxilli 150～350g, Radix Puerariae 100～250g, Radix Salviae Miltiorrhizae 150～350g, Rhizoma Alismatis 100～350g, Herba Cirsii 80～200g, Radix Polygalae 100～200g, Radix Cyathulae 100～250g.
Make 1000, the 0.5g/ grain.
2, preparation method
More than Radix Polygoni Multiflori, Radix Puerariae, Rhizoma Alismatis, Radix Cyathulae in the ten flavor prescription medical materials with 50～70% alcohol reflux of 6～10 times of amounts 2～3 times, each 1～3 hour, merging filtrate, reclaiming ethanol, being evaporated to relative density is that 1.20～1.35 (60 ℃ of surveys) thick paste is standby; Spica Prunellae, Radix Salviae Miltiorrhizae be with 60～95% alcohol reflux of 8～12 times of amounts 1～3 time, and each 1～3 hour, merging filtrate, reclaim ethanol, concentrating under reduced pressure becomes the thick paste of the same requirement standby; Spica Prunellae, Radix Salviae Miltiorrhizae decoction dregs and Flos Sophorae, Herba Taxilli, Herba Cirsii, Radix Polygalae are boiled 2～3 times with 10～14 times decocting, and each 1～2 hour, merging filtrate, concentrating under reduced pressure became the thick paste of the same requirement standby.Merge above-mentioned all thick paste mixings, drying under reduced pressure, pulverizing, add an amount of dextrin, granulate, load into 1000 of capsules and promptly get (seeing capsule for clearing liver and reducing blood pressure preparation technology flow chart for details).
Pressing the property of medicine of the capsule for clearing liver and reducing blood pressure of above-mentioned method for making and explained hereafter stablizes.Capsule for clearing liver and reducing blood pressure obtains National Drug Administration approval and is new Chinese medicine after 4 years, once more its drug effect is tested.Through the clear-headed spontaneous hypertensive rat of Tianjin Inst. of Medicinal Materials, National Drug Supervision and Management B, carry out the stable curative effect evidence, the capsule for clearing liver and reducing blood pressure of storing 4 years has tangible hypotensive effect, blood pressure lowering continues 3 hours, medicine with new production is compared, hypotensive effect does not have significant difference, and pharmacologically active does not reduce; Heart rate does not have significant change during blood pressure lowering.
Two, pharmacological action
The pharmacological action of capsule for clearing liver and reducing blood pressure is: liver and kidney tonifying, expansion heart periphery and distal vessels reduce total peripheral resistance and blood pressure lowering improves the heart, cerebral blood supply insufficiency.Pharmacodynamics test through Tianjin Inst. of Medicinal Materials, National Drug Supervision and Management B proves, with 4.0g crude drug/kg to the dog duodenal administration after, blood pressure drops is obvious, total peripheral resistance and the acting of left chamber reduce; Heart rate, left indoor pressure rising and decline maximum rate and cardiac pumping function all there is not obvious influence.
Three, function cures mainly
The heat clearing away suppressing the hyperactive liver, liver and kidney tonifying.Be used for hypertension overabundant liver-fire, syndrome of yin deficiency of liver and kidney.That disease is seen is dizzy, headache, flushing conjunctival congestion, being irritable and getting angry easily, dry mouth with bitter taste, soreness of the waist and knees, cardiopalmus are insomnia, tinnitus is forgetful, constipation old man Huang.Usage and dosage: oral, one time 3,3 times on the one, or follow the doctor's advice.
Four, curative effect characteristics
This medicine treatment hypertension is evident in efficacy and steady, takes safety, has no adverse reaction and toxic and side effects.Five tame national clinical pharmacology bases such as Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Dongzhimen Hospital, Beijing Univ of Traditional Chinese Medicine, Guang-amen Hospital, China Traditional Chinese Medicine Instl, Xiyuan Hospital, Chinese Medicine Academy of China, the hospital of traditional Chinese hospital, Beijing, adopt the randomized controlled method, the hypotensive effect of capsule for clearing liver and reducing blood pressure has been carried out II phase clinical research; Testing routine number is 431 examples.The result shows that capsule for clearing liver and reducing blood pressure efficacy of antihypertensive treatment obvious effective rate is 51.5%, and total effective rate is 84.4%; The obvious effective rate of tcm syndrome curative effect is 52.5%, and total effective rate is 91.7%.Show that with similar Chinese medicine SONGLING XUEMAIKANG JIAONANG contrast test the capsule for clearing liver and reducing blood pressure efficacy of antihypertensive treatment significantly is better than SONGLING XUEMAIKANG JIAONANG (P＜0.01); Improve the tcm syndrome curative effect and also significantly be better than SONGLING XUEMAIKANG JIAONANG (P＜0.01).
1. the liver protecting and kidney
Capsule for clearing liver and reducing blood pressure has the merit of liver and kidney tonifying, is better than damaging the blood pressure lowering medicine of Liver and kidney, so be suitable for taking for a long time.This medicine plays a protective role to liver and kidney when effectively treating hypertension, has prevented to cause because of drug induced injury the depletion of liver, renal function.
2. the protection heart prevents target organ damage
Capsule for clearing liver and reducing blood pressure has the effect of expansion heart periphery and distal vessels, has reduced total peripheral resistance, has overcome depressor expanding cardiovascular commonly used and has caused the sick drawback of cardiac muscle expansion; Not only protected heart but also prevented to cause blood supply insufficiency equivalent damage target organ among the treatment hypertension.
3. what the treatment diastolic pressure raise is evident in efficacy
Think through being expounded through peer review of the former bureau of drug administration of Ministry of Public Health tissue: " it is its characteristic that the hypotensive effect that capsule for clearing liver and reducing blood pressure raises to diastolic pressure is better than present conventional Chinese medicine." capsule for clearing liver and reducing blood pressure is to the treatment curative effect that diastolic pressure (low pressure) raises, and significantly is better than similar drugs (seeing " report of capsule for clearing liver and reducing blood pressure II clinical trial phase ", " Beijing Tiantan Hospital and Peking University First Hospital's clinical observation, research report " respectively) such as SONGLING XUEMAIKANG, NAOLIQING and yufeng ningxin tablets, yufeng ningxin pian; Thereby it is not obvious to have solved depressor reduction diastolic pressure commonly used effect, causes the unusual clinical application problem of pressure reduction.
4. take safety, have no side effect
Capsule for clearing liver and reducing blood pressure is taken safe and reliable, has no adverse reaction and toxic and side effects.Toxicologic study shows, surpasses 450 times of clinical consumptions, no acute toxic reaction; Through 6 months long term toxicity tests, animal did not see tangible toxic reaction at aspects such as growth, growth, hematology, serum biochemistries, and pathologic finding is not found the pathological change relevant with medicine (seeing " report of capsule for clearing liver and reducing blood pressure rat long term toxicity test ").The safety of capsule for clearing liver and reducing blood pressure II phase clinical research detects and shows, in the whole clinical trial process, do not see any untoward reaction and toxic and side effects, the heart, liver, renal function are not found harmful effect (seeing " report of capsule for clearing liver and reducing blood pressure treatment hypertension II clinical trial phase ").Peking University First Hospital, the clinical research for the treatment of the diabetic hypertension patient with capsule for clearing liver and reducing blood pressure shows that the capsule for clearing liver and reducing blood pressure hypotensive effect is remarkable and steady, take safely, have no side effect, heart rate there is not influence, harmless to liver, renal function, just conventional harmless to hematuria.
The Pharmacodynamic test of active extract data that capsule for clearing liver and reducing blood pressure is relevant with therapeutical effect
Summary
Behind clear-headed spontaneous hypertensive rat single oral removing heat from the liver to lower the high blood pressure extractum 2,4,8g (the crude drug)/Kg, 8g (crude drug)/Kg organizes blood pressure drops, and heart rate does not have significant change; Behind kidney type hypertension dog single oral removing heat from the liver to lower the high blood pressure extractum 1,2,4g (the crude drug)/Kg, 1g (crude drug)/Kg does not have obvious influence to blood pressure; 2,4g (crude drug)/Kg can make blood pressure drops, and heart rate is not had obvious influence.Once a day, and continuous 14 days oral removing heat from the liver to lower the high blood pressure extractum (spontaneous hypertensive rat 2,4,8g (crude drug)/Kg/d, kidney type hypertension dog 1,2g (crude drug)/Kg/d) blood pressure all obviously descend, and heart rate does not have significant change; 2～4 days blood pressures return to the control period level after the drug withdrawal, and the weight of animals, appetite and behavior do not have obvious change.After the anesthetized open-chest dog duodenum gave removing heat from the liver to lower the high blood pressure extractum 2,4g (crude drug)/Kg, blood pressure was dose dependent ground and descends, and heart rate does not have obvious change; ± LVdp/dt
MaxNo change, the acting of left chamber reduces; Cardiac pumping function does not have significant change, and total peripheral resistance reduces.The mice single reaches and gives removing heat from the liver to lower the high blood pressure extractum 5,10,20g (crude drug)/Kg continuously, does not influence the mice autonomic activities, does not have synergism with the eleventh of the twelve Earthly Branches barbital sodium.
Capsule for clearing liver and reducing blood pressure has the heat clearing away suppressing the hyperactive liver, and the function of liver and kidney tonifying is mainly used in each phase hypertension of overabundant liver-fire liver and kidney tonifying type clinically.This research spontaneous hypertensive rat, kidney type hypertension dog are observed its resisting hypertension and render a service, and have carried out the research of open chest anesthetized cardiac hemodynamics of dogs, in the hope of providing experimental basis for clinical practice.
Experiment material
1. animal:
(1) spontaneous hypertensive rat (SHR):, meet the primary standard (quality certification number: the moving word of doctor 01-1086 number) available from Fuwai Hospital, Chinese Academy of Medical Sciences Beijing zoopery section.Raising in observation ward by central air conditioner system regulation and control, 26 ± 2 ℃ of room temperatures, artificial lighting 12h every day, by the sex sub-cage rearing, mouse cage 43 * 27 * 18cm, 4 in every cage is freely drunk water, feed with high protein piece material once every day, renews bright tap water once, and the pressure measuring chamber temperature is 26 ± 2 ℃.
(2) the kidney type hypertension dog (RHD) of this laboratory formation: raise in 2.5 * 1.5m separate room receptacle by the central air conditioner system regulation and control, 25 ± 3 ℃ of room temperatures, freely drink water, every day is respectively at 7 o'clock in the morning and at 4 o'clock in afternoon feeding pellet (Ai Fen company in Beijing provides) once.
(3) hybrid dog:, raise more than two weeks standby available from the suburbs, Tianjin.
(4) Kunming mouse: the court animal housing provides, and meets the primary standard (quality certification number: No. the 001st, the real moving accurate word of facility in Tianjin).
2. medicine and preparation:
(1) removing heat from the liver to lower the high blood pressure fluid extract (abbreviation removing heat from the liver to lower the high blood pressure): brown sticky suspension, every ml is equivalent to 2.08 gram crude drugs, provide by Beijing flood day power Medicines and Health Product institute, lot number 960515, with distilled water be diluted to 0.2,0.4 respectively, the medicinal liquid of 0.8g (crude drug)/ml irritates stomach for SHR, be diluted to 1, the medicinal liquid of 2g (crude drug)/ml irritates stomach and hybrid dog duodenal administration for RHD, is diluted to 0.25,0.5,1.0g (crude drug)/ml, for mouse stomach.
(2) Bezoar pill for lowering blood pressure: commercially available, Darentang Traditional Chinese Medicine Factory, Tianjin produces, lot number 940204, the heavy 1.6g of every ball, with distilled water grind to form 0.05,0.08, the medicinal liquid of 0.2g ball weight/ml, respectively for mice, SHR, RHD filling stomach and hybrid dog duodenal administration.
(3) the eleventh of the twelve Earthly Branches barbital sodium: the SERVA product is configured to 2.3mg/ml with normal saline, for the mouse peritoneal injection.
Experimental technique and result
One, acute drop test
1. to the acute hypotensive effect of SHR:
SHR male and female dual-purpose, body weight 280 ± 64g puts into 36 ± 1 ℃ of electrothermostats with rat before the pressure measurement and heats, and uses CRS-III type rat computer blood pressure cardiotachometer indirect determination rat arteria caudalis systolic pressure (SBP) and heart rate (HR) behind the 10min.Pressure measurement every day once before the formal experiment; about two weeks; treat that rat conforms; experimentize again behind the blood pressure stabilization; SHR is divided into 5 groups at random by blood pressure, body weight, 8 every group, gavages distilled water, removing heat from the liver to lower the high blood pressure extractum 2,4,8g (crude drug)/Kg and positive control medicine Bezoar pill for lowering blood pressure 0.8g/Kg respectively; volume is 1ml/100g, measure before the administration and after the administration 1,2,3,4,6,8,12, systolic pressure and the heart rate of 24h.
The result shows, matched group SBP and HR in 24h do not have significant change.Gavage removing heat from the liver to lower the high blood pressure 2,4g (crude drug)/kg does not also have obvious influence to SBP and HR, after dosage increased to 8g (crude drug)/Kg, SBP 1h behind the medicine began to descend, 2h peaking, maximum reducing are 20 ± 12mmHg, effect is maintained until after the administration more than the 3h; HR does not have significant change during blood pressure lowering.2h SBP obviously descends after gavaging Bezoar pill for lowering blood pressure 0.8g/Kg, and reaches maximum reducing effectiveness, has reduced by 10 ± 11mmHg, and HR is not had obvious influence, the results are shown in Table 1,2.
2. to the acute hypotensive effect of RHD:
5 kidney vascular type hypertension dogs that form through a narrow side renal artery, body weight 19 ± 4Kg moves common carotid artery blood pressure in sheath with the auscultation measurement, measures heart rate with Palpation, writes down the II lead electrocardiogram simultaneously.Under 5 days blood pressures keep stable condition; begin administration by orthogonal design; matched group is irritated with distilled water; the administration group gavages removing heat from the liver to lower the high blood pressure 1,2,4, the g (crude drug)/Kg of various dose respectively; positive control drug Bezoar pill for lowering blood pressure 0.2g/Kg, except that 4g (crude drug)/Kg group administration volume is the 2ml/Kg, other is respectively organized volume and is 1ml/Kg; measure before the administration and after the administration 1,2,3,4,6,8h systolic pressure, diastolic pressure (DBP) and heart rate, twice dosing interval is 5 days.Adopt paired t-test, relatively the significance of mean difference before and after the administration.
The result shows, no significant change in the blood pressure of matched group and the heart rate 8h.Gavage removing heat from the liver to lower the high blood pressure 1g (crude drug)/Kg blood pressure is not had obvious influence, give 2, about 1h blood pressure begins to descend behind 4g (crude drug)/Kg, reach maximum reducing in 2h, blood pressure (SBP/DBP) decline maximum is respectively 10 ± 4/8 ± 3,14 ± 5/12 ± 2mmHg, effect is maintained until 3-4h, and heart rate does not have significant change during blood pressure lowering.The 1h blood pressure promptly obviously descends after gavaging Bezoar pill for lowering blood pressure 0.2g/Kg, and 2-3h descends the most obvious, and the maximum reducing value is 18 ± 4/16 ± 3mmHg, and hypotensive effect can be kept 6h, and heart rate does not have significant change during blood pressure lowering, the results are shown in Table 3,4.
Removing heat from the liver to lower the high blood pressure extractum does not have obvious influence to electrocardiographic wave.
Two, experimental therapy test
1.SHR 14 days hypotensive effect of successive administration:
Behind 5 days control period blood pressure stabilizations, gavaged distilled water, removing heat from the liver to lower the high blood pressure 2,4,8g (crude drug)/Kg/d, Bezoar pill for lowering blood pressure 0.8g/Kg/d continuous 14 days to SHR respectively, measure before the administration and SBP and the HR of 2h after the administration, the results are shown in Table 5,6.
As can be seen from the table, treatment phase internal reference group SBP, HR fluctuation is little.Gavage removing heat from the liver to lower the high blood pressure 2g (crude drug)/Kg/d in the treatment phase SBP, HR also do not have significant change, give 4, the SBP before 8g (crude drug)/Kg/d administration every day is since the 3rd day, drop-out value has been compared notable difference with the control period meansigma methods, on average descends 7 ± 5 in 14 days respectively, 12 ± 3mmHg; Compare 14 days with the control period meansigma methods respectively average descends 14 ± 10,22 ± 7mmHg for the SBP of 2h after administration every day, and each dosage group blood pressure recovered the control period level in 2～4 days after respectively at drug withdrawal; Positive control drug (Bezoar pill for lowering blood pressure) SBP 12 ± 6mmHg that on average descended before administration every day in 14 days treatment phases; Average 19 ± the 9mmHg that descends after administration every day.In the whole treatment phase, removing heat from the liver to lower the high blood pressure extractum, Bezoar pill for lowering blood pressure do not have obvious influence to heart rate.During the treatment, the weight of animals, diet, amount of drinking water have no significant change.
2.RHD 14 days hypotensive effect of successive administration:
The oral removing heat from the liver to lower the high blood pressure 1 of RHD, 2g (crude drug)/Kg/d, continuous 14 days, measure before administration every day respectively and administration after blood pressure and the heart rate of 2～3h, the results are shown in Table 7.
The result shows that the blood pressure of control period and heart rate all do not have obvious change.Behind oral removing heat from the liver to lower the high blood pressure 1,2g (the crude drug)/Kg/d, obviously descend since the 11st, 7 day blood pressure respectively, before the administration in 14 days blood pressure on average descended 1 ± 4/3 ± 3 respectively, 9 ± 9/7 ± 5mmHg, on average descended 4 ± 5/5 ± 5 after the administration respectively, 15 ± 7/12 ± 5mmHg.Heart rate does not have obviously change in the treatment phase.It is unusual not observe animal behavior in the treatment phase, and body weight and food ration are not had obvious influence yet.
Three, to the influence of open chest anesthetized cardiac hemodynamics of dogs
The healthy hybrid dog of body weight 16.9 ± 2.2 (13.0～19.5) Kg, the male and female dual-purpose.Quiet notes 3% the eleventh of the twelve Earthly Branches barbital sodium 30mg/Kg anesthesia, tracheal intubation connects SC-3 type electric pulmotor pedestrian worker positive pressure respiration.Left side the 4th intercostal is opened breast, exposes heart, separates aortic root, and the electromagnetic flowmeter of diameter 12 or 14mm (FC-120/140T) probe through MFV-3200 type square wave electromagnetic flowmeter determination aorta flow, is represented cardiac output (CO) with this on the card; The apex intubate is to left ventricle, connect the AP-641G blood pressure amplifier through TP-400T type pressure transducer and measure left indoor systolic pressure (LVSP), and, measure left indoor pressure and rise and decline maximum rate (± LVdp/dt the processing of LVSP electric signal input EQ-601G differentiator
Max); Separate right femoral artery, intubate connects the AP-641G blood pressure amplifier through TP-400T type pressure transducer and measures systolic pressure (SBP), diastolic pressure (DBP) to ventral aorta; The subcutaneous insertion needle electrode of extremity through AC-601G ecg amplifier mapping standard I I lead electrocardiogram (ECG II), and with ECG electric signal input AT-601G cardiotachometer, is measured heart rate (HR).Above-mentioned observation index is traced synchronously in RM-6300 type eight and is led on the RTA-1200 type heat battle array monitor of physiograph.Simultaneously HR, SBP, DBP and LVSP are deposited in the disk of VM-187G type memorizer, dynamic observe and the controlled experiment process in the variation of heart rate and blood pressure.Cut open the belly, separate duodenum and intubate, in order to administration.Left femoral vein intubate is separately made the usefulness of fluid infusion.
Operation finishes and treats the preceding value of the stable back of every index record medicine.Duodenal administration, except that 4g (crude drug)/Kg group administration volume is the 2ml/Kg, other is respectively organized volume and is 1ml/Kg.
Experiment is divided into 4 groups: (1) blank group: distilled water 1ml/Kg; (2) removing heat from the liver to lower the high blood pressure 2g (crude drug)/Kg group; (3) removing heat from the liver to lower the high blood pressure 4g (crude drug)/Kg group; (4) positive drug control group: Bezoar pill for lowering blood pressure 0.2g/Kg.
Write down after the administration 0.5,1,1.5,2 respectively, above-mentioned all the index of 3h.By formula derive and calculate cardiac output (SV), cardiac index (CI), the acting of left chamber (LVW) and total peripheral resistance (TPR).(X ± SD) expression is with the significance of mean difference before and after the paired t-test comparison administration with mean ± standard deviation for experimental data.
1. to blood pressure, heart rate and Electrocardiographic influence:
After anesthetized open-chest dog was injected distilled water, SBP, DBP, HR and ECG II did not have significant change in 3h.
Tangible hypotensive effect appearred in 0.5～2h after duodenum gave removing heat from the liver to lower the high blood pressure 2,4g (crude drug)/Kg, maximum decline percent SBP is respectively 6.2 ± 2.8%, 10.3 ± 2.9% (P all＜0.01), DBP is respectively 12.9 ± 6.0% (P＜0.01), 15 ± 5.0% (P＜0.001), dosage increases hypotensive effect and strengthens, and the persistent period also prolongs (table 8).
Removing heat from the liver to lower the high blood pressure does not have obvious influence to heart rate and ECG II waveform.
2. the influence of being done work in left chamber:
Matched group give behind the distilled water LVSP in the 3h, ± LVdp/dt
Max, LVW do not have significant change.
Give 1h behind removing heat from the liver to lower the high blood pressure 2,4g (the crude drug)/Kg, LVSP obviously reduces, and maximum decline percent is respectively 5.7 ± 2.9% (P＜0.05), 12.5 ± 2.5% (P＜0.01).
Removing heat from the liver to lower the high blood pressure 2,4g (crude drug)/Kg be right ± LVdp/dt
MaxThere is not obviously influence.But LVW 1-1.5h after administration obviously reduces, and maximum decline percent is respectively 11.1 ± 7.0% (P＜0.05), 14.9 ± 1.7% (P＜0.01), the results are shown in Table 9.
3. to the influence of cardiac pumping function and total peripheral resistance:
After matched group gave distilled water, CO, SV, CI and TPR be essentially no significant change in 3h.
Removing heat from the liver to lower the high blood pressure 2,4g (crude drug)/Kg also do not have obvious influence to CO, SV, CI.But TPR obviously reduces, and maximum reduces by 8.7 ± 3.5%, 14.8 ± 4.5% (P all＜0.01) respectively, the results are shown in Table 10.
4. the positive control drug Bezoar pill for lowering blood pressure obviously brings high blood pressure down and total peripheral resistance, does not change heart rate, reduces the acting of left chamber, and cardiac pumping function is not had obvious influence.
Four, mice sedation experiment
(1) single-dose is to the neural influence of mice:
1) to the influence of mice autonomic activities:
50 of Kunming kind healthy mices; body weight 18～22g; male and female half and half; be divided into five groups at random by body weight; every group 10; according to results of pharmacodynamic test; RHD drop test effective dose is 2g (crude drug)/Kg; be converted to the mice dose,equivalent by body surface area and be about 10.3g (crude drug)/Kg; the dose,equivalent that is equivalent to pharmacodynamics is selected in this experiment for use, and administration group is in view of the above irritated stomach respectively and given removing heat from the liver to lower the high blood pressure 5; 10; 20g (crude drug)/Kg, blank group ig equal-volume distilled water; volume is 0.2ml/10g; positive controls ig Bezoar pill for lowering blood pressure 1g (ball is heavy)/Kg, 1h puts into the general aktograph autonomic activities of TDW-02 type case, one in every case with mice after administration; mice autonomic activities number of times in the record 5min the results are shown in Table 11.
Table 11. single gives the influence of capsule for clearing liver and reducing blood pressure to the mice autonomic activities (X ± SD)
| Medicine | Dosage g/Kg | Number of animals (only) | The autonomic activities number of times (inferior/5min) | Change percentage ratio (%) |
| Distilled water removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 5 10 20 1 | 10 10 10 10 10 | 647±161 565±192 626±166 648±112 504±159 | - -16.2 -7.1 -3.9 -25.2 |
Annotate: 1. compare with the blank group: P＜0.05;
2. dosage unit: removing heat from the liver to lower the high blood pressure is pressed crude drug g/Kg and is calculated,
Bezoar pill for lowering blood pressure is pressed preparation g/Kg and is calculated, down together.
The result shows, 1h after the administration compares each administration group mice autonomic activities and all do not have obvious change with matched group, can obviously reduce mice autonomic activities number of times and give Bezoar pill for lowering blood pressure 1h, and movable number of times has reduced by 25.2% (P＜0.05).
2) influence that the eleventh of the twelve Earthly Branches barbital sodium under the threshold is slept:
Get the mice of above-mentioned survey autonomic activities, 70min ip sub-threshold dose the eleventh of the twelve Earthly Branches barbital sodium 23mg/Kg behind medicine, to be sleeping index more than the righting reflex loss 1min in injection the eleventh of the twelve Earthly Branches barbital sodium 15min, each organizes sleeping number of animals after the observation administration, calculate sleeping percent, the results are shown in Table 12.
Table 12. capsule for clearing liver and reducing blood pressure single-dose is to the influence of the eleventh of the twelve Earthly Branches barbital sodium sleep under the valve
| Medicine | Dosage g/Kg | Number of animals (only) | Sleeping number of animals (only) | Sleeping percentage ratio (%) |
| Distilled water removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 5 10 20 1 | 10 10 10 10 10 | 2 1 0 1 5 | 20.2 10.0 0 10.0 50.0 |
Annotate: relatively do not have apparent property difference with the blank group.
The result shows that 70min after the administration, removing heat from the liver to lower the high blood pressure do not increase the sleeping number of animals of the eleventh of the twelve Earthly Branches barbital sodium under the threshold, do not have synergism with the eleventh of the twelve Earthly Branches barbital sodium.
(2) successive administration is to the neural influence of mice:
Get 40 mices of above-mentioned blank group and administration group, once a day, successive administration three days, 1h repeats above-mentioned two experiments after the last administration, the results are shown in Table 13,14.
Table 13. capsule for clearing liver and reducing blood pressure successive administration is to the influence of mice autonomic activities (X ± SD)
| Medicine | Dosage g/Kg | Number of animals (only) | The autonomic activities number of times (inferior/5min) | Change percentage ratio (%) |
| Distilled water removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure | - 5 10 20 | 10 10 10 10 | 542±168 571±193 512±109 505±95 | - 5.4 -5.5 -6.8 |
Annotate: compare there was no significant difference with the blank group.
Table 14. capsule for clearing liver and reducing blood pressure single-dose is to the influence of the eleventh of the twelve Earthly Branches barbital sodium sleep under the valve
| Medicine | Dosage g/Kg | Number of animals (only) | Sleeping number of animals (only) | Sleeping percentage ratio (%) |
| Distilled water removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure | - 5 10 20 | 10 10 10 10 | 1 0 0 0 | 10.0 0 0 0 |
Annotate: compare there was no significant difference with the blank group.
The result shows, the removing heat from the liver to lower the high blood pressure successive administration does not influence the mice autonomic activities, does not also have synergism with the eleventh of the twelve Earthly Branches barbital sodium.
Brief summary
1.SHR single oral removing heat from the liver to lower the high blood pressure extractum 2g (crude drug)/Kg does not have obvious influence to blood pressure, gives 4, blood pressure obviously descends behind 8g (crude drug)/Kg, three dosage all do not have obvious influence to heart rate.RHD single oral removing heat from the liver to lower the high blood pressure extractum 1g (crude drug)/Kg hypotensive effect is not obvious, and 2,4g (crude drug)/Kg has obvious hypotensive effect, the heart rate no change.Each dosage group does not have obvious influence to electrocardiogram.
Removing heat from the liver to lower the high blood pressure extractum once a day, 14 days SHR2 of successive administration, 4,8g (crude drug)/Kg/d, 2g (crude drug)/Kg/d hypotensive effect is not obvious, 4,8g (crude drug)/Kg/d begins to descend respectively at 5,3 days blood pressures; RHD1,2g (crude drug)/Kg/d blood pressure began to descend respectively at administration in the 11st, 7 days; Heart rate does not have significant change, and 2～4 days blood pressures can return to the control period level after the drug withdrawal.
3. after the anesthetized open-chest dog duodenum gave removing heat from the liver to lower the high blood pressure extractum 2,4g (crude drug)/Kg, blood pressure (SBP, DBP) descended, and total peripheral resistance (TPR) reduces, and heart rate does not have significant change, ± LVdp/dt
MaxDo not have obviously and change left chamber acting (LVW) minimizing, the no significant change of cardiac pumping function (CO, CI).
4. the mice single reaches and gives removing heat from the liver to lower the high blood pressure extractum 5,10,20g (crude drug)/Kg continuously, and the mice autonomic activities does not have significant change, does not have synergism with the eleventh of the twelve Earthly Branches barbital sodium.
Experimental unit: Tianjin Pharmaceuticals Inst., State Medicine Administration Bureau
Experimenter: 1.RHD experiment: what cloudling of Xu Xiangwei
2.SHR experiment: Yang Yi Xu is to big
3. cardiac hemodynamic experiment: Xu is to big Yang Yi
4. calm experiment: Xu is to what cloudling of the thick filial piety of big Liu
Director: Liu Houxiao
The experiment date: 1996.4～1997.2
The place is preserved in protocol:
Tianjin Inst. of Materia Medica hypertension pharmacology research department
Table 1. capsule for clearing liver and reducing blood pressure single-dose to the influence of SHR systolic pressure and heart rate (X ± SD, n=8)
| Index | Medicine | Dosage (g/kg) | Before the administration | After the administration (h) | |||||||
| 1 | 2 | 3 | 4 | 6 | 8 | 12 | 24 | ||||
| Systolic pressure mmHg | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 8.0 0.8 | 215±17 218±12 217±12 216±10 216±10 | 214±14 216±12 212±15 202±13 ** 213±10 | 216±13 215±10 210±15 197±16 ** 206±10 * | 217±13 215±12 212±14 204±15 * 208±12 * | 218±15 217±11 215±10 211±16 209±13 * | 215±13 215±11 217±14 213±11 214±9 | 216±16 217±9 215±13 213±9 213±10 | 214±15 218±9 214±11 214±10 212±8 | 218±15 217±14 217±13 216±11 215±11 |
| Heart rate bpm | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 8.0 0.8 | 379±23 378±18 381±22 382±24 386±20 | 386±28 384±26 377±27 376±28 379±25 | 382±27 375±27 385±28 380±28 376±28 | 377±25 374±22 380±17 382±19 385±22 | 375±25 387±24 375±24 377±27 382±24 | 371±24 383±29 387±23 380±26 386±25 | 374±18 377±20 382±23 381±28 375±25 | 380±26 379±27 380±28 378±18 383±28 | 381±24 384±25 379±27 377±27 379±25 |
Annotate: with comparison before the administration
*P＜0.05
*P＜0.01.
Table 2. capsule for clearing liver and reducing blood pressure single-dose is to influence (X ± SD, n=8, the unit: %) of SHR systolic pressure
| Medicine | Dosage g/kg | Basic value before the administration | Percent change after the administration | |||||||
| 1 | 2 | 3 | 4 | 6 | 8 | 12 | 24 | |||
| Blank clearing liver and reducing blood pressure clearing liver and reducing blood pressure clearing liver and reducing blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 8.0 0.8 | 215±17 218±12 217±12 216±10 216±10 | -0.6 ±1.9 -1.0 ±1.9 -1.9 ±2.9 -6.2 ±4.7 * -1.5 ±1.1 | 0.8 ±3.1 -1.3 ±1.5 -3.7 ±5.4 -8.9 ±5.6 ** -2.9 ±3.4 | 1.1 ±3.2 -1.1 ±2.8 -2.7 ±3.3 -5.5 ±5.3 * -3.7 ±4.2 | 1.6 ±2.3 -0.4 ±1.8 -0.4 ±2.2 -2.1 ±7.7 -3.1 ±3.8 * | 0.1 ±2.9 -1.4 ±2.2 -0.4 ±2.8 -1.1 ±3.7 -0.9 ±3.9 | 0.3 ±3.7 -0.5 ±2.0 -1.3 ±2.0 -1.3 ±3.7 -1.3 ±2.7 | -0.2 ±2.1 -0.3 ±2.3 -1.7 ±2.8 -1.0 ±3.0 -1.4 ±2.7 | 0.3 ±2.6 -0.4 ±2.5 -0.2 ±1.9 0.4 ±2.1 -0.5 ±2.8 |
Annotate: 1. basic value unit: mmHg before the administration;
2. compare the same period with matched group:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
Table 3. single oral capsule for clearing liver and reducing blood pressure to the effect of RHD blood pressure and heart rate (X ± SD, n=5)
| Index | Medicine | Dosage (g/kg) | Before the administration | After the administration (h) | |||||
| 1 | 2 | 3 | 4 | 6 | 8 | ||||
| Systolic pressure mmHg | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 1.0 2.0 4.0 0.2 | 181±19 185±24 183±23 182±27 186±24 | 180±22 185±30 178±20 173±28 ** 176±22 ** | 182±18 184±27 173±19 ** 168±28 ** 173±21 * | 182±20 180±29 177±22 ** 174±30 * 172±24 *** | 185±23 182±24 178±20 174±26 * 175±22 * | 186±19 185±24 184±20 180±24 180±24 * | 185±21 184±26 182±20 181±27 186±22 |
| Diastolic pressure mmHg | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 1.0 2.0 4.0 0.2 | 120±18 124±25 123±21 123±25 124±22 | 117±19 124±28 120±20 * 118±27 * 115±23 ** | 120±17 124±28 116±19 ** 112±24 *** 113±21 ** | 119±16 122±30 118±22 ** 115±26 ** 112±26 * | 122±23 124±27 119±21 118±24 * 112±24 * | 123±18 124±25 123±18 125±27 119±23 * | 121±21 126±28 123±21 126±30 123±22 |
| Heart rate bpm | Contrast removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 1.0 2.0 4.0 0.2 | 107±8 103±12 101±12 101±9 103±11 | 106±8 102±11 98±15 97±15 103±17 | 110±7 103±10 101±15 95±16 103±12 | 109±7 100±9 100±12 100±13 105±12 | 110±7 103±14 100±12 98±6 106±12 | 113±5 102±10 103±14 97±11 106±11 | 110±5 104±14 102±12 98±13 106±8 |
Annotate: compare before and after the administration:
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Table 4. capsule for clearing liver and reducing blood pressure single-dose is to influence (X ± SD, the n=5 unit: %) of RHD blood pressure
| Index | Medicine | Dosage g/kg | Basic value before the administration | Percent change after the administration | |||||
| 1 | 2 | 3 | 4 | 6 | 8 | ||||
| Systolic pressure | Blank clearing liver and reducing blood pressure clearing liver and reducing blood pressure clearing liver and reducing blood pressure Bezoar pill for lowering blood pressure | - 1.0 2.0 4.0 0.2 | 181±19 185±24 183±23 182±27 186±24 | -0.6 ±1.8 -0.4 ±4.0 -2.7 ±2.1 -5.0 ±2.2 ** -5.0 ±1.9 ** | 0.5 ±2.2 -1.0 ±4.8 -5.4 ±1.3 *** -7.6 ±2.7 *** -6.9 ±3.1 ** | 0.3 ±2.8 -3.3 ±5.7 -3.3 ±1.2 * -4.9 ±3.2 * -7.5 ±1.9 *** | 2.1 ±5.0 -1.7 ±3.4 -2.8 ±2.6 -4.4 ±2.3 * -5.7 ±3.6 * | 2.7 ±3.5 -0.3 ±1.9 0.8 ±2.5 -0.9 ±2.3 -3.0 ±1.9 ** | 2.1 ±3.6 -0.8 ±4.1 -0.3 ±1.9 -0.7 ±1.1 0.4 ±3.6 |
| Diastolic pressure | Blank clearing liver and reducing blood pressure clearing liver and reducing blood pressure clearing liver and reducing blood pressure Bezoar pill for lowering blood pressure | - 1.0 2.0 4.0 0.2 | 120±18 124±25 123±21 123±25 124±22 | -1.9 ±1.8 -0.4 ±5.1 -3.1 ±2.0 -4.5 ±3.2 -8.1 ±3.7 * | 0.3 ±3.1 -0.5 ±7.5 -5.6 ±2.2 ** -8.9 ±2.2 *** -9.3 ±4.1 ** | -0.4 ±3.1 -1.8 ±8.7 -4.5 ±2.4 * -6.6 ±3.3 * -10.6 ±6.6 * | 2.1 ±4.7 -0.3 ±3.9 -3.3 ±3.4 -4.3 ±3.0 -10.6 ±5.8 * | 3.3 ±3.6 -0.2 ±2.4 0.0 ±2.9 -1.2 ±3.3 -4.4 ±2.9 ** | 1.3 ±4.8 1.0 ±3.0 -0.6 ±1.4 1.4 ±3.6 -1.0 ±3.1 |
Annotate: 1. basic value unit: mmHg before the administration:
2. compare the same period with matched group:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
Table 5. capsule for clearing liver and reducing blood pressure long term administration (14d) to the influence of SHR systolic pressure (X ± SD, n=8)
| Medicine | Dosage (g/kg) | Control period (my god) | The administration phase (my god) | Withdrawal time (my god) | |||||||||||||||||
| 1 | 2 | 3 | 4 | 5 | X | 1 | 2 | 3 | 5 | 7 | 9 | 11 | 13 | 14 | 1 | 2 | 3 | 4 | |||
| Contrast clearing liver and reducing blood pressure clearing liver and reducing blood pressure clearing liver and reducing blood pressure Bezoar pill for lowering blood pressure | -- 2.0 4.0 8.0 0.8 | Before and after before and after before and after before and after the front and back | 216 ±17 219 ±13 216 ±10 216 ±10 216 ±12 | 218 ±13 218 ±12 218 ±12 218 ±12 214 ±13 | 217 ±16 218 ±11 217 ±11 217 ±11 217 ±11 | 218 ±16 216 ±12 214 ±11 214 ±11 216 ±10 | 215 ±14 217 ±12 215 ±10 215 ±10 217 ±11 | 217 ±15 218 ±11 217 ±12 216 ±10 216 ±11 | 217 ±15 218 ±13 218 ±11 215 ±10 217 ±12 210 ±15 216 ±10 197 ±16 ** 216 ±11 208 ±9 * | 215 ±15 217 ±14 217 ±13 213 ±11 215 ±10 | 219 ±14 217 ±14 216 ±11 215 ±13 214 ±12 208 ±12 * 205 ±17 ** 194 ±15 *** 207 ±13 198 ±10 ** | 219 ±15 218 ±14 218 ±11 216 ±10 210 ±13 ** 203 ±12 * 201 ±15 ** 195 ±12 *** 201 ±14 ** 192 ±13 *** | 217 ±14 220 ±12 215 ±10 212 ±10 ** 208 ±12 ** 202 ±10 ** 203 ±9 *** 197 ±9 ** 205 ±10 * 195 ±10 *** | 217 ±11 216 ±11 215 ±9 211 ±12 ** 207 ±14 * 201 ±13 ** 203 ±10 *** 192 ±13 *** 200 ±17 ** 196 ±16 ** | 215 ±16 218 ±17 218 ±11 213 ±12 207 ±12 * 201 ±14 ** 200 ±15 *** 192 ±8 *** 201 ±12 ** 197 ±8 *** | 219 ±14 217 ±12 214 ±10 210 ±10 ** 206 ±9 ** 199 ±14 ** 198 ±11 *** 190 ±11 *** 202 ±12 *** 193 ±10 *** | 217 ±13 215 ±11 205 ±11 *** 196 ±10 *** 198 ±8 *** | 216 ±11 216 ±13 205 ±9 *** 198 ±10 *** 200 ±11 *** | 218 ±12 216 ±13 211 ±12 *** 203 ±7 ** 208 ±13 | 219 ±15 217 ±13 213 ±14 * 208 ±8 * 214 ±13 | 217 ±14 219 ±12 217 ±9 213 ±9 216 ±15 |
Annotate: 1. " X " refers to the control period meansigma methods, and before " preceding " referred to administration every day, " back " referred to after administration every day 2 hours,
2. with the X paired comparison:
*P＜0.05,
*P＜0,01,
* *P＜0.001;
Table 6. capsule for clearing liver and reducing blood pressure long term administration (14d) to the influence of SHR heart rate (X ± SD, n=8)
| Medicine | Dosage (g/kg) | Control period (my god) | The administration phase (my god) | Withdrawal time (my god) | |||||||||||||||||
| 1 | 2 | 3 | 4 | 5 | X | 1 | 2 | 3 | 5 | 7 | 9 | 11 | 13 | 14 | 1 | 2 | 3 | 4 | |||
| Contrast clearing liver and reducing blood pressure clearing liver and reducing blood pressure clearing liver and reducing blood pressure Bezoar pill for lowering blood pressure | -- 2.0 4.0 8.0 0.8 | Before and after before and after before and after before and after the front and back | 386 ±28 386 ±20 386 ±20 383 ±29 382 ±27 | 379 ±23 379 ±23 375 ±25 379 ±23 380 ±28 | 379 ±27 384 ±18 380 ±15 373 ±25 375 ±25 | 383 ±22 373 ±25 383 ±29 383 ±22 380 ±22 | 390 ±17 378 ±20 381 ±22 381 ±22 386 ±20 | 383 ±20 380 ±19 382 ±20 379 ±17 380 ±15 | 383 ±20 376 ±24 380 ±19 381 ±22 382 ±20 381 ±24 379 ±17 377 ±19 380 ±15 378 ±23 | 380 ±22 380 ±24 379 ±21 382 ±24 379 ±25 | 379 ±29 380 ±25 379 ±32 375 ±25 382 ±24 385 ±30 379 ±32 375 ±25 389 ±23 385 ±27 | 376 ±18 371 ±24 382 ±24 378 ±28 375 ±21 378 ±19 371 ±16 381 ±22 380 ±24 384 ±23 | 373 ±23 381 ±27 380 ±24 384 ±23 373 ±23 381 ±27 386 ±25 383 ±23 379 ±32 375 ±25 | 382 ±24 385 ±30 379 ±21 376 ±27 379 ±29 380 ±25 374 ±23 387 ±23 385 ±18 377 ±19 | 378 ±19 375 ±21 373 ±23 381 ±27 382 ±24 378 ±28 378 ±17 379 ±24 372 ±24 376 ±28 | 379 ±21 376 ±27 3S2 ±24 385 ±30 379 ±32 375 ±25 379 ±29 380 ±25 382 ±24 378 ±28 | 387 ±16 381 ±24 382 ±26 387 ±16 383 ±28 | 381 ±24 375 ±27 374 ±22 381 ±26 386 ±25 | 374 ±18 380 ±20 381 ±24 375 ±17 379 ±25 | 379 ±25 373 ±23 379 ±25 382 ±26 374 ±22 | 381 ±24 382 ±24 377 ±19 381 ±24 382 ±26 |
Annotate: 1. " X " refers to the control period meansigma methods, and before " preceding " referred to administration every day, " back " referred to after administration every day 2 hours;
2. with X paired comparison there was no significant difference.
Table 7. capsule for clearing liver and reducing blood pressure long term administration (14d) to the effect of RHD blood pressure and heart rate (X ± SD, n=5)
| Index | Medicine | Dosage (g/kg) | Control period (my god) | The administration phase (my god) | Convalescent period (my god) | ||||||||||||||||
| 1 | 2 | 3 | 4 | 5 | X | 1 | 2 | 3 | 5 | 7 | 9 | 11 | 13 | 14 | 1 | 2 | 3 | ||||
| Systolic pressure mmHg | Removing heat from the liver to lower the high blood pressure | 1.0 2.0 | Before and after the front and back | 183 ±20 188 ±23 | 187 ±21 185 ±18 | 189 ±22 188 ±19 | 193 ±21 189 ±20 | 188 ±20 185 ±19 | 188 ±20 187 ±19 | 191 ±23 189 ±22 191 ±20 183 ±17 * | 190 ±24 189 ±23 | 190 ±18 188 ±20 184 ±16 176 ±15 * | 189 ±22 190 ±19 184 ±17 175 ±13 * | 191 ±23 187 ±19 175 ±15 * 173 ±16 * | 187 ±21 182 ±19 173 ±11 * 168 ±15 * | 182 ±22 * 177 ±20 ** 170 ±13 * 165 ±13 * | 183 ±20 * 178 ±19 ** 170 ±11 * 165 ±18 ** | 179 ±19 ** 170 ±13 * | 179 ±21 ** 167 ±14 ** | 185 ±18 178 ±17 * | 191 ±21 187 ±21 |
| Diastolic pressure mmHg | Removing heat from the liver to lower the high blood pressure | 1.0 2.0 | Before and after the front and back | 124 ±17 125 ±22 | 124 ±17 125 ±16 | 130 ±16 123 ±15 | 131 ±14 127 ±17 | 126 ±17 123 ±17 | 127 ±14 125 ±17 | 126 ±17 124 ±21 124 ±19 119 ±15 * | 127 ±21 124 ±19 | 125 ±19 125 ±21 121 ±16 116 ±16 * | 126 ±21 128 ±17 123 ±15 117 ±15 * | 127 ±21 124 ±16 117 ±17 ** 114 ±17 ** | 123 ±18 120 ±19 115 ±16 * 112 ±19 ** | 120 ±20 115 ±18 ** 111 ±17 * 107 ±16 ** | 122 ±17 * 116 ±17 ** 114 ±13 ** 107 ±18 ** | 118 ±20 * 111 ±14 *** | 116 ±18 ** 110 ±14 ** | 123 ±16 117 ±15 * | 126 ±18 124 ±16 |
| Heart rate bpm | Removing heat from the liver to lower the high blood pressure | 1.0 2.0 | Before and after the front and back | 111 ±7 110 ±8 | 108 ±11 110 ±12 | 108 ±8 103 ±5 | 114 ±7 107 ±9 | 108 ±11 111 ±10 | 110 ±7 108 ±7 | 107 ±9 110 ±6 108 ±10 109 ±7 | 111 ±12 107 ±10 | 112 ±12 109 ±8 114 ±9 110 ±7 | 113 ±8 110 ±14 110 ±8 105 ±8 | 109 ±7 110 ±14 108 ±12 110 ±7 | 111 ±7 110 ±12 109 ±12 108 ±9 | 111 ±10 109 ±2 110 ±13 108 ±8 | 113 ±2 110 ±4 111 ±10 110 ±13 | 110 ±4 107 ±13 | 109 ±5 112 ±8 | 110 ±7 113 ±5 | 108 ±11 109 ±12 |
Annotate: 1. " X " refers to the control period meansigma methods, and before " preceding " referred to administration every day, " back " referred to after administration every day 2～3 hours,
2. compare with X:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
Table 8. capsule for clearing liver and reducing blood pressure is to anesthetized open-chest dog systolic pressure (SBP), diastolic pressure (DBP)
And the influence of heart rate (HR) (X ± SD, n=5)
| Index | Medicine | Dosage (g/kg) | Before the administration | After the administration (h) | ||||
| 0.5 | 1 | 1.5 | 2 | 3 | ||||
| SBP | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 110±5 110±7 113±8 107±14 | 112±5 (1.8) 108±7 (-1.8) 107±8 * (-5.3) 101±16 ** (-5.6) | 111±5 (0.9) 104±8 * (-5.5) 107±8 ** (-5.3) 100±16 * (-6.5) | 112±4 (1.8) 105±7 ** (-4.5) 105±8 ** (-7.1) 96±18 ** (-10.3) | 111±7 (0.9) 110±7 (0) 105±10 * (-7.1) 98±14 *** (-8.4) | 110±5 (0) 112±7 (1.8) 106±10 (-6.2) 100±13 * (-6.5) |
| DBP | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 72±5 77±4 77±9 73±11 | 74±6 (2.8) 74±6 (-3.9) 71±11 (-7.8) 65±11 *** (-11.0) | 73±5 (1.4) 89±6 (-10.4) 71±11 * (-7.8) 65±11 ** (-11.0) | 72±4 (0) 70±5 * (-9.1) 88±9 *** (-11.7) 62±10 *** (-15.1) | 72±8 (0) 71±4 (-7.8) 68±11 * (-11.7) 64±11 ** (-12.3) | 70±7 (-2.8) 74±4 (-3.9) 71±11 (-7.8) 64±14 * (-12.3) |
| HR | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 154±35 143±17 144±23 148±15 | 155±35 (0.6) 144±16 (0.7) 146±18 (1.4) 150±20 (1.4) | 154±36 (0) 143±19 (0) 146±20 (1.4) 152±16 (2.7) | 156±38 (1.3) 141±19 (-1.4) 146±17 (1.4) 148±20 (0) | 151±36 (-1.9) 142±17 (-0.7) 142±20 (-1.4) 146±17 (-1.4) | 153±36 (-1.6) 144±15 (0.7) 143±20 (-0.7) 114±19 (-2.7) |
Annotate: 1) compare before and after the administration:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
2) percent change after the interior expression of the bracket administration, unit: %;
3) unit: SBP, DBP:mmHg;
HR：beats/min。
Table 9. capsule for clearing liver and reducing blood pressure is to anesthetized open-chest dog left indoor pressure (LVSP), maximum the rate of change (± dp/dt of left indoor pressure
Max)
With the influence of left chamber acting (LVW) (X ± SD, n=5)
| Index | Medicine | Dosage (g/kg) | Before the administration | After the administration (h) | ||||
| 0.5 | 1 | 1.5 | 2 | 3 | ||||
| LVSP | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 125±10 122±8 125±10 122±4 | 128±13 (2.4) 123±7 (0.8) 116±15 (-7.2) 118±5 * (-3.3) | 127±12 (1.6) 118±6 (-3.3) 114±6 ** (-8.8) 115±6 ** (-5.7) | 128±11 (2.4) 119±12 (-2.5) 113±6 ** (-9.6) 111±8 ** (-9.0) | 128±11 (0.8) 122±6 (0) 116±11 ** (-7.2) 112±8 ** (-8.2) | 127±11 (1.6) 125±8 (2.5) 118±10 (-5.6) 116±9 * (-4.9) |
| +dp / dt | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 3080±912 2810±409 2800±323 2832±577 | 3192±1007 (3.6) 2910±517 (3.6) 2648±350 (-5.4) 2982±528 (5.3) | 3112±829 (1.0) 2830±541 (0.7) 2608±358 (-6.9) 2834±386 (0.1) | 3158±797 (2.5) 2802±555 (0.3) 2642±484 (-5.6) 2678±447 (-5.4) | 3108±861 (0.9) 2816±582 (0.2) 2744±444 (-2.0) 2710±501 (-4.3) | 3096±805 (0.5) 2892±402 (2.9) 2898±620 (3.5) 2656±393 (-6.2) |
| -dp / dt | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 2290±583 2150±484 2262±403 2050±241 | 2354±583 (2.8) 2232±487 (3.8) 2266±331 (0.2) 1946±285 (-5.1) | 2298±817 (0.3) 1970±253 (-8.4) 2222±293 (-1.8) 1894±474 (-7.6) | 2366±618 (3.3) 2080±296 (-3.3) 2196±417 (-2.9) 1798±270 (-12.3) | 2324±620 (1.5) 2160±407 (0.5) 2222±383 (-1.8) 1888±237 (-7.9) | 2256±543 (-1.5) 2270±334 (5.6) 2388±307 (5.6) 1872±336 (-8.7) |
| LVW | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 3.03±0.83 3.31±1.07 3.35±1.12 3.39±1.02 | 3.14±0.87 (3.6) 3.34±1.09 (0.9) 3.12±0.98 (-6.9) 3.23±1.06 * (-4.7) | 3.10±0.85 (2.3) 3.15±1.14 (-4.8) 3.11±1.05 * (-7.2) 3.06±1.09 ** (-9.7) | 3.08±0.90 (1.7) 3.00±0.97 * (-9.4) 2.98±0.94 * (-11.0) 2.93±1.07 ** (-13.6) | 3.00±0.83 (-1.0) 3.13±1.06 (-5.4) 2.99±1.04 ** (-10.7) 3.04±1.02 * (-10.3) | 2.95±0.80 (-2.6) 3.19±1.07 (-3.6) 3.17±1.23 (-5.4) 3.11±1.16 (-8.3) |
Annotate: 1) compare before and after the administration:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
2) percent change after the interior expression of the bracket administration, unit: %;
3) unit: LVSP:mmHg;
±dp/dt
max：mmHg/s；
LVW：kg·m/min/m
2。
Table 10. capsule for clearing liver and reducing blood pressure is to anesthetized open-chest dog cardiac output (CO), cardiac output (SV), cardiac index (CI)
And the influence of total peripheral resistance (TPR) (X ± SD, n=5)
| Index | Medicine | Dosage (g/kg) | Before the administration | After the administration (h) | ||||
| 0.5 | 1 | 1.5 | 2 | 3 | ||||
| CO | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 1.84±0.53 1.83±0.67 1.96±0.77 1.99±0.49 | 1.87±0.56 (1.6) 1.85±0.69 (1.1) 1.97±0.76 (0.5) 2.05±0.50 (3.0) | 1.84±0.54 (0) 1.86±0.72 (1.6) 1.96±0.76 (0) 1.97±0.53 (-1.0) | 1.85±0.55 (0.5) 1.78±0.70 (-2.7) 1.95±0.74 (-0.5) 1.98±0.52 (-0.5) | 1.81±0.53 (-1.6) 1.78±0.70 (-2.7) 1.97±0.76 (0.5) 2.00±0.49. (0.5) | 1.81±0.53 (-1.6) 1.76±0.68 (-3.8) 1.99±0.76 (1.5) 1.99±0.49 (0) |
| SV | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 11.9±2.4 12.4±4.8 13.5±5.0 13.4±3.4 | 12.0±2.7 (0.8) 12.4±5.0 (0) 13.4±4.9 (-0.7) 13.7±3.4 (2.2) | 12.0±2.8 (0.8) 12.6±5.3 (1.6) 13.3±5.0 (-1.5) 13.0±3.5 (-3.0) | 11.8±2.6 (-0.8) 12.3±5.2 (-0.8) 13.5±5.3 (0) 13.4±3.5 (0) | 12.1±2.7 (1.7) 12.0±5.0 (-3.2) 13.9±5.4 (3.0) 13.7±3.2 (2.2) | 11.9±2.7 (0) 12.0±5.0 (-3.2) 13.6±4.9 (0.7) 13.9±3.1 (4.5) |
| CI | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 2.66±0.74 2.77±0.89 2.72±0.80 2.86±0.46 | 2.69±0.78 (1.1) 2.82±0.90 (1.8) 2.73±0.77 (0.4) 2.95±0.54 (3.1) | 2.65±0.75 (-0.4) 2.82±0.98 (1.8) 2.72±0.78 (0) 2.84±0.58 (-0.7) | 2.66±0.79 (0) 2.70±0.94 (-2.5) 2.71±0.73 (-0.4) 2.84±0.57 (-0.7) | 2.60±0.73 (-2.3) 2.69±0.92 (-2.9) 2.74±0.79 (0.7) 2.87±0.52 (0.3) | 2.61±0.73 (-1.9) 2.67±0.92 (-3.6) 2.77±0.79 (1.8) 2.87±0.53 (0.3) |
| TPR | Blank removing heat from the liver to lower the high blood pressure removing heat from the liver to lower the high blood pressure Bezoar pill for lowering blood pressure | - 2.0 4.0 0.2 | 3955±1243 3690±813 3616±1016 3565±577 | 4032±1372 (1.9) 3614±881 (-2.1) 3370±946 (-6.8) 3188±497 ** (-10.6) | 4065±1361 (2.8) 3416±770 * (-7.4) 3379±941 * (-6.6) 3266±487 * (-8.4) | 4067±1470 (2.8) 3651±1065 (-1.1) 3262±889 * (-9.8) 3196±751 * (-10.4) | 4058±1188 (2.6) 3768±962 (2.1) 3223±1035 * (-10.9) 3187±583 *** (-10.6) | 3986±1204 (0.8) 3899±999 (5.7) 3239±781 (-10.4) 3221±472 ** (-9.6) |
Annotate: 1) compare before and after the administration:
*P＜0.05,
*P＜0.01,
* *P＜0.001;
2) percent change after the interior expression of the bracket administration, unit: %;
3) unit: CO:l/min;
SV：ml/beats；
CI：l/min/m
2；
TPR·mmHg/ml/s。
Capsule for clearing liver and reducing blood pressure treatment hypertension
The report of (overabundant liver-fire, liver-kidney yin deficiency) II clinical trial phase
Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College
Dongzhimen Hospital, Beijing Univ of Traditional Chinese Medicine
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Xiyuan Hospital, Chinese Medicine Academy of China
The hospital of traditional Chinese hospital, Beijing
Summary
Capsule for clearing liver and reducing blood pressure is three class new Chinese medicines by Beijing flood day treatment hypertension (overabundant liver-fire, syndrome of yin deficiency of liver and kidney) that power Medicines and Health Product institute is developed, observe through Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Dongzhimen Hospital, Beijing Univ of Traditional Chinese Medicine, Gate of Pervasive Peace hospital of the academy of traditional Chinese medicine, Xiyuan hospital of the academy of traditional Chinese medicine, five tame hospitals of Beijing Hospital of Traditional Chinese Medicine, test routine number and amount to 431 examples, test group 161 examples wherein, matched group 130 examples, open group 140 examples.The result shows: efficacy of antihypertensive treatment test group obvious effective rate is 49.7%, total effective rate 82.6%, and compare with matched group: P＜0.01 has utmost point significant difference.Total treatment group obvious effective rate is 51.5%, and total effective rate is 84.4%, and compare with matched group: P＜0.01 has utmost point significant difference.Tcm syndrome test group obvious effective rate is 52.8%, and total effective rate 89.4% compares P＜0.01 with matched group, has utmost point significant difference.Total treatment group obvious effective rate is 52.5%, and total effective rate is 91.7%, and compare with matched group: P＜0.01 has utmost point significant difference.Also do not find toxic and side effects and untoward reaction in the process of the test.
Test objective
Formulated the plan of capsule for clearing liver and reducing blood pressure treatment hypertension (overabundant liver-fire, liver-kidney yin deficiency) II clinical trial phase according to Ministry of Public Health bureau of drug policy ﹠ administration (98) ZL-033 certification and " new Chinese medicine clinical research guideline ", and in April, 1998～December capsule for clearing liver and reducing blood pressure is treated hypertension and carried out clinical sight Cai of II phase, mainly investigate its curative effect and safety.
Physical data
Select altogether to be in hospital and out-patient's 431 examples, test group patient totally 301 examples wherein, inpatient 140 examples account for 46.51%, and out-patient's 161 examples account for 53.49%; The matched group patient is totally 130 examples, and inpatient 68 examples account for 52.31%, and out-patient's 62 examples account for 47.69%.Before test group and matched group are treated at sex, age, the course of disease, the state of an illness and hypertension typing, by stages, aspects such as symptom, tongue arteries and veins all do not have significant difference.P＞0.05 has comparability, sees table 1-9 for details.
Table 1 patient sex distribution situation
| Group | The example number | The man | The woman | Man: woman | ||
| Example | (％) | Example | (％) | |||
| Test group matched group treatment group always | 161 130 301 | 95 67 148 | (59.00) (51.54) (49.17) | 66 63 153 | (41.00) (48.46) (50.83) | 1.44∶1 1.06∶1 0.97∶1 |
Statistical procedures result: test group and matched group be X relatively
2Total treatment group in=1.63 P＞0.05 and matched group be X relatively
2=0.20 P＞0.05.
Table 2 patient age distribution situation
| Group | The example number | 18～30 | ～40 | ～50 | ～60 | ～70 |
| Test group matched group treatment group always | 161 130 301 | 1 1 1 | 13 7 19 | 24 16 51 | 37 39 86 | 86 67 144 |
Test group the oldest 70 years old minimum 22 years old,
Matched group the oldest 70 years old minimum 34 years old,
Statistical procedures result: test group and matched group be X relatively
2=2.54 P＞0.05;
Total treatment group and matched group be X relatively
2=2.23 P＞0.05.
Table 3 patient course of disease distribution situation
| Group | The example number | The course of disease (year) | ||||
| ＜I | 1～ | 3～ | 5～ | 10～ | ||
| Test group matched group treatment group always | 161 130 301 | 9 6 16 | 23 16 50 | 22 13 49 | 29 27 62 | 78 68 124 |
The test group course of disease is the longest 30 years, the shortest half a year.
The matched group course of disease is the longest 27 years, the shortest half a year.
Statistical procedures result: test group and matched group be X relatively
2=5.51, P＞0.05;
Total treatment group and matched group be X relatively
2=6.71, P＞0.05.
Table 4 patient traditional Chinese medical science severity extent
| Group | The example number | Slightly | Moderate | Severe | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Test group matched group treatment group always | 161 130 301 | 10 11 33 | (6.21) (8.46) (10.96) | 69 63 114 | (42.86) (48.46) (37.87) | 82 56 154 | (50.93) (43.08) (51.16) |
Statistical procedures result: test group and matched group be X relatively
2=2.30 P＞0.05;
Total treatment group and matched group be X relatively
2=4.24 P＞0.05.
The classification of table 5 patient hypertension doctor trained in Western medicine
| Group | The example number | Slightly | Middle severe | Pure systole | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Test group matched group treatment group always | 161 130 301 | 93 66 163 | (57.76) (50.77) (54.15) | 49 46 116 | (30.43) (35.38) (38.54) | 19 18 22 | (11.80) (13.85) (7.30) |
Statistical procedures result: test group and matched group be X relatively
2=1.42 P＞0.05;
Total treatment group and matched group be X relatively
2=4.42 P＞0.05.
Table 6 patient hypertension by stages
| Group | The example number | The I phase | The II phase | The III phase | |||
| Example | (％) | Example | (％) | Example | (％) | ||
| Test group matched group treatment group always | 161 130 301 | 29 18 61 | (18.01) (13.85) (20.27) | 124 103 210 | (77.02) (79.23) (69.77) | 8 9 30 | (4.97) (6.92) (9.97) |
Statistical procedures result: test group and matched group be X relatively
2=1.29 P＞0.05;
Total treatment group and matched group be X relatively
2=4.09 P＞0.05.
Table 7 patient hypertension situation (mmHg)
| Group | The example number | Systolic pressure | Diastolic pressure |
| X±S | X±S | ||
| Test group matched group treatment group always | 161 130 301 | 164.60±14.43 165.05±16.08 166.18±15.00 | 97.40±9.50 97.47±8.67 98.66±11.40 |
Statistical procedures result: test group and matched group are relatively
Systolic pressure t=0.2486 P＞0.05
Diastolic pressure t=0.3936 P＞0.05
Total treatment group and matched group are relatively
Systolic pressure t=0.6848 P＞0.05
Diastolic pressure t=0.6873 P＞0.05
Table 8 patient symptom distribution situation (example)
| Group | The example number | Dizzy | Headache | Being irritable and getting angry easily | Dry mouth with bitter taste | Soreness of the waist and knees | Cardiopalmus | Be insomnia | Tinnitus | Forgetful | Flushing conjunctival congestion | Dry stool |
| Test group matched group treatment group always test group and matched group be X relatively 2Total treatment group and matched group be X relatively 2 | 161 130 301 | 145 115 271 0.19 0.24 | 124 98 232 0.11 0.14 | 125 101 238 1.04 0.10 | 125 99 240 0.09 0.69 | 122 98 238 0.01 0.72 | 92 75 179 0.01 0.12 | 104 77 204 0.88 2.92 | 79 70 153 0.66 0.33 | 121 88 195 1.98 0.34 | 102 79 184 0.20 0.004 | 98 81 190 0.06 0.03 |
Statistical result shows: test group and matched group P＞0.05
Total treatment group and matched group P＞0.05
Table 9 patient tongue arteries and veins distribution situation (example)
| Group | The example number | Red tongue | Yellow fur | Abnormal pulse condition (string, thin, number) |
| Test group matched group treatment group always test group and matched group be X relatively 2P treatment group always and matched group be X relatively 2 P | 162 130 301 | 147 115 273 0.61 ＞0.05 0.23 ＞0.05 | 132 102 241 0.55 ＞0.05 0.15 ＞0.05 | 159 125 296 2.14 ＞0.05 1.94 ＞0.05 |
Study subject is selected
One, diagnostic criteria and foundation
(1) Western medicine diagnose standard
1. Evaluation of Diagnostic Criteria of Hypertension (standard of formulating with reference to national cardiovascular epidemiology in 1979 and crowd prevention and treatment forum).
Systolic pressure is equal to or higher than 160mmHg (21.3Kpa) diastolic pressure and is equal to or higher than 95mmHg (12.7Kpa), and the two has one through examining, and can make a definite diagnosis.
Past there was history of hypertension, long-term (more than 3 months) untreated, this checks the normotensive, does not promptly classify hypertension as.As one to medication treatment, this checks the normotensive, still classifies hypertension as, and the person of having a question can check after 1 month in drug withdrawal and remake diagnosis.
2. clinical stages standard (by WHO/ISH standard in 1993).
(1) I phase hypertension: blood pressure reaches the hypertension level of making a definite diagnosis, and clinically is not in the mood for, brain, kidney complication shower.
(2) II phase hypertension: blood pressure reaches makes a definite diagnosis the hypertension level, and a following person is arranged:
The X line, electrocardiogram or ultrasonic examination are seen left ventricular hypertrophy; Examination of ocular fundus is seen has tremulous pulse general or part in optical fundus to narrow down; Albuminuria or/and creatinine concentration of plasma slightly raises, (106-177mmol/L); Ultrasonic or X line has atherosclerotic plaque.
(3) III phase hypertension: blood pressure reaches determines the hypertension level, the clinical manifestation of organ injury occurs:
The heart: angina pectoris, myocardial infarction, heart failure.
Brain: transient ischemic attack (TIA), apoplexy, hypertensive encephalopathy.
The optical fundus: papilloedema is accompanied or do not accompanied to retinal hemorrhage, exudate.
Kidney: serum creatinine＞177mmol/L, renal failure.
Blood vessel: artery dissection, arteriosclerosis obliterans.
3. hypertension classification:
| SBP | DBP |
| Kpa(mmHg) | Kpa(mmHg) |
| Normal 18.7 (140) slight 18.7～24 (140～180) hypotype: severe in critical 18.7～21.3 (140～160)＞24 (180) pure systole phase property＞21.6 (160) hypotypes: critical systole phase type 18.7～21.3 (140～160) | With＜12 (90) and (or) 12～14 (90～105) and (or) 12～12.7 (90～95) and (or)＞14 (105) and (or)＜12 (90) and＜12 (90) |
(WHO/ISH, 1993)
(2) tcm diagnosis standard
Dialectical foundation:
Clinical research guideline with reference to " new Chinese medicine clinical research guideline " new Chinese medicine treatment hypertension: overabundant liver-fire, the hepatic and renal YIN deficiency.
Primary symptom: 1. dizzy, headache.
Inferior disease: 2. flushing conjunctival congestion, being irritable and getting angry easily, constipation, dry mouth with bitter taste.
3. soreness of the waist and knees, cardiopalmus is insomnia, and tinnitus is forgetful.
4. tongue arteries and veins: red tongue, yellow fur, stringy and thready pulse and count (perhaps string, thin, number)
1. 2. 3. respectively possess one or more than, can distinguish with reference to the tongue arteries and veins to be assertive evidence.
Two, case inclusion criteria
(1) meets the hypertension diagnosis
1. under the prerequisite that guarantees patient's life security, the former hypertension agents of taking, 2 week of drug withdrawal the back blood pressures reach Evaluation of Diagnostic Criteria of Hypertension.
2. pass by not medication, not 3 pressure measurement on the same day reach the hypertension diagnosis level in 1 week, and Chinese medical discrimination belongs to overabundant liver-fire, hepatic and renal YIN deficiency syndrome person, can include the test case in.
(2) be the main object of observation with II phase hypertension.
(3) essential hypertension.
(4) systolic pressure＜200mmHg, diastolic pressure＜115mmHg.
Three, case exclusion standard (comprising inadaptation or rejecting standard)
(1) gestation or women breast-feeding their children are to this medicine allergy sufferers at under-18s or more than 70 years old the age.
(2) secondary hypertension.
(3) systolic pressure 〉=200mmHg, diastolic pressure 〉=115mmHg.
(4) the hypertension Chinese medical discrimination does not meet overabundant liver-fire, hepatic and renal YIN deficiency syndrome person.
(5) merge to have the inclination, serious primary disease, psychotics such as brain, liver, kidney and hemopoietic system.
(6) all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
Test method
One, group technology
Test group, matched group, open group are set in this test.Wherein test group and matched group adopt randomized controlled method grouping dispensing.Test group 161 examples, matched group 130 examples, open group 140 examples amount to 431 examples.
Two, method of administration
The test group capsule for clearing liver and reducing blood pressure, every day 3 times, each 3 oral.
The matched group SONGLING XUEMAIKANG JIAONANG, every day 3 times, each 3 oral.
Open group is used capsule for clearing liver and reducing blood pressure, every day 3 times, each 3 oral.
Capsule for clearing liver and reducing blood pressure is produced by Beijing flood day power Medicines and Health Product institute, and lot number is 970926;
SONGLING XUEMAIKANG JIAONANG is produced by Chengdu Kanghong Pharmaceutical Co., Ltd, and lot number is 980314.
Three, the course of treatment
Be a course of treatment all around, observe a course of treatment.
Four, points for attention
1. survey blood pressure weekly 2～3 times, to be advisable seat during 9-10 the morning.Each fixing same upper limb of surveying.Pressure value adopts mmHg.Had a rest 20～30 minutes before the pressure measurement.
2. must not take the Chinese and western drugs of other treatment primary disease during the clinical trial, or adopt other Therapeutic Method.If blood pressure 〉=200/115mmHg can use nifedipine 5mg sublingual administration but need record consumption temporarily.
Five, observation index
1. diagnostic test
(1) chest X-ray
(2) ultrasonic cardiography inspection
(3) examination of ocular fundus
(4) electrocardiogram
2. health giving quality is observed
(1) situation of change of the tcm symptom before and after the observation treatment, tongue, arteries and veins.
(2) the blood pressure situation before and after the treatment.
3. security inspection
(1) blood, urine, stool routine examination chemical examination.
(2) liver, kidney function test.
(3) Electrocardioscopy.
Six, statistical analysis technique
Enumeration data adopts X
2Check, ranked data adopt Ridit to analyze, and measurement data adopts t or u-test.
Seven, criterion of therapeutical effect and foundation thereof:
(1) efficacy of antihypertensive treatment evaluation criteria (standard of formulating with reference to national cardiovascular epidemiology in 1979 and crowd prevention and treatment forum)
1, produce effects:＜1〉diastolic pressure decline 10mmHg (1.3Kpa) and more than, and reach normal range;＜2〉though diastolic pressure do not reduce to normally descended 20mmHg (2.7Kpa) or more than.Must possess wherein 1.
2, effective:＜1〉diastolic pressure descends not as good as 10mmHg (1.3Kpa), but has reached normal range;＜2〉decline 10～19mmHg (1.3-2.5Kpa) before diastolic pressure is treated, but do not reach normal range;＜3〉more than decline 30mmHg (4Kpa) reached before systolic pressure was treated.Must possess wherein 1.
3, invalid: as not reach above standard person and the 2 week back blood pressures of taking medicine do not fall and drug withdrawal person automatically.
(2) tcm syndrome efficacy assessment standard:
1. produce effects: the clinical symptoms integration reduce 2/3rds and more than.
2. effective: the clinical symptoms integration reduce 1/3rd and more than, less than 2/3rds.
3. invalid: as not reach above-mentioned standard person.
Attached: (1) Syndrome in TCM marquis's classification scoring method:
1. dizzy: a, conscious having a dizzy spell, there are not the sense of rotation of self or scenery or 2 minutes
Rolling is dynamic; Or simple head is murky and do not influence work.
B, conscious dizziness, and self rotation or rolling innervation are arranged, but do not influence 4 fens
Life; Or simple giddy and influence activity, but can adhere to work
C, conscious dizziness, and self and scenery sense of rotation are arranged, a body dare not 6 minutes
Rotate; Or simple dizzy, upset, be difficult to competent at a job
Headache: a, can bear, not influence work and learnt 2 fens
B, unbearably, influence work and learnt 4 fens
C, be not difficult to stand, must medication analgesic 6 minutes
3. being irritable and getting angry easily: a, slight 1 minute
B, weigh 2 fens
C, serious 3 minutes
4. dry mouth with bitter taste: a, xerostomia hardship can be born, drink water normal 1 minute
B, xerostomia suffering are born, must be drunk water 2 fens
C, xerostomia hardship are impatient at, were frequently drunk water 3 fens
Soreness of the waist and knees: a, do not influence work and learnt 1 fen
B, influence work and learnt 2 fens
C, can not adhere to work and learnt 3 fens
6. cardiopalmus: a, accidental cardiopalmus are 1 minute
B, every day more than 3 times 2 minutes
C, serious cardiopalmus need medication treatment 3 minutes
7. be insomnia: a, difficulty falling asleep but in 1 hour 1 minute
Can fall asleep, can reach 6 hours when sleeping
B, time for falling asleep can reach 2 hours 2 minutes
Maybe must be stable with 2
C, time for falling asleep must be more than 2 hours 3 minutes
Maybe must be more than 2 with stable
8. tinnitus: a, random thoughts tinnitus are 1 minute
B, persistent period are longer, influence work and learn 2 fens
C, persistence tinnitus can not be worked and learn 3 fen
9. forgetful: a, slight 1 minute
B, weigh 2 fens
C, serious 3 minutes
10. flushing conjunctival congestion: a, slight 1 minute
B, face are redder, sclera was seen the blood streak 2 minutes
C, a face redder than dates, scleral injection 3 minutes
11. dry stool: a, 2 days 1 row 1 minute
B, 3 days 1 row, dyschesia 2 minutes
C, more than 3 days, must be with medicine 3 minutes
Picture of the tongue: red tongue 1 minute
Yellow fur 1 minute
Pulse condition: string, thin, several 1 minute
Above transference cure is 0 minute.
(2) traditional Chinese medical science severity extent classification: slight≤10 minutes
Moderate 〉=11 minute＜18 minutes
Severe 〉=18 minute
Result of the test
One, efficacy analysis
1. hypertension curative effect: see Table 10.
Table 10 patient hypertension curative effect
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate | |||
| Example | (％) | Example | (％) | Example | (％) | (％) | ||
| Test group matched group treatment group always | 161 130 301 | 80 40 155 | (49.7) (30.8) (51.5) | 53 54 99 | (32.9) (41.5) (32.9) | 28 36 47 | (17.4) (27.7) (15.6) | 82.6 72.3 84.4 |
Statistical procedures result: Ridit analyzes,
Test group and matched group be U=3.06 P＜0.01 relatively
Total treatment group and matched group be U=3.85 P＜0.01 relatively
Statistical result shows: the investigational agent efficacy of antihypertensive treatment obviously is better than matched group.
2. total treatment group is respectively observed hospital's curative effect relatively: see Table 11.
The total treatment group of table 11 is respectively observed hospital's curative effect
| Hospital | The example number | Produce effects | Effectively | Invalid | Total effective rate | ||||
| Example | (％) | Example | (％) | Example | (％) | Example | (％) | ||
| The Tianjin traditional Chinese medical science one Xiyuan Beijing Hospital of Traditional Chinese Medicine of hospital of Gate of Pervasive Peace hospital of Dongzhimen hospital of attached institute | 51 50 60 80 60 | 26 25 29 47 28 | (50.98) (50.00) (48.30) (58.75) (46.67) | 18 16 19 27 19 | (35.29) (32.00) (31.70) (33.75) (31.67) | 7 9 12 6 13 | (13.73) (18.00) (20.00) (7.500) (21.67) | 44 41 48 74 47 | (86.27) (82.00) (80.00) (92.50) (78.33) |
Statistical procedures result: Ridit analyzes, X
2=3.8215 P＞0.05
Statistical result shows: each observes hospital aspect efficacy of antihypertensive treatment, no significant difference.
3. blood pressure before and after the treatment: see Table 12, table 13.
Blood pressure (mmHg) before and after each group treatment of table 12
| Group | The example number | Systolic pressure | Diastolic pressure | ||
| Before the treatment | After the treatment | Before the treatment | After the treatment | ||
| X±S | X±S | X±S | X±S | ||
| Test group matched group treatment group always | 161 130 301 | 164.60±14.43 165.05±16.08 166.18±15.00 | 143.8±15.72 146.60±16.70 145.7±14.55 | 97.14±9.50 97.47±8.67 98.66±11.40 | 85.98±9.24 89.07±7.62 86.38±8.59 |
Statistical procedures result: compare before and after each group treatment
Test group systolic pressure t=12.32 P＜0.01, diastolic pressure t=10.9 P＜0.01
Matched group systolic pressure t=9.2 P＜0.01, diastolic pressure t=8.15 P＜0.01
Total treatment group systolic pressure t=8.27 P＜0.01, diastolic pressure t=1.45 P＜0.01
Statistical result shows:
Investigational agent all has obvious hypotensive effect with the contrast medicine to hyperpietic's systolic pressure and diastolic pressure.
The blood pressure difference relatively before and after each group treatment of table 13
| Group | The example number | Difference before and after the treatment | |
| Systolic pressure (X ± S) | Diastolic pressure (X ± S) | ||
| Test group matched group treatment group always | 161 130 301 | 20.81±13.64 18.45±12.81 20.48±13.08 | 11.16±9.7 8.40±7.29 12.28±8.30 |
Statistical result shows:
Test group and matched group relatively shrink pressure reduction t=1.77 P＞0.05
Diastole pressure reduction t=2.93 P＜0.01
Total treatment group and matched group relatively shrink pressure reduction t=1.50 P＞0.05
Diastole pressure reduction t=4.61 P＜0.01
Statistical result shows:
Investigational agent obviously is being better than matched group aspect the reduction diastolic pressure curative effect.
4. treatment hypertension onset time comparison: see Table 14.
Each group treatment hypertension onset time comparison of table 14
| Group | The example number | Onset time (my god) |
| X±S | ||
| Test group matched group treatment group always | 133 94 255 | 9.46±3.11 12.70±4.11 7.33±4.26 |
Statistical result shows: test group and matched group be t=6.76 P＜0.01 relatively
Total treatment group and matched group be t=10.53 P＜0.01 relatively
The result shows: investigational agent is fast than matched group in onset time, and onset time obviously is better than contrasting the medicine group.
5. dissimilar hypertension curative effects are organized in total treatment: see Table 15.
Dissimilar hypertension curative effects are organized in the total treatment of table 15
| Classification | The example number | Produce effects | Effectively | Invalid | Total effective rate (%) | |||
| Example | (％) | Example | (％) | Example | (％) | |||
| The pure systole of severe in slight | 163 116 22 | 102 46 7 | (62.6) (39.7) (31.8) | 47 42 10 | (28.8) (36.2) (45.5) | 14 28 5 | (8.60) (24.1) (22.7) | 91.4 75.9 77.3 |
Statistical procedures result: Ridit analyzes, X
2=17.56 P＜0.01
Statistical result shows: this medicine is better than middle severe to the mild hypertension curative effect.
6. tcm syndrome curative effect: see Table 16.
Table 16 is respectively organized the tcm syndrome curative effect
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate (%) | |||
| Example | (％) | Example | (％) | Example | (％) | |||
| Test group matched group treatment group always | 161 130 301 | 85 43 158 | (52.8) (33.1) (52.5) | 59 56 118 | (36.6) (43.0) (39.2) | 17 31 25 | (10.6) (23.9) (8.3) | 89.4 76.1 91.7 |
Statistical procedures result: Ridit analyzes,
Test group and matched group be U=3.30 P＜0.01 relatively
Total treatment group and matched group be U=2.75 P＜0.01 relatively
Statistical result shows: curative effect is better than matched group to investigational agent aspect hyperpietic's tcm syndrome improving.
7. tcm symptom tongue arteries and veins curative effect: see Table 17.
Table 17 is respectively organized tcm symptom, tongue arteries and veins curative effect
| Group | Total treatment group | Matched group | X 2＝ | P | |
| Dizzy | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 271 135 136(50.2) | 115 66 49(42.6) | X 2＝1.86 | P＞0.05 |
| Headache | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 232 96 136(58.6) | 98 50 48 (48.98) | X 3＝2.75 | P＞0.05 |
| Being irritable and getting angry easily | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 238 132 106 (44.54) | 101 73 28(27.7) | X 3＝8.44 | P＜0.01 |
| Dry mouth with bitter taste | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 240 114 126(52.5) | 99 48 51(51.5) | X 2＝2.72 | P＞0.05 |
| Soreness of the waist and knees | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 238 145 93(39.1) | 98 76 22(22.4) | X 2＝8.52 | P＜0.01 |
| Cardiopalmus | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 179 73 106(59.22) | 75 36 39(52.0 0) | X 2＝1.12 | P＞0.05 |
| Be insomnia | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 204 104 100(49.02) | 77 49 28(36.4) | X 2＝3.53 | P＞0.05 |
| Tinnitus | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 153 81 72(47.1) | 70 37 33(47.1) | X 2＝1.33 | P＞0.05 |
| Forgetful | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 195 143 52(26.7) | 88 70 18(20.5) | X 2＝1.26 | P＞0.05 |
| Flushing conjunctival congestion | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 184 82 102 (55.43) | 79 44 35(44.3) | X 2＝2.61 | P＞0.05 |
| Group | Test group | Matched group | |||
| Dry stool | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 190 63 127(66.8) | 81 40 41(50.6) | X 2＝6.04 | P＜0.01 |
| Red tongue | Treat the precedent number and treat the routine number in the back routine number that disappears | 273 181 92(33.7) | 115 75 40(34.78) | X 2＝0.06 | P＞0.05 |
| Yellow fur | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 241 103 138(57.3) | 102 42 60(58.8) | X 3＝0.07 | P＞0.05 |
| Abnormal pulse condition (string, thin, number) | Treat the precedent number and treat the routine number in the back routine number (%) that disappears | 296 262 34(11.5) | 125 108 17(13.6) | X 2＝0.37 | P＞0.05 |
Statistical result shows: investigational agent has curative effect preferably aspect the tcm syndrome improving, and is particularly evident in efficacy to being irritable and getting angry easily, soreness of the waist and knees, disease such as be hard and dry, and is better than matched group.
8. the relation of total treatment group tcm syndrome degree and therapeutic effect of syndrome: see Table 18.
The relation of total treatment group tcm syndrome degree of table 18 and therapeutic effect of syndrome
| Degree | The example number | Produce effects | Effectively | Invalid | Total effective rate (%) | |||
| Example | (％) | Example | (％) | Example | (％) | |||
| Slight moderate severe | 33 114 154 | 17 75 66 | (51.5) (65.8) (42.9) | 14 30 74 | (42.4) (26.3) (48.1) | 2 9 14 | (6.1) (7.9) (9.1) | 93.9 92.1 90.9 |
Statistical procedures result: Ridit analyzes, X
2=9.17 P＞0.05
Statistical result shows: investigational agent is to tcm syndrome curative effect no significant difference in various degree.
Two. safety indexes is observed: see Table 19,20.
Blood, urine, just conventional variation before and after table 19 patient treatment
| Group | Routine blood test | Routine urinalysis | Just conventional | ||||||||||
| The example number | Normally | Unusually | Increase the weight of | The example number | Normally | Unusually | Increase the weight of | The example number | Normally | Unusually | Increase the weight of | ||
| The open group of test group matched group | Before and after treatment | 160 160 125 125 297 297 | 160 160 125 125 297 297 | 0 0 0 0 0 0 | 0 0 0 | 157 157 125 125 293 293 | 125 142 109 115 233 257 | 32 15 16 10 60 26 | 0 0 0 | 119 119 104 104 225 225 | 119 119 104 104 225 225 | 0 0 0 0 0 0 | 0 0 0 |
The heart, liver, renal function change before and after table 20 patient treatment
| Group | Liver function | Renal function | Electrocardiogram | ||||||||||
| GPT | Gr | BUN | |||||||||||
| The example number | Normally | Unusually | The example number | Normally | Unusually | The example number | Normally | Unusually | The example number | Normally | Unusually | ||
| Test group matched group treatment group always | Before and after treatment | 157 157 125 125 293 293 | 157 157 125 125 286 289 | 0 0 0 0 7 4 | 98 98 95 95 234 234 | 96 96 95 95 234 234 | 0 0 0 0 0 0 | 158 158 125 125 295 295 | 150 150 120 120 283 284 | 6 8 5 5 12 11 | 160 160 130 130 296 296 | 56 58 33 34 119 125 | 104 102 97 96 177 171 |
Table 19,20 promptings: take investigational agent to patient's blood, urine, just routine and liver, renal function do not have obvious damage, individual patients makes moderate progress, and whether this medicine effect remains further to be investigated.
Three, analysis of adverse reactions:
Test group is observed 301 routine patients, there is no any untoward reaction.
Four, reject the case analysis of causes:
Reject 20 examples in the observation group altogether, wherein lose to visit 18 examples, 2 examples are because of taking other drug, can't estimate curative effect and reject.Matched group 2 examples are not rejected because of checking.
Model case
Example 1: the patient poplar * *, male, 66 years old cadre's admission number 64715
Head examines sequence number 80 on August 8 98 year date
Patient's main cause head is murky, feeling of fullness in the head, be admitted to hospital in one week of flushing conjunctival congestion.Previously hypertension history is 6 years.Be interrupted the oral sheet that falls again at ordinary times, blood pressure maintains 180/100mmHg, does not obey depressor closely over the past half year.Disease is seen dizzy, slight headache, flushing red, hypomnesis, vexed uncomfortable in chest, irritability, big dry stool, red tongue with yellow fur, stringy and thready pulse when being admitted to hospital.
Have a medical check-up and show: 70 times/minute BP 180/100mmHg of T36.7 ℃ of P, look into the optical fundus and show that tremulous pulse narrows down, the tortuous A.V of vein intersects, and examines to be the hypertension II phase, and the back tcm diagnosis of being admitted to hospital is dizzy, hyperactivity of liver-fire, Western medicine diagnose is the hypertension IT phase, meets MethodsThe cases enrolled.Include test group at random in and give capsule for clearing liver and reducing blood pressure, one time 3,3 times on the one, oral.After taking medicine three days, have a dizzy spell, murky symptom obviously alleviates, slight xerostomia, no bitter taste, the behavior in a day of defecating is normal, measuring blood pressure 160/95mmHg, blood pressure is 160/90mmHg after one week, and after two weeks, all diseases all alleviate, there is not dizzy murky sense, no headache, blood pressure is at 140/80mmHg, this medicine blood pressure of clothes that continues remains and steadily is 140/80mmHg, red tongue with yellow fur transfers pink tongue to, thin and whitish fur, the unhappy transference cure of irritability.Treat back check blood, urine, just routine, liver function, kidney merit are no abnormal.The tcm syndrome efficacy evaluation is a produce effects, and the blood pressure curative effect is a produce effects.
Example 2: Dong * *, the man, 68 years old, the workman, admission number: 61115, first visit period: on October 6th, 98.
The main suit: often dizzy, headache, the dizziness of 2 weeks increases the weight of.
History of present illness: patient's hypertension history 10 years, nearly 2 weeks are dizzy, headache is obvious, simultaneously with being irritable and getting angry easily, flushing conjunctival congestion, forgetful, xerostomia hardship, soreness of the waist and knees.Dimly red tongue, yellow fur, stringy,thready and rapid pulse.Symptom integral is 24 minutes.
Have a medical check-up: T36.5 ℃, R:20 time/minute, 78 times/minute BP:160/105mmHg of P.
Tcm diagnosis: dizzy
Chinese medical discrimination: overabundant liver-fire, the hepatic and renal YIN deficiency
Western medicine diagnose: hypertension
Doctor trained in Western medicine is by stages: the II phase
The patient begins to take capsule for clearing liver and reducing blood pressure on October 6th, 98, and 3/time, 3 times/day, the period in a medicine compliance is good, does not have in the therapeutic process to miss drug condition.Take medicine after the week, blood pressure begins to descend, and two all back blood pressure drops also maintain 120/80mmHg, and clinical symptoms and tongue, pulse condition obviously improve, integration 6 minutes, and efficacy of antihypertensive treatment and therapeutic effect of syndrome are produce effects.Safety detects, and is all normal before and after every index treatment, shows before the electrocardiogram treatment that the T ripple changes, and treats the back no change.In the observation process, the patient does not find obvious adverse reaction yet.
Discuss
One, unites in April, 1998 to December by Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College, Dongzhimen, Beijing hospital, Gate of Pervasive Peace hospital, Beijing Hospital of Traditional Chinese Medicine, five tame hospitals of Xiyuan hospital and carry out capsule for clearing liver and reducing blood pressure treatment hypertension (overabundant liver-fire, liver-kidney yin deficiency) II clinical trial phase.Test group is selected patient's 301 examples, and matched group is selected 130 examples.Clinical test results shows: test group efficacy of antihypertensive treatment obvious effective rate is 49.7%, and total effective rate is 82.6%, total treatment group obvious effective rate 51.5%, and total effective rate 84.4% is learned processing P all＜0.01 more by statistics with matched group, and the investigational agent curative effect is better than matched group.Tcm syndrome clinical trial group obvious effective rate is 52.8%, total effective rate 89.4%, and total treatment group obvious effective rate is 52.5%, and total effective rate 91.7% is learned more by statistics with matched group and is handled P all＜0.05, and test group is better than contrasting medicine.
Show by clinical observation that two, capsule for clearing liver and reducing blood pressure has the improvement effect to overabundant liver-fire, hypertension of deficiency of yin of liver and kidney type patient's tcm syndrome, wherein symptoms such as soreness of the waist and knees, being irritable and getting angry easily, dry stool, yellow fur is improved significantly, and is better than matched group.
Three, in the observation process, do not see any untoward reaction and toxic and side effects, liver, renal function are not found harmful effect.
Show by clinical observation that four, that this medication is imitated is reliable, clinical application is reasonable, take easy, have no side effect, be applicable to the hyperpietic of overabundant liver-fire, the hepatic and renal YIN deficiency.Suggestion cures mainly function and is decided to be: heat clearing away suppressing the hyperactive liver, liver and kidney tonifying.Be used for the hypertension overabundant liver-fire, syndrome of yin deficiency of liver and kidney.Disease is seen dizzy, headache, and flushing conjunctival congestion, being irritable and getting angry easily, dry mouth with bitter taste, soreness of the waist and knees, cardiopalmus is insomnia, and tinnitus is forgetful, the patients with hypertension of constipation yellow urine.
Conclusion
Observe through clinical trial, this medicine has tangible hypotensive effect to hypertension (overabundant liver-fire, syndrome of yin deficiency of liver and kidney) the II phase, especially hypertensive patient's diastolic pressure is had good hypotensive effect and clinically takes easyly, safe and reliable, have no side effect, have promotional value.
EXPERIMENTAL DESIGN unit: Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College
EXPERIMENTAL DESIGN person: Zhao Jianguo, Li Yan chief physician
The person is responsible in test: Zhao Jianguo, Li Yan chief physician
Date of test: in April, 98-98 year December
Raw data preservation place: Hospital No.1 Attached to Tianjin Traditional Chinese Medicine College
Contact person, phone: Han Li 022-27383144
Test unit affixes one's seal:
Capsule for clearing liver and reducing blood pressure treatment diabetic hypertension patient's clinical research
Feng Jinguang
1Li Wenhua
2Wang Xinfang
2
Summary: purpose, observe capsule for clearing liver and reducing blood pressure assessment is made in diabetic hypertension patient's curative effect and safety.Method: select diabetic hypertension (I phase or II phase) patient's 60 examples, be divided into treatment group (removing heat from the liver to lower the high blood pressure group) 30 examples at random, 30 example 4 weeks of treatment of matched group (Yufengningxin group).The result: the total effective rate of (1) capsule for clearing liver and reducing blood pressure and yufeng ningxin tablets, yufeng ningxin pian is 70% and 46.7%; Compared significant difference (P＜0.001) for two groups; (2) two groups are not all had hepatic and renal function injure in observing, blood, urine, just conventional harmless, and (3) are not seen and are had no side effect untoward reaction.Conclusion: capsule for clearing liver and reducing blood pressure brings high blood pressure down and is better than yufeng ningxin tablets, yufeng ningxin pian and safe without toxic side effect.
Key word: capsule for clearing liver and reducing blood pressure yufeng ningxin tablets, yufeng ningxin pian
Diabetic hypertension
The internal medicine outpatient service of 1 No.1 Hospital Affiliated to Beijing Medical Univ.
The education doctor of 2 No.1 Hospital Affiliated to Beijing Medical Univ.
Capsule for clearing liver and reducing blood pressure is the compound preparation according to the development of traditional Chinese medical science network ens morbi.The author receives good effect from adopting the 10--12 month in 1999 capsule for clearing liver and reducing blood pressure treatment diabetic hypertension patient 60 examples, now is reported as follows:
Object and method
Clinical data: those selected is my institute's special outpatient clinic diabetics, meets the hypertension diagnosis of WHO and standard by stages 1..
Select 60 routine diabetic hypertension patients at random, stop at least 2 weeks of depressor.If 2. average systolic (MSBP) 〉=21.3Kpa (160mHg) or AvDP (SDBP) 〉=12.6Kpa (95mmHg) or equal conformance with standard person side enter the treatment phase.
Exclusion standard: (1) has myocarditis, angina pectoris, cerebrovascular accident, orthostatic hypotension, ulcer active stage, serious hepatic renal dysfunction, diabetes acute complications and serious chronic vascular complication patient in 6 months in the past, all be not included in this seminar.
Those selected is divided into capsule for clearing liver and reducing blood pressure group (30 examples are organized in treatment) and yufeng ningxin tablets, yufeng ningxin pian group (matched group 30 examples) at random.Age, sex, average course of disease, cardiac functional grading, blood fat, blood glucose, blood pressure there are no significant difference between two groups.
Observational technique: be a course of treatment all around
1, surveys serum, hepatic and renal function, blood glucose, blood fat, electrolyte, optical fundus, alkali phosphatase, blood, urine, just conventional, electrocardiogram before and after the treatment.
2, survey the seat blood pressure weekly once, and recorded heart rate, the situation of taking medicine and side reaction.
3, method of administration: capsule for clearing liver and reducing blood pressure every day three times, each three; (a flood day power Pharmaceutical in Beijing is produced lot number (1999) 2-94 number) Yu's wind mind calming sheet every day three times, each three, all hands after the meal warm water take.
Curative effect is judged: with last 2 SBP, the average of DBP is as judging quota, and other select common cardiovascular diseases's epidemiological study of canonical reference and crowd prevention and treatment work 1979-1985 planning, divides produce effects, effective, invalid three grades.
Statistics: calculate treatment front and back MSBP, MDBP means standard deviation (x+S), do significant difference t check.
The result
1, treatment group and matched group blood pressure lowering curative effect are more as shown in table 1:
The blood pressure of table 1 capsule for clearing liver and reducing blood pressure and yufeng ningxin tablets, yufeng ningxin pian treatment diabetic hypertension relatively
*P＜0.05
**P＜0.001
2, total effective rate sees Table 2
Table 2 liang group antihypertensive effect is P＜0.05 relatively
3, before and after the treatment, just routine, blood glucose, blood fat, alkali phosphatase, heart rate, electrocardiogram no abnormality seen change for two groups of hepatic and renal functions, hematurias.
4, have no adverse reaction no side effects in the observation.
Discuss
Hypertension is modal cardiovascular diseases, is the great public health problem in the global range.China's hypertension markization prevalence was 11.26% in 1991.To the year two thousand twenty, noninfectious will account for 79% of China's mortality rate, and wherein 1. the cardiovascular diseases will account for the first place.
Treat hypertensive purpose and 1. not only be to bring high blood pressure down itself, also be to reduce from now on cardiovascular diseases's incidence rate and mortality rate.
The main flavour of a drug Spica Prunellae of capsule for clearing liver and reducing blood pressure, Radix Polygoni Multiflori etc. have heat clearing away, suppressing the hyperactive liver, liver and kidney tonifying, are used for hypertension, migraine, cardiopalmus, tinnitus, vexed, irritability, capsule for clearing liver and reducing blood pressure had good hypotensive effect during this group was observed, the pharmacodynamic study hypotensive effect is to expand peripheral blood vessel, reduces total peripheral resistance, and heart rate and cardiac pumping function are not all had influence, this observation confirms that heart rate is not had influence, and hypotensive effect is remarkable and steady.It is the prevention of brain apoplexy to be that good effect is arranged to improving the diabetics cardio cerebral function 3. by control hypertension that the hypertension philtrum of receiving treatment has suitable major part.
Can prevent and reduce the generation and the development of diabetics cardiovascular and cerebrovascular complication, have no side effect, safe in utilization.
Be applicable to light, the moderate hypertension patient of diabetes companion.
Document
1, Chinese hypertension prevention and control guide 1999.10
2, refined cloud Liu of Liu state instrument king Lik-Sang etc., the observation of hypertension curative effect is rather treated in blood pressure lowering
3, heart disease and hypertension current research prospect, the first volume. the 9th phase 44-45
Capsule for clearing liver and reducing blood pressure treatment hypertension 30 examples
Clinical observation on the therapeutic effect
Traditional medicine section of Beijing Tiantan Hospital
On May 30th, 1999, (authentication code: the accurate word of traditional Chinese medicines (1999) Z-94 number) clinical efficacy of treatment overabundant liver-fire, hypertension of deficiency of yin of liver and kidney type carried out preliminary observation, now 30 observed routine patients clinical efficacy is done a brief summary to Beijing capsule for clearing liver and reducing blood pressure that power pharmaceutcal corporation, Ltd produced in big vast day to JIUYUE my section on the 1st.
Clinical data
1. physical data case source, 30 routine patients are my section's in May, 99 to 9 moon gate people that diagnoses a disease, and clear and definite essential hypertension history is all arranged, and can abide by the observation requirement of observing the table design, to not on request 15 routine patients' rejectings.Man, each 15 example of woman in 30 examples, the oldest 83 years old, minimum 28 years old, 53.7 years old mean age.The course of disease did not wait in 1 to 45 year.All secondary hypertensions or essential hypertension belong to other pattern of syndrome of Chinese medical discrimination person and all do not list this group range of observation in.If matched group 30 examples, two groups in age, sex, the course of disease and hypertension by stages etc. there are no significant in aspect difference.
2. treatment is observed the patient with observational technique be divided into two groups at random behind Chinese medical discrimination, and the treatment group gives capsule for clearing liver and reducing blood pressure, and each 3, every day 3 times is oral, and matched group gives NAOLIQING, and each 10, every day 3 times is oral.Two groups of basically identicals of other medicining conditions.Taking medicine continued for 3 weeks, took medicine preceding and the 1st, 2,3 weeks of back of taking medicine are monitored the blood pressure situation with desk-top mercury column sphygomanometer, and unit represents with mmHg.
3. observation index is observed take medicine back 1,2,3 all clinical symptoms, blood pressure situation, electrocardiogram variation before and after taking medicine and the toxicity in the drug administration process.That concrete symptom comprises is dizzy, headache, flushing conjunctival congestion, being irritable and getting angry easily, dry mouth with bitter taste, soreness of the waist and knees, cardiopalmus, be insomnia, tinnitus, forgetful, dry stool and picture of the tongue and pulse condition.
The result
1. criterion of therapeutical effect is formulated with reference to Ministry of Public Health in 1993 and " the new Chinese medicine clinical research guideline " of promulgation, and in conjunction with clinical practice evaluation curative effect, mainly with clinical symptoms and the evaluation of blood pressure lowering information summary.Produce effects wherein: more than the systolic pressure decline 20mmHg, diastolic pressure decline 10mmHg is above or reduce to normally, and clinical symptoms is significantly improved, and the half symptom is eliminated; Effectively: more than the systolic pressure decline 10mmHg, more than the diastolic pressure decline 5mmHg, clinical symptoms is also improved.
2. therapeutic outcome (1) hypotensive effect: capsule for clearing liver and reducing blood pressure has and relaxes hypotensive effect stably.The contraction of the 1st week, diastolic pressure all have obvious decline, and the 2nd all systolic pressures have remarkable decline again, continue in the 3rd week to descend on the 2nd all bases, and also there were significant differences, and matched group the 1st all systolic pressures descend obviously (p＜0.05), and to the 3rd week, slowly, amplitude is little though systolic pressure still descends.Diastolic pressure also has remarkable decline (p＜0.05) before the treatment.See Table 1
The hypotensive effect of table 1. capsule for clearing liver and reducing blood pressure (x ± s, mmHg)
| Grouping | n | Before the treatment | Treatment 1 week of back | Treatment 2 weeks of back | Treatment 3 weeks of back | ||||
| Systolic pressure | Diastolic pressure | Systolic pressure | Diastolic pressure | Systolic pressure | Diastolic pressure | Systolic pressure | Diastolic pressure | ||
| Treatment | 30 | 189.3± 32.4 | 105.7± 15.8 | 177.6± 29.5 Δ | 99.9± 14.3 Δ | 170.5± 24.4 yΔ* | 96.4± 13.4 y | 160.3± 16.7y Δ* | 92.3± 10.3 y*Δ |
| Contrast | 30 | 192.8± 35.7 | 106.9± 19.4 | 182.7± 30.7 Δ | 103.2± 19.9 | 180.9± 27.7 Δ | 102.1± 17.5 | 172.3 Δ ±22.7 Δ | 100.8 ±19.4 Δ |
Δ and the preceding ratio of treatment, * and first all ratios, two groups of ratios of y, p＜0.05
(2) capsule for clearing liver and reducing blood pressure treatment (preceding) back (the 3rd week) obvious effective rate and total effective rate all are significantly higher than matched group.See Table 2
Table 2. liang group efficacy of antihypertensive treatment relatively
| Grouping | n | Obvious effective rate % | Total effective rate % |
| The treatment group | 30 | 43.3 Δ | 83.3 ΔΔ |
| Matched group | 30 | 36.7 | 66.7 |
Δp＜0.05，ΔΔp＜0.01
(3) capsule for clearing liver and reducing blood pressure is to the improvement effect of clinical symptoms
Capsule for clearing liver and reducing blood pressure improves clinical symptoms steadily and significantly, increase along with medicine time, obvious effective rate and total effective rate also increase gradually, 3 whens week to the obvious effective rate of headache, flushing conjunctival congestion, cardiopalmus, total effective rate all apparently higher than matched group, to be insomnia, the total effective rate of tinnitus is also apparently higher than matched group (p＜0.01).Improvement situation and matched group to other symptoms and picture of the tongue, pulse condition do not have significant difference.See Table 3
Table 3 capsule for clearing liver and reducing blood pressure is to the improvement effect of hypertension symptom
| Group | Symptom | n | The 1st week | The 2nd week | The 3rd week | ||||||
| Produce effects (%) | Effectively (%) | Total effective rate (%) | Produce effects (%) | Effectively (%) | Total effective rate (%) | Produce effects (%) | Effectively (%) | Total effective rate (%) | |||
| Treatment | Dizzy | 28 | 8(28) | 9(32.1) | 60.1 | 10(35.7) | 9(32.1) | 67.8 | 13(46.4) | 10(35.7) | 82.1 |
| Contrast | 29 | 7(24.1) | 7(24.1) | 48.2 | 9(33.3) | 10(36.6) | 69.9 | 12(41.4) | 10(34.5) | 75.9 | |
| Treatment | Headache | 27 | 8(30) | 10(37.1) | 67.1 | 10(37.1) | 11(40.1) | 77.1 | 14(51.9) Δ | 11(40.1) | 92.0 Δ |
| Contrast | 27 | 6(22.2) | 8(30) | 52.2 | 8(30) | 10(37.1) | 67.1 | 9(33.3) | 12(44.4) | 77.7 | |
| Treatment | Flushing conjunctival congestion | 13 | 1(8) | 3(23.1) | 31.1 | 2(15.4) | 5(38.5) | 43.9 | 5(38.5) Δ | 7(53.8) | 92.3 Δ |
| Contrast | 14 | 2(12.3) | 2(12.3) | 24.6 | 3(21.4) | 4(24.6) | 46.0 | 4(24.6) | 6(42.8) | 77.4 | |
| Treatment | Being irritable and getting angry easily | 22 | 5(23) | 7(31.8) | 54.8 | 7(31.8) | 7(31.8) | 63.6 | 9(40.9) | 10(45.5) | 86.4 |
| Contrast | 25 | 5(20) | 8(32) | 52 | 8(32) | 8(32) | 64 | 8(32) | 10(40) | 72 | |
| Treatment | Dry mouth with bitter taste | 25 | 4(16) | 5(20) | 36 | 5(20) | 7(28) | 48 | 8(32) | 10(40) | 72 |
| Contrast | 24 | 4(16.7) | 4(16.7) | 33.4 | 6(25) | 7(29.2) | 54.2 | 8(33.4) | 9(37.5) | 70.9 | |
| Treatment | Soreness of the waist and knees | 11 | 1(9) | 2(18) | 27 | 3(27.3) | 3(27.3) | 54.6 | 4(36) | 5(45.6) | 81.6 |
| Contrast | 12 | 3(25) | 25 | 2(16.7) | 4(33.3) | 50.0 | 4(33.3) | 6(50) | 83.3 | ||
| Treatment | Cardiopalmus | 16 | 2(13) | 2(13) | 26 | 4(26) | 4(26) | 52 | 6(37.5) | 7(43.8) | 81.3 Δ |
| Contrast | 13 | 1(8) | 2(16) | 24 | 2(16) | 3(23.1) | 39.1 | 3(23.1) | 5(38.5) | 61.4 | |
| Treatment | Be insomnia | 22 | 2(9) | 2(9) | 18 | 5(24.7) | 6(27) | 51.7 | 7(31.8) | 10(45.5) | 77.3 Δ |
| Contrast | 24 | 3(12.5) | 2(9) | 21.5 | 4(16.7) | 5(20.9) | 37.6 | 6(25) | 7(29.2) | 54.2 | |
| Treatment | Tinnitus | 22 | 3(14) | 2(9.1) | 23.1 | 5(23) | 5(23) | 46 | 8(36.7) | 8(36.7) | 73.4 Δ |
| Contrast | 24 | 3(12.5) | 3(12.5) | 25 | 4(16.7) | 5(20.9) | 37.6 | 7(29.2) | 7(29.2) | 58.4 | |
| Treatment | Forgetful | 11 | 2(18) | 1(9.1) | 27.1 | 3(27.3) | 3(27.3) | 54.6 | 4(36) | 4(36) | 72 |
| Contrast | 10 | 1(10) | 1(10) | 20 | 3(30) | 3(30) | 60 | 3(30) | 4(40) | 70 | |
| Treatment | Dry stool | 20 | 5(25) | 6(30) | 55 | 7(35) | 7(35) | 70 | 8(40) | 9(45) | 85 |
| Contrast | 18 | 3(16.7) | 6(33.3) | 50 | 5(27.8) | 9(50) | 77.8 | 7(27.8) | 9(50) | 77.8 | |
| Treatment | Red tongue | 27 | 1(3.7) | 5(19) | 22.7 | 3(11.1) | 7(25.6) | 36.7 | 5(19) | 8(29.9) | 48.9 |
| Contrast | 26 | 1(3.8) | 5(19.2) | 23 | 4(16) | 6(23.1) | 39.1 | 6(23) | 8(30.8) | 54.1 | |
| Treatment | Yellow fur | 27 | 2(7.5) | 4(15) | 22.5 | 5(18.5) | 8(30) | 48.5 | 10(37.1) | 12(44.4) | 81.5 |
| Contrast | 27 | 2(7.5) | 4(15) | 22.5 | 4(15) | 6(22.2) | 37.2 | 10(37.1) | 11(40.7) | 77.8 | |
| Treatment | Stringy pulse | 30 | 1(3.3) | 5(17) | 20.3 | 4(13.3) | 8(26.7) | 41 | 7(23.3) | 13(43.3) | 66.9 |
| Contrast | 28 | 2(7.1) | 4(14.3) | 21.4 | 4(14.3) | 8(28.9) | 43.2 | 6(21.2) | 14(50) | 71.2 | |
Δp＜0.05
(4) to Electrocardiographic influence
11 routine patients are organized in treatment electrocardiographic abnormality, through the treatment of 3 weeks, produce effects 3 examples, obvious effective rate 27.3% improves 3 examples, total effective rate 54.5%, matched group 13 routine patient's electrocardiographic abnormalities, through the treatment of 3 weeks, electrocardiogram significantly improves 1 example, obvious effective rate 7.7%, 3 examples make moderate progress, total effective rate 30.8%, two group of obvious effective rate, total effective rate are compared, and p all＜0.05.
Brief summary
1. capsule for clearing liver and reducing blood pressure has better antihypertensive effect, and hypotensive effect is stable, does not have knock-on and blood pressure drops and crosses low phenomenon, and second week of taking medicine, the 3rd all antihypertensive effects are better than NAOLIQING.
2. capsule for clearing liver and reducing blood pressure headache, flushing conjunctival congestion, cardiopalmus that hypertension is caused has significant improvement effect, obvious effective rate and total effective rate are better than NAOLIQING, to be insomnia, the total effective rate of tinnitus also obviously is better than NAOLIQING (p＜0.05), and is suitable to the improvement effect and the NAOLIQING of other symptoms and picture of the tongue, pulse condition.
3. capsule for clearing liver and reducing blood pressure also has certain improvement effect to hyperpietic's electrocardiographic abnormality.Because case is very few, remain further to be observed.
4. capsule for clearing liver and reducing blood pressure is not seen obvious toxic-side effects in the process of taking.
One on October 26, in 999
Description of drawings
Fig. 1 capsule for clearing liver and reducing blood pressure preparation technology flow process
The specific embodiment
Embodiment 1 is stable by the capsule for clearing liver and reducing blood pressure property of medicine that prescription Spica Prunellae 250g, Radix Polygoni Multiflori 250g, Flos Sophorae 150g, Herba Taxilli 290g, Radix Puerariae 150g, Radix Salviae Miltiorrhizae 220g, Rhizoma Alismatis 290g, Herba Cirsii 80g, Radix Polygalae 200g, Radix Cyathulae 100g amplify production, and drug effect can reach clinical requirement of taking.Its preparation technology is: Radix Polygoni Multiflori, Radix Puerariae, Rhizoma Alismatis, Radix Cyathulae be with 60% alcohol reflux of 8 times of amounts 3 times, and each 2 hours, merging filtrate, reclaiming ethanol, being evaporated to relative density is that 1.20～1.35 (60 ℃ of surveys) thick paste is standby; Spica Prunellae, Radix Salviae Miltiorrhizae be with 80% alcohol reflux of 10 times of amounts 2 times, and each 2 hours, merging filtrate, reclaim ethanol, concentrating under reduced pressure becomes the thick paste of the same requirement standby; Spica Prunellae, Radix Salviae Miltiorrhizae decoction dregs and Flos Sophorae, Herba Taxilli, Herba Cirsii, Radix Polygalae are boiled 2 times with 12 times decocting, and each 1.5 hours, merging filtrate, concentrating under reduced pressure became the thick paste of the same requirement standby.Merge above-mentioned all thick paste mixings, drying under reduced pressure, pulverizing, add an amount of dextrin, granulate, load into 1000 of capsules promptly.
Embodiment 2 is stable by the capsule for clearing liver and reducing blood pressure property of medicine that prescription Spica Prunellae 200g, Radix Polygoni Multiflori 150g, Flos Sophorae 300g, Herba Taxilli 300g, Radix Puerariae 150g, Radix Salviae Miltiorrhizae 220g, Rhizoma Alismatis 290g, Herba Cirsii 100g, Radix Polygalae 150g, Radix Cyathulae 120g amplify production, and drug effect also can reach clinical requirement of taking.Its preparation technology is: Radix Polygoni Multiflori, Radix Puerariae, Rhizoma Alismatis, Radix Cyathulae be with 50% alcohol reflux of 10 times of amounts 3 times, and each 2 hours, merging filtrate, reclaiming ethanol, being evaporated to relative density is that 1.20～1.35 (60 ℃ of surveys) thick paste is standby; Spica Prunellae, Radix Salviae Miltiorrhizae be with 70% alcohol reflux of 12 times of amounts 2 times, and each 2 hours, merging filtrate, reclaim ethanol, concentrating under reduced pressure becomes the thick paste of the same requirement standby; Spica Prunellae, Radix Salviae Miltiorrhizae decoction dregs and Flos Sophorae, Herba Taxilli, Herba Cirsii, Radix Polygalae are boiled 3 times with 10 times decocting, and each 1.5 hours, merging filtrate, concentrating under reduced pressure became the thick paste of the same requirement standby.Merge above-mentioned all thick paste mixings, drying under reduced pressure, pulverizing, add an amount of dextrin, granulate, load into 1000 of capsules promptly.
Claims (2)
1. capsule for clearing liver and reducing blood pressure, it is as follows to it is characterized in that making capsule for clearing liver and reducing blood pressure raw materials of effective components medicine and consumption thereof: Spica Prunellae 150～350g, Radix Polygoni Multiflori 120～400g, Flos Sophorae 100～300g, Herba Taxilli 150～350g, Radix Puerariae 100～250g, Radix Salviae Miltiorrhizae 150～350g, Rhizoma Alismatis 100～350g, Herba Cirsii 80～200g, Radix Polygalae 100～200g, Radix Cyathulae 100～250g; 1000 preparations, the 0.5g/ grain.
2. capsule for clearing liver and reducing blood pressure, the preparation method that it is characterized in that capsule for clearing liver and reducing blood pressure: 120～400g Radix Polygoni Multiflori, 100～250g Radix Puerariae, 100～350g Rhizoma Alismatis, 100～250g Radix Cyathulae are with 50～70% alcohol reflux of 6～10 times of amounts 2～3 times, 150～350g Spica Prunellae, 150～350g Radix Salviae Miltiorrhizae are with 60～95% alcohol reflux of 8～12 times of amounts 1～3 time, and Spica Prunellae, Radix Salviae Miltiorrhizae decoction dregs and 100～300g Flos Sophorae, 150～350g Herba Taxilli, 80～200g Herba Cirsii, 100～200g Radix Polygalae are boiled 2～3 times with 10～14 times decocting; Extract filtrate with above-mentioned three kinds and be condensed into thick paste respectively, merge three kinds of thick pastes and mixing; Through drying under reduced pressure, pulverizing, granulation, load into capsule for clearing liver and reducing blood pressure.
Priority Applications (1)
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| CN101214296B (en) * | 2008-01-04 | 2011-06-01 | 山西省晋城市医药科学研究所 | Hypertension-treating medicine and preparation thereof |
| CN103550438A (en) * | 2013-10-29 | 2014-02-05 | 董倩 | Traditional Chinese medicine preparation for treating hypertension |
| CN104857071A (en) * | 2015-06-29 | 2015-08-26 | 强红枫 | Medicinal preparation for reducing blood fat and preparation method and application thereof |
| CN105287967A (en) * | 2015-10-30 | 2016-02-03 | 重庆市洪欣食用菌有限公司 | Traditional Chinese medicine composition for treating hypertension and herbal decoction preparation method thereof |
| CN116139212B (en) * | 2022-09-09 | 2024-05-31 | 贾洪章 | Ocular hypotensive pharmaceutical composition, preparation method and application thereof |
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| CN1411830A (en) * | 2001-10-17 | 2003-04-23 | 宋大文 | Medicine for curing hypertension and its preparation method |
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Assignee: Beijing Hong Tianli Pharmaceutical Co. Ltd. Assignor: Jia Hongzhang Contract record no.: 2012990000497 Denomination of invention: Liver clearing blood pressure lowering capsule nd its preparation method Granted publication date: 20070124 License type: Exclusive License Open date: 20050810 Record date: 20120713 |
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Effective date of registration: 20160804 Address after: 100000, Tongzhou District Zhongguancun science and Technology Park, Tongzhou Park, Jinqiao Technology Industrial base, No. 5-5 middle section of Ring Road, Beijing Patentee after: Beijing Hong Tianli Pharmaceutical Co. Ltd. Address before: 100054, room 1701, block B, 80 South Street, Xuanwu District, Beijing, Guanganmen Patentee before: Jia Hongzhang |
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