CN102475780B - Preparation method for traditional Chinese drug composition for treating primary hypertension - Google Patents
Preparation method for traditional Chinese drug composition for treating primary hypertension Download PDFInfo
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- CN102475780B CN102475780B CN201010564324.XA CN201010564324A CN102475780B CN 102475780 B CN102475780 B CN 102475780B CN 201010564324 A CN201010564324 A CN 201010564324A CN 102475780 B CN102475780 B CN 102475780B
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Abstract
The invention relates to a preparation method for a traditional Chinese drug composition for treating primary hypertension. The composition is prepared by the following preparation method: adding rhubarb (stir-fried with wine) and curcuma to water, soaking, heating until the water is boiled, extracting and filtering, adding water to the resulting drug residue to carry out extraction, filtering, removing the drug residue, and mixing the extracting solutions from the two extraction treatments to obtain an extracting solution 1; adding uncaria tomentosa, obtuseleaf senna seed, and common motherwort fruit to ethanol, soaking, heating until the water is boiled, extracting and filtering, adding ethanol to the resulting drug residue to carry out extraction, filtering, removing the drug residue, and mixing the extracting solutions from the two extraction treatments to obtain an extracting solution 2; adding common selfheal spike, lumbricus, and red monas rice to water, soaking, heating until the water is boiled, extracting and filtering, adding water to the resulting drug residue to carry out decoction, filtering, removing the drug residue, and mixing the extracting solutions from the two extraction treatments, carrying out vacuum concentration to obtain a concentrated solution, cooling to the room temperature, adding an alcohol to carry out alcohol precipitation, standing and filtering, removing the precipitation, concentrating the filtrate to obtain the extracting solution 3; mixing the extracting solution 1, the extracting solution 2 and the extracting solution 3, concentrating the resulting mixture until the fluid extract or the dry powder is obtained.
Description
Technical field
The present invention relates to a kind of field of medicaments, especially relate to a kind of Chinese medicine composition for the treatment of essential hypertension and preparation method thereof.
background technology
The modern civilization diseases that the metabolism syndrome of take is representative, closely related with some modern life style, custom etc.Be the high risk factor of type 2 diabetes mellitus and cardiovascular disease, early diagnosis and early intervention metabolism syndrome, contribute to the control of type 2 diabetes mellitus and cardiovascular disease.
The definition of metabolism syndrome be take central obesity as core, merges blood pressure, blood glucose, triglyceride rising and/or HDL-C and reduces.Wherein relevant central obesity is adopted waistline as diagnosis index.
Hypertension is to take systemic arterial pressure to increase the clinical syndrome as main manifestations, it is modal cardiovascular disease, can be divided into essential hypertension and the large class of secondary hypertension two, most hypertension pathogenies are not clear, are called essential hypertension, account for total hypertensive more than 95%, in the patient of less than 5%, hypertension is a kind of clinical manifestation of some disease, and this,, in the clear and definite and independently cause of disease, is called secondary hypertension.
In hypertension prevention and control, exist " three-hypers ", " three is low " phenomenon, three-hypers is that hypertensive sickness rate is high, rate of increase is high, hazardness is high, in China, hypertensive high harm is apoplexy, is secondly heart infarction, renal damage; Three low be that hypertensive awareness is low, treatment rate is low, control rate is low.Within 04 year, announce generaI investigation and show, hypertensive awareness is 30.3%, treatment rate 24.7%, control rate 6.1%.Illustrate that people are to hypertension and hypertensive recognizing dangers wretched insufficiency.
The essential hypertension Chinese patent medicine that antimetabolic syndrome in the market causes is few, and existing medicine a bit belongs to and cures the symptoms, not the disease, and some uses expensive composition, some in application process because uncertain therapeutic efficacy is cut and is interrupted using.
The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.
summary of the invention
The object of the present invention is to provide a kind of Chinese medicine composition for the treatment of essential hypertension.
Another object of the present invention is to provide the preparation method of described Chinese medicine composition.
Compositions of the present invention, by the Raw material processing of following weight parts, made:
Radix et Rhizoma Rhei (stir-fried with wine) 3-12 part prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 7.5-30 part Semen Cassiae 15-60 part
Ramulus Uncariae Cum Uncis 15-60 part Fructus Leonuri 15-60 part Spica Prunellae 22.5-90 part
Pheretima 15-60 part Monas cuspurpureus Went 3-12 part
Compositions of the present invention, preferably by the Raw material processing of following weight parts, made:
Radix et Rhizoma Rhei (stir-fried with wine) 5-7 part prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 10-20 part Semen Cassiae 20-40 part
Ramulus Uncariae Cum Uncis 20-40 part Fructus Leonuri 20-40 part Spica Prunellae 40-50 part
Pheretima 20-40 part Monas cuspurpureus Went 5-7 part
Compositions of the present invention, particularly preferably is by the Raw material processing of following weight parts and makes:
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
In more than forming, weight is calculated with crude drug, and part is weight portion, if in grams, above composition can be made into a pharmaceutical preparation 5-50 preparation unit, and described preparation unit refers to, the final drug preparation of making, as make solid preparation 5-50 unit, oral liquid 5-50ml etc.
More than form the preparation that can be made into 1-6 taking dose, as tablet, make 18, each taking dose can be 3-18 sheet, can take 1-6 time altogether.As granule, make 6 bags, each serving using 1-2 bag, can take 3-6 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production, can take kilogram is unit, Huo Yidunwei unit, small-scale production also can be take milligram as unit, weight can increase or reduce, but the constant rate of each raw medicinal herbs weight proportion between forming.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount can corresponding adjustment forming, increases or reduces being no more than 300%, and drug effect is constant.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming, also can be replaced by the suitable Chinese medicine with the identical property of medicine, and its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine composition of the present invention, is that the raw material of Chinese medicine by above-mentioned formula is formed is processed through extraction or other modes, makes pharmaceutically active substance, subsequently, take this material as raw material, while needing, add medicine acceptable carrier, according to the routine techniques of galenic pharmacy, make.Described active substance can obtain by extracting respectively raw material of Chinese medicine, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverizing, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the method such as ketone is carried, chromatography obtains, these active substances can be the material of extractum form, can be that dry extract can be also fluid extract, according to the difference of preparation, need to determine to make different concentration.
Pharmaceutically active substance in Chinese medicine composition of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical composition of the present invention, exists with unit dosage form, and described unit dosage form refers to the unit of preparation, as every of tablet, and every capsules of capsule, every bottle of oral liquid, every bag of granule etc.
Chinese medicine composition of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.
Chinese medicine composition of the present invention, the preparation of its oral administration can contain conventional excipient, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet if desired.
Applicable filler comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of suitable medicine comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are conventional is prepared solid oral composition.Repeatedly mix and can make active substance be distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid can be for example aqueous or oily suspensions, solution, Emulsion, syrup or elixir, or can be a kind of available water before use or the composite dry products of other suitable carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if need, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this compound can be suspended or dissolve.The preparation of solution is normally by active substance being dissolved in a kind of carrier, and filter-sterilized before being packed into a kind of suitable bottle or ampoule, then seals.Adjuvant for example a kind of local anesthetic, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after packing bottle into, this compositions is freezing, and under vacuum, water is removed.
Chinese medicine composition of the present invention, when being prepared into medicament, optionally add applicable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, EDETATE SODIUM, Ethylenediaminetetraacetic Acid Calcium Salt, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Compositions of the present invention is determined usage and dosage according to patient's situation in use, can take every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
The preparation method of the preferred present composition is as follows:
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 5～10 times of water soaking 0.5～1h, are heated to, after boiling, extract 1～3h, filter, and medicinal residues add 5～10 times of water extraction 1～3h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1.
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 5～10 times of 60～95% soak with ethanol 0.5～1h, are heated to, after boiling, extract 1～3h, filter, medicinal residues add 5～10 times of 60～95% ethanol extraction 1～3h, filter, medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2.
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 5～10 times of water soaking 0.5～1h, are heated to, after boiling, extract 1～3h, filter, medicinal residues add 5～10 times of decoctings and boil 1～3h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 60～90%, standing 12h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3.
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ are evaporated to fluid extract (density=1.2～1.4) or dry powder.
The active substance that above technique obtains mixes with medicine acceptable carrier, according to galenic pharmacy routine techniques, makes pharmaceutical preparations composition.
The most preferred preparation method of the present invention in an embodiment.
By following experiment, further illustrate the therapeutic effect of pharmaceutical composition of the present invention.
This experiment is the animal drug efficacy study carrying out for compound traditional Chinese medicine, and the animal model of employing is spontaneous hypertension rat model, and route of administration is oral administration gavage, and main observation index is mean arterial pressure (MBP).
Mean arterial pressure (MBP)=cardiac output (CO) * total peripheral vascular resistance (PR).
Experimental section mainly comprises dose-effect, the aging research of four kinds of Chinese medicine preparation blood pressure lowering.
One, materials and methods
(1) experiment material
1, tested material: comprise four kinds of Chinese medicine preparation (CT-1, CT-5, ZF-7, ZY-1), provided by Tianjin Tasly Institute Chinese medicine.Positive drug adopts irbesartan, and (Irbesartan Tablets, France produces, Hangzhou Sanofi-Aventis people's livelihood pharmaceutical Co. Ltd subpackage.Lot number of the repackaged products: 0906193. batch number: 1797. dates of manufacture: 2009.02).
2, laboratory animal: adopt spontaneous hypertension rat (SHR), matched group adopts capital of a country Wistar Kyoto rat (WKY).Purchased from Beijing Vital River Experimental Animals Technology Co., Ltd., the quality certification number: SCXK (capital) 2006-0009.
3, instrument: the non-invasive blood pressure instrument (CODA of U.S. Kent company
tM2).
(2) experimental technique
1. experiment grouping: totally six groups: model group, positive drug group, A, B, C, tetra-administration groups of D.Each group is SHR rat, and every group of 6-8 only.
2. dosage design: each kind dosage all calculates according to crude drug amount, obtains following dosage every day.
The design of table 1 dosage
| Group | Sample number into spectrum | Every day is to crude drug amount | Every day is to medicated powder amount | Administration every day | Administration volume |
| A | CT-1 | 39.68g/kg | 3.0g/kg | 2 times | 1ml/100g |
| B | CT-5 | 39.68g/kg | 3.6g/kg | 2 times | 1ml/100g |
| C | ZF-7 | 39.68g/kg | 2.0g/kg | 2 times | 1ml/100g |
| D | ZY-1 | 39.68g/kg | 2.8g/kg | 2 times | 1ml/100g |
| Positive group | Irbesartan | 15.5mg/kg | 1 time | 1ml/100g |
[0057]
| Model group | Tap water | 1ml/100g |
3, timeliness experiment: animal arrives after laboratory, raises one week in advance, measures basic blood pressure (basic blood pressure need to be measured 1-2 week, guarantees that animal has adapted to instrument, and the blood pressure measuring is true value).According to basic blood pressure random packet.Fasting after grouping, gastric infusion, the animal blood pressure of 0h, 12h, 24h after METHOD FOR CONTINUOUS DETERMINATION administration.Animal starts to carry out long term administration experiment next day after detecting.
4, long-term experiment scheme: animal finishes after single-dose experiment, starts long-term experiment next day, every day gastric infusion, successive administration one month.Measure weekly blood pressure once during this time.And grasp the time, guarantee that animal measuring substantially at the same time, avoid in the daytime the impact of self fluctuation of blood pressure.Because animal is more, guarantee that consistent (due to twice administration every day, the animal detecting afternoon is just given medicine for the first time in the morning, pulls open delivery time for the time point that detects after every animals administer.The animal that detect the morning, gives medicine for the first time again after having surveyed.Guarantee that animal does not pass through fierce struggle before tested).Administration stops administration after one month, after observation drug withdrawal, in convalescent period, the fluctuation situation of blood pressure, detects weekly twice, continues 2-3 week (depending on concrete blood pressure situation).
(3) observation index
1, MAIN OUTCOME MEASURES: blood pressure, comprises systolic pressure, diastolic pressure, mean arterial pressure.
2, other: body weight, heart rate, blood biochemical.
Two, experimental result
1, timeliness experiment
According to experimental result, after single-dose, the blood pressure of each administration group all has certain downward trend.But and model group does not more all have significance to reduce.Heart rate is not found significant change.The results are shown in Table 2,3,4,5
Mean arterial pressure timeliness experiment after table 2 single-dose.mean±SD
Note: and model group comparison in the same time:
* *: p < 0.001
The variation of mean arterial pressure after Fig. 1 single-dose
The time-effect relationship table that the after-contraction of table 3 single-dose is pressed.mean±SD
Note: and model group comparison in the same time:
* *: p < 0.001
The variation that the after-contraction of Fig. 2 single-dose is pressed
The timeliness data of diastolic pressure after table 4 single-dose.mean±SD
Note: and model group comparison in the same time:
* *: p < 0.001
The variation of heart rate after table 5 single-dose.mean±SD
Note: and model group comparison in the same time:
* *: p < 0.001
2, the mean arterial pressure of long term administration experiment changes
According to experimental result, in successive administration one month, the mean arterial pressure that observes weekly each administration group all has certain fluctuation.Administration more all has significance to the mean arterial pressure of each medicine group of surrounding and model group after two weeks and reduces (p < 0.05).The results are shown in Table 3.
The impact of table 6 long term administration on each treated animal mean arterial pressure.mean±SD
Note: and model group comparison in the same time:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
The variation of a monthly average arterial pressure of Fig. 3 administration.
3, the systolic pressure of long term administration experiment changes
According to experimental result, in successive administration one month, the systolic pressure that observes weekly each administration group all has certain fluctuation.Administration more all has significance to the systolic pressure of each medicine group of surrounding and model group after two weeks and reduces (p < 0.05).The results are shown in Table 4.
The impact of table 7 long term administration on each treated animal systolic pressure.mean±SD
Note: and model group comparison in the same time:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
The variation that Fig. 4 administration after-contraction in month is pressed.
4, the diastolic pressure of long term administration experiment changes
According to experimental result, in successive administration one month, the diastolic pressure that observes weekly each administration group all has certain fluctuation.Administration more all has significance to the diastolic pressure of each medicine group of surrounding and model group after two weeks and reduces (p < 0.05).The results are shown in Table 5.
The impact of table 8 long term administration on each treated animal diastolic pressure.mean±SD
Note: and model group comparison in the same time:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
The variation of Fig. 5 administration diastolic pressure after month
5, the changes in heart rate of long term administration experiment
The heart rate of each treated animal all, within normal range, the results are shown in Table 6.
The heart rate impact of table 9 long term administration blood pressure lowering experiment.mean±SD
Note: and model group comparison in the same time:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
6, body weight change during administration.
Each group of spontaneous hypertension rat, a month body weight amount of increase of administration is not very large, increasess slowly.
The impact of table 10 long term administration on each treated animal body weight.mean±SD
Note: and model group comparison in the same time:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
A month the weight of animals of Fig. 6 administration changes
7, administration is after one month, and the blood biochemical of animal changes.
After administration one month, the blood glucose value of each treated animal does not have significant difference.Between each group of ALT, also there is no significant difference, the ALT of CT-1 group has significant reduction (p < 0.05), belongs within the scope of normal physiological.The detection discovery of AST, the AST of positive drug group compares with model group, obviously increases (p < 0.05).The AST of CT-1, CT-5 group compares with model group, significantly reduces (p < 0.05).The testing result of TP (total serum protein) shows, removes ZY-1 group, and the total protein of other each groups is compared with model group, all has and decline significantly (p < 0.001).Sero-abluminous detection discovery, each administration treated animal is compared with model group, and albumin is significantly decline (p < 0.01) all.
Lipids detection, administration one month, the triglyceride of CT-1, CT-5 group, and model more all has reduction (p < 0.01) very significantly.After administration one month, T-CHOL value and the model group of ZY-1 group significantly increase (p < 0.01).But all the other each administration group and model group comparisons, T-CHOL all reduces (p < 0.01) very significantly
Prompting medicine has certain regulating action to Proteometabolism and lipid metabolism.
Table 11 administration is after one month, and the blood biochemical of animal changes (mean ± SD).
Note: and model group comparison:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
Table 12 administration is after one month, and the blood biochemical of animal changes (mean ± SD).
Note: and model group comparison:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
8, convalescent period animal blood pressure testing result
After administration one month, through drug withdrawal one week, positive drug was compared with model group with the systolic pressure of ZF-7 group, still had significance to reduce (p < 0.05), and reduction value > 20mmHg.
After drug withdrawal two weeks, systolic pressure, diastolic pressure and the mean arterial pressure of positive drug, ZF-7 and ZY-1 group, compare with model group, still has significance to reduce (p < 0.05), but reduction value < 20mmHg, does not have biological significance.
After drug withdrawal three weeks, each administration group is compared with model group, does not all have significant difference.
Table 13 administration is after one month, through over recovery one week, and the body weight blood pressure (mean ± SD) of animal.
Note: and model group comparison:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
Table 14 administration is after one month, through over recovery two weeks, and the body weight blood pressure (mean ± SD) of animal.
Note: and model group comparison:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
Table 15 administration is after one month, through over recovery three weeks, and the body weight blood pressure (mean ± SD) of animal.
Note: and model group comparison:
*: p < 0.05;
*: p < 0.01;
* *: p < 0.001
Compositions in the cited all embodiment of the present invention has the essentially identical effect of same embodiment 1-4.
Compositions of the present invention has function and cures mainly: dampness eliminating to alleviate water retention, suppressing the hyperactive liver and subsiding YANG.Be used for the treatment of the diseases such as essential hypertension that metabolism syndrome causes.Composition stable of the present invention is good, few side effects, long shelf-life, the feature such as therapeutic effect is remarkable.Meanwhile, preparation method of the present invention is simple, is applicable to production, and extraction ratio is high; In this invention, composition prescription is conventional Chinese medicine, avoids the use of rare Chinese medicine and animal drugs, has reduced production cost, benefits extensive patients, is applicable to promoting.
Accompanying drawing explanation
The variation of mean arterial pressure after Fig. 1 single-dose
The variation that the after-contraction of Fig. 2 single-dose is pressed
The variation of a monthly average arterial pressure of Fig. 3 administration.
The variation that Fig. 4 administration after-contraction in month is pressed.
The variation of Fig. 5 administration diastolic pressure after month
A month the weight of animals of Fig. 6 administration changes
The specific embodiment:
By specific embodiment below, being only to explain content of the present invention, is not the further restriction to protection domain of the present invention.
Embodiment 1, pharmaceutical composition of the present invention (CT-1)
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
The independent cold water soak of Ramulus Uncariae Cum Uncis (150mL/ prescription), all the other flavour of a drug add cold water soak 20min (700mL/ prescription), are heated to after boiling slow fire boiling 20min.Medical material and decoction liquor and Ramulus Uncariae Cum Uncis and soak thereof merge, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60～65 ℃ are evaporated to dry.
Embodiment 2, pharmaceutical composition of the present invention (CT-5)
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
Full side adds 8 times of water soaking 0.5h, is heated to, after boiling, extract 1h, filter, medicinal residues add 7 times of decoctings and boil 1h, filter, medicinal residues discard, and extracted twice liquid is merged, and 60～65 ℃ are evaporated to D60=1.05-1.10, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant containing alcohol 70%, standing 12h, filter, precipitation discards, and 60～65 ℃ of filtrates are evaporated to dry.
The active substance that above technique obtains mixes with medicine acceptable carrier, according to galenic pharmacy routine techniques, makes.
Embodiment 3 pharmaceutical composition of the present invention (ZY-1)
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
Radix et Rhizoma Rhei (stir-fried with wine) adds the 50% ethanol extraction 1h of 8 times, filters, and medicinal residues add the 50% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid,, 60～65 ℃ of 4 times of volumes that are evaporated to medical material, are diluted with water to 15 times of volumes of medical material, standing 12h, centrifuging and taking supernatant, D101 purification (medical material amount 1.5 times), loading, washing (5 column volumes), 80% ethanol elution (7 column volumes), 60～65 ℃ of eluents are evaporated to dry.
Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice adds the 70% ethanol extraction 1h of 8 times, filters, and medicinal residues add the 70% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid,, 60～65 ℃ of 3 times of volumes that are evaporated to medical material, be cooled to after room temperature, add concentrated hydrochloric acid and regulate pH to 1.5, the standing 12h of cold preservation, filters, filtrate discards, and gets precipitation part and is drying to obtain.
All the other flavour of a drug except Radix et Rhizoma Rhei (stir-fried with wine) and prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice, add 8 times of water soaking 0.5h, are heated to, after boiling, extract 1h, filter, medicinal residues add 7 times of decoctings and boil 1h, filter, medicinal residues discard, and extracted twice liquid is merged, and 60～65 ℃ are evaporated to D60=1.05-1.10, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant containing alcohol 70%, standing 12h, filter, precipitation discards, and 60～65 ℃ of filtrates are evaporated to dry.
In prescription ratio, by above-mentioned three kinds of dry powder blend.
Embodiment 4 pharmaceutical composition of the present invention (ZF-7)
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
Radix et Rhizoma Rhei (stir-fried with wine) and Semen Cassiae add the 50% ethanol extraction 1h of 8 times, filter, and medicinal residues add the 50% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid,, 60～65 ℃ of 4 times of volumes that are evaporated to medical material, are diluted with water to 15 times of volumes of medical material, standing 12h, centrifuging and taking supernatant, D101 purification (medical material amount 1.7 times), loading, washing (5 column volumes), 80% ethanol elution (16 column volumes), 60～65 ℃ of eluents are evaporated to dry.
Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice adds the 70% ethanol extraction 1h of 8 times, filters, and medicinal residues add the 70% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid,, 60～65 ℃ of 3 times of volumes that are evaporated to medical material, be cooled to after room temperature, add concentrated hydrochloric acid and regulate pH to 1.5, the standing 12h of cold preservation, filters, filtrate discards, and gets precipitation part and is drying to obtain.
Spica Prunellae adds 13 times of water soaking 0.5h, is heated to, after boiling, extract 1h, filter, medicinal residues add 13 times of decoctings and boil 1h, filter, medicinal residues discard, extracted twice liquid is merged, be cooled to after room temperature, D101 purification (medical material 1.5 times), loading, washing (5 column volumes), 80% ethanol elution (medical material 15 times), 60～65 ℃ of eluents are evaporated to dry.
Ramulus Uncariae Cum Uncis and Fructus Leonuri add 9 times of water soaking 0.5h, are heated to, after boiling, extract 1h, filter, medicinal residues add 9 times of decoctings and boil 1h, filter, medicinal residues discard, extracted twice liquid is merged, be cooled to after room temperature, D101 purification (medical material 1.5 times), loading, washing (5 column volumes), 80% ethanol elution (medical material 15 times), 60～65 ℃ of eluents are evaporated to dry.
Pheretima and Monas cuspurpureus Went add 8 times of water soaking 0.5h, are heated to, after boiling, extract 1h, filter, medicinal residues add 7 times of decoctings and boil 1h, filter, medicinal residues discard, and extracted twice liquid is merged, and 60～65 ℃ are evaporated to D60=1.05-1.10, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant containing alcohol 70%, standing 12h, filter, precipitation discards, and 60～65 ℃ of filtrates are evaporated to dry.
In prescription ratio, by above-mentioned five kinds of dry powder blend.
Embodiment 5 pharmaceutical composition of the present invention
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 8 times of water soaking 1h, are heated to, after boiling, extract 2h, filter, and medicinal residues add 8 times of water extraction 2h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1.
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 8 times of 80% soak with ethanol 1h, are heated to, after boiling, extract 2h, filter, and medicinal residues add 8 times of 80% ethanol extraction 2h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2.
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 8 times of water soaking 1h, are heated to, after boiling, extract 2h, filter, medicinal residues add 8 times of decoctings and boil 2h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 80-95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 60～90%, standing 12-24h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3.
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ are evaporated to fluid extract (density=1.2～1.4) or dry powder.
Or
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 5 times of water soaking 0.5h, are heated to, after boiling, extract 1h, filter, and medicinal residues add 5 times of water extraction 1h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1.
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 5 times of 60% soak with ethanol 0.5h, are heated to, after boiling, extract 1h, filter, and medicinal residues add 5 times of 60% ethanol extraction 1h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2.
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 5 times of water soaking 0.5h, are heated to, after boiling, extract 1h, filter, medicinal residues add 5 times of decoctings and boil 1h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 60%, standing 12h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3.
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ are evaporated to fluid extract (density=1.2～1.4) or dry powder.
Or
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 10 times of water soaking 1h, are heated to, after boiling, extract 3h, filter, and medicinal residues add 10 times of water extraction 3h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1.
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 10 times of 95% soak with ethanol 1h, are heated to, after boiling, extract 3h, filter, and medicinal residues add 10 times of 95% ethanol extraction 3h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2.
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 10 times of water soaking 1h, are heated to, after boiling, extract 3h, filter, medicinal residues add 10 times of decoctings and boil 3h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 90%, standing 24h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3.
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ are evaporated to fluid extract (density=1.2～1.4) or dry powder.
Embodiment 6, granule
Get 100 parts of any one pharmaceutically active substances of embodiment 1-5, add the dextrin of 1.5 times of amounts, 0.5% sucrose, 1.5% microcrystalline Cellulose, makes soft material with appropriate dissolve with ethanol, granulates, and 60 ℃ of forced air dryings, granulate, and granulate, obtains granule.
Embodiment 7, drop pill
Get 100 parts of any one pharmaceutically active substances of embodiment 1-5, add the Polyethylene Glycol of 1000 parts, mix homogeneously, melting, upper pill dripping machine, makes drop pill.
Embodiment 8, oral cavity disintegration tablet
Get 100 parts of any one pharmaceutically active substances of embodiment 1-5, add 5% polyvinylpolypyrrolidone, 0.1% magnesium stearate, 50% microcrystalline Cellulose, with appropriate alcoholic solution, make soft material, granulate, 60 ℃ of forced air dryings, granulate, granulate, compacting in flakes, obtains oral cavity disintegration tablet.
Embodiment 9, injectable powder
Get 0.5 part of embodiment 1-5 any one pharmaceutically active substance, 4.5 parts of glucoses, 0.9 part, sodium thiosulfate and distilled water 1ml, after said components mix homogeneously, lyophilization, 500 of subpackages, obtain injectable powder.
Embodiment 10, capsule
Get 100 parts of embodiment 1-5 any one pharmaceutically active substances, add equivalent starch, sucrose and magnesium stearate, granulate, and incapsulates, and obtains capsule.
Embodiment 11, tablet
Get 100 parts of embodiment 1-5 any one pharmaceutically active substances, with starch, sodium carboxymethyl cellulose, Pulvis Talci mix homogeneously, granulate, and tabletting obtains tablet.
Embodiment 12, oral liquid
Get 2 parts of embodiment 1-5 any one pharmaceutically active substances, with 4 parts, syrup, be dissolved in the pure water of 100ml, homogenizing, filters, through high-temperature short-time sterilization (135 ℃, 4s).Sterile filling, subpackage, make oral liquid.
Embodiment 13, pharmaceutical composition of the present invention
15 parts of 7.5 parts of Semen Cassiaes of 3 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
22.5 parts of 15 parts of Spica Prunellaes of 15 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
3 parts, 15 parts of Monas cuspurpureus Went of Pheretima
The independent cold water soak of Ramulus Uncariae Cum Uncis (150mL/ prescription), all the other flavour of a drug add cold water soak 20min (700mL/ prescription), are heated to after boiling slow fire boiling 20min.Medical material and decoction liquor and Ramulus Uncariae Cum Uncis and soak thereof merge, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, 60～65 ℃ of concentrating under reduced pressure as for.
Embodiment 14, pharmaceutical composition of the present invention
60 parts of 30 parts of Semen Cassiaes of 12 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
90 parts of 60 parts of Spica Prunellaes of 60 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
12 parts, 60 parts of Monas cuspurpureus Went of Pheretima
The independent cold water soak of Ramulus Uncariae Cum Uncis (150mL/ prescription), all the other flavour of a drug add cold water soak 20min (700mL/ prescription), are heated to after boiling slow fire boiling 20min.Medical material and decoction liquor and Ramulus Uncariae Cum Uncis and soak thereof merge, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60～65 ℃ are evaporated to dry.
Embodiment 15, pharmaceutical composition of the present invention
20 parts of 10 parts of Semen Cassiaes of 5 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
40 parts of 20 parts of Spica Prunellaes of 20 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
5 parts, 20 parts of Monas cuspurpureus Went of Pheretima
The independent cold water soak of Ramulus Uncariae Cum Uncis (150mL/ prescription), all the other flavour of a drug add cold water soak 20min (700mL/ prescription), are heated to after boiling slow fire boiling 20min.Medical material and decoction liquor and Ramulus Uncariae Cum Uncis and soak thereof merge, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60～65 ℃ are evaporated to dry.
Embodiment 16, pharmaceutical composition of the present invention
40 parts of 20 parts of Semen Cassiaes of 7 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
50 parts of 40 parts of Spica Prunellaes of 40 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
7 parts, 40 parts of Monas cuspurpureus Went of Pheretima
The independent cold water soak of Ramulus Uncariae Cum Uncis (150mL/ prescription), all the other flavour of a drug add cold water soak 20min (700mL/ prescription), are heated to after boiling slow fire boiling 20min.Medical material and decoction liquor and Ramulus Uncariae Cum Uncis and soak thereof merge, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60～65 ℃ are evaporated to dry.
The active substance that above different process obtains mixes with medicine acceptable carrier, according to galenic pharmacy routine techniques, makes pharmaceutical preparations composition; Group component in above-described embodiment can expand or reduce in scale according to need of production simultaneously.
Claims (6)
1. a preparation method for the treatment of the pharmaceutical composition of essential hypertension, is characterized in that, described compositions is processed into by the crude drug process of following weight portion:
Radix et Rhizoma Rhei (stir-fried with wine) 3-12 part prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 7.5-30 part Semen Cassiae 15-60 part
Ramulus Uncariae Cum Uncis 15-60 part Fructus Leonuri 15-60 part Spica Prunellae 22.5-90 part
Pheretima 15-60 part Monas cuspurpureus Went 3-12 part,
Described preparation method comprises the following steps:
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 5～10 times of water soaking 0.5～1h, are heated to, after boiling, extract 1～3h, filter, and medicinal residues add 5～10 times of water extraction 1～3h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1;
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 5～10 times of 60～95% soak with ethanol 0.5～1h, are heated to, after boiling, extract 1～3h, filter, medicinal residues add 5～10 times of 60～95% ethanol extraction 1～3h, filter, medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2;
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 5～10 times of water soaking 0.5～1h, are heated to, after boiling, extract 1～3h, filter, medicinal residues add 5～10 times of decoctings and boil 1～3h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to relative density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 80-95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 60～90%, standing 12-24h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3;
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ of fluid extract or dry powder that are evaporated to relative density=1.2～1.4, obtain active substance;
The active substance that above technique obtains mixes with medicine acceptable carrier, according to galenic pharmacy routine techniques, makes.
2. preparation method according to claim 1, is characterized in that, described compositions is processed into by the crude drug process of following weight portion:
Radix et Rhizoma Rhei (stir-fried with wine) 5-7 part prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 10-20 part Semen Cassiae 20-40 part
Ramulus Uncariae Cum Uncis 20-40 part Fructus Leonuri 20-40 part Spica Prunellae 40-50 part
Pheretima 20-40 part Monas cuspurpureus Went 5-7 part.
3. preparation method according to claim 2, is characterized in that, described compositions is processed into by the crude drug process of following weight portion:
30 parts of 15 parts of Semen Cassiaes of 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice of Radix et Rhizoma Rhei (stir-fried with wine)
45 parts of 30 parts of Spica Prunellaes of 30 parts of Fructus Leonuris of Ramulus Uncariae Cum Uncis
6 parts, 30 parts of Monas cuspurpureus Went of Pheretima.
4. according to any one preparation method described in claim 1-3, wherein said compositions is any pharmaceutically useful dosage form.
5. preparation method according to claim 4, wherein said compositions is peroral dosage form.
6. preparation method according to claim 1, is characterized in that, comprises the following steps:
Radix et Rhizoma Rhei (stir-fried with wine), prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice add 8 times of water soaking 1h, are heated to, after boiling, extract 2h, filter, and medicinal residues add 8 times of water extraction 2h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 1;
Ramulus Uncariae Cum Uncis, Semen Cassiae, Fructus Leonuri add 8 times of 80% soak with ethanol 1h, are heated to, after boiling, extract 2h, filter, and medicinal residues add 8 times of 80% ethanol extraction 2h, filter, and medicinal residues discard, and extracted twice liquid is merged, and obtain extracting solution 2;
Spica Prunellae, Pheretima, Monas cuspurpureus Went add 8 times of water soaking 1h, are heated to, after boiling, extract 2h, filter, medicinal residues add 8 times of decoctings and boil 2h, filter, and medicinal residues discard, extracted twice liquid is merged, and 55～65 ℃ are evaporated to relative density=1.05-1.20, obtain concentrated solution, be cooled to after room temperature, add 80-95% ethanol precipitate with ethanol, limit edged stirs, to supernatant, containing alcohol 60～90%, standing 12-24h, filters, precipitation discards, and 55～65 ℃ of concentrating under reduced pressure of filtrate, obtain extracting solution 3;
By extracting solution 1, extracting solution 2 and extracting solution 3 mix homogeneously, 55～65 ℃ of fluid extract or dry powder that are evaporated to relative density=1.2～1.4, obtain active substance;
The pharmaceutically active substance more than obtaining, this active substance mixes with medicine acceptable carrier, according to galenic pharmacy routine techniques, makes.
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| CN101579480B (en) * | 2008-05-15 | 2011-06-29 | 北京北大维信生物科技有限公司 | Medicinal dripping pill for treating hypertension |
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