CN1935192B - Chinese medicine composition, and its preparing method and quality control method - Google Patents
Chinese medicine composition, and its preparing method and quality control method Download PDFInfo
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- CN1935192B CN1935192B CN2005102005566A CN200510200556A CN1935192B CN 1935192 B CN1935192 B CN 1935192B CN 2005102005566 A CN2005102005566 A CN 2005102005566A CN 200510200556 A CN200510200556 A CN 200510200556A CN 1935192 B CN1935192 B CN 1935192B
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention discloses a Chinese medicine composition. Said medicine composition includes 11 Chinese medicinal materials of carthamus flower, wingless cockroach, nux vomica, prepared myrrh, notoginseng, borneol, calcined pyrite and others. Said medicine composition can be used for effectively curing the diseases of traumatic injury, sudden sprain in the lumbar region, pain in the chest when breathing, injury of the muscle and tendon, swelling pain and ischemic necrosis of femoral head, etc. Besides, said invention also provides its preparation process and concrete steps.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, especially a kind of is the Chinese medicine composition of raw material with the Chinese medicine ultra-fine powder, belongs to the field of Chinese medicines.The preparation method and the method for quality control that also relate to this Chinese medicine composition simultaneously.
Background technology
Superfine communication technique is an advanced person's growing up in the world in recent years a crushing technology.In crushing process, medical material is subjected to the effect of intensive forward extrusion power and tangential shearing force, utilization at a high speed, high-energy is pulverized, cell is extruded, shear, cell wall is torn, disconnect, cell is fractured into fragment or is crushed, resulting powder diameter generally reaches more than 300 orders, medium particle diameter reaches 15～35 μ m, the cell wall breaking rate reaches more than 95%, its contained chemical constituent of the medicated powder of " breaking cellular wall " directly comes out, compare with the medicated powder (chemical constituent is present in the complete cell wall) of existing Chinese medicine, produced the variation of " matter ", preliminary pharmacological evaluation confirms: the cell grade super fine can obviously improve drug effect, is widely used aspect the modernization of Chinese medicine.Its principle is tentatively thought at present: the ultra-micro powder after the cell wall breaking can keep wherein each kind of composition by whole part, form oil/water type or the solid state emulsified thing of water/oil type between these compositions, the cell grade super fine is easily long by small intestinal sorption, the time of staying, be beneficial to absorption, the whole part of chemical constituent that directly exposes and emulsifying attitude is easy to the permeable membrane absorption simultaneously, has improved its bioavailability greatly.
Chinese medicine ultra-fine powder is broken to have brought a revolution to the form of Chinese drug reform and the modernization of Chinese medicine; cell wall breaking rate, specific surface area, effective ingredient dissolution, bioavailability have been improved; pharmacological action be can strengthen, reduce dosage, medical material and protection herb resource saved; also can improve abnormal smells from the patient, mouthfeel simultaneously, improve drug quality.Though the research in this field is many at present, all rest on theoretical level, the application of this new technique in the field of Chinese medicines especially applied research in the Chinese medicine compound is less, can the person of trying out still less.
Chinese patent medicine kind---the bone setting tablet that " Ministry of Health of the People's Republic of China's ministry standard " recorded, form (Myrrha wherein (processing) be Myrrha (processed), Asterias amurensis Lutken (processing) be Asterias amurensis Lutken (processed), Os Gallus domesticus (processing) are Os Gallus domesticus (processed), Olibanum (processing) is Olibanum (processed)) by Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processing), Radix Notoginseng, Asterias amurensis Lutken (processing), Os Gallus domesticus (processing), Borneolum Syntheticum, Pyritum (forging), Olibanum (processing), Semen Melo 12 flavor medicines, blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, the Shujin bone strengthening.Be used for traumatic injury, lumbar sprain and QI divergeny, injured in the sinews or bones, swelling and pain due to blood stasis, disease such as damage redness etc. has been widely used in clinically, and comparatively ideal effect is arranged.But also there is following deficiency:
1, medicament contg inaccuracy, it is bigger to fluctuate;
2, drug technique content is low, and the medical material dose is big, and square Chinese crude drug price is more expensive, brings difficulty for the popularization and application of this product.
3, Cinnabaris is drug toxicity, and large usage quantity in the side easily causes accumulate poisoning, the decrement or need not of therefore should considering to recombinate on the basis of following former side's rule of treatment.
As adopt micronizing, and can reduce dosage, save medical material, significant to reducing drug cost.This research is the useful trial of the modernization of Chinese medicine, has opened up the frontier of Chinese patent medicine preparation research; Because of Olibanum (system), Myrrha (processed) in " bone setting tablet " side are the resinae medical material, Radix Notoginseng, Semen Strychni Pulveratum, Flos Carthami, Semen Melo are plant amedica, Eupolyphaga Seu Steleophaga, Asterias amurensis Lutken, Os Gallus domesticus are animal drugs, Borneolum Syntheticum is a fat-soluble medicine, Cinnabaris, Pyritum are mineral drug, the character that can more comprehensively reflect Chinese medicine, the application in Chinese medicine compound has reference value preferably and theory directive significance to the research micronizing therefore to select this prescription.
Summary of the invention
In conjunction with existing result of study, technical problem to be solved by this invention is the utilization ultramicrotechnique, the new technical process of design one cover makes old prescription produce new effect, with the purpose that reaches the content that develops skill, reduces dose, saves medical material, makes things convenient for the patient to take.
According to the result of basic research as can be seen, because superfine powder has reached the degree of cell wall breaking, whole releases of the various chemical substances in the histiocyte must bring the change on medical substance basis; Thereby, to compare with the common pulverizing of medical material, superfine powder should belong to the new medical substance of the variation that matter is arranged.This point also is confirmed in inventor's zoopery subsequently.
At this moment, crude drug of the present invention is: 4～7 parts of Flos Carthami superfine powder, 17～23 parts of Eupolyphaga Seu Steleophaga superfine powder, 8～12 parts of Semen Strychni Pulveratum superfine powder, 1～3 part of Myrrha (processed) superfine powder, 35～45 parts of superfine notoginseng powders, 8～12 parts of Asterias amurensis Lutken (processed) superfine powder, 17～23 parts of Os Gallus domesticus (processed) superfine powder, 1～2 part of Borneolum Syntheticum superfine powder, 8～12 parts of Pyritum (calcined) superfine powder, 1～3 part of Olibanum (processed) superfine powder, 1～3 part of Semen Melo superfine powder.
Preferred back: 6 parts of Flos Carthami superfine powder, 20 parts of Eupolyphaga Seu Steleophaga superfine powder, 10 parts of Semen Strychni Pulveratum superfine powder, 2 parts of Myrrha (processed) superfine powder, 40 parts of superfine notoginseng powders, 10 parts of Asterias amurensis Lutken (processed) superfine powder, 20 parts of Os Gallus domesticus (processed) superfine powder, 1 part of Borneolum Syntheticum superfine powder, 10 parts of Pyritum (calcined) superfine powder, 2 parts of Olibanum (processed) superfine powder, 2 parts of Semen Melo superfine powder.
Need be pointed out that once more, because the raising of the drug effect brought of superfine powder, make acting on of Cinnabaris in the former prescription insignificant here, so, do not contain Cinnabaris in inventor's the above-mentioned prescription for fear of the toxic and side effects of Cinnabaris.Certainly, we also can list in the crude drug by the Cinnabaris powder, but Cinnabaris can not be with other flavour of a drug micronizing, and water flies to handle separately, and is used with the form of coating, and the crude drug of this moment is:
6 parts of Flos Carthami superfine powder, 20 parts of Eupolyphaga Seu Steleophaga superfine powder, 10 parts of Semen Strychni Pulveratum superfine powder, 2 parts of Myrrha (processed) superfine powder, 40 parts of superfine notoginseng powders, 10 parts of Asterias amurensis Lutken (processed) superfine powder, 20 parts of Os Gallus domesticus (processed) superfine powder, 1 part of Borneolum Syntheticum superfine powder, 10 parts of Pyritum (calcined) superfine powder, 2 parts of Olibanum (processed) superfine powder, 2 parts of Semen Melo superfine powder, 5 parts in Cinnabaris powder.
Next inventor's thinking is: micronizing is the crushing process of cell grade, and chemical reaction easily takes place in directly contact between chemical constituent, thereby will divide into groups according to the property feature of each flavour of a drug to pulverize; As required superfine powder is added suitable adjuvant then, make required dosage form.
According to above thinking, the inventor analyzes and researches, and has finally formulated following technical scheme:
Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo are pulverized together, and Cinnabaris is pulverized separately, and two kinds of superfine powder combine with suitable manner, make required dosage form.
Can be divided into following two kinds of situations specifically.
1) if do not contain Cinnabaris, then divided for two steps:
A. get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo mixing, pulverize, get medicated powder; Medicated powder is micronizing again, makes superfine powder;
B. the superfine powder that step a is made adds the conventional adjuvant of medicament, makes the product of required dosage form.
2), then need following several steps if contain Cinnabaris:
A. get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo mixing, pulverize, get medicated powder; Medicated powder is micronizing again, makes superfine powder;
B. get Cinnabaris water and fly into impalpable powder, particle diameter is made coating materials less than 50 μ m;
C. the superfine powder that step a is made adds the conventional adjuvant of medicament, makes the semi-finished product of required dosage form; Behind the coating materials coating that reuse step b makes, make final products.
In above two kinds of situations, the breaking method among the step a can be divided into two kinds again, i.e. dry method and wet method:
Dry pulverization process: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo, drying is mixed, and pulverizes the back with common pulverizer and crosses 10～100 mesh sieves; The combination of the arbitrary or several method in medicated powder reuse comminution by gas stream, ball mill pulverizing, vibromill pulverizing or the Ultrasonic Pulverization method makes the superfine powder of medium particle diameter less than 30 μ m.
Waterproof pulverization: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo, drying is mixed, and pulverizes the back with common pulverizer and crosses 10～100 mesh sieves; Medicated powder adds 0.5～3 times of suitable substrate of amount and is uniformly dispersed, and the reuse vibromill is pulverized, and makes the superfine powder of medium particle diameter less than 25 μ m.
Said substrate can be soybean oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, PEG400, Macrogol 600, cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, glycerol, 1, any in 2-propylene glycol, the phospholipid or several mixture in the waterproof pulverization.
Above crushing process is the key point that reaches the object of the invention, pulverizes by ultramicronising, has improved the utilization rate of medical material, has also reduced the medical material consumption when improving drug effect, has made things convenient for the patient.
After pulverizing is finished, just can superfine powder be added suitable adjuvant made required dosage form,, behind 90% alcohol granulation, dress up capsule as with admixing starch in the superfine powder as doing ordinary preparation.But the situation difference when Cinnabaris is arranged, discover, if the Cinnabaris powder is directly mixed with superfine powder, easily produce untoward reaction, if but the Cinnabaris powder is made coating materials or with inclusion body inclusion, mixed use again with superfine powder, just safe and reliable, so the dosage form of this moment is: with superfine powder add an amount of wetting agent, adhesive is made pill, dry back is with Cinnabaris powder coating; Or superfine powder is added an amount of wetting agent make granule, dry back is with Cinnabaris powder coating; Or superfine powder is added an amount of wetting agent make granule, dry back tabletting, plain sheet reuse Cinnabaris powder coating; Or superfine powder is added an amount of wetting agent make granule, dry back is with Cinnabaris powder coating, the grain packing capsule behind the coating.
In research preparation method process of the present invention, in order to control production process and product quality, the inventor has also formulated a cover method of quality control, and this method comprises following content:
The microscopy of a, superfine powder
Get the superfine powder mixing, take by weighing 40mg, put in the 50ml volumetric flask, glycerol adding acetic acid test solution is to scale, and jolting makes dispersion, mixing fully, and get one and put on the microscope slide, covered, device is observed.Field of microscope is amplified to 400 times, 5 visuals field of random observation.Particle number is no more than 30 under each visual field, in 5 visuals field, greater than 75 μ m persons, amounts to and is no more than 30, and must not have 2 to surpass 100 μ m.Two devices of parallel making are observed.
B, thin layer chromatography are checked Radix Notoginseng
Get this product preparation 8～12g, porphyrize adds methanol 30ml, and supersound process 30 minutes filters, and filtrate is as need testing solution.Other gets the ginsenoside Rg
1And Panax Notoginseng saponin R
1, add methanol and make the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw need testing solution 10 μ l, reference substance solution 5 μ l, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with 15: 40: 22: lower floor's solution that chloroform-ethyl acetate of 10-methanol-water was placed 12 hours below 10 ℃ was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance on, show the speckle of same color.
C, thin layer chromatography are checked Olibanum
Get this product preparation 8～12g, porphyrize, the 50ml that adds diethyl ether, supersound process 20 minutes filters, and volatilizes, and residue adds ethanol 2ml makes dissolving, as need testing solution.Other gets Olibanum control medicinal material 1g, the 20ml that adds diethyl ether, and supersound process 10 minutes filters, and filtrate evaporate to dryness, residue add dehydrated alcohol 5ml makes dissolving, in contrast medical material solution.Test according to thin layer chromatography, draw need testing solution, each 5 μ l of control medicinal material solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with the petroleum ether is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid of 5% vanillin, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
D, high performance liquid chromatography are checked the content of strychnine in the Semen Strychni
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica.10: 90 acetonitrile-1% glacial acetic acid is a mobile phase, detects wavelength 254nm, column temperature: 40 ℃.Flow velocity is 1.0ml/min.Number of theoretical plate calculates by the strychnine peak should be not less than 2000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the strychnine reference substance, adds mobile phase and make the solution that every 1ml contains 45 μ g, promptly.
This product preparation is got in the preparation of need testing solution, and porphyrize is got 2～4g, and accurate the title decides, put in the conical flask, add ammonia 5ml, precision adds chloroform 50ml, claims to decide weight, water-bath reflux, extract, 60 minutes is put coldly, weighs, supply the weight that subtracts mistake with chloroform, filter, precision is measured subsequent filtrate 25ml, water bath method, residue quantitatively is transferred in the 25ml measuring bottle with mobile phase, shakes up, filter with 0.45 μ m microporous filter membrane, get subsequent filtrate, promptly.
Accurate respectively reference substance and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
E, titrimetry are measured the content of cinnabar in the Cinnabaris
Get the about 10g of this product powder, the accurate title, decide, put in the kjeldahl flask, add sulphuric acid 50ml and potassium nitrate 5g, heating makes dissolving, put cold, add water 50ml, and add 1% potassium permanganate solution, drip 2% copperas solution again to red the disappearance to showing pink, add ammonium ferric sulfate indicator 2ml, with the ammonium thiocyanate volumetric solution titration of 0.1mol/L.Every 1ml ammonium thiocyanate volumetric solution is equivalent to the cinnabar of 11.63mg.
Pharmaceutical preparation of the present invention has blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, the effect of Shujin bone strengthening.Be used for traumatic injury, lumbar sprain and QI divergeny, injured in the sinews or bones, swelling and pain due to blood stasis, diseases such as damage redness.Because the existence of function of promoting blood circulation to disperse blood clots illustrates that pharmaceutical preparation of the present invention also has the effect of treatment femur head necrosis.In order to prove pharmaceutical preparation of the present invention in the contribution aspect saving medical material, the raising drug effect, the inventor cures mainly according to its function, has carried out the contrast pharmacodynamic experiment with former bone setting tablet.
One, basic document
1, be subjected to the reagent thing: superfine powder No. 1 (not containing the Cinnabaris powder), superfine powder No. 2 (containing the Cinnabaris powder), Shangke bone-knitting http://www.ephar connect the company limited production of the Metro pharmaceutical factory of traditional Chinese medicine).
2, experimental animal: Kunming mouse 18～22g, male and female dual-purpose, Wistar rat, male and female dual-purpose, 200～250g; Provide by Shandong Medical University's Experimental Animal Center.
3, test apparatus: electronic balance, Beijing Sai Duolisi Instr Ltd.; Hot-plate instrument, Shandong Academy of Medical Sciences's experimental apparatus institute.
Two, content of the test:
Test 1: the hot plate method test of mice
Regulating the water bath with thermostatic control hot plate temperature is 55 ± 0.5 ℃, preheating 10min.The qualified mice of screening of learning from else's experience is divided into 6 groups, 10 every group at random.Be respectively Shangke bone-knitting group, superfine powder group and blank group, gastric infusion.Above-mentioned mice is put into hot-plate instrument, measure the pain threshold of different time sections (30min, 60min, 90min, 120min).The results are shown in following table:
The influence of table 1 pair mice pain threshold (X ± S)
Compare with the blank group: * * P＜0.01, * * * P＜0.001
Result of the test shows, compares with the blank group, and Shangke bone-knitting group and superfine powder group all can significantly improve the pain threshold of mice, and superfine powder 1/2 dosage is suitable with Shangke bone-knitting group effect, plays the effect that decrement is used.
Test 2: to the influence of Oleum Tiglii induced mice ear swelling
Get test mice, random packet is respectively Shangke bone-knitting group, superfine powder group and blank group, and 10 every group, cause inflammation by the 5mg/kg body weight in left ear with 2% Oleum Tiglii, cause scorching back 1 hour, the external application administration.Got left and right sides same area auricle scales/electronic balance weighing in 3 hours after the medication, represent the swelling degree with weight difference in two sides.The results are shown in following table:
The influence of table 2 pair Oleum Tiglii induced mice ear swelling (X ± S)
| Group | Dosage (g/kg) | The swelling degree |
| The blank group | 10.4±1.3 | |
| Shangke bone-knitting | 0.468 | 4.6±0.9 |
| No. 1, superfine powder | 0.117 | 6.9±1.1 |
| No. 1, superfine powder | 0.234 | 3.8±0.6* |
| No. 2, superfine powder | 0.117 | 6.3±1.2 |
| No. 2, superfine powder | 0.234 | 4.0±0.8* |
Compare with the blank group: * P＜0.05.
Result of the test shows that superfine powder 1/2 dosage group and bone setting tablet have the obvious suppression effect to the ear swelling due to the Oleum Tiglii.
Test 3: hemostasis trial
Get test mice, random packet is respectively Shangke bone-knitting group, this product preparation and blank group, 12 every group.Gastric infusion, successive administration 3d.After the last medication 2 hours, apart from tail point 2mm place docking, observation bleeding time.The results are shown in following table:
Result of the test shows that superfine powder 1/2 dosage group and Shangke bone-knitting all have tangible haemostatic effect.
Test 4: blood circulation promoting and blood stasis dispelling test
Get test mice, random packet, anaesthetize with 0.2% pentobarbital sodium ip30mg/kg, keep experimental enviroment and the medicine constant temperature of giving (30 ± 0.5 ℃), anesthetized mice is put on the observation platform, the auricle unhairing, and pad ear holder, make it open and flat so that observe, dropping liquid paraffin body between auricle and ear holder places multi-section position microcirculation viewing system microscopically to observe access panel, and carry out date processing and demonstration with computer, mouse ear medium-sized artery the 3rd branch's arteriole before the record administration, the blood vessel diameter of venule and blood flow rate as normal index, are coated with different pharmaceutical at auricle respectively; Dab the medicine that is coated with cotton examination behind the 10min, observe the situation of change of above-mentioned every index.Blood vessel diameter and velocity of blood flow increase percentage rate computing formula is after the medication:
Blood vessel diameter increases %=(the preceding blood vessel diameter of blood vessel diameter-medication after the medication)/preceding blood diameter of medication * 100%;
Vascular flow rate increases %=(the preceding vascular flow rate of vascular flow rate-medication after the medication)/preceding velocity of blood flow of medication * 100%.
The results are shown in following table
Result of the test shows, superfine powder group and Shangke bone-knitting all have tangible dilating effect to Mice Auricle arteriole, venule, and the interior blood flow rate of blood vessel is obviously increased, and especially increasing significantly with arteriectasia, arterial blood flow velocity, prompting this product has the effect of microcirculation improvement preferably.I.e. prompting can improve the blood circulation in femur head necrosis zone, thereby plays the effect of treatment.In the test, superfine powder 1/2 dosage group is suitable with Shangke bone-knitting group effect, has proved the tangible pharmacological effect of superfine powder.
Test 5: acute toxicity test in mice
Give mouse stomach this product preparation 85g/kg in one day, be equivalent to more than 145 times of clinical 70kg people's per kilogram of body weight consumption per day, observed continuously seven days, mice generally in order, none death illustrates this product low toxicity, safety.
Test 6: rat long term toxicity test
Get the Wistar rat, stablized before the test 7 days, observe general situation: situations such as body weight, feed, feces, activity are all no abnormal, be divided into four groups at random by body weight, blank group and superfine powder high dose group, middle dosage group, low dose group, 30 every group, 5 in every cage, begin administration then, press heavy timing every day of 1ml/100g Mus gastric infusion.Surveyed a body weight in per 7 days and press body weight change adjustment dosage, successive administration 45 days notes observing situations such as animal activity, hair color feces, feed, body weight change during the administration.Water is eaten, decided to body weight of weighing weekly surely weekly, claims surplus after 24 hours, and the difference of addition and surplus is daily diet, daily drink amount.After the administration 21 days, water 12h is can't help in fasting, carries out hematology, the biochemical check of blood, gets 20 sacrifice of animal for every group and carries out pathological anatomy and histopathologic examination.All the other rats are cooked 10 day convalescent period and observe the repetition measurement These parameters.
Successive administration 21 days, general situation such as the activity of rat, behavior, feed, drinking-water, hair color, fecaluria is not seen appreciable impact, and none death, the hematology of rat, blood biochemical learn and important organ pathological tissue index does not all have remarkable change, recovered to observe through 10 days after administration finishes, do not observe other the back something lost and the toxic action of secondary.Safety, the low toxicity of prompting ultrafine preparation.
By above results of pharmacodynamic test, except that its therapeutical effect of proof, also further specify its need 1/2 recipe quantity, can meet or exceed the effect of former prescription, illustrate that the variation of matter has taken place this medical substance, be a kind of new medical substance.
The specific embodiment:
Below further specify technical process of the present invention by specific embodiment:
Embodiment one:
Prescription: Flos Carthami 7g Eupolyphaga Seu Steleophaga 23g Semen Strychni Pulveratum 12g
Myrrha (processing) 3g Radix Notoginseng 45g Asterias amurensis Lutken (processing) 12g
Os Gallus domesticus (processing) 23g Borneolum Syntheticum 2g Pyritum (forging) 12g
Olibanum (processing) 2g Semen Melo 3g Cinnabaris 7g
Method for making: get Cinnabaris and identify that water flies into impalpable powder, particle diameter is less than 50 μ m, and is standby; Get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; With Cinnabaris powder and superfine powder mix homogeneously, promptly get ultra micro powder.
Embodiment two:
Prescription: Flos Carthami 4g Eupolyphaga Seu Steleophaga 17g Semen Strychni Pulveratum 8g
Myrrha (processing) 1g Radix Notoginseng 35g Asterias amurensis Lutken (processing) 8g
Os Gallus domesticus (processing) 17g Borneolum Syntheticum 1g Pyritum (forging) 8g
Olibanum (processing) 1g Semen Melo 1g Cinnabaris 4g
Method for making: get Cinnabaris and identify that water flies into impalpable powder, particle diameter is less than 50 μ m, and is standby; Get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 20 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 15g, and it is an amount of to add starch, mixing adds water and makes wetting agent in right amount, and mix homogeneously closes and sticks together 5 minutes, pill bar, gradation and round, and drying is got Cinnabaris powder coating, polishing, and packing promptly gets the ultra micro pill.
Embodiment three:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g Cinnabaris 5g
Method for making: get Cinnabaris and identify that water flies into impalpable powder, particle diameter is less than 50 μ m, and is standby; Get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 40 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added water granulate in right amount, dry below 60 ℃, granulate is got dried granule Cinnabaris powder coating, drying, and packing promptly gets the ultramicro powder agent.
Embodiment four:
Prescription: Flos Carthami 4g Eupolyphaga Seu Steleophaga 23g Semen Strychni Pulveratum 11g
Myrrha (processing) 3g Radix Notoginseng 42g Asterias amurensis Lutken (processing) 8g
Os Gallus domesticus (processing) 18g Borneolum Syntheticum 1g Pyritum (forging) 12g
Olibanum (processing) 1g Semen Melo 3g Cinnabaris 5g
Method for making: get Cinnabaris and identify that water flies into impalpable powder, particle diameter is less than 50 μ m, and is standby; Get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 60 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 10g, add water and granulate in right amount, dry below 60 ℃, granulate adds magnesium stearate 2g, and granulate adds starch and regulates total amount in right amount, tabletting, plain sheet Cinnabaris powder coating, and drying, packing promptly gets the ultra micro tablet.
Embodiment five:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g Cinnabaris 5g
Method for making: get Cinnabaris and identify that water flies into impalpable powder, particle diameter is less than 50 μ m, and is standby; Get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 80 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 10g, add water and granulate in right amount, dry below 60 ℃, granulate is got dried granule Cinnabaris powder coating, and drying adds magnesium stearate 2g, and granulate adds starch and regulates total amount in right amount, and capsule charge promptly gets the ultra micro capsule.
Embodiment six:
Prescription: Flos Carthami 7g Eupolyphaga Seu Steleophaga 23g Semen Strychni Pulveratum 12g
Myrrha (processing) 3g Radix Notoginseng 45g Asterias amurensis Lutken (processing) 12g
Os Gallus domesticus (processing) 23g Borneolum Syntheticum 2g Pyritum (forging) 12g
Olibanum (processing) 2g Semen Melo 3g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 100 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m, add 0.5% magnesium stearate, mix homogeneously, packing promptly gets ultra micro powder.
Embodiment seven:
Prescription: Flos Carthami 4g Eupolyphaga Seu Steleophaga 17g Semen Strychni Pulveratum 8g
Myrrha (processing) 1g Radix Notoginseng 35g Asterias amurensis Lutken (processing) 8g
Os Gallus domesticus (processing) 17g Borneolum Syntheticum 1g Pyritum (forging) 8g
Olibanum (processing) 1g Semen Melo 1g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 60 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 15g, and it is an amount of to add starch, mixing adds water and makes wetting agent in right amount, and mix homogeneously closes and sticks together 5 minutes, pill bar, gradation and round, and drying, polishing, packing promptly gets the ultra micro pill.
Embodiment eight:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added water granulate in right amount, dry below 60 ℃, granulate, drying, packing promptly gets the ultramicro powder agent.
Embodiment nine:
Prescription: Flos Carthami 4g Eupolyphaga Seu Steleophaga 23g Semen Strychni Pulveratum 11g
Myrrha (processing) 3g Radix Notoginseng 42g Asterias amurensis Lutken (processing) 8g
Os Gallus domesticus (processing) 18g Borneolum Syntheticum 1g Pyritum (forging) 12g
Olibanum (processing) 1g Semen Melo 3g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 10g, and microcrystalline Cellulose 40g adds water and granulates in right amount, and is dry below 60 ℃, and granulate adds magnesium stearate 2g, and granulate adds starch and regulates total amount in right amount, tabletting, and packing promptly gets the ultra micro tablet.
Embodiment ten:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 100 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; Superfine powder is added carboxymethylstach sodium 10g, add water and granulate in right amount, dry below 60 ℃, add magnesium stearate 2g, granulate adds starch and regulates total amount in right amount, and capsule charge promptly gets the ultra micro capsule.
Embodiment 11:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 40 mesh sieves, what coarse powder added 1.5 times of amounts contains 10%1, the PEG400 solution of 2-propylene glycol is pulverized with vibrating mill, makes the superfine powder runny plaste of medium particle diameter less than 25 μ m; The superfine powder runny plaste at 40 ℃ of retrofilling soft capsules, is promptly got the ultra micro soft capsule.
Embodiment 12:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo is identified, dry, mix, pulverize the back with common pulverizer and cross 80 mesh sieves, coarse powder joins in the polyethylene glycol 6000 solution that contains 40% Macrogol 4000 of fused 1.5 times of amounts, and adjust total amount with substrate, stir under airtight, under 60 ℃, pulverize with vibrating mill, make the superfine powder runny plaste of medium particle diameter, keep 80 ℃ of temperature, splash into (1～5 ℃) in the liquid paraffin less than 25 μ m, make drop pill, promptly get the ultra micro drop pill.
Embodiment 13:
Prescription: Flos Carthami 6g Eupolyphaga Seu Steleophaga 20g Semen Strychni Pulveratum 10g
Myrrha (processing) 2g Radix Notoginseng 40g Asterias amurensis Lutken (processing) 10g
Os Gallus domesticus (processing) 20g Borneolum Syntheticum 1g Pyritum (forging) 10g
Olibanum (processing) 2g Semen Melo 2g
Method for making: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 mesh sieves, coarse powder reuse vibrating mill is pulverized, and makes the superfine powder of medium particle diameter less than 30 μ m; In addition in sodium polyacrylate: gelatin: Kaolin: glycerol=4: 3: 6: 20 ratios are got sodium polyacrylate, gelatin, Kaolin, glycerol, gelatin is added the suitable quantity of water swelling, in 60 ℃ of water-baths after the heating for dissolving, slowly adding sodium polyacrylate, Kaolin, glycerol stir, be dispersed to evenly, 45 ℃ of constant temperature, add above-mentioned gained superfine powder, stirred 1 hour, evenly coat on the non-woven fabrics then, thickness is about 1.5mm, area 4cm * 5cm, and the covering polyethylene plastic film, promptly get ultra micro and stick agent.
Claims (7)
1. Chinese medicine composition that is used for the treatment of traumatic injury and femur head necrosis is characterized in that this Chinese medicine composition made by following bulk drugs: 4～7 parts of Flos Carthami superfine powder, 17～23 parts of Eupolyphaga Seu Steleophaga superfine powder, 8～12 parts of Semen Strychni Pulveratum superfine powder, 1～3 part of Myrrha (processed) superfine powder, 35～45 parts of superfine notoginseng powders, 8～12 parts of Asterias amurensis Lutken (processed) superfine powder, 17～23 parts of Os Gallus domesticus (processed) superfine powder, 1～2 part of Borneolum Syntheticum superfine powder, 8～12 parts of Pyritum (calcined) superfine powder, 1～3 part of Olibanum (processed) superfine powder, 1～3 part of Semen Melo superfine powder.
2. Chinese medicine composition according to claim 1 is characterized in that the optimum ratio of each crude drug is: 6 parts of Flos Carthami superfine powder, 20 parts of Eupolyphaga Seu Steleophaga superfine powder, 10 parts of Semen Strychni Pulveratum superfine powder, 2 parts of Myrrha (processed) superfine powder, 40 parts of superfine notoginseng powders, 10 parts of Asterias amurensis Lutken (processed) superfine powder, 20 parts of Os Gallus domesticus (processed) superfine powder, 1 part of Borneolum Syntheticum superfine powder, 10 parts of Pyritum (calcined) superfine powder, 2 parts of Olibanum (processed) superfine powder, 2 parts of Semen Melo superfine powder.
3. Chinese medicine composition as claimed in claim 1 or 2, it is characterized in that this pharmaceutical composition can make any in the following dosage form: pill, powder, tablet, granule, capsule, drop pill, soft capsule and external stick agent.
4. the preparation method of Chinese medicine composition as claimed in claim 3 is characterized in that:
A. get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo mixing, pulverize, get medicated powder; Medicated powder is micronizing again, makes superfine powder;
B. the superfine powder that step a is made adds the conventional adjuvant of medicament, makes the product of required dosage form.
5. the preparation method of Chinese medicine composition as claimed in claim 4, it is characterized in that the concrete breaking method among the step a is: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo, dry, mix, pulverize the back with common pulverizer and cross 10～100 mesh sieves; The combination of any in medicated powder reuse comminution by gas stream, ball mill pulverizing, vibromill pulverizing or the Ultrasonic Pulverization method or several method makes the superfine powder of medium particle diameter less than 30 μ m.
6. the preparation method of Chinese medicine composition as claimed in claim 4, it is characterized in that the concrete breaking method among the step a is: get Flos Carthami, Eupolyphaga Seu Steleophaga, Semen Strychni Pulveratum, Myrrha (processed), Radix Notoginseng, Asterias amurensis Lutken (processed), Os Gallus domesticus (processed), Borneolum Syntheticum, Pyritum (calcined), Olibanum (processed), Semen Melo, dry, mix, pulverize the back with common pulverizer and cross 10～100 mesh sieves; Medicated powder adds 0.5～3 times of suitable substrate of amount and is uniformly dispersed, and the reuse vibromill is pulverized, and makes the superfine powder of medium particle diameter less than 25 μ m;
Aforementioned used suitable substrate is meant the combination of following one or more: soybean oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, PEG400, Macrogol 600, cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, glycerol, 1,2-propylene glycol, phospholipid.
7. Chinese medicine composition as claimed in claim 3 is used for the treatment of traumatic injury, lumbar sprain and QI divergeny, injured in the sinews or bones in preparation, the application in the medicine of swelling and pain due to blood stasis, damage redness and/or femur head necrosis.
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| CN102512499A (en) * | 2011-12-27 | 2012-06-27 | 大连美罗中药厂有限公司 | External application preparation for traumatology bone knitting, and preparation method thereof |
| CN108117557B (en) * | 2016-11-28 | 2022-05-27 | 北京盈科瑞创新医药股份有限公司 | Extraction, separation and purification method of strychnine |
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| Title |
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| 卫生部颁药品标准（中药成方制剂第十六册）.中华人民共和国卫生部药典委员会编,1998,41. * |
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