CN102475785B - Preparation method of Chinese medicinal composition for treating essential hypertension - Google Patents
Preparation method of Chinese medicinal composition for treating essential hypertension Download PDFInfo
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- CN102475785B CN102475785B CN201010566577.0A CN201010566577A CN102475785B CN 102475785 B CN102475785 B CN 102475785B CN 201010566577 A CN201010566577 A CN 201010566577A CN 102475785 B CN102475785 B CN 102475785B
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Abstract
The invention relates to a preparation method of a Chinese medicinal composition for treating essential hypertension. The method is characterized in that the composition is prepared by processing the following bulk medicines by weight: 3-12 parts of rheum officinale; 7.5-30 parts of ginger-processed coptis; 15-60 parts of cassia seeds; 15-60 parts of uncaria rhynchophylla; 15-60 parts of motherwort fruits; 22.5-90 parts of prunella vulgaris; 15-60 parts of lumbricus; and 3-12 parts of red koji. The preparation method consists of the steps of: adding 5-10 times of 60-95% ethanol into the above total formula for immersion of 0.5-1h, heating the mixture to boiling, then conducting extraction for 1-3h as well as filtration, adding 5-10 times of 60-95% ethanol into a medicine residue, and carrying out extraction for 1-3h as well as filtration, removing the medicine residue, merging the two extracting solution, and performing pressure reduced concentration at a temperature of 55-65DEG C till obtaining a fluid extract or dry powder, finally mixing the obtained active substance with a pharmaceutically acceptable carrier according to a routine pharmaceutic technology.
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
Take metabolism syndrome as the modern civilization diseases of representative, closely related with the life style, custom etc. in some modern times.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 take central obesity as core, merges blood pressure, blood glucose, triglyceride raises and/or HDL-C reduces.Wherein relevant central obesity adopts waistline as diagnosis index.
Hypertension increases clinical syndrome for main manifestations with systemic arterial pressure, it is modal cardiovascular disease, essential hypertension and the large class of secondary hypertension two can be divided into, most hypertension pathogeny is failed to understand, is called essential hypertension, accounts for always hypertensive more than 95%, less than in the patient of 5%, it is a kind of clinical manifestation of some disease that blood pressure raises, and this, in the clear and definite and independently cause of disease, is called secondary hypertension.In hypertension prevention and control, there is " three-hypers ", " three is low " phenomenon, three-hypers is that hypertensive sickness rate is high, rate of increase is high, hazardness is high, and in China, hypertensive height 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 display, hypertensive awareness be 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 belongs to a bit cures the symptoms, not the disease, and some uses expensive composition, and some interrupts because uncertain therapeutic efficacy is cut using in application process.
The invention provides the pure traditional Chinese compound medicine that a kind of determined curative effect, safe ready, side effect are little, cheap.
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 the preparation method that described Chinese medicine composition is provided.
Compositions of the present invention, be made up of the Raw material processing of following weight parts:
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, be preferably made up of the Raw material processing of following weight parts:
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 and is made up of the Raw material processing of following weight parts:
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went
More than in composition, weight calculates 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 made, as made solid preparation 5-50 unit, oral liquid 5-50ml etc.
More than composition can be made into the preparation of 1-6 taking dose, and as tablet, make 18, each taking dose can be 3-18 sheet, can take 1-6 time altogether.As granule, making 6 bags, each serving using 1-2 bag, can take 3-6 time altogether.
More than composition is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as large-scale production can by kilogram in units of, or in units of ton, small-scale production also can in units of milligram, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion is through that science screening obtains, and for especial patient, as serious symptom or mild, fat or modest patient, can the proportioning of amount of corresponding adjustment composition, and increase or reduce being no more than 300%, drug effect is constant.
Single medicinal material more than in composition, especially ministerial drug and adjuvant drug, also can be replaced by the suitable Chinese medicine with the identical property of medicine, its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine composition of the present invention, being that the raw material of Chinese medicine by being formed by above-mentioned formula is processed through extraction or other modes, making pharmaceutically active substance, subsequently, with this material for raw material, when needing, add medicine acceptable carrier, make according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can be obtained by the common raw material of Chinese medicine that extracts, also can obtain by other means, as: by pulverizing, squeezing, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the material that method obtains, these active substances can be extractum form such as ketone is carried, chromatography, can be dry extract also can be fluid extract, need to determine to make different concentration according to the difference of preparation.
Pharmaceutically active substance in Chinese medicine composition of the present invention, its in the formulation shared percentage by weight can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical composition of the present invention, exists in a unit, and described unit dosage form refers to the unit of preparation, as every sheet of tablet, and every capsules of capsule, every bottle of oral liquid, granule every bag 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, preferably peroral dosage form, 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 containing conventional excipient, and 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.
The filler be suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycollate.Suitable lubricant comprises, such as magnesium stearate.The suitable acceptable wetting agent of medicine comprises sodium lauryl sulphate.
By mixing, fill, the method that tabletting etc. are conventional prepares solid oral composition.Repeatedly mix and active substance can be made to be distributed in those compositionss of a large amount of filler of whole use.
The form of oral liquid can be such as aqueous or oily suspensions, solution, Emulsion, syrup or elixir, or can be the composite dry products of a kind of available water before use or other suitable carrier.This liquid preparation can containing conventional additive, such as suspending agent, such as sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agent, such as lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), the oily ester of the such as ester of almond oil, fractionated coconut oil, such as glycerol, propylene glycol or ethanol; Antiseptic, such as para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if need, can containing conventional flavouring agent or coloring agent.
For injection, the fluid unit dosage form 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 being dissolved in a kind of carrier by active substance, filter-sterilized before being loaded a kind of suitable bottle or ampoule, then seals.Adjuvant such as a kind of local anesthetic, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, by freezing for this compositions after loading bottle, and under vacuo water can be removed.
Chinese medicine composition of the present invention, applicable medicine acceptable carrier is optionally added when being prepared into medicament, 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 its derivates, 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 according to the situation determination usage and dosage of patient, can take three every day in use, each 1-20 agent, as: 1-20 bag or grain or sheet.
The preparation method of the preferred present composition is as follows:
Full side adds 5-10 times of water soaking 0.5-1h, after being heated to boiling, extracts 1-3h, filter, medicinal residues add 5-10 times of soak by water 1-3h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 60-95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 50-70%, leaves standstill 12-24h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is evaporated to dry.
Or
Full side adds 5 ~ 10 times of 60 ~ 95% soak with ethanol 0.5 ~ 1h, after being heated to boiling, extract 1 ~ 3h, filter, medicinal residues add 5 ~ 10 times of 60 ~ 95% ethanol extraction 1 ~ 3h, and filter, medicinal residues discard, merged by extracted twice liquid, 55 ~ 65 DEG C are evaporated to fluid extract (density=1.2 ~ 1.4) or dry powder.
Or
Full side adds 5 ~ 10 times of water soaking 0.5 ~ 1h, after being heated to boiling, extracts 1 ~ 3h, filters, medicinal residues add 5 ~ 10 times of soak by water 1 ~ 3h, and filter, medicinal residues discard, merged by extracted twice liquid, 55 ~ 65 DEG C 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, makes pharmaceutical preparations composition according to galenic pharmacy routine techniques.
The most preferred preparation method of the present invention in an embodiment.
The therapeutic effect of pharmaceutical composition of the present invention is further illustrated by following experiment.
This experiment is the animal drug efficacy study carried 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 Kent company of the U.S.
tM2).
(2) experimental technique
1. experiment grouping: totally six groups: model group, positive drug group, A, B, C, D tetra-administration groups.Each group is SHR rat, only often organizes 6-8.
2. dose design: each kind dosage all according to raw medicine calculation, obtains following daily dosage.
Table 1 dose design
| Group | Sample number into spectrum | Every day is to crude drug amount | Daily powder amount | Daily | 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 |
| Model group | Tap water | 1ml/100g |
3, timeliness experiment: after animal arrives laboratory, pre-raising one week, measures basic blood pressure (basic blood pressure needs to measure 1-2 week, and guarantee that animal adapts to instrument, the blood pressure measured 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 after detecting next day.
4, long-term experiment scheme: animal finish single-dose experiment after, next day starts long-term experiment, every day gastric infusion, successive administration one month.Period measures weekly blood pressure once.And grasp the time, ensure that animal is measuring substantially at the same time, avoid the impact of self fluctuation of blood pressure in the daytime.Because animal is more, the time point detected after ensureing every animals administer is consistent, and (due to twice administration every day, the animal detected afternoon just gives medicine for the first time in the morning, pulls open delivery time.The animal that detect in the morning, gives medicine for the first time after having surveyed again.Ensure that animal does not pass through fierce struggle before tested).Administration stopped administration after one month, and after observation drug withdrawal in convalescent period, the fluctuation situation of blood pressure, detects twice weekly, 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
Experimentally result, after single-dose, the blood pressure of each administration group all has certain downward trend.But with model group does not more all have significance to reduce.Heart rate does not find 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: compare with model group in the same time: * * *: p < 0.001
The change of mean arterial pressure after Fig. 1 single-dose
The time-effect relationship table of table 3 single-dose after-contraction pressure.mean±SD
Note: compare with model group in the same time: * * *: p < 0.001
The change of Fig. 2 single-dose after-contraction pressure
The timeliness data of diastolic pressure after table 4 single-dose.mean±SD
Note: compare with model group in the same time: * * *: p < 0.001
The change of heart rate after table 5 single-dose.mean±SD
Note: compare with model group in the same time: * * *: p < 0.001
2, the mean arterial pressure change of long term administration experiment
Experimentally result, in successive administration one month, observes that weekly the mean arterial pressure of 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.
Table 6 long term administration is on the impact of each treated animal mean arterial pressure.mean±SD
Note: compare with model group in the same time: *: p < 0.05; *: p < 0.01; * *: p < 0.001
The change of Fig. 3 administration monthly average arterial pressure.
3, the systolic pressure change of long term administration experiment
Experimentally result, in successive administration one month, observes that weekly the systolic pressure of 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.
Table 7 long term administration is on the impact of each treated animal systolic pressure.mean±SD
Note: compare with model group in the same time: *: p < 0.05; *: p < 0.01; * *: p < 0.001
The change of Fig. 4 administration month after-contraction pressure.
4, the diastolic pressure change of long term administration experiment
Experimentally result, in successive administration one month, observes that weekly the diastolic pressure of 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.
Table 8 long term administration is on the impact of each treated animal diastolic pressure.mean±SD
Note: compare with model group in the same time: *: p < 0.05; *: p < 0.01; * *: p < 0.001
The change 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 influences of table 9 long term administration blood pressure lowering experiment.mean±SD
Note: compare with model group 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, an administration month body weight amount of increase is not very large, increasess slowly.
Table 10 long term administration is on the impact of each treated animal body weight.mean±SD
Note: compare with model group in the same time: *: p < 0.05; *: p < 0.01; * *: p < 0.001
Fig. 6 administration the weight of animals change in month
7, administration is after one month, the blood biochemical change of animal.
Administration is after one month, and the blood glucose value of each treated animal does not have significant difference.ALT does not have significant difference between respectively organizing yet, and the ALT of CT-1 group has significant reduction (p < 0.05), belongs in normal physiologic range.The detection of AST finds, 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, then significantly reduce (p < 0.05).The testing result of TP (total serum protein) shows, removing ZY-1 group, and other total proteins respectively organized are compared with model group, all have and decline (p < 0.001) significantly.Sero-abluminous detection finds, each administration treated animal is compared with model group, and albumin all significantly declines (p < 0.01).
Lipids detection, administration one month, the triglyceride of CT-1, CT-5 group, and model more all has reduction (p < 0.01) very significantly.Administration is after one month, and the T-CHOL value of ZY-1 group and model group significantly increase (p < 0.01).But all the other each administration groups and model group compare, T-CHOL reduces (p < 0.01) all 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: compare with model group: *: 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: compare with model group: *: p < 0.05; *: p < 0.01; * *: p < 0.001
8, convalescent period animal blood pressure detecting result
Administration is after one month, and through drug withdrawal one week, positive drug was compared with model group with the systolic pressure of ZF-7 group, still has significance to reduce (p < 0.05), and decreasing value > 20mmHg.
Drug withdrawal is after two weeks, the systolic pressure of positive drug, ZF-7 and ZY-1 group, diastolic pressure and mean arterial pressure, compare with model group, still has significance to reduce (p < 0.05), but decreasing value < 20mmHg, does not have biological significance.
Drug withdrawal is after three weeks, and 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: compare with model group: *: 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: compare with model group: *: 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: compare with model group: *: p < 0.05; *: p < 0.01; * *: p < 0.001
Compositions in all embodiments cited by the present invention has the substantially 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 the essential hypertension that metabolism syndrome causes.Compositions good stability of the present invention, few side effects, long shelf-life, the features such as therapeutic effect is remarkable.Meanwhile, preparation method of the present invention is simple, and be applicable to production, extraction ratio is high; In this invention, composition prescription is conventional Chinese medicine, avoids the use of rare Chinese medicine and animal drugs, reduces production cost, benefit extensive patients, is applicable to promoting.
Accompanying drawing explanation
The change of mean arterial pressure after Fig. 1 single-dose
The change of Fig. 2 single-dose after-contraction pressure
The change of Fig. 3 administration monthly average arterial pressure.
The change of Fig. 4 administration month after-contraction pressure.
The change of Fig. 5 administration diastolic pressure after month
Fig. 6 administration the weight of animals change in month
Detailed description of the invention:
Being only explain content of the present invention by specific embodiment below, is not the further restriction to scope.
Embodiment 1, pharmaceutical composition of the present invention (CT-1)
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went
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), after being heated to boiling, slow fire boiling 20min.Medical material and decoction liquor merge with Ramulus Uncariae Cum Uncis and soak thereof, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60 ~ 65 DEG C are evaporated to dry.
Embodiment 2, pharmaceutical composition of the present invention (CT-5)
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went
Full side adds 8 times of water soaking 0.5h, after being heated to boiling, extracts 1h, filter, medicinal residues add 7 times of soak by water 1h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 70%, leaves standstill 12h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is evaporated to dry.
Or
Full side adds 5 times of water soaking 0.5h, after being heated to boiling, extracts 1h, filter, medicinal residues add 5 times of soak by water 1h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 DEG C are evaporated to D60=1.05, obtain concentrated solution, after being cooled to room temperature, add 60% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 50%, leaves standstill 12h, filter, precipitation discards, and filtrate 60 DEG C is evaporated to dry.
Or
Full side adds 10 times of water soaking 1h, after being heated to boiling, extracts 3h, filter, medicinal residues add 10 times of soak by water 3h, filter, medicinal residues discard, and merged by extracted twice liquid, 65 DEG C are evaporated to D60=11.10, obtain concentrated solution, after being cooled to room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 70%, leaves standstill 24h, filter, precipitation discards, and filtrate 65 DEG C is evaporated to dry.
Or
Full side adds 5 times of 60% soak with ethanol 0.5h, and after being heated to boiling, extract 1h, filter, medicinal residues add 5 times of 60% ethanol extraction 1h, and filter, medicinal residues discard, and merged by extracted twice liquid, 55 DEG C are evaporated to fluid extract or dry powder,
Full side adds 10 times of 95% soak with ethanol 1h, after being heated to boiling, carries 3h, and filter, medicinal residues add 10 times of 95% ethanol extraction 3h, and filter, medicinal residues discard, and merged by extracted twice liquid, 65 DEG C are evaporated to fluid extract or dry powder,
Or
Full side adds 5 times of water soaking 0.5h, after being heated to boiling, extract 1h, filter, medicinal residues add 5 times of soak by water 1h, filter, medicinal residues discard, and merged by extracted twice liquid, 55 DEG C are evaporated to fluid extract (density=1.2) or dry powder, the active substance that above technique obtains mixes with medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
Or
Full side adds 10 times of water soaking 1h, after being heated to boiling, extract 3h, filter, medicinal residues add 10 times of soak by water 3h, filter, medicinal residues discard, and merged by extracted twice liquid, 65 DEG C are evaporated to fluid extract (density=1.4) or dry powder, the active substance that above technique obtains mixes with medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
Or
Full side adds 8 times of 95% soak with ethanol 0.5h, and after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of 95% ethanol extraction 1h, and filter, medicinal residues discard, and merged by extracted twice liquid, 65 DEG C are evaporated to fluid extract or dry powder,
Or
Full side adds 8 times of water soaking 0.5h, and after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of soak by water 1h, and filter, medicinal residues discard, and merged by extracted twice liquid, 55 ~ 65 DEG C are evaporated to fluid extract or dry powder,
Embodiment 3 pharmaceutical composition of the present invention (ZY-1)
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went
Radix et Rhizoma Rhei (stir-fried with wine) adds the 50% ethanol extraction 1h of 8 times, and filter, medicinal residues add the 50% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid, 60 ~ 65 DEG C of 4 times of volumes being evaporated to medical material, are diluted with water to 15 times of volumes of medical material, leave standstill 12h, centrifuging and taking supernatant, D101 purification (1.5 times of medical material amount), loading, washing (5 column volumes), 80% ethanol elution (7 column volumes), eluent 60 ~ 65 DEG C is evaporated to dry.
Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice adds the 70% ethanol extraction 1h of 8 times, and filter, medicinal residues add the 70% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid, 60 ~ 65 DEG C of 3 times of volumes being evaporated to medical material, after being cooled to room temperature, add concentrated hydrochloric acid and regulate pH to 1.5, cold preservation leaves standstill 12h, filters, filtrate discards, and gets sediment fraction 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, after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of soak by water 1h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 70%, leaves standstill 12h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is 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)
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went
Radix et Rhizoma Rhei (stir-fried with wine) and Semen Cassiae add the 50% ethanol extraction 1h of 8 times, and filter, medicinal residues add the 50% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid, 60 ~ 65 DEG C of 4 times of volumes being evaporated to medical material, are diluted with water to 15 times of volumes of medical material, leave standstill 12h, centrifuging and taking supernatant, D101 purification (1.7 times of medical material amount), loading, washing (5 column volumes), 80% ethanol elution (16 column volumes), eluent 60 ~ 65 DEG C is evaporated to dry.
Prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice adds the 70% ethanol extraction 1h of 8 times, and filter, medicinal residues add the 70% ethanol extraction 1h of 8 times, filter, medicinal residues discard, merge extractive liquid, 60 ~ 65 DEG C of 3 times of volumes being evaporated to medical material, after being cooled to room temperature, add concentrated hydrochloric acid and regulate pH to 1.5, cold preservation leaves standstill 12h, filters, filtrate discards, and gets sediment fraction and is drying to obtain.
Spica Prunellae adds 13 times of water soaking 0.5h, after being heated to boiling, extracts 1h, filter, medicinal residues add 13 times of soak by water 1h, filter, medicinal residues discard, extracted twice liquid is merged, after being cooled to room temperature, D101 purification (1.5 times of medical material), loading, washing (5 column volumes), 80% ethanol elution (15 times of medical material), eluent 60 ~ 65 DEG C is evaporated to dry.
Ramulus Uncariae Cum Uncis and Fructus Leonuri add 9 times of water soaking 0.5h, after being heated to boiling, extract 1h, filter, medicinal residues add 9 times of soak by water 1h, filter, medicinal residues discard, extracted twice liquid is merged, after being cooled to room temperature, D101 purification (1.5 times of medical material), loading, washing (5 column volumes), 80% ethanol elution (15 times of medical material), eluent 60 ~ 65 DEG C is evaporated to dry.
Pheretima and Monas cuspurpureus Went add 8 times of water soaking 0.5h, after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of soak by water 1h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 70%, leaves standstill 12h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is evaporated to dry.
In prescription ratio, by above-mentioned five kinds of dry powder blend.
Embodiment 5, granule
Any one pharmaceutically active substance of Example 1-5 100 parts, adds the dextrin of 1.5 times amount, 0.5% sucrose, 1.5% microcrystalline Cellulose, and dissolve by ethanol in proper amount and make soft material, granulate, 60 DEG C of forced air dryings, granulate, granulate, obtains granule.
Embodiment 6, drop pill
Any one pharmaceutically active substance of Example 1-5 100 parts, add the Polyethylene Glycol of 1000 parts, mix homogeneously, melting, upper pill dripping machine, makes drop pill.
Embodiment 7, oral cavity disintegration tablet
Any one pharmaceutically active substance of Example 1-5 100 parts, adds 5% polyvinylpolypyrrolidone, the magnesium stearate of 0.1%, the microcrystalline Cellulose of 50%, make soft material with ethanol in proper amount solution, granulate, 60 DEG C of forced air dryings, granulate, granulate, tabletted, obtains oral cavity disintegration tablet.
Embodiment 8, injectable powder
Example 1-5 any one pharmaceutically active substance 0.5 part, glucose 4.5 parts, 0.9 part, sodium thiosulfate and distilled water 1ml, after said components mix homogeneously, lyophilization, subpackage 500, obtains injectable powder.
Embodiment 9, capsule
Example 1-5 any one pharmaceutically active substance 100 parts, adds equivalent starch, sucrose and magnesium stearate, granulates, incapsulates, obtain capsule.
Embodiment 10, tablet
Example 1-5 any one pharmaceutically active substance 100 parts, with starch, sodium carboxymethyl cellulose, Pulvis Talci mix homogeneously, granulate, namely tabletting obtains tablet.
Embodiment 11, oral liquid
Example 1-5 any one pharmaceutically active substance 2 parts, with 4 parts, syrup, is dissolved in the pure water of 100ml, homogenizing, filters, through high-temperature short-time sterilization (135 DEG C, 4s).Sterile filling, subpackage, obtained oral liquid.
Embodiment 12, pharmaceutical composition of the present invention
Radix et Rhizoma Rhei (stir-fried with wine) 3 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 7.5 parts of Semen Cassiaes 15 parts
Ramulus Uncariae Cum Uncis 15 parts of Fructus Leonuris 15 parts of Spica Prunellaes 22.5 parts
3 parts, Pheretima 15 parts of Monas cuspurpureus Went
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), after being heated to boiling, slow fire boiling 20min.Medical material and decoction liquor merge with Ramulus Uncariae Cum Uncis and soak thereof, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60 ~ 65 DEG C are evaporated to dry.
Embodiment 13, pharmaceutical composition of the present invention
Radix et Rhizoma Rhei (stir-fried with wine) 12 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 30 parts of Semen Cassiaes 60 parts
Ramulus Uncariae Cum Uncis 60 parts of Fructus Leonuris 60 parts of Spica Prunellaes 90 parts
12 parts, Pheretima 60 parts of Monas cuspurpureus Went
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), after being heated to boiling, slow fire boiling 20min.Medical material and decoction liquor merge with Ramulus Uncariae Cum Uncis and soak thereof,
After intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60 ~ 65 DEG C are evaporated to dry.
Embodiment 14, pharmaceutical composition of the present invention
Radix et Rhizoma Rhei (stir-fried with wine) 5 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 10 parts of Semen Cassiaes 20 parts
Ramulus Uncariae Cum Uncis 20 parts of Fructus Leonuris 20 parts of Spica Prunellaes 40 parts
5 parts, Pheretima 20 parts of Monas cuspurpureus Went
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), after being heated to boiling, slow fire boiling 20min.Medical material and decoction liquor merge with Ramulus Uncariae Cum Uncis and soak thereof, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60 ~ 65 DEG C are evaporated to dry.
Embodiment 15, pharmaceutical composition of the present invention
Radix et Rhizoma Rhei (stir-fried with wine) 7 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 20 parts of Semen Cassiaes 40 parts
Ramulus Uncariae Cum Uncis 40 parts of Fructus Leonuris 40 parts of Spica Prunellaes 50 parts
7 parts, Pheretima 40 parts of Monas cuspurpureus Went
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), after being heated to boiling, slow fire boiling 20min.Medical material and decoction liquor merge with Ramulus Uncariae Cum Uncis and soak thereof, and after intense fire boils, slow fire boiling 5min, pours out medicinal liquid, and 60 ~ 65 DEG C are evaporated to dry.
The active substance that above different process obtains mixes with medicine acceptable carrier, makes pharmaceutical preparations composition according to galenic pharmacy routine techniques; Group component in above-described embodiment can expand or reduce in scale according to need of production simultaneously.
Claims (6)
1. be used for the treatment of a preparation method for the pharmaceutical composition of essential hypertension, it is characterized in that, described compositions is passed through by the crude drug of following weight portion and is processed into:
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:
Full side adds 5-10 times of water soaking 0.5-1h, after being heated to boiling, extracts 1-3h, filter, medicinal residues add 5-10 times of soak by water 1-3h, filter, medicinal residues discard, and merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 60-95% ethanol precipitate with ethanol, limit edged stirs, and to supernatant containing alcohol 50-70%, leaves standstill 12-24h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is evaporated to dry;
Or
Full side adds 5 ~ 10 times of 60 ~ 95% soak with ethanol 0.5 ~ 1h, after being heated to boiling, extracts 1 ~ 3h, filters, medicinal residues add 5 ~ 10 times of 60 ~ 95% ethanol extraction 1 ~ 3h, and filter, medicinal residues discard, merged by extracted twice liquid, 55 ~ 65 DEG C are evaporated to fluid extract or dry powder
Or
Full side adds 5 ~ 10 times of water soaking 0.5 ~ 1h, after being heated to boiling, extract 1 ~ 3h, filter, medicinal residues add 5 ~ 10 times of soak by water 1 ~ 3h, filter, medicinal residues discard, and are merged by extracted twice liquid, 55 ~ 65 DEG C of fluid extract or dry powder being evaporated to density=1.2 ~ 1.4, the active substance that above technique obtains mixes with medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
2. preparation method according to claim 1, is characterized in that, described compositions is passed through by the crude drug of following weight portion and is processed into:
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 passed through by the crude drug of following weight portion and is processed into:
Radix et Rhizoma Rhei (stir-fried with wine) 6 parts of prepared RHIZOMA COPTIDIS with rhizoma zingiberis recens juice 15 parts of Semen Cassiaes 30 parts
Ramulus Uncariae Cum Uncis 30 parts of Fructus Leonuris 30 parts of Spica Prunellaes 45 parts
6 parts, Pheretima 30 parts of Monas cuspurpureus Went.
4. any one preparation method according to claim 1-3, is characterized in that, described compositions is any pharmaceutically useful dosage form.
5. any one preparation method according to claim 1-3, is characterized in that, described compositions is peroral dosage form.
6. preparation method according to claim 1, is characterized in that, comprises the following steps:
Full side adds 8 times of water soaking 0.5h, after being heated to boiling, extracts 1h, filters, medicinal residues add 7 times of soak by water 1h, and filter, medicinal residues discard, merged by extracted twice liquid, 60 ~ 65 DEG C are evaporated to D60=1.05-1.10, obtain concentrated solution, after being cooled to room temperature, add 95% ethanol precipitate with ethanol, limit edged stirs, to supernatant containing alcohol 70%, leave standstill 12h, filter, precipitation discards, and filtrate 60 ~ 65 DEG C is evaporated to dry
Or
Full side adds 8 times of 95% soak with ethanol 0.5h, and after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of 95% ethanol extraction 1h, and filter, medicinal residues discard, and merged by extracted twice liquid, 65 DEG C are evaporated to fluid extract or dry powder,
Or
Full side adds 8 times of water soaking 0.5h, and after being heated to boiling, extract 1h, filter, medicinal residues add 7 times of soak by water 1h, and filter, medicinal residues discard, and merged by extracted twice liquid, 55 ~ 65 DEG C are evaporated to fluid extract or dry powder,
The pharmaceutically active substance more than obtained, this active substance mixes with medicine acceptable carrier, makes according to galenic pharmacy routine techniques.
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| CN1611234A (en) * | 2003-10-29 | 2005-05-04 | 齐娜 | Brain-quieting hypertension-treating medicine, and its preparing method and use |
| CN1657085A (en) * | 2004-09-06 | 2005-08-24 | 青岛国风药业股份有限公司 | Oral Chinese medicinal composition for treating hypertension |
| CN101579480A (en) * | 2008-05-15 | 2009-11-18 | 北京北大维信生物科技有限公司 | Medicinal dripping pill for treating hypertension |
| CN101693062A (en) * | 2009-10-13 | 2010-04-14 | 李隆基 | Health-care product for reducing pressure and sugar and eliminating fat |
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| US7258877B2 (en) * | 2001-12-21 | 2007-08-21 | Sunten Phytotech Co., Ltd. | Herbal pharmaceutical composition for treatment of cardiovascular disease |
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|---|---|---|---|---|
| CN1611234A (en) * | 2003-10-29 | 2005-05-04 | 齐娜 | Brain-quieting hypertension-treating medicine, and its preparing method and use |
| CN1657085A (en) * | 2004-09-06 | 2005-08-24 | 青岛国风药业股份有限公司 | Oral Chinese medicinal composition for treating hypertension |
| CN101579480A (en) * | 2008-05-15 | 2009-11-18 | 北京北大维信生物科技有限公司 | Medicinal dripping pill for treating hypertension |
| CN101693062A (en) * | 2009-10-13 | 2010-04-14 | 李隆基 | Health-care product for reducing pressure and sugar and eliminating fat |
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| 大黄、红曲配伍方案干预颈动脉粥样硬化斑块的临床研究;张莉;《中国优秀硕士学位论文全文数据库 医药卫生科技辑》;20091115(第11期);参见第23页 六、血压、空腹血糖水平比较项下，参见第3页 三、治疗方法项下，参见第32页第4段，第33页第2段 * |
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