CN1935242A - 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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Abstract
The present invention discloses a Chinese medicine composition with obvious therapeutic effect for curing the diseases of traumatic injury, swelling pain caused by blood stasis and ischemic necrosis of femoral head. Said medicine composition is a preparation made up by using 7 Chinese medicinal materials of dragon's blood, prepared frankincense, myrrh, carthamus flower, cutch, borneol and musk through a certain preparation process. Said invention also discloses its preparation method and quality control method.
Description
Technical field
The present invention relates to a kind of medication medication compositions, 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 Anisodus carniolicoides C.Y.Wu et C.Chen that the Pharmacopoeia of the People's Republic of China 2000 editions records, form by Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, Cinnabaris eight flavor medicines that (Olibanum wherein (system) is Olibanum (processed), Myrrha (processed) is Myrrha (processed)), effect with blood stasis dispersing and deswelling, analgesic hemostatic, be used for the treatment of injury from falling down, blood stasis pain, traumatology diseases such as traumatic hemorrhage have 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 Sanguis Draxonis, Moschus price of medicinal material costliness in the side, and price of medicinal materials such as Cinnabaris, Flos Carthami, Olibanum, Myrrha, Borneolum Syntheticum, catechu are all more valuable, bring 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, especially be fit to the pulverizing of precious rare Chinese medicines such as Moschus.This research is that the modernization of Chinese medicine useful repaid examination, has opened up the frontier of Chinese patent medicine preparation research; Because of Sanguis Draxonis, Olibanum (system), Myrrha (processed) in " Anisodus carniolicoides C.Y.Wu et C.Chen " side are the resinae medical material, Flos Carthami is a plant amedica, catechu is that extract is used as medicine, Moschus, Borneolum Syntheticum are fat-soluble medicine, Cinnabaris is mineral drug, except that not containing the animal drugs, can more comprehensively reflect the character of Chinese medicine in this prescription, 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: 450～550 parts of Sanguis Draxonis superfine powder, 60～90 parts of Olibanum (processed) superfine powder, 60～90 parts of Myrrha (processed) superfine powder, 60～90 parts of Flos Carthami superfine powder, 100～140 parts of catechu superfine powder, 4～8 parts of Borneolum Syntheticum superfine powder, 4～8 parts of Moschus superfine powders.
Preferred back: 500 parts of Sanguis Draxonis superfine powder, 75 parts of Olibanum (processed) superfine powder, 75 parts of Myrrha (processed) superfine powder, 75 parts of Flos Carthami superfine powder, 120 parts of catechu superfine powder, 6 parts of Borneolum Syntheticum superfine powder, 6 parts of Moschus superfine powders.
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 need special handling, be that Cinnabaris can not be with other flavour of a drug micronizing, water flies to handle separately, and be used with the form of coating, the crude drug of this moment is: 500 parts of Sanguis Draxonis superfine powder, 75 parts of Olibanum (processed) superfine powder, 75 parts of Myrrha (processed) superfine powder, 75 parts of Flos Carthami superfine powder, 120 parts of catechu superfine powder, 6 parts of Borneolum Syntheticum superfine powder, 6 parts of Moschus superfine powders, 60 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:
Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus 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 Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus 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 Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus 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 Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, 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 Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, 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.
All pulverize finish after, just can superfine powder be added suitable adjuvant make required dosage form as doing ordinary preparation, as with admixing starch in the superfine powder, behind 90% alcohol granulation, dress up capsule.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, gas chromatography are checked Moschus, Borneolum Syntheticum
It is an amount of to get this product, grinds, and gets 35mg, accurately claims surely, puts in the tool plug conical flask, and precision adds ethyl acetate 25ml, and supersound process 20min is put coldly, filters, and gets subsequent filtrate, and is standby, according to the gas chromatography test.It is an amount of that other gets the Borneolum Syntheticum reference substance, and accurate the title decides, and adds ethyl acetate and makes the solution that every 1ml contains 0.8mg, in contrast product solution.It is an amount of that other gets the muscone reference substance, and accurate the title decides, and adds ethyl acetate and makes the solution that every 1ml contains 0.4mg, in contrast product solution.Chromatographic condition and system suitability test HP-1 0.32mm * 30m fused-silica capillary column.Column temperature: 130 ℃.Get each 0.4～1.0 μ l of reference substance solution and need testing solution respectively, the injection gas chromatography view.The retention time of test sample chromatographic peak should be consistent with the retention time of reference substance chromatographic peak.
C, high performance liquid chromatography are measured the Dracoalban
The chromatographic condition chromatographic column is the C18 post.Mobile phase is that ratio is the 0.05mol/L potassium dihydrogen phosphate of 35: 65 acetonitrile-0.1% phosphoric acid.Flow velocity is 08ml/min.Column temperature is 40 ℃.Theoretical cam curve is not less than 4000 by the Dracoalban peak.
The preparation precision of reference substance solution takes by weighing Dracoalban's reference substance 9mg, puts in the brown measuring bottle of 50ml, adds 3% phosphoric acid methanol solution and makes dissolving and be diluted to scale, shakes up, and precision is measured 1ml, puts in the brown measuring bottle of 5ml, adds methanol to scale, shakes up, promptly.
Superfine powder 0.1～0.3g is got in the preparation of need testing solution, and accurate the title decides, and puts in the brown measuring bottle of 10ml, alcoholic solution 10ml in accurate adding 3% phosphoric acid, close plug, the accurate title, decide, ultrasonic 10min is placed to room temperature, supplies weight with methanol, shake up, filter, precision is measured subsequent filtrate 1ml and is put in the brown measuring bottle of 5ml, adds methanol and is diluted to scale, shake up, promptly.
Measure and do not get reference substance solution and each 20 μ l of need testing solution, inject high performance liquid chromatograph, measure, promptly.
Pharmaceutical preparation of the present invention has blood stasis dispersing and deswelling, and the effect of analgesic hemostatic is used for injury from falling down, blood stasis pain, the disease of symptoms such as traumatic hemorrhage.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 animal contrast pharmacodynamic experiment from aspects such as pain relieving, detumescence, hemostasis.
One, basic document
1, is subjected to the reagent thing: No. 1, ultra micro-the do not contain superfine powder of Cinnabaris; No. 2, ultra micro contains the superfine powder of Cinnabaris; Anisodus carniolicoides C.Y.Wu et C.Chen: Jianjin Pharmaceutical Factory No. 5 of Traditional Chinese Medicines produces.
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 Anisodus carniolicoides C.Y.Wu et C.Chen 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
| Group | Dosage (g/kg) | Pain threshold (s) before the administration | Pain threshold after the administration (s) | |||
| 30min | 60min | 90min | 120min | |||
| Blank | 18.35± 2.98 | 19.40± 4.33 | 20.00± 2.65 | 21.10± 2.35 | 19.50± 1.47 | |
| Anisodus carniolicoides C.Y.Wu et C.Chen | 0.585 | 18.15± 3.66 | 31.30± 5.37*** | 42.30± 7.45*** | 40.70± 8.89*** | 38.60± 6.89*** |
| No. 1, ultra micro | 0.146 | 18.34± 4.07 | 26.20± 6.43** | 37.30± 9.86** | 35.30± 11.24** | 31.10± 9.49* |
| No. 1, ultra micro | 0.293 | 17.65± 2.53 | 32.20± 5.25*** | 41.80± 6.38*** | 40.20± 7.19*** | 38.20± 5.78*** |
| No. 2, ultra micro | 0.146 | 18.25± 2.39 | 28.50± 2.69*** | 35.20± 7.88*** | 36.60± 7.49*** | 30.40± 6.12*** |
| No. 2, ultra micro | 0.293 | 18.75± 1.55 | 32.30± 6.15*** | 44.20± 6.43*** | 41.40± 8.52*** | 39.30± 10.09*** |
Compare with the blank group: * P＜0.05, * * P＜0.01, * * * P＜0.001; Compare #P＜0.05 with the Anisodus carniolicoides C.Y.Wu et C.Chen group.
Result of the test shows, compare with the blank group, Anisodus carniolicoides C.Y.Wu et C.Chen group and ultrafine preparation group all can significantly improve the pain threshold of mice, and 2 groups of this product dosage are suitable with Anisodus carniolicoides C.Y.Wu et C.Chen group action effect, be that 1/2 times of amount of the quite former prescription of this product superfine powder is suitable with Anisodus carniolicoides C.Y.Wu et C.Chen group effect, play the effect that decrement is used.
Test 2: hemostasis trial
Get test mice, random packet is respectively Anisodus carniolicoides C.Y.Wu et C.Chen group, superfine powder group and blank group, 10 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:
Table 2 hemostasis trial
| Group | Dosage (g/kg) | Bleeding time (min) |
| Blank | 5.35±1.46 | |
| Anisodus carniolicoides C.Y.Wu et C.Chen | 0.585 | 3.65±1.87* |
| No. 1, ultra micro | 0.146 | 4.64±0.73 |
| No. 1, ultra micro | 0.293 | 3.22±1.63* |
| No. 2, ultra micro | 0.146 | 4.35±1.29 |
| No. 2, ultra micro | 0.293 | 3.37±1.66* |
Compare with the blank group: * P＜0.05; Compare #P＜0.05 with the Anisodus carniolicoides C.Y.Wu et C.Chen group.
Result of the test shows, superfine powder group produce effects when being equivalent to Anisodus carniolicoides C.Y.Wu et C.Chen 1/4 dosage, and when being equivalent to Anisodus carniolicoides C.Y.Wu et C.Chen 1/2 dosage, existing tangible haemostatic effect.
Test 3: 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:
Table 3 pair microcirculation of mouse auricle influence
| Group | Dosage (g/kg) | Vasodilation changes (%) | Blood flow speed changes (%) | ||
| Arteriole | Venule | Arteriole | Venule | ||
| Blank | 0.82 | 0.90 | -2.27 | -2.25 | |
| Anisodus carniolicoides C.Y.Wu et C.Chen | 0.585 | 40.23*** | 15.02*** | 39.30*** | 15.76*** |
| No. 1, ultra micro | 0.146 | 28.13** | 11.53** | 22.20** | 9.05** |
| No. 1, ultra micro | 0.293 | 43.87*** | 17.28*** | 44.96*** | 18.73*** |
| No. 2, ultra micro | 0.146 | 25.16** | 9.64** | 27.65** | 10.28** |
| No. 2, ultra micro | 0.293 | 45.54*** | 17.24*** | 42.71*** | 18.23*** |
Compare with the blank group: * * P＜0.01, * * * P＜0.001.
Result of the test shows, superfine powder group and Anisodus carniolicoides C.Y.Wu et C.Chen group 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 Anisodus carniolicoides C.Y.Wu et C.Chen group effect, has proved the tangible pharmacological effect of superfine powder.
Test 4: acute toxicity test in mice
Give two kinds of each 85g/kg of superfine powder of mouse stomach 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 5: 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 No. 1 high dose group of ultra micro, low dose group and No. 2 high dose group of ultra micro, 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.Prompting ultra micro preparation clinical practice safety, low toxicity.
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: Sanguis Draxonis 550g Olibanum (system) 90g Myrrha (processed) 90g
Flos Carthami 90g catechu 140g Borneolum Syntheticum 8g
Moschus 8g Cinnabaris 65g
Method for making: get Cinnabaris, water flies into impalpable powder, and particle diameter is less than 50 μ m, and is standby; Get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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, packing, promptly.
Embodiment two:
Prescription: Sanguis Draxonis 450g Olibanum (system) 60g Myrrha (processed) 60g
Flos Carthami 60g catechu 100g Borneolum Syntheticum 4g
Moschus 4g Cinnabaris 55g
Method for making: get Cinnabaris, water flies into impalpable powder, and particle diameter is less than 50 μ m, and is standby; Get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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.
Embodiment three:
Prescription: Sanguis Draxonis 550g Olibanum (system) 75g Myrrha (processed) 80g
Flos Carthami 70g catechu 110g Borneolum Syntheticum 5g
Moschus 5g Cinnabaris 60g
Method for making: get Cinnabaris, water flies into impalpable powder, and particle diameter is less than 50 μ m, and is standby; Get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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.
Embodiment four:
Prescription: Sanguis Draxonis 450g Olibanum (system) 70g Myrrha (processed) 60g
Flos Carthami 60g catechu 130g Borneolum Syntheticum 4g
Moschus 8g Cinnabaris 55g
Method for making: get Cinnabaris, water flies into impalpable powder, and particle diameter is less than 50 μ m, and is standby; Get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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, capsule charge, promptly.
Embodiment five:
Prescription: Sanguis Draxonis 550g Olibanum (system) 90g Myrrha (processed) 90g
Flos Carthami 90g catechu 140g Borneolum Syntheticum 8g
Moschus 8g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, 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, promptly gets powder.
Embodiment six:
Prescription: Sanguis Draxonis 450g Olibanum (system) 60g Myrrha (processed) 60g
Flos Carthami 60g catechu 100g Borneolum Syntheticum 4g
Moschus 4g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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.
Embodiment seven:
Prescription: Sanguis Draxonis 550g Olibanum (system) 75g Myrrha (processed) 80g
Flos Carthami 70g catechu 110g Borneolum Syntheticum 5g
Moschus 5g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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.
Embodiment eight:
Prescription: Sanguis Draxonis 450g Olibanum (system) 70g Myrrha (processed) 60g
Flos Carthami 60g catechu 130g Borneolum Syntheticum 4g
Moschus 8g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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.
Embodiment nine:
Prescription: Sanguis Draxonis 500g Olibanum (system) 75g Myrrha (processed) 75g
Flos Carthami 75g catechu 120g Borneolum Syntheticum 6g
Moschus 6g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, and pulverizes the back with common pulverizer and crosses 10 mesh sieves, and 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, capsule charge, promptly.
Embodiment ten:
Prescription: Sanguis Draxonis 500g Olibanum (system) 75g Myrrha (processed) 75g
Flos Carthami 75g catechu 120g Borneolum Syntheticum 6g
Moschus 6g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 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; With the superfine powder runny plaste at 40 ℃ of retrofilling soft capsules, promptly.
Embodiment 11:
Prescription: Sanguis Draxonis 500g Olibanum (system) 75g Myrrha (processed) 75g
Flos Carthami 75g catechu 120g Borneolum Syntheticum 6g
Moschus 6g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, dry, mix, pulverize the back with common pulverizer and cross 10 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.
Embodiment 12:
Prescription: Sanguis Draxonis 500g Olibanum (system) 75g Myrrha (processed) 75g
Flos Carthami 75g catechu 120g Borneolum Syntheticum 6g
Moschus 6g
Method for making: get Sanguis Draxonis, Olibanum (system), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus evaluation, drying is mixed, and pulverizes the back with common pulverizer and crosses 40 mesh sieves, and 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 (10)
1. Chinese medicine composition is characterized in that this Chinese medicine composition made by following bulk drugs: 450～550 parts of Sanguis Draxonis superfine powder, 60～90 parts of Olibanum (processed) superfine powder, 60～90 parts of Myrrha (processed) superfine powder, 60～90 parts of Flos Carthami superfine powder, 100～140 parts of catechu superfine powder, 4～8 parts of Borneolum Syntheticum superfine powder, 4～8 parts of Moschus superfine powders.
2. Chinese medicine composition as claimed in claim 1 is characterized in that the best proportion of each crude drug is: 500 parts of Sanguis Draxonis superfine powder, 75 parts of Olibanum (processed) superfine powder, 75 parts of Myrrha (processed) superfine powder, 75 parts of Flos Carthami superfine powder, 120 parts of catechu superfine powder, 6 parts of Borneolum Syntheticum superfine powder, 6 parts of Moschus superfine powders.
3. Chinese medicine composition as claimed in claim 1 or 2 is characterized in that can also having in the crude drug Cinnabaris water to fly 55～65 parts of impalpable powders.
4. as Chinese medicine composition as described in the claim 3, 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 application.
5. the preparation method of Chinese medicine composition as claimed in claim 4 is characterized in that:
Technical process when 1) not containing the Cinnabaris powder is:
A. get Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus 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.
Technical process when 2) containing the Cinnabaris powder is:
A. get Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus 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.
6. the preparation method of Chinese medicine composition as claimed in claim 5, it is characterized in that the concrete breaking method among the step a is: get Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, drying is mixed, and pulverizes the back with common pulverizer and crosses 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.
7. the preparation method of Chinese medicine composition as claimed in claim 5, it is characterized in that the concrete breaking method among the step a is: get Sanguis Draxonis, Olibanum (processed), Myrrha (processed), Flos Carthami, catechu, Borneolum Syntheticum, Moschus, 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.
8. the preparation method of Chinese medicine composition as claimed in claim 7, used disperse matrix can be the combination of following one or more when it is characterized in that superfine powder: soybean oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, PEG400, Macrogol 600, cetomacrogol 1000, Macrogol 4000, polyethylene glycol 6000, glycerol, 1,2-propylene glycol, phospholipid.
9. as the quality control method of Chinese medicine composition as described in the claim 4, it is characterized in that this method comprises in the following content any or several combinations:
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, gas chromatography are checked Moschus, Borneolum Syntheticum
It is an amount of to get this product, grinds, and gets 35mg, accurately claims surely, puts in the tool plug conical flask, and precision adds ethyl acetate 25ml, and supersound process 20min is put coldly, filters, and gets subsequent filtrate, and is standby, according to the gas chromatography test; It is an amount of that other gets the Borneolum Syntheticum reference substance, and accurate the title decides, and adds ethyl acetate and makes the solution that every 1ml contains 0.8mg, in contrast product solution; It is an amount of that other gets the muscone reference substance, and accurate the title decides, and adds ethyl acetate and makes the solution that every 1ml contains 0.4mg, in contrast product solution; Chromatographic condition and system suitability test HP-10.32mm * 30m fused-silica capillary column; Column temperature: 130 ℃; Get each 0.4～1.0 μ l of reference substance solution and need testing solution respectively, the injection gas chromatography view; The retention time of test sample chromatographic peak should be consistent with the retention time of reference substance chromatographic peak;
C, high performance liquid chromatography are measured the Dracoalban
The chromatographic condition chromatographic column is the C18 post; Mobile phase is that ratio is the 0.05mol/L potassium dihydrogen phosphate of 35: 65 acetonitrile-0.1% phosphoric acid; Flow velocity is 0.8ml/min; Column temperature is 40 ℃; Theoretical cam curve is not less than 4000 by the Dracoalban peak;
The preparation precision of reference substance solution takes by weighing Dracoalban's reference substance 9mg, puts in the brown measuring bottle of 50ml, adds 3% phosphoric acid methanol solution and makes dissolving and be diluted to scale, shake up, precision is measured 1ml, puts in the brown measuring bottle of 5ml, add methanol to scale, shake up, promptly;
Superfine powder 0.1～0.3g is got in the preparation of need testing solution, and accurate the title decides, and puts in the brown measuring bottle of 10ml, alcoholic solution 10ml in accurate adding 3% phosphoric acid, close plug, the accurate title, decide, ultrasonic 10min is placed to room temperature, supplies weight with methanol, shake up, filter, precision is measured subsequent filtrate 1ml and is put in the brown measuring bottle of 5ml, adds methanol and is diluted to scale, shake up, promptly;
Measure and get reference substance solution and each 20 μ l of need testing solution respectively, inject high performance liquid chromatograph, measure, promptly.
10. be used for the treatment of application in the medicine of diseases such as injury from falling down, blood stasis pain and femur head necrosis in preparation as Chinese medicine composition as described in the claim 3.
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| CNA2005102005551A CN1935242A (en) | 2005-09-22 | 2005-09-22 | Chinese medicine composition, and its preparing method and quality control method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101524391B (en) * | 2008-03-04 | 2012-08-15 | 北京亚东生物制药有限公司 | Detection method for Xihuang pills |
| CN102973757A (en) * | 2012-12-27 | 2013-03-20 | 王绪友 | Compound traditional Chinese medicine for treating fracture and preparation method thereof |
| CN105663867A (en) * | 2016-03-24 | 2016-06-15 | 周传杰 | Preparation method of traditional Chinese medicine for treating acute and chronic traumatic injury |
| CN107648578A (en) * | 2017-11-04 | 2018-02-02 | 黄文学 | Treat the external medicine composition of muscles and bones injury of muscle |
| CN110101782A (en) * | 2019-06-17 | 2019-08-09 | 贵州联盛药业有限公司 | A kind of preparation method of dragon's blood Ultramicro-powder |
| CN111012860A (en) * | 2020-01-10 | 2020-04-17 | 山东郭氏生物科技有限公司 | Traditional Chinese medicine composition for treating orthopedic diseases and traditional Chinese medicine preparation thereof |
-
2005
- 2005-09-22 CN CNA2005102005551A patent/CN1935242A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101524391B (en) * | 2008-03-04 | 2012-08-15 | 北京亚东生物制药有限公司 | Detection method for Xihuang pills |
| CN102973757A (en) * | 2012-12-27 | 2013-03-20 | 王绪友 | Compound traditional Chinese medicine for treating fracture and preparation method thereof |
| CN105663867A (en) * | 2016-03-24 | 2016-06-15 | 周传杰 | Preparation method of traditional Chinese medicine for treating acute and chronic traumatic injury |
| CN107648578A (en) * | 2017-11-04 | 2018-02-02 | 黄文学 | Treat the external medicine composition of muscles and bones injury of muscle |
| CN110101782A (en) * | 2019-06-17 | 2019-08-09 | 贵州联盛药业有限公司 | A kind of preparation method of dragon's blood Ultramicro-powder |
| CN111012860A (en) * | 2020-01-10 | 2020-04-17 | 山东郭氏生物科技有限公司 | Traditional Chinese medicine composition for treating orthopedic diseases and traditional Chinese medicine preparation thereof |
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Open date: 20070328 |