CN102266407B - Traditional Chinese medicinal composition for treating hypertension and preparation method thereof - Google Patents
Traditional Chinese medicinal composition for treating hypertension and preparation method thereof Download PDFInfo
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- CN102266407B CN102266407B CN 201110223918 CN201110223918A CN102266407B CN 102266407 B CN102266407 B CN 102266407B CN 201110223918 CN201110223918 CN 201110223918 CN 201110223918 A CN201110223918 A CN 201110223918A CN 102266407 B CN102266407 B CN 102266407B
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Abstract
The invention discloses a traditional Chinese medicinal composition for treating hypertension, and the traditional Chinese preparation comprises the following effective components in parts by weight: uncaria alcohol extract 5-20 parts and radish seed water extract 3-12 parts. The invention also discloses a preparation method of the composition, and the preparation method is simple and easy for operation. The traditional Chinese medicinal composition disclosed by the invention has good antihypertensive effect and can be used for treating hypertension due to hyperactivity of the liver-yang. Also, the composition can improve vertigo, headache, tinnitus, dryness and uncomfortable feeling of eyes, giddiness, ache and weakness at waist and knees, asthenia, constipation and other symptoms.
Description
Technical field
The present invention relates to a kind of hypertensive medicine and preparation method thereof for the treatment of, be specifically related to a kind of pharmaceutical composition with the effect for the treatment of hypertension form and preparation method thereof that extracted by Chinese medicine ingredients.
Background technology
Hypertension (EH) is modal cardiovascular diseases, and sickness rate has become worldwide commonly encountered diseases, frequently-occurring disease, serious threat human life quality and life and health up to 10～20% at present.The antihypertensive drug that has at present clear and definite pharmacological effect and an evidence-based medical is take the chemicals product of transnational Pharmaceutical Group as main, and has certain side effect more.The market share of the Anti-hypertension Chinese medicine (such as Bezoar pill for lowering blood pressure, Zhenju Jiangya Tablet, compound recipe Ramulus Uncariae Cum Uncis sheet and QINGXUAN JIANGYA PIAN) of having researched and developed at present is lower, and at curative effect, technique, mouthfeel, single oral dose, carry the aspect such as convenient degree and also have obvious deficiency.
Using the Chinese medicine prevention hypertension is characteristic and the advantage of China's hypertension prevention and control work.Tradition thinks that excessive rising of liver-YANG is the main pathogenesis of hypertension; nourishing YIN for suppressing the hyperactive YANG is its main method for the treatment of; TIANMA GOUTENG YIN, Zhengan Xifeng Tang etc. are square medicine commonly used; and develop accordingly blood pressure lowering Chinese patent medicine Bezoar pill for lowering blood pressure, Zhenju Jiangya Tablet, compound recipe Ramulus Uncariae Cum Uncis sheet etc., obtain clinically application to a certain degree.In recent years, along with deepening continuously to the research of senile hypertension etiology and pathogenesis, proposing the kidney qi virtual loss is the important pathogenesis of senile hypertension, invigorating kidney qi is the important method for the treatment of of senile hypertension, JISHENG SHENQI WAN, eight flavor Antihypertensive Decoctions are square medicine commonly used, and develop accordingly Chinese patent medicine Kang Heng Jiangya Granules and the celestial Mulberry Jiangya Granula for the treatment of senile hypertension, its efficacy and saferry is still needed and is wanted further clinical verification, not yet obtains the approval in market.So the pure Chinese medicinal preparation that efficacy of antihypertensive treatment is definite, side effect is little, market prospect is clear and definite at present is still few; It is disorderly to improve in the patient body substance metabolism, payes attention to target-organ protection, to reverse the bad Chinese patent medicine preparation of reinventing of blood vessel more rarely seen; And under the guidance of hepatopathy theory screening of medicaments, extract its antihypertensive activity component, adopt the Anti-hypertension Chinese medicine preparation of " hypotensive effect mechanismic design, active component synergistic combination, combination target spot are comprehensively intervened " still to belong to blank.
Summary of the invention
The present invention provides a kind of hypertensive Chinese medicine composition for the treatment of in order to overcome the deficiency of existing Anti-hypertension Chinese medicine preparation, and this Chinese medicine composition efficacy of antihypertensive treatment is definite, few side effects.
The present invention also provides the preparation method of this Chinese medicine composition, and the present invention optimizes the extraction process of each effective ingredient, fully extracts effective ingredient, and the gained effect of drugs is good.
The present invention is under the guidance of Chinese medical theory, filter out antihypertensive Ramulus Uncariae Cum Uncis and Semen Raphani Chinese medicine compound, Optimized Extraction Process, extract its antihypertensive active component (being respectively uncaria total alkaloids, Soluble Semen Raphani alkaloids), principle according to " hypotensive effect mechanismic design, active component synergistic combination, combination target spot are comprehensively intervened ", the dosage ratio of preferred blood pressure lowering component, be prepared into the compositions of Ramulus Uncariae Cum Uncis Semen Raphani resisting hypertension active component, lay the foundation for further developing modern Chinese medicine.
Realize that technical scheme of the present invention is as follows:
A kind ofly treat hypertensive Chinese medicine composition, it is characterized in that effective ingredient comprises: Ramulus Uncariae Cum Uncis ethanol extract 5～20 mass parts, Semen Raphani water extract 3～12 mass parts.
Preferred effective ingredient comprises: Ramulus Uncariae Cum Uncis ethanol extract 10～20 mass parts, Semen Raphani water extract 6～12 mass parts.
Most preferred, effective ingredient comprises that mass ratio is Ramulus Uncariae Cum Uncis ethanol extract and the Semen Raphani water extract of 5:6.
Main effective ingredient is uncaria total alkaloids in the above-mentioned Ramulus Uncariae Cum Uncis ethanol extract, and uncaria total alkaloids content is more than 50%, and main effective ingredient is Soluble Semen Raphani alkaloids in the Semen Raphani water extract, and Soluble Semen Raphani alkaloids content is more than 50%.
The present invention treats the preparation method of hypertensive Chinese medicine composition, it is characterized in that may further comprise the steps:
A. adopt ethanol refluxing process to extract the Ramulus Uncariae Cum Uncis ethanol extract
(1) with Ramulus Uncariae Cum Uncis with ethanol extraction repeatedly, merge extractive liquid,, concentrating under reduced pressure ethanol gets concentrated solution;
(2) concentrated solution pH is reconciled to 9～10, then extremely colourless with chloroform extraction, the chloroform extraction liquid of merging gained boils off chloroform and gets dry extract;
(3) dried cream dilute hydrochloric acid ultrasonic dissolution, then sucking filtration is got filtrate, and filtrate is used the chloroform defat, the water intaking phase;
(4) water is reconciled pH to 9～10, and then with chloroform extraction repeatedly, combining extraction liquid is washed to neutrality with extract, then except anhydrating, boil off chloroform, gets the Ramulus Uncariae Cum Uncis ethanol extract;
B. adopt the decocting cooking method to extract the Semen Raphani water extract
(1) the Semen Raphani water is decocted repeatedly merge extractive liquid;
(2) extracting solution is concentrated, adding ethanol to pure content is 80 volume %, and hold over night is filtered, and supernatant evaporate to dryness ethanol is got dry extract;
(3) with dried cream water dissolution, upper AB-8 absorption with macroporous adsorbent resin then with the distilled water eluting, carry out gradient elution with ethanol again, is collected the ethanol part eluent of 10～30vol%;
(4) with eluent evaporate to dryness ethanol, get the Semen Raphani water extract;
C. Ramulus Uncariae Cum Uncis alcohol extract and the Semen Raphani water extract that makes mixed by proportioning, add the adjuvant of survival dose, make.
In the said method, when extracting the Ramulus Uncariae Cum Uncis ethanol extract, the volumetric concentration of ethanol is 70～80%, consumption be Ramulus Uncariae Cum Uncis 8～12 quality doubly, extract 2h at every turn; The quality of concentrated solution is 1～2 times of drug quality.
In the said method, the concentration of dilute hydrochloric acid is 1～5wt%.
In the said method, when extracting the Semen Raphani water extract, the consumption of water be Semen Raphani 8～12 quality doubly, extract 1.5h at every turn; Extracting solution is concentrated into 1-2 times of drug quality.
The mensuration of uncaria total alkaloids content adopts uncaria total alkaloids through water dissolution, it is 10 that ammonia is transferred pH, chloroform extraction, evaporate to dryness after the chloroform solution washing, residue adds the chloroform dissolving, precision adds 0.0100mol/l sulphuric acid liquid 20m1, methylate is red-the methylene blue indicator, with the molten solution that is titrated to of 0.0175mol/l caustic lye of soda by the shallow orange red yellow green that changes into, adopt uncaria total alkaloids that the inventive method extracts more than 50wt%, reach as high as more than the 99wt%, but along with the raising of alkaloid, cost also improves, and therefore the uncaria total alkaloids about normal operation 50wt% can reach good effect in actual production.
The Soluble Semen Raphani alkaloids assay, adopt ammonium tetrathiocyanodiaminochromate method precipitation, washing of precipitate is dried to precision weighing behind the constant, the same with uncaria total alkaloids, the Semen Raphani alkaloid also can reach more than the 99wt%, just cost can increase, so the Soluble Semen Raphani alkaloids about normal operation 50wt%.
Now, there are some researches prove, Ramulus Uncariae Cum Uncis and Semen Raphani extract all have the effect that reduces blood pressure, but find through retrieval, listing now or document, patent in do not carry out composite pharmacy with Ramulus Uncariae Cum Uncis extract and Semen Raphani extract, most of Chinese medicines all are that to adopt the multi-medicament raw material to carry out composite to reach the hypertensive purpose for the treatment of.These medicine material kinds are many, and need to assemble simultaneously plurality of raw materials when producing could patent medicine, relatively very complicated.And the present invention is take Semen Raphani and Ramulus Uncariae Cum Uncis as raw material, be simple and easy to, therapeutic effect is good, more is beneficial to and applies.
Chinese medicine composition dosage form of the present invention can be tablet, granule, capsule, mixture or pill.The method of extracting in the preparation Ramulus Uncariae Cum Uncis and active ingredient from radish seed is identical, and just the later stage is made corresponding dosage form according to different dosage forms according to the adjuvant that prior art adds dosage forms, and the therapeutic effect of the medicine of gained different dosage form is close.The used adjuvant of preparation tablet is starch, microcrystalline Cellulose, pregelatinized Starch, lactose, carboxymethylstach sodium, hypromellose, Pulvis Talci, magnesium stearate etc., the adjuvant of granule is multitudinous Icing Sugar etc., and the adjuvant of capsule is starch, pregelatinized Starch, carboxymethylstach sodium, hypromellose, magnesium stearate etc.; Mixture with water as solvent; The adjuvant of pill is starch, microcrystalline Cellulose, carboxymethylstach sodium, hypromellose etc.The consumption of adjuvant adds according to existing pharmaceutic adjuvant consumption or slightly adjusts.
The inventor is through for many years experience, drawn that uncaria total alkaloids and Soluble Semen Raphani alkaloids are composite treats hypertensive inventive concept, in order better to improve the invention technical scheme and to verify the reasonable of this compound medicine, carried out a large amount of Research experiments, to draw the magnitude relation of using of these two kinds of compositions, further prioritization scheme is to determine best drug ratio relation.Experimental technique is as follows:
1. experiment grouping
Effective ingredient with Ramulus Uncariae Cum Uncis and Semen Raphani---uncaria total alkaloids and Soluble Semen Raphani alkaloids are tested, these two kinds of effective ingredients are got respectively basic, normal, high three dosage during experiment, combination obtains 9 groups of medicine groups, and these 9 groups are respectively: uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (greatly), uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (in), uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (low), uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (greatly), uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (in), uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (low), uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (greatly), uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (in), uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (low).
Select 8 ages in week, male spontaneously hypertensive rat model (SHR), be purchased from Beijing dimension tonneau China laboratory animal company limited.According to the dosage modular design, this research is divided into following 10 groups with animal, and every group of 5 SHR are respectively SHR model group (model control group) and above-mentioned 9 groups of medicine groups.In addition, get 5 healthy rats as Wistar group (Normal group).
2. experimental technique
All laboratory animals are all adopted raise in cages, light and shade each 12 hours.Experimental session carries out gastric infusion to each rat, and the administration volume is each 2ml200g
-1, weekly administration 7d, afternoon regularly administration every day, continuous 2 weeks are by the corresponding dosage of body weight situation adjustment.It is as follows specifically respectively to organize dosage:
Normal group: 0.9%NaCl, gavage
,2ml200g
-1Model group: 0.9%NaCl, gavage
,2ml200g
-1Uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (greatly) group: uncaria total alkaloids (20mg200g
-1)
+Soluble Semen Raphani alkaloids (12mg200g
-1); Uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (in) group: uncaria total alkaloids (20mg200g
-1)
+Soluble Semen Raphani alkaloids (6mg200g
-1); Uncaria total alkaloids (greatly)
+Soluble Semen Raphani alkaloids (low) group: uncaria total alkaloids (20mg200g
-1)
+Soluble Semen Raphani alkaloids (3mg200g
-1); Uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (greatly) group: uncaria total alkaloids (10mg200g
-1)
+Soluble Semen Raphani alkaloids (12mg200g
-1); Uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (in) group: uncaria total alkaloids (10mg200g
-1)
+Soluble Semen Raphani alkaloids (6mg200g
-1); Uncaria total alkaloids (in)
+Soluble Semen Raphani alkaloids (low) group: uncaria total alkaloids (10mg200g
-1)
+Soluble Semen Raphani alkaloids (3mg200g
-1); Uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (greatly) group: uncaria total alkaloids (5mg200g
-1)
+Soluble Semen Raphani alkaloids (12mg200g
-1); Uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (in) group: uncaria total alkaloids (5mg200g
-1)
+Soluble Semen Raphani alkaloids (6mg200g
-1); Uncaria total alkaloids (low)
+Soluble Semen Raphani alkaloids (low) group: uncaria total alkaloids (5mg200g
-1)
+Soluble Semen Raphani alkaloids (3mg200g
-1).
, experimental result
The systolic pressure of each treated animal tail vein under 4 hours, one week of administration, administration two all waking states before measuring respectively administration, after the first administration.It is as follows that each organizes the blood pressure result:
4, conclusion
Take the meansigma methods of administration 2 all blood pressures as foundation, adopt the variance analysis method of orthogonal design to carry out statistical procedures, with
P＜0.05 for having significant difference.Statistical result showed, Ramulus Uncariae Cum Uncis and Semen Raphani resisting hypertension active component---uncaria total alkaloids and Soluble Semen Raphani alkaloids compatible combination are at uncaria total alkaloids (5mg200g
-1～20mg200g
-1) dosage range and Soluble Semen Raphani alkaloids (3mg200g
-1～12mg200g
-1) compatibility all has the experimental effect that reduces the SHR blood pressure in the dosage range, wherein with uncaria total alkaloids (10mg200g
-1) compatibility Soluble Semen Raphani alkaloids (12mg200g
-1) the pressure reduction effect optimum.
Can find out that from top zoopery the compositions that makes in drug ratio scope provided by the invention all has treats hypertensive effect preferably, and laboratory animal is without the sudden death phenomenon during medication, toxic and side effects is little.In order better to prove the human body adaptability of this medicine, further carried out following clinical experiment, verify that this medicine is to the clinical efficacy of hypertension syndrome of upper hyperactivity of liver yang.
Clinical trial
One, carries out the clinical comparison experiment with QINGXUAN JIANGYA PIAN and medicine of the present invention
1, case source
With reference to the diagnostic criteria of " 1999WHO/ISH Treatment Guidelines for Hypertension " and the dialectical standard of " new Chinese medicine Hypertension guideline of clinical investigations " syndrome of upper hyperactivity of liver yang, select 1 grade and 2 grades of essential hypertension Patients With Liver Yang Rising 72 examples, get rid of simultaneously 3 grades of essential hypertensions, secondary hypertensions and do not meet the dialectical standard person of traditional Chinese medical science syndrome of upper hyperactivity of liver yang.Adopt the table of random number method to be divided into 2 groups 36 routine patients, treatment group age reckling 28 years old, the oldest person 72 years old, 54 ± 12.34 years old mean age; Matched group age reckling 31 years old, the oldest person 68 years old, 52.8 ± 11.74 years old mean age.The shortest person of the treatment group course of disease 0.5 year, the elder of the course of disease 40 years, average 9.37 ± 10.17 years; The shortest person of the matched group course of disease 0.5 year, the most normal elder of the course of disease 36 years.Average 8.86 ± 9.73 years.The treatment group blood pressure level belongs to 1 grade of person's 14 example, 2 grades of person's 22 examples; The matched group blood pressure level belongs to 1 grade of person's 17 example, 2 grades of person's 19 examples.Two groups at equal zero differences in aspect (p＜0.05) such as age, the course of disease and blood pressure level, has comparability.
2, Therapeutic Method:
Treatment group gives medicine of the present invention and treats, and its medicine is tablet, and every contains uncaria total alkaloids 75mg and Soluble Semen Raphani alkaloids 90mg, and each 2, every day 3 times, warm water takes.
Matched group: select QINGXUAN JIANGYA PIAN, oral, one time 3,2～3 times on the 1st.Two groups all with 4 Zhou Weiyi courses for the treatment of.Take medicine to rise in front 1 week and withdraw other antihypertensive drug or to keep the dosage of original antihypertensive drugs and kind stable, rear as serious hypertension occurs, should give emergency case at once and process, period in a medicine is avoided spicy food and spirits, strong tea, coffee etc.
3, observation index
The a safety indexes: comprise pulse, breathing, heart rate, blood pressure, body weight etc., weekly; Blood, urine, just routine and hepatic and renal function inspection, per month once.
B parameters for observation on effect: mainly refer to blood pressure and tcm syndrome integration, with the meansigma methods for the treatment of front non-on the same day 3 blood pressures as observing blood pressure, with the course for the treatment of last the week non-on the same day 3 blood pressures meansigma methods as the efficacy evaluation blood pressure, weekly pressure measurement 2 times of viewing duration outpatient, weekly pressure measurement 3～5 times of inpatient.Observe simultaneously the common sympton of hypertension syndrome of upper hyperactivity of liver yang, respectively at before the treatment, treatment is inquired after finishing item by item and note down, and is judged by symptom score standard and score that every routine case symptom sum is this case disease total mark value.
4, statistical method
Measurement data adopts the t check, and enumeration data adopts X 2 test, and the clinical-grade data adopts the Ridit check, and data represent that with mean ± standard deviation p＜0.05 is significant difference, and p＜0.01 is significant differences.
5, efficacy assessment standard
A. the blood pressure efficacy evaluation is with reference to " new Chinese medicine Hypertension clinical guidance principle ".
⑴ produce effects: more than the diastolic pressure decline 10mmHg (1.3KPa), and reach normal range; Though diastolic pressure is not down to normally, descended 20mmHg (2.67KPa) or more than; Systolic pressure is treated more than the front decline 30mmHg, and reaches normal range.Possesses wherein one.
⑵ effective: diastolic pressure descends not as good as 10mmHg (1.67KPa), but reaches normal range; Diastolic pressure decline 10～19mmHg, but do not reach normal range; Systolic pressure is treated more than the front decline 30mmHg, but does not reach normal range.Possesses wherein one.
⑶ invalid: do not reach above standard.
B. the efficacy evaluation of clinical symptoms is evaluated with reference to the regulation of " new Chinese medicine guideline of clinical investigations ".
⑴ produce effects: all transference cures after the treatment, or total mark reduces 〉=66.7%;
⑵ effective: total mark reduces more than 33.3% after the treatment, and does not reach 66.7%;
⑶ invalid: total mark reduces less than 33.3% after the treatment.
Therapeutic index n=［ integration before (integration after integration before the treatment-treatment) ÷ treatment ］ * 100%.
6, result
A, hypertension curative effect: test group produce effects 10 examples, effective 19 examples, invalid 7 examples, total effective rate 80.6%; Matched group produce effects 6 examples, effective 16 examples, invalid 14 examples, total effective rate 61.1%.With two groups of checks significant difference (P＜0.05) is arranged through young.
B, clinical symptoms curative effect: test group produce effects 11 examples, effective 20 examples, invalid 5 examples, total effective rate 86.1%; Matched group produce effects 6 examples, effective 17 examples, invalid 13 examples, total effective rate 63.9%.Through checking two groups of obvious effective rates and total effective rate that significant difference (P＜0.05) is all arranged.Wherein the curative effect of dizzy, headache, dizzy swollen, vexed irritability, xerostomia hardship, constipation with dry stool, flushing scorching hot, uncomfortable in chest pain, yellow fur all is better than matched group (P＜0.05) significantly.
C, safety evaluatio: before the treatment 72 routine patients have been carried out hepatic and renal function, the inspection of hematuria stool routine examination, the result shows equal to unusual, after finishing the course for the treatment of all patients is all checked, and (P＞0.05) also has no significant change.Treatment group 36 routine patients, slight stomachache, diarrhoea appear in 2 examples, continue 1～2 day respectively, and without drug withdrawal, symptom is died away; Matched group 36 routine patients also have 2 examples to occur feeling sick or diarrhoea, continue 1～2 day, and without drug withdrawal, symptom is died away.
Two, carry out the clinical comparison experiment with Bezoar pill for lowering blood pressure and medicine of the present invention
1, case source
With reference to the diagnostic criteria of " 1999WHO/ISH Treatment Guidelines for Hypertension " and the dialectical standard of " new Chinese medicine Hypertension guideline of clinical investigations " syndrome of upper hyperactivity of liver yang, select 1 grade and 2 grades of essential hypertension Patients With Liver Yang Rising 92 examples, get rid of simultaneously 3 grades of essential hypertensions, secondary hypertensions and do not meet the dialectical standard person of traditional Chinese medical science syndrome of upper hyperactivity of liver yang.Adopt the table of random number method to be divided into 2 groups 92 routine patients, treatment group age reckling
25Year, the oldest person
68Year, the mean age
52 ± 10.96Year; Matched group age reckling
27Year, the oldest person
67Year, the mean age
53 ± 12.12Year.The shortest person of the treatment group course of disease 1 year, the elder of the course of disease
35Year, average
10.02 ± 12.33Year; The shortest person of the matched group course of disease 0.5 year, the most normal elder of the course of disease
37Year, average
11.02 ± 9.99Year.The treatment group blood pressure level belongs to 1 grade of person's 6 example, 2 grades of person's 40 examples; The matched group blood pressure level belongs to 1 grade of person's 10 example, 2 grades of person's 38 examples.Two groups at equal zero differences in aspect (p＜0.05) such as age, the course of disease and blood pressure level, has comparability.
2, method
Treatment group gives medicine of the present invention and treats, and its medicine is tablet, and every contains uncaria total alkaloids 75mg and Soluble Semen Raphani alkaloids 90mg, and each 2, every day 3 times, warm water takes.
Matched group gives Bezoar pill for lowering blood pressure and treats, and is oral, 1～2 ball, 2～3 times on the 1st.
Two groups all with 4 Zhou Weiyi courses for the treatment of.Take medicine to rise in front 1 week and withdraw other antihypertensive drug, rear as serious hypertension occurs, should give emergency case at once and process, period in a medicine is avoided spicy food and spirits, strong tea, coffee etc.
3, result
Adopt and with top identical observation index, statistical method, efficacy assessment standard curative effect of medication is estimated, the result is as follows:
A. hypertension curative effect: test group produce effects 14 examples (30.4%), effective 24 examples (52.2%), invalid 8 examples (17.4%), total effective rate 82.6%; Matched group produce effects 4 examples (15.4%), effective 13 examples (50%), no effect 9 (34.4%), total effective rate 65.39%.Through checking two groups of obvious effective rates and total effective rate that significant difference (P＜0.05) is all arranged.
B. clinical symptoms curative effect: test group produce effects 18 examples (39.1%), effective 22 examples (54.35%), invalid 6 examples (6.52%), total effective rate 93.48%; Matched group produce effects 5 examples (19.2%), effective 13 examples (50%), invalid 8 examples (30.3%), total effective rate 69.23%.Through checking two groups of obvious effective rates and total effective rate that significant difference (P＜0.05) is all arranged.Wherein the curative effect of dizzy, headache, dizzy swollen, vexed irritability, xerostomia hardship, constipation with dry stool, flushing scorching hot, uncomfortable in chest pain, yellow fur all is better than matched group (P＜0.05) significantly.
C. safety evaluatio: before the treatment 92 routine patients have been carried out hepatic and renal function, the inspection of hematuria stool routine examination, the result shows equal to unusual, finishes the course for the treatment of afterwards all patients all to be checked, and (P＞0.05) also has no significant change.Treatment group 46 routine patients, slight stomachache, diarrhoea appear in 2 examples, continue 1～2 day respectively, and without drug withdrawal, symptom is died away; Matched group 46 routine patients also have 2 examples to occur feeling sick or diarrhoea, continue 1～2 day, and without drug withdrawal, symptom is died away.
Can draw from above-mentioned clinical data; the sick syndrome of upper hyperactivity of liver yang of hypertension therapy that is comprised of uncaria total alkaloids and Soluble Semen Raphani alkaloids has good pressure reduction effect expression; effect all is better than QINGXUAN JIANGYA PIAN and Bezoar pill for lowering blood pressure; and can improve that dizzy, headache, tinnitus, fever sensation of the face are lit a fire, the puckery dim eyesight of order, soreness of the waist and knees, fatigue and weakness, the symptom such as be hard and dry; and without obvious toxic-side effects, thereby regulate and the treatment effect from too many levels, multi-level, many target spots performance function.
It is that uncaria total alkaloids and Soluble Semen Raphani alkaloids are carried out the composite medicine of making that the present invention mainly fills a prescription, in the preparation take Ramulus Uncariae Cum Uncis and Semen Raphani as raw material, adopt special means fully to extract their effective ingredient, be used for the treatment of hypertension, can find out that from the data of above-mentioned zoopery and clinical trial this two kinds of effective ingredient composite played good therapeutical effect.Except uncaria total alkaloids and Soluble Semen Raphani alkaloids, can also be according to the compatibility relationship of mutual reinforcement between, the mutual-assistance in the present invention's prescription, add some medicines identical or close with the Semen Raphani drug effect with Ramulus Uncariae Cum Uncis to increase curative effect, such as adding the Chinese medicine ingredients such as Radix Scrophulariae, Spica Prunellae, Flos Chrysanthemi, Radix Salviae Miltiorrhizae, play synergism, increase curative effect.
The specific embodiment
The present invention will be further elaborated below by specific embodiment, should be understood that, following explanation only is in order to explain the present invention, its content not to be limited.
Embodiment 1
Take Semen Raphani and Ramulus Uncariae Cum Uncis as raw material, prepare medicine of the present invention, method is as follows:
(1) with Ramulus Uncariae Cum Uncis with the ethanol extraction of 75vol% 3 times, each 2h, the amount of ethanol is 10 times of Ramulus Uncariae Cum Uncis quality, merges the Ramulus Uncariae Cum Uncis extracting solution, concentrating under reduced pressure ethanol gets concentrated solution, concentrated solution be drug quality 1-2 doubly; It is 10 that concentrated solution adds strong aqua ammonia accent pH, then extremely colourless with chloroform extraction, and combining extraction liquid reclaims chloroform to doing, and gets dry extract; Dried cream dissolves with the hydrochloric ultrasonic wave of 1wt%, sucking filtration, and filtrate is used the chloroform defat, the water intaking phase, transfer pH to 9-10 with ammonia, then use chloroform extraction, combining extraction liquid is washed to neutrality, use anhydrous sodium sulfate dehydration, extract reclaims chloroform to doing, and gets uncaria total alkaloids, and content is more than 50%.
(2) Semen Raphani is boiled 3 times with 10 quality decocting doubly, each 1.5h, merge extractive liquid, is concentrated into the extracting solution quality and is the 1-2 of drug quality doubly, concentrated solution adds ethanol and is 80vol% to containing the alcohol amount, and hold over night is filtered, Recycled ethanol, water bath method, drying obtains dried cream; Dried cream is dissolved in water, upper AB-8 macroporous adsorbent resin, use first distilled water flush away impurity, then carry out gradient elution with ethanol, collect 10～30vol% ethanol part eluent, resin column can continue to carry out gradient elution with the ethanol of 30-70vol%, until material is deviate from totally, macroporous resin is recycled.With 10～30vol% ethanol part eluent water bath method of gained, the dry Soluble Semen Raphani alkaloids that gets, content is more than 50%.
(3) Ramulus Uncariae Cum Uncis extract and the Semen Raphani extract mass ratio (being the mass ratio of 10:12) according to 5:6 is mixed, the adjuvant that adds survival dose, make tablet, capsule, granule, mixture or pill, Ramulus Uncariae Cum Uncis extract 75mg in the tablet, Semen Raphani extract 90mg.
Embodiment 2
Take Semen Raphani and Ramulus Uncariae Cum Uncis as raw material, prepare medicine of the present invention, method is as follows:
(1) with Ramulus Uncariae Cum Uncis with the ethanol extraction of 70wt% 3 times, each 2h, the amount of ethanol is 12 times of Ramulus Uncariae Cum Uncis quality, merges the Ramulus Uncariae Cum Uncis extracting solution, concentrating under reduced pressure ethanol gets concentrated solution, concentrated solution be drug quality 1-2 doubly; It is 9-10 that concentrated solution adds strong aqua ammonia accent pH, then extremely colourless with chloroform extraction, and combining extraction liquid reclaims chloroform to doing, and gets dry extract; Dried cream dissolves with the hydrochloric ultrasonic wave of 5wt%, sucking filtration, and filtrate is used the chloroform defat, the water intaking phase, transfer pH to 9-10 with ammonia, then use chloroform extraction, combining extraction liquid is washed to neutrality, use anhydrous sodium sulfate dehydration, extract reclaims chloroform to doing, and gets uncaria total alkaloids, and content is more than 50%.
(2) Semen Raphani is boiled 3 times with 12 quality decocting doubly, each 1.5h, merge extractive liquid, is concentrated into the extracting solution quality and is the 1-2 of drug quality doubly, it is 80% to containing the alcohol amount that concentrated solution adds ethanol, and hold over night is filtered, Recycled ethanol, water bath method, drying obtains dried cream; Dried cream is dissolved in water, and upper AB-8 macroporous adsorbent resin is used first distilled water flush away impurity, then carry out gradient elution with ethanol, collect 10～30vol% ethanol part eluent, Recycled ethanol, water bath method, the dry Soluble Semen Raphani alkaloids that gets, content is more than 50%.
(3) Ramulus Uncariae Cum Uncis extract and the Semen Raphani extract mass ratio (being the mass ratio of 10:6) according to 5:3 is mixed, the adjuvant that adds survival dose, make tablet, capsule, granule, mixture or pill, Ramulus Uncariae Cum Uncis extract 103mg in the tablet, Semen Raphani extract 62mg.
Embodiment 3
Take Semen Raphani and Ramulus Uncariae Cum Uncis as raw material, prepare medicine of the present invention, method is as follows:
(1) with Ramulus Uncariae Cum Uncis with the ethanol extraction of 80wt% 3 times, each 2h, the amount of ethanol is 12 times of Ramulus Uncariae Cum Uncis quality, merges the Ramulus Uncariae Cum Uncis extracting solution, concentrating under reduced pressure ethanol gets concentrated solution, concentrated solution be drug quality 1-2 doubly; It is 9-10 that concentrated solution adds strong aqua ammonia accent pH, then extremely colourless with chloroform extraction, and combining extraction liquid reclaims chloroform to doing, and gets dry extract; Dried cream dissolves with the hydrochloric ultrasonic wave of 1wt%, sucking filtration, and filtrate is used the chloroform defat, the water intaking phase, transfer pH to 9-10 with ammonia, then use chloroform extraction, combining extraction liquid is washed to neutrality, use anhydrous sodium sulfate dehydration, extract reclaims chloroform to doing, and gets uncaria total alkaloids, and content is more than 50%.
(2) Semen Raphani is boiled 3 times with 8 quality decocting doubly, each 1.5h, merge extractive liquid, is concentrated into the extracting solution quality and is the 1-2 of drug quality doubly, it is 80% to containing the alcohol amount that concentrated solution adds ethanol, and hold over night is filtered, Recycled ethanol, water bath method, drying obtains dried cream; Dried cream is dissolved in water, and upper AB-8 macroporous adsorbent resin is used first distilled water flush away impurity, then carry out gradient elution with ethanol, collect 10～30vol% ethanol part eluent, Recycled ethanol, water bath method, the dry Soluble Semen Raphani alkaloids that gets, content is more than 50%.
(3) Ramulus Uncariae Cum Uncis extract and the Semen Raphani extract mass ratio (being the mass ratio of 10:10) according to 1:1 is mixed, the adjuvant that adds survival dose, make tablet, capsule, granule, mixture or pill, Ramulus Uncariae Cum Uncis extract 82.5mg in the tablet, Semen Raphani extract 82.5mg.
Embodiment 4
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is that 10:3(is the mass ratio of 20:6), every middle Ramulus Uncariae Cum Uncis extract 127mg, Semen Raphani extract 38mg.
Embodiment 5
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is that 2:1(is the mass ratio of 20:10), every middle Ramulus Uncariae Cum Uncis extract 110mg, Semen Raphani extract 55mg.
Embodiment 6
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is that 3:2(is the mass ratio of 15:10), every middle Ramulus Uncariae Cum Uncis extract 99mg, Semen Raphani extract 66mg.
Embodiment 7
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is 5:3, every middle Ramulus Uncariae Cum Uncis extract 103mg, Semen Raphani extract 62mg.
Embodiment 8
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is 5:12, every middle Ramulus Uncariae Cum Uncis extract 68.3mg, Semen Raphani extract 96.7mg.
Embodiment 9
Adopt the method for embodiment 1 that this medicine is made tablet, different is that the mass ratio of Ramulus Uncariae Cum Uncis extract and Semen Raphani extract is 20:3, every middle Ramulus Uncariae Cum Uncis extract 143.2mg, Semen Raphani extract 21.8mg.
Take tablet as example, the medicine of above-described embodiment is carried out clinical experiment, its curative effect is as follows:
1, choose patient's 250 examples of suffering from 1 grade and 2 grades essential hypertension syndrome of upper hyperactivity of liver yang at this city, patient age between 30～68 years old, the course of disease between 1～20 year, 1 grade of person's 60 example of blood pressure level, 2 grades of person's 190 examples; The patient is equally divided into 5 groups, and each group has comparability at equal zero differences in aspect (p＜0.05) such as age, the course of disease and blood pressure level.
2, with the grouping the patient adopt respectively medicine of the present invention to treat, each 2, every day 3 times, warm water takes, and is used in conjunction a course for the treatment of, according to top clinical experiment according to observation index and efficacy assessment standard evaluate curative effect, its result is as follows.
The curative effect of other embodiment and embodiment 2,4,8,9 close, the proportioning of embodiment 1 is best to hypertensive therapeutic effect as can be known by data.
Claims (8)
1. treat hypertensive Chinese medicine composition for one kind, it is characterized in that effective ingredient is: Ramulus Uncariae Cum Uncis ethanol extract 5～20 mass parts, Semen Raphani water extract 3～12 mass parts, main effective ingredient is uncaria total alkaloids in the described Ramulus Uncariae Cum Uncis ethanol extract, uncaria total alkaloids content is more than 50%, main effective ingredient is Soluble Semen Raphani alkaloids in the described Semen Raphani water extract, and Soluble Semen Raphani alkaloids content is more than 50%.
2. Chinese medicine composition according to claim 1 is characterized in that effective ingredient comprises: Ramulus Uncariae Cum Uncis ethanol extract 10～20 mass parts, Semen Raphani water extract 6～12 mass parts.
3. Chinese medicine composition according to claim 1, it is characterized in that: effective ingredient comprises that mass ratio is Ramulus Uncariae Cum Uncis ethanol extract and the Semen Raphani water extract of 5:6.
4. Chinese medicine composition according to claim 1, it is characterized in that: dosage form is tablet, granule, capsule, mixture or pill.
5. the preparation method of the hypertensive Chinese medicine composition for the treatment of claimed in claim 1 is characterized in that may further comprise the steps:
A. adopt ethanol refluxing process to extract the Ramulus Uncariae Cum Uncis ethanol extract
(1) with Ramulus Uncariae Cum Uncis with ethanol extraction repeatedly, merge extractive liquid,, concentrating under reduced pressure ethanol gets concentrated solution;
(2) concentrated solution pH is reconciled to 9～10, then extremely colourless with chloroform extraction, the chloroform extraction liquid of merging gained boils off chloroform and gets dry extract;
(3) dried cream dilute hydrochloric acid ultrasonic dissolution, then sucking filtration is got filtrate, and filtrate is used the chloroform defat, the water intaking phase;
(4) water is reconciled pH to 9～10, and then with chloroform extraction repeatedly, combining extraction liquid is washed to neutrality with extract, then except anhydrating, boil off chloroform, gets the Ramulus Uncariae Cum Uncis ethanol extract;
B. adopt the decocting cooking method to extract the Semen Raphani water extract
(1) the Semen Raphani water is decocted repeatedly merge extractive liquid;
(2) extracting solution is concentrated, adding ethanol to pure content is 80vol%, and hold over night is filtered, and supernatant evaporate to dryness ethanol is got dry extract;
(3) with dried cream water dissolution, upper AB-8 absorption with macroporous adsorbent resin then with the distilled water eluting, carry out gradient elution with ethanol again, is collected the ethanol part eluent of 10～30vol%;
(4) with eluent evaporate to dryness ethanol, get the Semen Raphani water extract;
C. Ramulus Uncariae Cum Uncis alcohol extract and the Semen Raphani water extract that makes mixed by proportioning, add the adjuvant of survival dose, make.
6. preparation method according to claim 5 is characterized in that: when extracting the Ramulus Uncariae Cum Uncis ethanol extract, the volumetric concentration of ethanol is 70～80%, consumption be Ramulus Uncariae Cum Uncis 8～12 quality doubly, extract 2h at every turn; The quality of concentrated solution is 1～2 times of drug quality.
7. preparation method according to claim 5, it is characterized in that: the concentration of dilute hydrochloric acid is 1～5wt%.
8. preparation method according to claim 5 is characterized in that: when extracting the Semen Raphani water extract, the consumption of water be Semen Raphani 8～12 quality doubly, extract 1.5h at every turn; Extracting solution is concentrated into 1～2 times of drug quality.
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| CN103948909A (en) * | 2014-05-29 | 2014-07-30 | 张军 | Traditional Chinese medicine preparation for lowering blood pressure |
| CN104256576B (en) * | 2014-07-04 | 2017-03-22 | 武汉哈福科技有限公司 | Functional food capable of regulating blood pressure |
| CN105535924A (en) * | 2016-01-13 | 2016-05-04 | 安徽生物肽产业研究院有限公司 | Compound lumbricus small peptide composition for treating cardiovascular diseases |
| CN106138514A (en) * | 2016-08-02 | 2016-11-23 | 山东中医药大学附属医院 | A kind of Chinese medicine composition treating intermingled phlegm and blood stasis type hypertension and preparation method thereof |
| CN112741832A (en) * | 2021-03-04 | 2021-05-04 | 山东中医药大学 | Antihypertensive pharmaceutical composition and preparation method and application thereof |
| CN114010699B (en) * | 2021-12-22 | 2023-04-28 | 山东中医药大学 | Traditional Chinese medicine composition for treating hypertension and preparation method thereof |
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| CN101757569A (en) * | 2010-01-19 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating cerebral thrombosis and cerebral infarction and preparation method thereof |
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| CN101757569A (en) * | 2010-01-19 | 2010-06-30 | 泰一和浦（北京）中医药研究院有限公司 | Traditional Chinese medicine composition for treating cerebral thrombosis and cerebral infarction and preparation method thereof |
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