CN1037151C - Blood pressure lowing plaster and its preparation - Google Patents

Abstract

The present invention relates to ginseng and chrysanthemum blood pressure reducing plaster and a preparation method thereof, the ginseng and chrysanthemum blood pressure reducing plaster is a pure traditional Chinese medicine compound preparation, and is used for treating hypertension. The blood pressure reducing plaster is composed of medicine liquid for ginseng and chrysanthemum plaster, absorbent cotton coated by special hat-shaped rubber sleeves and gauze. The main prescriptions of the medicine liquid comprises figwort root, twotoothed achyranthes root, tall gastrodis tuber, baical skullcap root, wild chrysanthemum, Indian bread, thinleaf milkwort root, oriental waterplantain rhizome, milkvetch root, peppermint oil, etc. The present invention has the effects of nourishing yin, suppressing yang, calming the liver and reducing blood pressure, and can be used for treating hypertension caused by hyperactivity of yang due to yin deficiency. The present invention has the characteristics of rapid effect taking, long maintenance term of medicine effect, convenient use and no toxic or side effect.

Description

Blood pressure lowing preparation of compositions method

The present invention relates to a kind of Chinese medicine preparation, especially a kind of pure compound Chinese medicinal preparation that is used for the treatment of hypertension.

Hypertension is one of modal chronic disease.China's hypertension prevalence of being grown up more than 20 years old is 5.8%, and the borderline hypertension prevalence is 3.3%, adds up to that adult's hypertension prevalence is 9.1% more than 20 years old, more than about 5,000 ten thousand people.Hypertension has become one of the most serious disease of harm modern humans life.In hypertension therapeutic, many patients take medicine all the life.Though constantly there is new drug to come out at present, but ideal medicine is also few, and most of antihypertensives also often have various toxic and side effects: may cause ulcerative hemorrhage as reserpine to the Peptic Ulcers patient, take for a long time and can occur depressedly, also can increase the danger of breast carcinoma morbidity; During the propranolol intravenous injection, the visible hypertension of small number of patients to stopping administration suddenly with patients with coronary heart disease in application process, can make severity of symptoms, causes myocardial infarction; Even new and effective antihypertensive captopril also can cause heating, pimple, to itch, dysgeusia, poison such as leukopenia is paid effect.And the onset time of various antihypertensive drug is also widely different, and all there is crucial clinical meaning these medicine two aspects of selecting for use urgent antihypertensive drugs and long-term treatment to select for use to have no side effect for hypertensive emergency.Therefore, seek new antihypertensive drug and be still the problem that people study energetically.

Purpose of the present invention just be to develop a kind of onset rapidly, lasting medicine, have no side effect again, or the new drug of minimum toxic and side effects.

The objective of the invention is to realize by following approach.Blood pressure lowing plaster is by Shenju Tieyong Yaoye, and the absorbent cotton and the gauze that add special medicated cap shape gum cover parcel constitute.Its medicinal liquid is big compound Chinese patent medicine, writes out a prescription to be:

Radix Scrophulariae 15g Radix Achyranthis Bidentatae 12g Concha Haliotidis 30g, Rhizoma Gastrodiae 5g Spica Prunellae 15g Semen Celosiae 15g Radix Scutellariae 15g Flos Chrysanthemi Indici 15g Radix Aristolochiae 9g Scorpio 3g Radix Polygalae 20g Poria 15g Rhizoma Chuanxiong 9g Flos Magnoliae 9g Rhizoma Alismatis 15g Radix Astragali 20g Oleum menthae 0.2% tween one 800.4% glycerol 10%

Wherein Flos Chrysanthemi Indici and Flos Chrysanthemi are replaceable or with using.

Preparation method of the present invention is as follows: with medical materials such as rhizome in above-mentioned prescription section (section), Flos Magnoliae is decocted a drug wrapped, and Scorpio adds low amounts of water, and freezing is rubbed.Concha Haliotidis goes into to fry in shallow oil earlier, and except that Scorpio was singly fried in shallow oil, other medical material was dipped to the heart, added water to submerge the decoction secondary with Concha Haliotidis.Merge secondary decoction filtrate, and Scorpio decoction filtrate, centrifuge adds the filter cloth compartment and filters, and filtrate concentrates, and adds proper amount of active carbon, and the adding ethanol (95%) that stirs leaves standstill, and precipitation is got supernatant, the activated carbon coating filtration.Filtrate decompression reclaims an amount of ethanol, regulates pH value to 4.0-5.4, presses the preparation total amount, again with an amount of Oleum menthae, and tween 80, glycerol mixes the back and adds medicinal liquid, stirs evenly.Embedding is in the special bottle of 1ml.Make unique applicator material-umbilicus eye with medical absorbent cotton, gauze, latex circle and paste, can preserve medicinal liquid, it is subcutaneous that medicinal liquid is infiltrated slowly.Fix with special rubberized tape during use.

Remove tween 80 in this prescription, Oleum menthae, glycerol, ethanol can be used as oral medicine and use.

This product is the rufous supernatant liquid, and the hot cold air flavor of Oleum menthae is arranged.PH value is 4.0-5.4.During use, medicinal liquid is clamp-oned the umbilicus eye paste, be applied to Qizhong (SHENJUE acupoint) and be adjacent to adhesive plaster.Every subsides survival dose is 0.5ml, subsides in 2-3 days, and each application time must not be less than 8 hours.The person of being in a bad way can subsides in a day.

The present invention adopts the big compound recipe external plaster application agent of pure Chinese medicine, has nourishing YIN for attracting YANG, and the effect of suppressing the hyperactive liver blood pressure lowering can be used for treating the hypertension that is caused by hyperactivity of YANG due to deficiency of YIN.Hypertension belongs to the disease category such as " headache ", " dizzy " of motherland's medical science.Primary disease is with headache, dizzy, top-heavy, and row is carried out unstable, fidgety irritability, and soreness of the waist and knees, tinnitus, palpitation and insomnia, forgetful dreaminess is its feature.It is a kind of clinical common stubborn disease.Primary disease is divided into according to the Chinese medicine differentiation of symptoms and signs for classification of syndrome: " hyperactivity of YANG due to deficiency of YIN ", " wind-yang and up-boring " and types such as " deficiency in both YIN and YANG ".In fact, all types of causes of disease, relevant mutually, state of an illness weight and different just.This sick occurrence cause belongs to due to the Liver and kidney imbalance of YIN and YANG more.Chinese medicine thinks that liver and kidney all belong to the human body part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels, forked rubbings all, i.e. and liver-yin, kidney yang, kidney yin, liver-yang, because of kidney master water, liver master wood is mutual promotion, the relation of mutual dependence for existence is so two dirtyly must keep relative equilibriums.If because of some reason, cause that a side is not enough, can cause high partially on the other hand.As because of intemperate sexual intercourse, damage kidney yin, cloudy blood scarcity can not nourishing the liver, and forms " the kidney failing to nourish the liver ", causes excessive rising of liver-YANG, and liver is a viscus attriguted to wind and wood, the main liter initiatively, if the moon is not made sun, then the high up reversal of yang-energy is risen, so see headache, dizziness; " liver opens in order ", if wind-yang and up-boring, then clear key is unfavorable, so see dizzy tinnitus, so " the most pure virginity will be discussed greatly between element " cloud: " all wind trembling and dizziness all belong to liver " promptly is this meaning.If the moon is not tieed up sun, cause hyperactivity of deficient fire, then see fidgety irritability.On the contrary, contain partially on the other hand, also can cause deficiency on the other hand, contain partially as liver-yang, following moving kidney yin can form a little less than the deficiency of the kidney yin.Because liver governing tendons, kidney governing bones, waist are house of kidney, so can occur soreness of the waist and knees simultaneously, the stride foot is light; The deficiency of YIN then sun is no made, and refreshing nothing is supported, and negative and positive had not both been helped mutually, so see palpitation and insomnia, diseases such as forgetful dreaminess.In a word, primary disease plays the disease being located in the liver, and root is at kidney, and real is that the real deficiency in origin of mark is managed more than the pathological changesization.So we are with the nourishing kidney easing the affected liver, nourishing YIN for attracting YANG, suppressing the hyperactive liver blood pressure lowering and making laws.

Fang Zhongzhu with nourishing the liver wood, and can go up scorching asthenic fire with the Radix Scrophulariae kidney nourishing water clearly; With the Radix Achyranthis Bidentatae the liver and the kidney tonifying, strong waist knee joint, but and conducting blood to flow downwards; With Concha Haliotidis Rhizoma Gastrodiae suppressing the hyperactive liver and subsiding YANG, be apt to the dizzy for the treatment of the liver sun rising, and energy tonifying liver the moon, clearing away heat to improve acuity of vision more than is monarch drug.This disease is mainly the liver-yang hyperactivity of suffering from a deficiency of the kidney, and the cause of disease of hyperactivity of deficient fire is not to fall straight discharging the retained water product with hardship can prove effective, so with the medicine of Spica Prunellae, Semen Celosiae, Radix Scutellariae, Flos Chrysanthemi Indici, Radix Aristolochiae group removing heat from the liver, with the floating sun of system rising, and strong hypotensive effect is arranged all.Wherein the collaborative Concha Haliotidis of Spica Prunellae, Semen Celosiae, Flos Chrysanthemi Indici can the clear sharp head, more than is ministerial drug.To put out endogenous wind, join Radix Polygalae, Poria cum Radix Pini's restoring normal coordination between the heart and kidney, mind tranquilizing and the heart calming as scorpion; Add Rhizoma Chuanxiong, Flos Magnoliae less and declare the head clearly, with pain relieving, but Rhizoma Chuanxiong and bar reach stagnation of liver-QI, dismiss the Liver Channel stagnated fire with its medicine; Help the descending sedimentation of Rhizoma Alismatis and diuresis, be intended to draw deficiency-heat and discharge, and diffusing the exaggerating of harm Rhizoma Chuanxiong a surname, the positive pattern that goes up drawn.Chinese medicine is thought, human body physiological function and pathological change focus on whether balance of negative and positive, so " vital QI of the body connecting with natural QI opinion between element " cloud: " YIN and YANG in a relative equilibrium, life activities being normally maintained, dissociation of YIN from YANG, exhaustion of vital essence ".The cloudy blood of human body is material base, but the promotion of the functional activity of palpus yang-energy just can make negative and positive maintain maintenance normally, so solely get Radix Astragali invigorating the spleen and replenishing QI in the side, regulating YIN and YANG promotes enriching yin and nourishing kidney, and the suppressing the hyperactive liver to relieve the wind syndrome medicine is brought into play curative effect.As " medical science agricultural middle school ginseng blood record " cloud: " Radix Astragali with deliver the same usefulness of medicine, the exogenous wind of dispelling, with the same usefulness of yin-nourishing drug, in more putting out also ".Be adjuvant more than the event.We form, and compatibility is precise and appropriate, have main have from, bring out the best in each other, group's medicine plays nourishing YIN for attracting YANG, the effect of suppressing the hyperactive liver blood pressure lowering altogether.

The present invention adopts unique umbilical part medication, and its peculiar structure is applicable to the umbilicus eye, because the gum cover medicated cap closely contacts with umbilical part, the medicinal liquid that is contained in the interior absorbent cotton of cover is slowly emitted, be equivalent to the effect of slow release formulation, reached the length of holding time, the purpose that antihypertensive effect is good.Adopt the externally applied plaster dosage form, follow the logos of plaster, but not office in form, easy to use, also do not pollute clothing, meet modern applied mental.The more important thing is and avoided inconvenience oral and that injection drug brings.

The present invention adopts specific process external " god faints " (abdomen umbilicus) acupuncture point administration.SHENJUE acupoint is the main acupuncture point of human body " conception vessel " meridians, logical internal organs in it, and circumscribed skin by Transdermal absorption, has to get and imitates rapidly characteristics easy to use.And recent studies is thought, umbilicus is the last closed place of stomach wall in embryo development procedure, and horny layer of epidermis is the thinnest, and barrier function is relatively poor, and fat-free mass under the umbilicus, and the skin fascia directly links to each other with peritoneum.So permeability strengthens, drug molecule more easily sees through the horny layer of umbilical part skin, enters intercellular substance, and disperse is gone into blood and sensible whole body rapidly.Peritoneum is big under the umbilicus an abundant venous rete, is connected in portal vein, thereby medicine is able to through the through liver of this shortcut.

Further set forth reliability of the present invention and safety below in conjunction with liquid medicine stability of the present invention, toxicological test, pharmacology test and clinical research and with the contrast of other antihypertensive drugs in clinical practice.

Stability test:

Get the investigation that keeps sample of three lot number samples of blood pressure lowing plaster.

1.pH variation: the results are shown in Table 1

Table 1 blood pressure lowing plaster keeps sample and investigates the pH variation

Keep sample 20 months pH all between 4.0-6.0 by visible three samples of table 1, meet the requirements.

2. the variation of relative density: the results are shown in Table 2

Table 2 blood pressure lowing plaster keeps sample and investigates the relative density variation

Keep sample the relative density variation between 0.99-1.11 by the visible blood pressure lowing plaster of table 2, meet the regulation of target level of product quality.

3. n-butanol extract assay: three samples its value of n-butyl alcohol assay in each that keeps sample in the 0.041-0.045g/ml scope, is met the 0.005-0.05g/ml scope of target level of product quality regulation in period.

By blood pressure lowing plaster preparation stabilization sexual factor is investigated, its pH that keeps sample, relative density, n-butanol extract assay all meet the target level of product quality requirement, and its effect duration is in 1 year more than half.

Acute toxicity test:

1. mouse peritoneal injection blood pressure lowing plaster acute toxicity test: 80 mices are equally divided into 4 groups, 20 every group, male and female half and half.Respectively group difference lumbar injection blood pressure lowing plaster calculates 10g/kg with crude drug, 20g/kg, and 40g/kg and 80g/kg, injection capacity are 0.2ml/10g, but the 80g/kg group then is 0.4ml/10g, the upper and lower noon is respectively once observed its general situation and the mortality rate in 7 days.

Experimental result is observation 7 days, none death of mice, and its minimum lethal dose is greater than 80g/kg.

2. rat skin coating blood pressure lowing plaster acute toxicity test: with 40 of rats, be equally divided into 4 groups, 10 every group, male and female half and half.The rat back cropping, area 5 * 6cm ², account for body surface area 1/10, divide secondary to be applied to cropping place skin by following dosage 12g/kg, 15g/kg, 20g/kg, 23g/kg, be separated by between twice about 1 hour.

Experimental result shows observed for 1 week, and all rat is all no abnormal, and death is not arranged, and its minimum lethal dose is greater than 23g/kg.

By above-mentioned experiment, mouse peritoneal injection 80g/kg, rat is applied to 23g/kg and does not also see any unusual.And about the about 20mg/kg of people's consumption, suitable is little, so this blood pressure lowing plaster is safe.

Long term toxicity test:

Get 9 of new zealand rabbits, be divided into three groups, three every group, be respectively heavy dose of group (1.25g/ml), small dose group (0.5g/ml), matched group (equivalent normal saline), the rabbit right side is the damaged skin group, and the left side is the intact skin group.Administration every day 1ml, continuous 14 days, rabbit had or not scytitis after the observation medication, and the damaged skin healing has or not influence, and does pathological section and carry out pathological examination.Experimental result sees Table 3,4.

Table 3 blood pressure lowing plaster is to rabbit skin local toxicity parameter

Group	Dosage	Number of animals	Natural law	Erythema edema integration	The incrustation time	Healing time
							The damaged skin group	1.25g/ml 0.5g/ml	3 3	14 14	0 0 0 0 0 0	1.5 they 1.5 days	10.25 ± 0.41 day 9.66 ± 0.47 days
The intact skin group	1.25g/ml 0.5g/ml	3 3	14 14	0 0 0 0 0 0
							Contrast skin group	Damaged complete	3 3	14 14	0 0 0 0 0 0	1.5 my god	9.66 ± 0.47 day

Table 4 blood pressure lowing plaster is to rabbit skin local toxicity pathological parameter

Group numbering project	Damaged skin	Intact skin
			1.25g/ml 0.5g/ml contrast	1.25g/ml 0.5g/ml contrast
	①②③ ①②③ ①②③	①②③ ①②③ ①②③
			The bundle layer is plump	0 0 0	0 0 0
Hypergranulosis	0 0 0	0 0 0
			Cuticle thickening	0 0 0	0 0 0
Other table matter change	0 0 0	0 0 0
			Corium changes	4.5 5 4	4 3.5 2
The smallclothes index	4.5 5 4	4 3.5 2
			Average	1.5 1.66 1.33	1.33 1.15 0.66

By experimental result as can be known, it is 0 that medicine stimulates integration to intact skin, and damaged skin is respectively organized the healing time no significant difference, and the pathology integration is all less than 4 minutes.Result of the test shows that the blood pressure lowing plaster medicinal liquid stimulates to be divided equally, and healing time, incrustation time, pathology stimulate to be divided equally, and each organizes no significant difference, and blood pressure lowing plaster is a kind of relatively medicine for external use of safety.

Pharmacology test:

Owing to can not duplicate successfully in rat one fashion according to the route of administration at clinical acupuncture point, so following experiment all observes to the rat oral gavage blood pressure lowing plaster whether can produce hypotensive effect.

1. blood pressure lowing plaster is irritated the influence of stomach to the anesthetized rat blood pressure: rat is divided into five groups: first group gavages normal saline 5ml/kg in contrast; Second and third, four groups gavage blood pressure lowing plaster 1.25,2.5 and 5.0ml/kg respectively; The 5th group gavages captopril 4mg/kg.Before the record administration and the variation of 15,30,60,90,120,150,180 minutes blood pressures after the administration.Experimental result sees Table 5.

Table 5 blood pressure lowing plaster is irritated the influence of stomach to the anesthetized rat blood pressure

Medicine	Dosage (ml/g)	Number of animals	Mean arterial pressure (mmHg)
											Before the medication	After the medication (min)
			15	30	60	90	120	150	180
										The NS blood pressure lowering is pasted blood pressure lowering and is pasted blood pressure lowering subsides mercapto first		5 1.25 2.5 5.0 4ml/kg	6 6 6 5 5	102.5±6.7 91.5±8.6 100.2±5.4 104.8±14.3 108.4±5.3	104.0±13.3* 85.2±11.1* 90.7±9.0* 87.0±13.9* 93.0±11.8*	101. 3±12.0* 89.5±11.2* 83.7±8.4*** 81.0±21.8* 79.0±13.8**	99.3±19.1* 92.0±9.9* 81.7±7.9*** 59.3±11.2*** 71.2±9.7***	95.0±11.5* 88.2±10.6* 89.2±4.3*** 76.0±15.9** 71.6±12.9***	104.3±13.4* 79.8±9.0* 90.5±4.7*** 79.2±16.4** 71.0±6.0***	94.8±9.2* 79.8±18.6* 78.0±5.1***	94.3±7.6* 91.0±10.9* 78.8±6.3***

Compare P＞0.05 before X ± SD* and the administration; * P＜0.05, * * * P＞0.01NS=normal saline, blood pressure lowering subsides=blood pressure lowing plaster, mercapto first=captopril.

Can find out that from table 5 blood pressure lowing plaster 1.25ml/kg irritates stomach does not have tangible hypotensive effect to anesthetized rat; Then can produce significant pressure reduction effect 2.5ml/kg irritate stomach, mean pressure decline 10-19mmHg, 30 minutes hypotensive effects promptly very remarkable (P＜0.01) behind the filling stomach, blood pressure recovered substantially in 150 minutes.When 5ml/kg irritated stomach, its hypotensive effect was stronger, and mean pressure descends and reaches 17-45mmHg, and 150 minutes blood pressures progressively recover behind the filling stomach.The rat hypotensive effect that gavages captopril 4mg/kg also clearly, and the persistent period is longer, irritate stomach after 180 minutes blood pressures do not recover yet.And gavage the rat of normal saline, and to observe continuously 2 hours, blood pressure does not have significant change.

2. blood pressure lowing plaster is irritated the influence of stomach to clear-headed kidney type hypertensive rat blood pressure: get 15 of kidney type Hypertensive Rats, be divided into three groups, and 5 every group, administration behind the mensuration blood pressure.

First group of every Mus gavages normal saline 5ml/kg

Second group of every Mus gavages blood pressure lowing plaster 1.65g (by crude drug)/kg (5ml/kg)

The 3rd group of every Mus gavages blood pressure lowing plaster 3.3g (by crude drug)/kg (5ml/kg)

1h after the administration, 2h, 3h and 4h observe blood pressure.Experimental data sees Table 6.

Table 6 blood pressure lowing plaster is in the renal hypertensive rat oral administration 24h

Relatively (unit: mmHg): the blood of the antihypertensive effect before and after the administration of group dosage number of animals in the different time is worth very much (systolic pressure) to antihypertensive effect

(g/kg) 1h 2h 3h 4h matched group normal saline 5 180.8 ± 181.6 ± 176.6 ± 179.6 ± 179.2 before (only) administration ±

9.7 big 3.30 5 137.8 ± 151 ± 145.2 ± 142 ± 166.8 ± dosage 14.5 27.7 18.7 16.04 18.6 of 10.2 10.9 12.1 14.4 ginseng chrysanthemums little 1.65 5 104.8 ± 151.6 ± 157 ± 165.4 ± 172 ± dosage 13.8 25.4 20.6 12.7 20.3 ginseng chrysanthemums

Low dose of blood pressure lowing plaster (1.65g/kg) gavages back 1h and remarkable hypotensive effect promptly occurs, and the pressure value reduction reaches 33mmHg, P＜0.05, and blood pressure slightly gos up behind the 2h, and blood pressure promptly gos up gradually subsequently, and the pressure value amount is still low behind the 3h, but has not had significance.

After heavy dose of blood pressure lowing plaster (3.3mg/kg) gavaged, blood pressure drops was more remarkable, and the 1h bleeding from anus descends very much and reaches 36 mmHg, P＜0.05,2h and 3h blood pressure reduce more very, reach about 40mmHg, the P value is all less than 0.01, the 24h bleeding from anus press off beginning rise P＞0.05 but＜0.1.

From experimental result as can be known, blood pressure lowing plaster gavages the hypotensive effect that kidney type Hypertensive Rats is had highly significant, and its dosage and effect have tangible dependency, compares with the normal arterial pressure rat, it is littler that blood pressure lowing plaster reduces the hypertensive rat blood pressure required dosage, and it is longer to hold time.

Clinical curative effect analysis:

Each phase hyperpietic that voluntary accepting blood pressure lowing plaster umbilical part sticks is totally 196 examples, wherein male 115 examples, women 81 examples.Age distribution: 30-39 year 4 examples; 40-49 year 26 examples; 50-59 year 70 examples; 60-69 year 76 examples; Person's 20 examples more than 70 years old.The blood pressure criterion adopts the standard of World Health Organization's suggestion in 1976, the hypertension of promptly being grown up systolic pressure (SBP) 〉=160mmHg, or diastolic pressure (DBP) 〉=95mmHg is as the criterion.Take other depressor bleeding from anus pressure drop to arm's length standard, or the borderline hypertension person forgo need not.Hypertension is by stages: the I phase, hypertension is arranged, but clinically be not in the mood for, the performance of brain, kidney aspect; The II phase, hypertension is arranged and just like the next item down person: general or local stenosis, albuminuria or serum creatinine concentration of tremulous pulse slightly increases at the bottom of left ventricular hypertrophy, the examination of ocular fundus anophthalmia; There is hypertension the III phase, and a following person is arranged: cerebral hemorrhage or hypertensive encephalopathy, heart failure, renal failure, optical fundus have hemorrhage or ooze out or papilledema arranged.Test method is first three day to withdraw all blood pressure lowerings and influence the medicine of blood pressure in treatment, and the blood pressure lowing plaster subsides are dripped the into special gum cover that contains absorbent cotton with medicinal liquid 0.5-1.0ml.Stick Qizhong (SHENJUE acupoint), blended rubber cloth is adjacent to, and repeatedly medication person sticked once in per 3 days.Result of the test is as follows:

1. blood pressure lowing plaster once sticks the pressure reduction effect in the hyperpietic 24 hours, the results are shown in Table 7.

Table 7 blood pressure lowing plaster once sticks hyperpietic 24 hours

Interior pressure reduction effect parameter (unit: mmHg)

The project group	Example number (people)	Blood pressure type (receiving/relax)	Pressure value (again ± SD) before the administration	1 hour pressure value (again ± SD)	12 hours pressure values (again ± SD)
						The normal saline group	14	The systolic pressure diastolic pressure	179.5±14.6 114.5±8.6	179.7±14.8 114.6±9.5	177.6±14.6 114±9
I phase hypertension group	34	The systolic pressure diastolic pressure	166.9±11.9 101.4±8.5	156.8±14.9* 88.7±5.7**	148.4±10.5** 83.6±4.1**
						I phase hypertension group	43	The systolic pressure diastolic pressure	183.1±18.9 122.1±10.9	159.2±17.6** 95.9±9.7**	151.8±15.5** 89.2±6.5**
I phase hypertension group	20	The systolic pressure diastolic pressure	186.7±20.2 110.5±11.9	159.9±17.6** 95.6±6.9**	152.4±13.9** 90.3±5.2**

With before the administration than P＜0.05; * P＜0.01

By table 7 as seen, the normal saline matched group sticks 24h, and systolic pressure and diastolic pressure do not have significant change, no matter and medication group I phase, II phase, III phase hyperpietic, no matter also be that systolic pressure and diastolic pressure medication 1h promptly have obvious decline, more remarkable to the 24h blood pressure drops, P＜0.01.Not only hypotensive effect is remarkable to show this product, and it is also long to hold time.

2. blood pressure lowing plaster once sticks, and observes pressure reduction effect in five days, the results are shown in Table 8.

Table 8 blood pressure lowing plaster once sticks the hyperpietic

Five days pressure reduction effect parameter (units: mmHg)

The group project	The blood pressure type	I phase hypertension group (again ± SD)	II phase hypertension group (again ± SD)	III phase hypertension group (again ± SD)
					The example number	(people)	7	24	5
Blood pressure before the administration	The systolic pressure diastolic pressure	178.6±3.9 111.4±3.2	190.5±9.6 119.3±4.9	208±11.5 127.2±2.7
					1 hour pressure value	The systolic pressure diastolic pressure	147.1±5.5** 85.4±7.1**	159.3±7.2** 96.2±9.4**	170.8±8.4** 100.8±0.9**
12 hours pressure values	The systolic pressure diastolic pressure	146.6±4.6** 82.6±2.8**	155.4±5.1** 90.5±6.2**	165.2±6.8** 96±2.2**
					First day pressure value	The systolic pressure diastolic pressure	146.8±5.2** 83.4±2.3**	155±4.6** 90.2±5.2**	162.6±6.1** 94.8±0.9**
Second day pressure value	The systolic pressure diastolic pressure	149.4±4.9** 63.1±2.6**	156.3±4.3** 90.8±4.9**	162.4±5.9** 95.2±0.9
					The 3rd day pressure value	The systolic pressure diastolic pressure	149.1±4.5** 83.4±2.1**	159±5.6** 92.7±6.4	165.2±6.5** 96.4±1.9**
The 4th day pressure value	The systolic pressure diastolic pressure	155.1±7.1** 90.6±7.9**	167.5±6.1** 98.6±7.9**	170.8±5.5** 101.2±3.7**
					The 5th day pressure value	The systolic pressure diastolic pressure	166.8±9.4 97.6±7.9**	177.5±5.8** 106.8±9.1**	184.6±7.7** 110.4±7.1**

With compare P＜0.05 before the administration;

Compare P＜0.01 before * and the administration

By table 8 as seen, each phase hyperpietic, 1 hour is produce effects after the medication, and systolic pressure and diastolic pressure all reduce, and promptly reduce as far as possible by 1-2 days, and bottom out in 3-4 days returned to former blood pressure level on the 5th day not yet, and the P value is still less than 0.01.Show that this product hypotensive effect is lasting.But because of observing time more of a specified duration, for exempting to meet accident, matched group is not established in this experiment.

3. blood pressure lowing plaster was exchanged cards containing all personal details and become sworn brothers and is sticked once in per 3 days, observed pressure reduction effect in the week, the results are shown in Table 9.

Table 9 blood pressure lowing plaster was exchanged cards containing all personal details and become sworn brothers to the hyperpietic in three days

Pressure reduction effect parameter (mmHg of unit) in one time one week

The group project	The blood pressure type is received/is relaxed	I phase hypertension group (again ± SD)	II phase hypertension group (again ± SD)	III phase hypertension group (again ± SD)
					The example number	(people)	18	18	9
Blood pressure before the administration	The systolic pressure diastolic pressure	154.3±18.1 100.6±14	170.1±17.8 112.2±16.4	195±20.5 116.4±11.8
					12 hours pressure values	The systolic pressure diastolic pressure	142.6±12.6* 93.2±14.9	153.1±11.2** 100.2±18.8
First day pressure value	The systolic pressure diastolic pressure	137.1±11.9** 89.1±13.8*	150.4±10.1* 97.3±18.3*	165.6±21.1* 100.2±14.8*
					Second day pressure value	The systolic pressure diastolic pressure	133.4±11.9** 87.3±12.6**	147±12.2** 96.2±17.1**	163.5±21.4** 100.1±15.6*
The 3rd day pressure value	The systolic pressure diastolic pressure	132.5±8.8** 86.4±10.4**	142.7±14.5** 95.1±16.6**	163.1±22.9** 99±16.1*
					The 4th day pressure value	The systolic pressure diastolic pressure	129.7±10.6* 84.6±11.7**	142.7±14.5** 95±14.9	161.1±22.1** 97.5±16.3*
The 5th day pressure value	The systolic pressure diastolic pressure	129.4±10.1** 84.2±11.5**	139.6±11.5** 90.3±14.5**	160.8±19.3** 97.6±15.6**
					The 6th day pressure value	The systolic pressure diastolic pressure	129.9±11.7** 82.6±8.6**	136.6±10.6** 87.2±12.4**	159.5±19.9** 96.1±14.3**

With compare P＞0.05 before the administration; * P＜0.01

By table 9 as seen, medication can begin blood pressure lowering in 12 hours, reduced as far as possible in general 3-4 days, maintained low-level until the 6th day always, as a whole systolic pressure reduce more remarkable, more than the P value less than 0.01, diastolic pressure to be reduced in I phase hypertension effect best, then poor slightly to III phase hypertension, the P value is many less than 0.05.

4. take the FUFANG JIANGYA PIAN blood pressure for a long time and fail to reduce to normally, use the pressure reduction effect after (per three days once) pasted in blood pressure lowering instead, case arrangement and antihypertensive effect see Table 10.

Table 10 blood pressure lowing plaster " falls sheet again " to long-term clothes and does not reduce to

Normal arterial pressure patient's antihypertensive effect parameter (unit: mmHg)

The project group	Example number (people)	After the administration (week)	Time (forward and backward)	Systolic pressure (again ± SD)	Diastolic pressure (again ± SD)
						Long changing the date overlays the sheet group with the multiple chrysanthemum side's step-down of clothes ginseng	35	One week	Front and back	173.1±21.3 157.8±20.5**	100.8±10.4 95.4±7.6
26	Two weeks	Front and back	171.1±19.6 149.3±16.8**	104.7±9.5 88.5±7.9**
					15		Three weeks	Front and back	178.5±19.8 152.6±16.3	107.1±10.4 86±8.6**
Take for a long time sheet group step-down to note in reply side	8	One week	Front and back	156.6±13.2 154.4±13.7							96.3±11.9 94.5±8.5
					8	Two weeks	Front and back	156.6±13.2 151.8±15.2	96.3±11.9 91.0±7.5
	8	Three weeks	Front and back	156.6±13.2 155±16.6						96.3±11.9 97.5±4.3

Before * and the administration than P＜0.05

By table 4 as seen, take the hyperpietic of FUFANG JIANGYA PIAN for a long time, drop to a certain degree at blood pressure, took continuously for three weeks, no matter systolic pressure and diastolic pressure no longer include significant change.And the patient who uses blood pressure lowing plaster instead, systolic pressure also can obviously reduce (P value＜0.01).Use all diastolic pressures to still have reduction, but not remarkable.Second all systolic pressures continue to reduce, and diastolic pressure also has remarkable reduction, P value＜0.01.The two all is reduced in the normal arterial pressure scope.The 3rd week continued to maintain this level.Therefore, take FUFANG JIANGYA PIAN for a long time but can't drop to normotensive hyperpietic, use instead or add and still can produce remarkable antihypertensive effect with this product.

Therefore, the blood pressure lowing plaster external sticks in the umbilical part SHENJUE acupoint, no matter all can produce obvious antihypertensive effect to various hypertensive patient's systolic pressure and diastolic pressure, using instead or adding with this product also has obvious hypotensive effect.Not only antihypertensive effect is good, and the length of holding time, and application in per three days once can the long term maintenance curative effect.

(annotate: this experiment is finished by the attached first hospital's department of Chinese medicine of Nanjing Medical College, Hospital Attached to Nanjing Railway Medical College's internal medicine, attached dagger-axe flesh mountain hospital of Wannan Medical College internal medicine, ShiShimonoseki, Nanjing laser hospital, Nanjing Chinese Medicine Hospital's cooperation.)

With the contrast of other antihypertensive drugs in clinical application taboo: the results are shown in Table 11.

Table 11 blood pressure lowing plaster and 11 kinds of antihypertensive drugs

Contrast in the clinical application taboo

Medicine

+: available;-: forbidding; ±: careful using.

As shown in Table 11, blood pressure lowing plaster is compared with other antihypertensive drugs, and clinical practice is more extensive, is applicable to the hyperpietic with other symptom.

In sum, the present invention all has good antihypertensive effect for each phase hypertension, and onset is rapid, lasting medicine, no obvious toxic-side effects.The present invention adopts umbilicus treatment method, innovates on dosage form, has both avoided gastrointestinal reaction, and and the antagonism and the side effect of other oral medicine, can conveniently use again, do not pollute clothes.

Below in conjunction with specific embodiment, the present invention is described further.

Embodiment 1;

Prescription:

Radix Scrophulariae 15g Radix Achyranthis Bidentatae 12g Concha Haliotidis 30g Rhizoma Gastrodiae 5g Spica Prunellae 15g Semen Celosiae 15g Radix Scutellariae 15g Flos Chrysanthemi Indici 15g Radix Aristolochiae 9g Scorpio 3g Radix Polygalae 20g Poria 15g Rhizoma Chuanxiong 9g Flos Magnoliae 9g Rhizoma Alismatis 15g Radix Astragali 20g Oleum menthae 0.2% tween 80 0.4% glycerol 10%

With medical materials such as rhizome section (section), Flos Magnoliae is decocted a drug wrapped, and Scorpio adds low amounts of water, and-2 ℃ freezing, rubs.Concha Haliotidis went into to fry in shallow oil earlier 30 minutes, singly fried in shallow oil 1 hour except that Scorpio, and other medical material is dipped to the heart, adds water to submerge the decoction secondary with Concha Haliotidis.Merge secondary and decoct filtrate, and Scorpio decoction filtrate, centrifuge adds the filter cloth compartment and filters, and filtrate is concentrated into 1.2:1 (decocting liquid ml: medical material g).Add proper amount of active carbon, stirring adds ethanol (95%), stirs, and reaches 65-80% to content, leaves standstill, and precipitation is got supernatant, and activated carbon coating filters.Decompression filtrate recycling ethanol makes the alcohol amount that contains that still keeps 10-20% in the medicinal liquid.Regulate pH value to 4.0-5.4.Press the preparation total amount, get 0.2% Oleum menthae, 0.4% tween 80,10% glycerol mixes the back and adds medicinal liquid, stirs evenly.Embedding is in the special bottle of 1ml.During use medicinal liquid is clamp-oned the umbilicus eye made from medical absorbent cotton, gauze, latex circle and paste, and fix with special rubberized tape.

Claims (2)

1. blood pressure lowing preparation of compositions method, it is characterized in that: described compositions contains Radix Scrophulariae 15g, Radix Achyranthis Bidentatae 12g, Concha Haliotidis 30g, Rhizoma Gastrodiae 5g, Spica Prunellae 15g, Semen Celosiae 15g, Radix Scutellariae 15g, Flos Chrysanthemi Indici 15g, Radix Aristolochiae 9g, Scorpio 3g, Radix Polygalae 20g, Poria 15g, Rhizoma Chuanxiong 9g, Flos Magnoliae 9g, Rhizoma Alismatis 15g, Radix Astragali 20g, described preparation method comprises the steps: the Scorpio water moistening, decocting 1 hour is rubbed in freezing back; Concha Haliotidis decocting 30 minutes, other medical material are added water to submerge the decoction secondary with Concha Haliotidis after cutting off, soaking into; Secondary is decocted filtrate and the merging of Scorpio decoction filtrate, filter, filtrate is concentrated into 1.2: 1, and (decocting liquid ml: medical material g), pH to 4.0-5.4 is regulated in decolouring.

2. preparation method as claimed in claim 1, its feature also is: between above-mentioned decolouring and adjusting pH step, add 95% ethanol, stir, make content reach 65-80%, leave standstill, get supernatant, again decolouring, filter, filtrate decompression concentrates, and makes to contain the alcohol amount in the medicinal liquid and be 10-20%; After regulating pH, add the mixture of counting 0.2% Oleum menthae, 0.4% tween 80 and 10% glycerol by the preparation total amount.