CN100353968C - Chinese medicine preparation for nourishing blood and tranquilizing mind and its preparation process - Google Patents
Chinese medicine preparation for nourishing blood and tranquilizing mind and its preparation process Download PDFInfo
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Abstract
The present invention relates to Chinese medicine preparation with the functions of blood nourishing and tranquilization, particularly to capsule preparation and a preparation method thereof. In the preparation process, effective components are extracted from seven kinds of medicinal materials, such as vine of multiflower knotweed, milletol, prepared rehmannia root, rehmannia root, albizia bark, herba ecliptae, agrimony, etc. by using water as solvent; then ethanol with different concentration is used for removing impurities. The capsule preparation prepared by the method of the present invention has the characteristics of high biologic utilization and quick disintegration; simultaneously, the capsule preparation removes bad odor, and is convenient for patients, such as children, old people, etc. to take.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation with nourishing blood to tranquillize the mind effect, particularly capsule preparations and preparation method thereof.
Technical background:
The nourishing blood to tranquillize the mind preparation be by Caulis Polygoni Multiflori, Caulis Spatholobi, Radix Rehmanniae Preparata, Radix Rehmanniae, Cortex Albiziae, Herba Ecliptae, Herba Agrimoniae altogether seven flavor medicine be prepared into have a nourishing YIN and benefiting blood, the compound Chinese medicinal preparation of mind tranquilizing and the heart calming effect, to upper respiratory tract infection, tracheitis, pneumonia, diseases such as cough have definite curative effect, be used for tired mind, insomnia forgetfulness, the bedroom dreaminess of crouching, the soreness of waist of suffering from a deficiency of the kidney, the dizzy weak disease of waiting.The nourishing blood to tranquillize the mind preparation that has gone on the market at present mainly contains pill, syrup, tablet.These preparations, what the extraction process of its Chinese medicine adopted all is the decocting cooking method, concrete grammar be part or all of medical material through decocting, concentrate extractum, or add medicated powder again and make pill, syrup or tablet.
Because Radix Rehmanniae Preparata, Radix Rehmanniae contain a large amount of saccharides and phlegmatic temperament composition in the prescription, Cortex Albiziae, Herba Ecliptae etc. then contain tannin, these medical materials are through after the water boiling and extraction, impurity component wherein can both be dissolved in the medicine of a warm nature liquid that solvent is a water, saccharide, phlegmatic temperament and tannin still can be passed through during the heat filter, concentrate at last and obtain more heavy-gravity extractum, these impurity are just stayed in the extractum.The existence of these impurity can cause some side effect, makes product not reach higher quality.For syrup, because the cause of saccharide and tannin at its lay up period, certainly leads to precipitation or mycete; For pill or tablet, and saccharide, mucilaginous existence, the both very easily aborning easily microbiological contamination and molten loosing transfinite, thereby influence the quality of the pharmaceutical preparations.
The present invention is directed to the defective of traditional handicraft, improved technology, proposing with water is solvent extraction medical material effective ingredient, and the reuse Different concentrations of alcohol makes contamination precipitation and the method for removing.Played the effect of remove impurity.In addition, through comparative study, the present invention finds, adopts capsule formulation to have more advantage to preparation of the present invention, particularly can cover the bad smell of medical material, and patients such as convenient for children, old man take.Can improve medicine stability and not be heated cold influence.Non-hygroscopic moisture should be controlled; The bioavailability height, disintegrate is fast, takes the general 3-10min in back and discharges medicine with regard to disintegrate, can regularly discharge medicine, and in mixing incapsulated, 30min promptly reached peak concentration in the blood, and lasting curative effect reaches 11h.
Summary of the invention:
The invention provides a kind of nourishing blood to tranquillize the mind Chinese medicine preparation.
Nourishing blood to tranquillize the mind Chinese medicine preparation of the present invention, its prescription is composed as follows:
Caulis Polygoni Multiflori 30-180 part, Caulis Spatholobi 30-180 part, Radix Rehmanniae Preparata 30-180 part, Radix Rehmanniae 30-180 part, Cortex Albiziae 30-180 part, Herba Ecliptae 30-180 part, Herba Agrimoniae 120-200 part.
Preferred prescription is composed as follows:
100 parts of Caulis Polygoni Multiflori, 100 parts of Caulis Spatholobis, 100 parts of Radix Rehmanniae Preparata, 100 parts of Radix Rehmanniae, 100 parts of Cortex Albiziaes, 140 parts of Herba Ecliptaes, 160 parts of Herba Agrimoniaes.
In more than forming, the weight of medicine is calculated with crude drug, and this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1-2 time.
More than form, can be made into the preparation of 50-1000 taking dose,, make 1000, make 1000 of capsules as tablet, each taking dose can be the 1-20 sheet/or, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 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 be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
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 of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Raw material of Chinese medicine, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine.
The present invention also provides the preparation method of above-described pharmaceutically active substance, the present invention is directed to effective ingredient and impurity such as all water-soluble characteristics of polysaccharide, phlegmatic temperament and tannin in the prior art, proposes to prepare described pharmaceutically active substance with decoction and alcohol sedimentation technique.
Preparation method of the present invention is according to the different dissolubilities of various compositions in each medical material in water and ethanol.By water and Different concentrations of alcohol alternate treatment, keep iridoid glycoside, the dissociated anthraquinone glycoside, effective ingredient such as alkaloid, make contamination precipitation, remove by filter one by one then, i.e. elder generation's employing ethanol content is that the alcoholic solution of 50-60% is removed gelatinized starch, phlegmatic temperament and saccharide, and the alcoholic solution of reuse more than 75% removed tannin and all the other most of impurity.Caulis Polygoni Multiflori contains anthraquinone analog compound, mainly contain chrysophanol and emodin, the effective ingredient of Radix Rehmanniae is that iridoid glycosideses such as catalpol are water-soluble, so use earlier water-boiling method, increase along with decocting time and temperature, the continuous stripping of saccharide, phlegmatic temperament and tannin, easily stick with paste during decoction in other medical material surfaces, stop up the cell wall passage, hinder the stripping of other effective ingredient, thus the present invention with catalpol content as index, to Radix Rehmanniae Preparata, Radix Rehmanniae, the optimum process condition when seven flavor medicine materials such as Caulis Polygoni Multiflori decoct is jointly selected.
The preparation method of preferred active substance of the present invention is as follows: above seven flavor medicine material, cut into chunks, and decoct with water, collecting decoction filters concentrate under reduced pressure at low temperature.Add Different concentrations of alcohol at twice, fully stir, leave standstill, divide and get supernatant, sucking filtration merges, and concentrate under reduced pressure at low temperature gets clear paste, active substance promptly of the present invention.
The preparation method of most preferred active substance of the present invention is as follows: seven flavor medicine materials such as Caulis Polygoni Multiflori, Radix Rehmanniae Preparata, Radix Rehmanniae, the section of being ground into or piece, add 6-10 times of water, soak after 0.5-5 hour and decoct 1-3 time, each 2 hours, collecting decoction filters, and gets the clear paste that filtrate concentrate under reduced pressure at low temperature to relative density is 1.05～1.15 (50 ℃).Add the ethanol of 50-60% in the time of 40 ℃, stir, make medicinal liquid contain the alcohol amount and reach 50-60%, under 5-10 ℃, left standstill 6-8 hour.Divide and get supernatant, the ethanol that adds 75-90% again, stir, make medicinal liquid contain the alcohol amount and reach 75-90%, under 5-10 ℃, left standstill the siphon supernatant 8-12 hour, lower floor's magma is sucking filtration slowly again, merging filtrate, concentrate under reduced pressure at low temperature to relative density are the clear paste of 1.10～1.20 (50 ℃), active substance promptly of the present invention.
These active substances can be the materials of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 5-800mg, preferably 20-500mg.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation, preferably capsule.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of 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 desired, 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 chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, 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, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, micropowder silica gel, magnesium carbonate, calcium stearate, magnesium stearate etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys 1-4 time every day, each 1-20 agent, as: 1-20 grain or sheet.
Another object of the present invention is to provide a kind of preparation method of Chinese medicine preparation-capsule preparations of the present invention.Preferred manufacturing procedure is as follows: active substance of the present invention, and spray drying selects for use micropowder silica gel+dextrin to make fluidizer, magnesium carbonate is made diluent, granulates, and granulate adds adjuvant again, and the capsule method for making promptly can be made into capsule product of the present invention routinely.
Find when the present invention makes capsule that medicated powder is extractum spray drying gained in the capsule, during the fill capsule, usually occur the medicated powder flowability relatively poor, easily draw problems such as wet, method of double differences instability.It is done further research back finds the following aspects controlled and can overcome this problem: 1, adding micropowder silica gel in this preparation can increase the medicated powder flowability.2, add magnesium carbonate in this preparation and keep the cream dried bean noodles dry, if magnesium carbonate is excessive, then saturation is excessive, and the formation speed of nucleus and crystalline coarsening rate are also accelerated, and easily form crystallization.
When the present invention makes capsule, how to select for use proper supplementary material to make the flowability of capsule of the present invention and the weight differential can be up to specification, particularly can increase mobility of particle, and don't influence the maximum difficult point that its weight differential is this preparation.Below be selection experimental result to adjuvant:
| Fluidizer | Diluent | The result | |||
| Mobile | Weight differential | Moisture (%) | Disintegrate (min) | ||
| 3% modified starch | 10% microcrystalline Cellulose | Difference | Defective | 3.5 | 14 |
| 3% modified starch | 0.5% magnesium carbonate | Good | Qualified | 3.6 | 11 |
| 3% crospolyvinylpyrrolidone | 10% microcrystalline Cellulose | Difference | Defective | 7.0 | 15 |
| 3% crospolyvinylpyrrolidone | 0.5% magnesium carbonate | Better | Qualified | 5.8 | 13 |
| 3% crosslinked carboxymethylstach sodium | 10% microcrystalline Cellulose | Good | Defective | 5.6 | 16 |
| 3% crosslinked carboxymethylstach sodium | 0.5% magnesium carbonate | Better | Qualified | 4.8 | 11 |
| 3% micropowder silica gel+dextrin (4: 1) | 0.5% magnesium carbonate | Better | Qualified | 3.1 | 10 |
According to above experimental result, above fluidizer and diluent all can reach the prescription of capsule, after taking all factors into consideration, select for use micropowder silica gel+dextrin to make fluidizer, magnesium carbonate is made diluent, existing the supplementary product consumption of selecting for use are selected:
1, sees the following form with the factor level table
| Factor | Level | ||
| 1 | 2 | ||
| A | Micropowder silica gel+dextrin | 1％ | 4％ |
| B | A factor proportioning | 4∶1 | 1∶1 |
| C | Magnesium carbonate | 1％ | 0.75％ |
2, orthogonal experiment design table and result
| The experiment number | 1 A | 2 B | 3 A×B | 4 C | 5 | 6 | 7 | The result | Scoring |
| 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | Mobile poor, the method for double differences is defective | 66.75 |
| 2 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | Good fluidity, the method for double differences is qualified | 93.34 |
| 3 | 1 | 2 | 2 | 1 | 1 | 2 | 2 | Mobile poor, the method for double differences is qualified | 86.64 |
| 4 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | Good fluidity, the method for double differences is defective | 80.82 |
| 5 | 2 | 1 | 2 | 1 | 2 | 1 | 2 | Better mobile; The method of double differences is qualified | 84.27 |
| 6 | 2 | 1 | 2 | 2 | 1 | 2 | 1 | Better mobile; The method of double differences is qualified | 96.45 |
| 7 | 2 | 2 | 1 | 1 | 2 | 2 | 1 | Good fluidity; The method of double differences is defective | 83.38 |
| 8 | 2 | 2 | 1 | 2 | 1 | 1 | 2 | Good fluidity; The method of double differences is qualified | 82.05 |
Find out to have only C factor and A * B reciprocal action influence bigger from table.At C
2Situation under, B is arranged
1A
2And B
1A
1Best under two kinds of combined state.Consider the B factor affecting than the A factor affecting more greatly, and select B among the B
1For good, so select A
2B
1The final decision optimum formula is A like this
2B
1C
2, promptly accounting for the powder silica gel of total amount 4% and dextrin by the composite auxiliary material of forming at 4: 1, magnesium carbonate is 0.75%.
Study on extraction of the present invention:
One, Study on extraction
With catalpol content, yield of extract as index.The factor level table is as follows:
1, the factor level table sees the following form:
| Level | Factor | |||||||
| A | B | C | D | |||||
| Number of times (inferior) | Solvent (doubly) | Decocting time (h) | The concentrated solution relative density | Concentration of alcohol (%) | Pulverizing medicinal materials degree (order) | |||
| For the first time | For the second time | For the first time | For the second time | |||||
| 1 | 1 | 6 | 3 | 1.05 | 1.10 | 40 | 75 | The cutting of rattan turf class, the stripping and slicing of stem class |
| 2 | 2 | 8 | 2、 2 | 1.10 | 1.15 | 60 | 95 | 60 |
| 3 | 3 | 10 | 2、1、0.5 | 1.15 | 1.20 | 55 | 85 | Do not pulverize |
2, orthogonal experiment design table and the results are shown in following table:
| Row number the experiment number | A | B | C | D | Yield of extract (%) | Catalpol content (mg/g) | Scoring |
| 1 | 1 | 1 | 1 | 1 | 19.55 | 0.9763 | 68.5 |
| 2 | 1 | 2 | 2 | 2 | 18.93 | 0.8963 | 63.7 |
| 3 | 1 | 3 | 3 | 3 | 19.44 | 0.8422 | 65.5 |
| 4 | 2 | 1 | 2 | 3 | 18.71 | 0.9854 | 60.1 |
| 5 | 2 | 2 | 3 | 1 | 27.64 | 1.3210 | 84.2 |
| 6 | 2 | 3 | 1 | 2 | 15.15 | 1.0154 | 44.6 |
| 7 | 3 | 1 | 3 | 2 | 20.32 | 1.1355 | 76.5 |
| 8 | 3 | 2 | 1 | 3 | 17.71 | 0.9554 | 58.5 |
| 9 | 3 | 3 | 2 | 1 | 19.28 | 0.8924 | 65.4 |
Above result optimised process as can be seen is A
2B
2C
3D
1, i.e. the seven flavor medicine material section of being ground in bulk adds the water of 8 times of amounts, decocts twice, each 2 hours.But be ground into comparatively difficulty of 60 orders filtration at the big Chinese crude drug of producing, and the influence of D factor is not remarkable, adopts optimised process A
2B
2C
3D
1, i.e. Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, the water that adds 8 times of amounts decocts twice, each 2 hours, twice spissated relative density is followed successively by the used concentration of alcohol of 1.10 and 1.15, twice alcohol extractions and is followed successively by 55% and 85%.
Below by pharmacodynamics test data declaration beneficial effect of the present invention:
The pharmacodynamic study of preparation for treating insomnia effect of the present invention:
Capsule of the present invention, the Chinese patent medicine by extracts such as Chinese medicine Radix Rehmanniae Preparata fleece-flower root rattan are formed has nourishing YIN and benefiting blood, and the effect of mind tranquilizing and the heart calming is mainly used in and is used for deficiency of YIN insufficiency of blood, dizzy cardiopalmus, diseases such as insomnia forgetfulness.For further its clinical efficacy and safety of proof to having a sleepless night, we are diagnosed as insomnia from JIUYUE, 2003～December to 100 examples, Chinese medical discrimination is that the insomnia patients of deficiency of YIN insufficiency of blood type and type of hyperactivity of fire caused by deficiency of YIN has carried out capsule clinical efficacy of the present invention and safety is observed, and has obtained curative effect preferably.
1 data and method
1.1 clinical data 100 routine insomnia patientses are the attached outpatient of institute of Guiyang College of Traditional Chinese Medicine, male 25 examples, and women 75 examples, men and women's ratio is 1: 3.18～65 years old age.51 ± 10.54 years old mean age, average course of disease 5.08 ± 3.28.Chinese medical discrimination is type of hyperactivity of fire caused by deficiency of YIN 38 examples; Deficiency of YIN insufficiency of blood type 42 examples; Type of deficiency of both the heart and spleen 20 examples.
1.2 diagnostic criteria (1) has the insomnia classical symptom, difficulty falling asleep, and awakening is often slept and shakiness, or can not sleep after waking up again, and wake up too early morning.Can not fall asleep night, daytime lethargic and drowsy state, 5h does not have enough sleep.(2) meet the Chinese medical discrimination typing, deficiency of YIN insufficiency of blood type, type of hyperactivity of fire caused by deficiency of YIN, type of deficiency of both the heart and spleen.(3) have a sleepless night more than lasting January.
1.3 observational technique capsule of the present invention: every day 1 time, 1～2, administered before bed time usefulness, 1 week was 1 course of treatment, period in a medicine is prohibited other medicines of sleeping peacefully of clothes.
1.4 observation index (1) sleep quality (sleep time, awakening number of times, time for falling asleep, the back mental status of waking up, sleep state) standards of grading are with reference to national traditional Chinese medical science medical diagnosis on disease standard.(2) tcm syndrome (dizziness headache, the Mental fatigue soreness of waist, tinnitus, cardiopalmus, agitation) standards of grading represent that with the sxemiquantitative integration method asymptomatic is 0 minute, slightly is 1 minute, and moderate is 2 minutes, and severe is 3 minutes.(3) safety indexes (general physical examination, hematuria routine, EKG, SGPT, BUN, Cr) before and after the treatment each 1 time.
1.5 curative effect determinate standard (1) sleep criterion: 1. clinical recovery: sleep recovers normal, or nighttime sleep time＞6h, and sleep is dull, and the back of waking up is energetic.2. produce effects: increase the length of one's sleep more than the 3h, the back spirit of waking up is clearly better.3. effective: increase not enough 3h the length of one's sleep, the back spirit of waking up take a favorable turn.4. invalid: sleep does not have obviously improvement, or does not increase the weight of the person on the contrary.(2) tcm syndrome criterion: 1. produce effects: treatment back symptom integral descends＞2/3.2. effective: treatment back symptom integral descends＞1/3.3. invalid: treatment back symptom integral descends＜1/3.
2 the results are shown in Table 1,2.
Table 1 insomnia observation of curative effect
| The Chinese medical discrimination typing | 1. clinical recovery | 2. produce effects | 3. effective | 4. invalid |
| Deficiency of YIN insufficiency of blood type | 29 | 8 | 5 | 0 |
| Type of hyperactivity of fire caused by deficiency of YIN | 28 | 4 | 6 | 0 |
| Type of deficiency of both the heart and spleen | 15 | 3 | 2 | 0 |
Table 2 tcm syndrome observation of curative effect
| Tcm syndrome | Produce effects | Effectively | Invalid |
| Deficiency of YIN insufficiency of blood type | 29 | 13 | 0 |
| Type of hyperactivity of fire caused by deficiency of YIN | 26 | 11 | 1 |
| Type of deficiency of both the heart and spleen | 13 | 6 | 1 |
Untoward reaction: (1) clinical symptoms: after having 2 routine patients to take capsule of the present invention among the 100 routine patients, feel feeling of fullness in the head obvious, drug withdrawal after transference cure when waking up the 2nd day morning.(2) lab testing: have no adverse reaction.
3 medical records for example
The patient, woman, 46 years old.This patient suffered from chronic hepatitis nearly 10 years, and it is poor sleep that fatigue is arranged over 2 years slightly, and only sleep about 4h every day.The dreaminess of easily waking up feels dizzy weak daytime, the soreness of waist, and tinnitus, cardiopalmus, dysphoria, the tender thin fur of tongue is from, thready and rolling pulse.On October 4th, 2003 went to a doctor, and was diagnosed as insomnia, deficiency of YIN insufficiency of blood type.Use capsule of the present invention, sleep preceding 1.Take sleep in back 2 days and promptly recover normal, can sleep about 7h every day, and very fast sleeping, and it is intoxicated to sleep, and next day, subjective symptoms was also obviously improved.
We show through 100 routine clinical case observed results: capsule of the present invention has the hypnotic effect of calming the nerves preferably, and especially to early stage light, medium-sized patient, effect is better, and is longer to those insomnia courses of disease, the patient that the state of an illness is heavier, and effect is relatively poor relatively.Apparent in view to some spirituality doing well,improvings, as dizziness headache cardio palmus shape, and to the soreness of waist, symptoms such as tinnitus do not have obvious curative effects.Capsule of the present invention reaches 98% through the clinical verification total effective rate, and does not have obvious toxic-side effects, is a kind of safe and reliable nourishing blood to tranquillize the mind good medicine.
Compared with prior art: preparation provided by the invention has the effect that nourishing YIN and benefiting blood is calmed the nerves, and insomnia, dizziness, cardiopalmus, disease such as forgetful are had definite curative effect.The preparations such as ball sheet of routine are made capsule, by water and Different concentrations of alcohol alternate treatment, promptly adopt decoction and alcohol sedimentation technique, keep iridoid glycoside, the dissociated anthraquinone glycoside, effective ingredient such as alkaloid have been removed gelatinized starch, phlegmatic temperament and saccharide overwhelming majority impurity, the quality and the clinical treatment effect that have improved preparation.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1:
Caulis Polygoni Multiflori 100g, Caulis Spatholobi 100g, Radix Rehmanniae Preparata 100g, Radix Rehmanniae 100g, Cortex Albiziae 100g, Herba Ecliptae 140g, Herba Agrimoniae 160g, powder silica gel and dextrin are by the composite auxiliary material 33.60g of 4: 1 compositions, magnesium carbonate 6.30g
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.10 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mix homogeneously promptly can be made into capsule by the capsule method for making.
Embodiment 2:
Caulis Polygoni Multiflori 30g, Caulis Spatholobi 30g, Radix Rehmanniae Preparata 30g, Radix Rehmanniae 30g, Cortex Albiziae 30g, Herba Ecliptae 30g, Herba Agrimoniae 120g, powder silica gel and dextrin are by composite auxiliary material 11.34g, the magnesium carbonate 2.13g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 3:
Caulis Polygoni Multiflori 180g, Caulis Spatholobi 180g, Radix Rehmanniae Preparata 180g, Radix Rehmanniae 180g, Cortex Albiziae 180g, Herba Ecliptae 180g, Herba Agrimoniae 200g, powder silica gel and dextrin are by composite auxiliary material 76.4g, the magnesium carbonate 14.33g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 4:
Caulis Polygoni Multiflori 30g, Caulis Spatholobi 180g, Radix Rehmanniae Preparata 30g, Radix Rehmanniae 180g, Cortex Albiziae 30g, Herba Ecliptae 180g, Herba Agrimoniae 120g, powder silica gel and dextrin are by composite auxiliary material 31.50g, the magnesium carbonate 5.90g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 5:
Caulis Polygoni Multiflori 180g, Caulis Spatholobi 30g, Radix Rehmanniae Preparata 180g, Radix Rehmanniae 30g, Cortex Albiziae 180g, Herba Ecliptae 30g, Herba Agrimoniae 200g, powder silica gel and dextrin are by composite auxiliary material 34.86g, the magnesium carbonate 6.54g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 6:
Caulis Polygoni Multiflori 180g, Caulis Spatholobi 180g, Radix Rehmanniae Preparata 180g, Radix Rehmanniae 30g, Cortex Albiziae 30g, Herba Ecliptae 30g, Herba Agrimoniae 160g, powder silica gel and dextrin are by composite auxiliary material 33.18g, the magnesium carbonate 6.22g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 7:
Caulis Polygoni Multiflori 30g, Caulis Spatholobi 30g, Radix Rehmanniae Preparata 30g, Radix Rehmanniae 30g, Cortex Albiziae 180g, Herba Ecliptae 180g, Herba Agrimoniae 200g, powder silica gel and dextrin are by composite auxiliary material 28.56g, the magnesium carbonate 5.35g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 800ml water, soak after 1 hour and decoct each 2h, collecting decoction 2 times, filter, add 55% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 55%, under 5 ℃, left standstill 8 hours.Get supernatant, add 85% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 85%, under 5 ℃, left standstill the siphon supernatant 10 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.15 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 8:
Caulis Polygoni Multiflori 30g, Caulis Spatholobi 30g, Radix Rehmanniae Preparata 30g, Radix Rehmanniae 30g, Cortex Albiziae 30g, Herba Ecliptae 30g, Herba Agrimoniae 120g, powder silica gel and dextrin are by composite auxiliary material 11.34g, the magnesium carbonate 2.13g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 600ml water, soak after 0.5 hour and decoct each 2h, collecting decoction 1 time, filter, add 50% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.05,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 50%, under 5 ℃, left standstill 6 hours.Get supernatant, add 70% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 70%, under 5 ℃, left standstill the siphon supernatant 8 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.10 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Embodiment 9:
Caulis Polygoni Multiflori 180g, Caulis Spatholobi 180g, Radix Rehmanniae Preparata 180g, Radix Rehmanniae 180g, Cortex Albiziae 180g, Herba Ecliptae 180g, Herba Agrimoniae 200g, powder silica gel and dextrin are by composite auxiliary material 76.4g, the magnesium carbonate 14.33g of 4: 1 compositions
Method for making: above seven flavors, Caulis Polygoni Multiflori, Caulis Spatholobi, Herba Agrimoniae and Cortex Albiziae cutting, Radix Rehmanniae Preparata, Radix Rehmanniae and Herba Ecliptae stripping and slicing, add 1000ml water, soak after 5 hours and decoct each 2h, collecting decoction 3 times, filter, add 60% ethanol during filtrate concentrate under reduced pressure at low temperature to 50 ℃ during 1.15,40 ℃ of relative densities, stir, make medicinal liquid contain the alcohol amount and reach 60%, under 10 ℃, left standstill 10 hours.Get supernatant, add 90% ethanol again, stir, make medicinal liquid contain the alcohol amount and reach 90%, under 10 ℃, left standstill the siphon supernatant 12 hours, lower floor's magma is sucking filtration slowly again, merging filtrate, and concentrate under reduced pressure at low temperature to relative density is the clear paste of 1.20 (50 ℃), spray-drying process, granulate adds micropowder silica gel and the dextrin composite auxiliary material by 4: 1 compositions, magnesium carbonate, mixing promptly can be made into capsule by the capsule method for making.
Claims (2)
1, a kind of preparation method of nourishing blood to tranquillize the mind Chinese medicine preparation, wherein said nourishing blood to tranquillize the mind Chinese medicine preparation is made by following Chinese medicinal raw materials:
Caulis Polygoni Multiflori 30-180 part, Caulis Spatholobi 30-180 part, Radix Rehmanniae Preparata 30-180 part, Radix Rehmanniae 30-180 part, Cortex Albiziae 30-180 part, Herba Ecliptae 30-180 part, Herba Agrimoniae 120-200 part,
Described preparation method is by raw material of Chinese medicine is processed through extraction or other modes, make pharmaceutically active substance, with this active substance is raw material, adds the medicine acceptable carrier and makes, and it is characterized in that, wherein extracting pharmaceutically active substance is to adopt decoction and alcohol sedimentation technique, described decoction and alcohol sedimentation technique process following steps: medical material is cut into chunks, and decocts with water collecting decoction, filter concentrate under reduced pressure at low temperature; Add Different concentrations of alcohol at twice, fully stir, leave standstill, divide and get supernatant, sucking filtration merges, and concentrate under reduced pressure at low temperature gets clear paste, promptly.
2, the preparation method of claim 1, wherein said decoction and alcohol sedimentation technique process following steps: pulverizing medicinal materials becomes section or piece, add 6-10 times of water, soak after 0.5-5 hour and decoct 1-3 time, each 2 hours, collecting decoction filters, and gets the filtrate concentrate under reduced pressure at low temperature and to relative density be 1.05～1.15 clear paste; Add the ethanol of 50-60% in the time of 40 ℃, stir, make medicinal liquid contain the alcohol amount and reach 50-60%, under 5-10 ℃, left standstill 6-8 hour.Divide and get supernatant, add the ethanol of 75-90% again, stir, make medicinal liquid contain the alcohol amount and reach 75-90%, left standstill under 5-10 ℃ 8-12 hour, siphon supernatant, lower floor's magma be sucking filtration slowly again, merging filtrate, concentrate under reduced pressure at low temperature to relative density are 1.10～1.20 clear paste, promptly.
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| CN105687335A (en) * | 2014-11-18 | 2016-06-22 | 郝建友 | Injection for treating upper respiratory tract infection |
| CN104306541A (en) * | 2014-11-26 | 2015-01-28 | 黑龙江省智诚医药科技有限公司 | Traditional Chinese medicine dispersible tablet capable of nourishing blood and tranquilization and preparation method thereof |
| CN105943696A (en) * | 2016-06-02 | 2016-09-21 | 瑞安市智造科技有限公司 | External antianxiety traditional Chinese medicine composition and preparing method thereof |
| CN107320564A (en) * | 2017-07-03 | 2017-11-07 | 广西大海阳光药业有限公司 | A kind of Chinese medicine preparation for treating vertigo and palpitation, insomnia forgetfulness and preparation method thereof |
| CN107362272A (en) * | 2017-08-31 | 2017-11-21 | 江西金顶药业有限公司 | A kind of Yangxue Anshen Syrup |
| CN107714849A (en) * | 2017-11-16 | 2018-02-23 | 广西博白县华春福家庭农场 | A kind of Chinese medicine composition for treating myocardial ischemia and preparation method thereof |
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| 药品标准(中药成方制剂第6册) 卫生部药典委员会，131，卫生部药典委员会 1992 * |
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