CN100563698C - Chinese medicine composition of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones and preparation method thereof - Google Patents
Chinese medicine composition of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to the Chinese medicine preparation of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones, the said preparation prescription comprises following Chinese medicine raw material: Radix Aconiti Preparata 90-95 part, Radix Aconiti Kusnezoffii Preparata 90-95 part, Semen Strychni (processed) 6-10 part, Rhizoma Pinelliae 25-35 part, Rhizoma Arisaematis (processed) 13-18 part, Pericarpium Citri Reticulatae 10-20 part, Radix Cyathulae 6-9 part, Fructus Chaenomelis 6-9 part, Radix Codonopsis 10-20 part, Ramulus Uncariae Cum Uncis 10-20 part, Herba Dendrobii 6-9 part, Radix Dipsaci 15.1-16 part, Lapis Micae Aureus 4.5-4.9 part, Pulvis Fumi Carbonisatus 4.5-4.9 part; By following prepared: above-mentioned raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule earlier, pulverize micronizing then again, behind the mixing again the preparation method according to Chinese medicine preparation add the various dosage forms that acceptable accessories is made suitable administration.The present invention is to the reasonable assembly of Chinese crude drug, and adopts superfine communication technique that it is pulverized, and improved the bioavailability of preparation, and human body significantly improves its absorbance.
Description
Technical field
The present invention relates to Chinese medicine composition of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones and preparation method thereof, the especially application of this Chinese medicine composition in preparation treatment rheumatic arthritis, rheumatoid arthritis and osteoporotic medicine.
Background technology
China joint disease patient sum surpasses 100,000,000, it is introduced that China's arthritis disease prevalence is high, is more common in the old people, statistics shows more than 50 years old among the crowd that 50% suffers from arthritis, suffers from this sick women and male among the over-65s crowd more up to more than 80%.Rheumatoid arthritis is about 0.35% in China's prevalence, but it easily causes patient's deformity, and brokenization of the bone rate in 2 years of the course of disease is 50%, the person of being in a bad way even shortening life-span 10-15.Although arthritis, rheumatoid arthritis are not incurable disease, the high sickness rate of arthritis should cause extensive concern, to reduce the threat that this modal chronic disease causes health of the masses.Knee joint osseous arthritis is mainly limitation in the change that pathologic goes up very much, and the hyperosteogeny of carrying out articular cartilage destruction and edge, joint forms, and hyperosteogeny forms the performance that is actually a reparation.Though osteoarthritis is the X radiodiagnosis x, and symptom is not necessarily arranged, the hospital admission person all goes to a doctor because of pain and swelling or limitation of activity, makes a definite diagnosis after film making, so clinical osteoarthritis patient all has symptom, is medically belonging to the rheumatism involving the bone scope.Patient's pain is that aseptic inflammation causes, has stagnation of blood stasis, yang deficiency cold coagulation and the marrow of suffering from a deficiency of the kidney to lose by the symptom typing.The Western medicine that is used for the treatment of pain diseases such as rheumatic arthritis, rheumatoid arthritis, osteoarthritis clinically mainly contains ibuprofen and piroxicam and ibuprofen, the effective percentage of ibuprofen is 70.69%, the pain rate that the relieves the pain effect of piroxicam and ibuprofen is obvious, but can not radical curing of disease.The Chinese patent medicine for the treatment of above-mentioned disease has FENGSHI GUANJIEYAN PIAN, KANGGU ZENGSHENG WAN, Fengshi maqian tablet, promoting blood air circulation and building up bone sheet etc., and the consumption of Fengshi maqian tablet is excessive and take for a long time, and toxicity is bigger.The promoting blood air circulation and building up bone sheet only cures mainly head necrosis, and therapeutic domain is little.The KANGGU ZENGSHENG WAN consumption of taking medicine is big, and therapeutic effect is slow, and therapeutic domain is little.FENGSHI GUANJIEYAN PIAN is mainly treated rheumatic arthritis, and therapeutic domain is little.
Long-term waist posture is bad, or is engaged in that waist is held power and work such as the activity of bending over, and can cause the fascia thoracolumbalis muscular strain, or fascia is lax, or blood stasis is arranged, or trickle damage is arranged, so that pain in the lumbar region is difficult; If exposure to wind when sweating reveals the greedy cold of crouching, or trickle damage is arranged, so that lumbago is difficult; If exposure to wind when sweating reveals the greedy cold of crouching, the cold-damp invasion and attack, band is superintended and directed in the numbness resistance, looses for a long time and not, and a little less than the flesh myospasm becomes to speeding, and patient's work is as before, and the flesh muscle easily causes damage a little less than then speeding, and makes strain and cold-damp complication.Suitable promoting flow of QI and blood in treatment, removing obstruction in the collateral to relieve pain.The clinically employing of lumbar muscle strain massaged more at present, and some oral Chinese patent medicines have also appearred in massage treatment on the market.
Chinese medicine composition of a kind of dispelling, collateral-activating, strengthening the tendons and bones and preparation method thereof is disclosed as Chinese patent application 200610160772.7, the especially application of this Chinese medicine composition in preparation treatment rheumatic arthritis, rheumatoid arthritis and osteoporotic medicine.The present invention is on the basis of research tradition Chinese herbal medicine, through test for many years, integrates theory with practice, and the advanced study and training summary draws with great concentration.Medicine of the present invention coaches with theory of Chinese medical science, with the temperature compensation Liver and kidney, strengthening the tendons and bones, blood-enriching and blood-promoting circulation, the circulation of qi promoting QI invigorating is main, sharp spleen and removing dampness, the appetizing of regulating the flow of vital energy is auxilliary, thereby it is strong to reach muscles and bones, and body is painless, QI and blood is lived wind from going out, and has significant curative effect for treatment rheumatic arthritis, rheumatoid arthritis and osteoporosis.
Chinese patent application 00100618.5 discloses a kind of capsule for treating arthritis and strengthening physique.The present invention adopt Semen Strychni (processed), Pheretima, system river Squama Manis, Radix Clematidis, Radix Saposhnikoviae, Scolopendra, gastropine, Radix Ginseng Rubra, Rhizoma Drynariae, the worm of spraining, Zaocys, system Semen Hydnocarpi, Radix Angelicae Sinensis, Herba speranskiae tuberculatae, vitamin B1 be primary raw material, and adopt: dredge the meridian passage, search wind, rheumatism, expelling wind and cold, reducing swelling and alleviating pain, principle that Shujin is deep realizes, cost of the present invention is low, raw material is easily got, and processing technology is simple.
Rhizoma Arisaematis has calmness, eases pain, eliminates the phlegm.Be used for the treatment of neural paralysis, the heap soil or fertilizer over and around the roots of middle wind-phlegm, hemiplegia etc. clinically.
Radix Aconiti, Radix Aconiti Kusnezoffii have the effect of expelling wind and removing dampness, jiao dispelling cold and analgesia.Clinical anemofrigid-damp arthralgia, joint bones and muscles pain, hemiplegia, the colic of cold type stomachache of being mainly used in.
The Semen Strychni pharmacological action show have analgesic activity, bacteriostasis.The clinical symptoms such as neural paralysis, trigeminal neuralgia, arthritis, myasthenia gravis that are mainly used in.
Radix Dipsaci, Radix Cyathulae have the effect of invigorating the liver and kidney, bone and muscle strengthening.The effect that rheumatism is had alleviating pain.
The Rhizoma Pinelliae has antitussive, phlegm-dispelling functions.Be used for the treatment of face muscle spasm, cervical lymphadenitis clinically.
Ramulus Uncariae Cum Uncis has calmness, anticonvulsant action.Clinically be used for diseases such as migraine, infantile convulsion tic, pregnant eclamposia, hypertension.
Radix Codonopsis has the effect that improves organism adaptation.Spleen invigorating lung benefiting, invigorating the spleen and replenishing QI, the clinical nerve functional disease that is used for the treatment of.
Chinese patent 200410026331.9 discloses a kind of Tendon and bone strengthening capsule, comprise (weight portion): 6～35 parts of Radix Aconiti Preparatas, 6～35 parts of Radix Aconiti Kusnezoffii Preparatas, 1～8 part of Herba Dendrobii, 1～8 part of Radix Cyathulae, 1～9 part of Radix Codonopsis, 4～10 parts of Fructus Chaenomeliss, 1～8 part of Ramulus Uncariae Cum Uncis, 5～15 parts of Radix Dipsacis, 1～6 part of Pericarpium Citri Reticulatae, 1～9 part of Semen Strychni (processed), 5～12 parts of Rhizoma Arisaematis (processed), 5～15 parts of Rhizoma Pinelliae Preparata, 6～16 parts of Pulvis Fumi Carbonisatuss, 5～14 parts of Lapis Micae Aureuss, the medicament of formulation method preparation routinely.It is through acute toxicity test and clinical observation test, mouse stomach administration maximum dosage-feeding every day 17.6g/kg.Clinical test results: the total effective rate of treatment osteoarthritis is 90.00%, the arthropathic total effective rate of kneecap is 86%, the total effective rate of scapulohumeral periarthritis is 88.7%, the total effective rate of prolapse of lumbar intervertebral disc is 94.4%, the total effective rate of apoplexy sequela is 86.1%, the cure rate of facial nerve paralysis is 90.2%.After State Food and Drug Administration's approval is produced, can promote the use of clinically.In this patent above-mentioned 14 flavor Chinese crude drugs are ground into fine powder, add pharmaceutic adjuvant commonly used again after sieving and be prepared into various preparations.The inventor finds only above-mentioned 14 flavor Chinese crude drugs to be ground into fine powder, and the dissolving release of the Chinese medicine preparation of its preparation, medicine absorption in vivo and bioavailability are bad.And adopt the alcoholic solution of polyvinylpyrrolidone to make binding agent in the preparation process, but find that the Pericarpium Citri Reticulatae quality is loose in its Chinese crude drug, make binding agent with the alcoholic solution of polyvinylpyrrolidone, its grain forming of making is bad.
In view of this, special proposition the present invention.
Summary of the invention
The Chinese medicine preparation that the purpose of this invention is to provide a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones, the bioavailability of this Chinese medicine preparation improves greatly, and human body significantly improves its degree of absorption, and preparations shaping is good.
For achieving the above object, the present invention adopts following technical scheme:
The Chinese medicine preparation of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones comprises following Chinese medicine raw material in the prescription of this Chinese medicine preparation:
Radix Aconiti Preparata 90-95 part
Radix Aconiti Kusnezoffii Preparata 90-95 part
Semen Strychni (processed) 6-10 part
Rhizoma Pinelliae 25-35 part
Rhizoma Arisaematis (processed) 13-18 part
Pericarpium Citri Reticulatae 10-20 part
Radix Cyathulae 6-9 part
Fructus Chaenomelis 6-9 part
Radix Codonopsis 10-20 part
Ramulus Uncariae Cum Uncis 10-20 part
Herba Dendrobii 6-9 part
Radix Dipsaci 15.1-16 part
Lapis Micae Aureus 4.5-4.9 part
Pulvis Fumi Carbonisatus 4.5-4.9 part;
Described Chinese medicine preparation is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing;
4) the various preparation formulations of the administration that suits will be made again behind the resulting ultra micro Chinese medicine powder mixing according to the preparation method adding acceptable accessories of Chinese medicine preparation.
How the medicinal ingredient in the Chinese crude drug fully and is to greatest extent extracted, this is the subject matter of preparation Chinese medicine preparation.Between the dissolving release of medical material miniaturization and solid drugs, medicine absorption in vivo and the bioavailability substantial connection is arranged.Therefore micronization is the key technology that a raising medical material utilizes effect.In the Chinese patent 200410026331.9 above-mentioned 14 flavor Chinese crude drugs are ground into fine powder, add pharmaceutic adjuvant commonly used again after sieving and be prepared into various preparations.The inventor finds only above-mentioned 14 flavor Chinese crude drugs to be ground into fine powder, and the dissolving release of the Chinese medicine preparation of its preparation, medicine absorption in vivo and bioavailability are bad.Among the present invention, above-mentioned 14 flavor Chinese medicine raw materials are concocted pulverizing and then micronizing more earlier, concoct the toxicity that to eliminate or to reduce medicine on the one hand, strong or side effect, change the performance of medicine, make it more can be fit to state of an illness needs, be convenient to preparation and storage, remove impurity and non-medicinal part, make medicine pure, could consumption accurate, or be beneficial to and take, pulverizing micronizing on the other hand earlier can make the granule of Chinese medicine diminish again, granularity reduces, it is big that area becomes, simply say to be exactly that the specific surface area of Chinese medicine is significantly improved, thereby obviously improve the bioavailability of Chinese medicine, human body is significantly improved the absorbance of Chinese medicine; And micronizing can make the direct breaking cellular wall of Chinese medicine cell, is very beneficial for the direct absorption of human body to effective ingredient like this.Adopt method of the present invention can obviously improve the bioavailability of Chinese medicine, human body is significantly improved the absorbance of Chinese medicine, be very beneficial for the direct absorption of human body effective ingredient.
In the above-mentioned preparation method, coarse grained particle diameter is less than 0.85mm described in the step 1).
In the above-mentioned preparation method, step 2) particle diameter of Chinese medicine fine powder is less than 150 μ m described in.
In the above-mentioned preparation method, the particle diameter of the Chinese medicine powder of ultra micro described in the step 3) is 5-10 μ m.
Whether the size of grain diameter directly influences its mixing even, and the inventor has carried out strict control to the size of particle diameter, and the quality of gained preparation is good.
The present invention, Chinese medicine fine powder superfine powder is broken into the step of ultra micro Chinese medicine powder, be that pulverizing is the ultra micro Chinese medicine powder for coarse grained Chinese medicine and air after lyophilization inject the super micron mill pulverizing jointly, air themperature after the lyophilization is 3-8 ℃, water content＜1%, pressure is 1.0-1.2MPa when injecting super micron mill, and the operating pressure of super micron mill is 1.0-1.2MPa, and the internal work temperature is 2-6 ℃.
In addition, the prescription to above-mentioned 14 flavor Chinese crude drugs among the present invention has carried out assembly, finds can reach better therapeutic when adopting prescription of the present invention.
Preferably, comprise in the prescription of described Chinese medicine preparation:
Radix Aconiti Preparata 91-93 part
Radix Aconiti Kusnezoffii Preparata 91-93 part
Semen Strychni (processed) 7-9 part
Rhizoma Pinelliae 28-32 part
Rhizoma Arisaematis (processed) 14-16 part
Pericarpium Citri Reticulatae 13-17 part
Radix Cyathulae 7-8 part
Fructus Chaenomelis 7-8 part
Radix Codonopsis 13-17 part
Ramulus Uncariae Cum Uncis 13-17 part
Herba Dendrobii 7-8 part
Radix Dipsaci 15.2-15.8 part
Lapis Micae Aureus 4.6-4.8 part
Pulvis Fumi Carbonisatus 4.6-4.8 part.
Preferred, comprise in the prescription of described Chinese medicine preparation:
92.3 parts of Radix Aconiti Preparatas
92.3 parts of Radix Aconiti Kusnezoffii Preparatas
7.7 parts of Semen Strychni (processed)s
30.8 parts of the Rhizoma Pinelliaes
15.4 parts of Rhizoma Arisaematis (processed)
15.4 parts of Pericarpium Citri Reticulataes
7.7 parts of Radix Cyathulaes
7.7 parts of Fructus Chaenomeliss
15.4 parts of Radix Codonopsis
15.4 parts of Ramulus Uncariae Cum Uncis
7.7 parts of Herba Dendrobiis
15.4 parts of Radix Dipsacis
4.7 parts of Lapis Micae Aureuses
4.7 parts of Pulvis Fumi Carbonisatuss.
Among the present invention, described preparation formulation is tablet, capsule, granule, powder, pill, syrup, mixture, medicinal tea, emplastrum or plaster.
Among the present invention, that described acceptable accessories is well known to those skilled in the art, for being used to prepare the usual excipients or the adjuvant of above-mentioned preparation.Excipient that oral formulations or external preparation are commonly used or adjuvant include but are not limited to filler or diluent, lubricant or fluidizer or antitack agent, dispersant, wetting agent, binding agent, regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent etc.Binding agent, for example syrup, arabic gum, gelatin, sorbitol, tragacanth, cellulose and derivant thereof, gelatine size, syrup, starch slurry or polyvinylpyrrolidone, preferred cellulose derivative is microcrystalline Cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl methylcellulose; Filler, for example lactose, Icing Sugar, dextrin, starch and derivant thereof, cellulose and derivant thereof, inorganic calcium salt, sorbitol or glycine, preferred inorganic calcium salt is calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate; Lubricant, for example micropowder silica gel, magnesium stearate, Pulvis Talci, aluminium hydroxide, boric acid, hydrogenated vegetable oil, Polyethylene Glycol; Disintegrating agent, for example starch and derivant thereof, polyvinylpyrrolidone or microcrystalline Cellulose, preferred starch derivatives is carboxymethyl starch sodium, Explotab, pregelatinized Starch, modified starch, hydroxypropyl starch, corn starch; Wetting agent, for example sodium lauryl sulphate, water or alcohol etc.; The pharmaceutically acceptable carrier of preferred oral preparation is microcrystalline Cellulose, magnesium stearate or ethanol etc.
Among the present invention, also active component can be mixed by its preparation requirement with pharmaceutically acceptable slow controlled release carrier, again according to the preparation method of sustained-release preparation well known in the art, as adding the blocker coating or with making micropill after the active principle microcapsulesization again, as slow-release micro-pill or controlled release micro pill; Described slow controlled release carrier includes but are not limited to oil agent, hydrophilic colloid or the coating blocker etc. of mixing, and described oil to mix agent be glyceryl monostearate, castor oil hydrogenated, Dormant oils, polysiloxanes, dimethyl siloxane; Described hydrophilic colloid is cellulose derivatives such as pregelatinized Starch, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, or PVP, arabic gum, tragcanth or carbopol etc.; Described coating blocker is ethyl cellulose (EC), hydroxypropyl methylcellulose (HMPC), polyvinylpyrrolidone (PVP), cellulose acetate-phthalate (CAP), acrylic acid resinoid etc.
Among the present invention, when described preparation formulation was tablet, used adjuvant was syrup, magnesium stearate and Pulvis Talci.
Full sheets of powder in the Chinese medicine is many makes binding agent with starch slurry.The method for making of starch slurry has a significant impact its viscosity, and the concentration of starch slurry, consumption are also influential to granulating, and in use simultaneously, should also be noted that and will use while hot, fully stir etc.Therefore, make binding agent more complicated in the preparation process of the full sheets of powder of Chinese medicine with starch slurry.Adopt the alcoholic solution of polyvinylpyrrolidone to make binding agent in the Chinese patent 200410026331.9, but find that the Pericarpium Citri Reticulatae quality is loose in its Chinese crude drug, make binding agent with the alcoholic solution of polyvinylpyrrolidone, its grain forming of making is bad.Among the present invention, select for use syrup to make binding agent, syrupy viscosity is very strong, and its grain forming of making is better.
The preparation method of described tablet comprises the steps:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing;
4) with behind the resulting ultra micro Chinese medicine powder of the step 3) mixing, add syrup and make granule, dry back adds magnesium stearate, Pulvis Talci, and mixing, tabletting are promptly.
Among the present invention, above-mentioned preparation method also comprises sugar coating or film-coat.
In the above-mentioned preparation method, coarse grained particle diameter is less than 0.85mm described in the step 1).
In the above-mentioned preparation method, step 2) particle diameter of Chinese medicine fine powder is less than 150 μ m described in.
In the above-mentioned preparation method, the particle diameter of the Chinese medicine powder of ultra micro described in the step 3) is 5-10 μ m.
In the above-mentioned preparation method, in the step 4) with particle drying to moisture≤6%, described tabletting is at ambient temperature 18-26 ℃, the condition lower sheeting of relative humidity 45-65%.
Whether the particle drying degree is suitable, and the moisture in the granule has important function to the formation and the quality of tablet.Suitable moisture is the plastic deformation that increases crisp particle, reduces elasticity and helps tabletting, and hardness is also better.Be controlled between the 1.5-2.0% then easily tabletting as the VITAMIN C TABLET pellet moisture, and moisture reduces to 1% when following, sliver, loose sheet phenomenon occur, even tablet is shaped, during by several pieces plate packing, a mao angle, unilateral phenomenon such as loose appear in about 30% slice, thin piece.On the contrary, moisture surpasses at 30% o'clock, easily produces the sticking phenomenon again.The inventor is through repetition test, finds among the present invention with particle drying to moisture to be at≤6% o'clock, and the shaping and the quality of prepared tablet are good.
In addition, environmental condition also can cause direct influence to tabletting, and well-known, when air humidity was too high, the phenomenon that sticking appears in the more intense drug particles of hygroscopicity was very obvious.The inventor finds through a large amount of test, when at ambient temperature 18-26 ℃, and during the condition lower sheeting of relative humidity 45-65%, the good moldability of Chinese medicinal tablet of the present invention, unilateral bright and clean, the sticking phenomenon does not appear.
Preferably, the preparation method of the Chinese medicinal tablet of dispelling wind and removing obstruction in the collateral of the present invention, strengthening the tendons and bones is:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule, wherein said coarse grained particle diameter is less than 0.85mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder, the particle diameter of wherein said Chinese medicine fine powder is less than 150 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing, the particle diameter of wherein said ultra micro Chinese medicine powder is 5-10 μ m;
4) with behind the resulting ultra micro Chinese medicine powder mixing, add syrup and make granule, be dried to moisture≤6% again, add magnesium stearate, Pulvis Talci then, mixing, at ambient temperature 18-26 ℃, the condition lower sheeting of relative humidity 45-65% is promptly.
The preparation method of above-mentioned tablet also comprises prepared tablet sugar coating or film-coat.
Preferred, the preparation method of the Chinese medicinal tablet of dispelling wind and removing obstruction in the collateral of the present invention, strengthening the tendons and bones is:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule, wherein said coarse grained particle diameter is less than 0.85mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder, the particle diameter of wherein said Chinese medicine fine powder is less than 150 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing, the particle diameter of wherein said ultra micro Chinese medicine powder is 5-10 μ m;
4) with behind the resulting ultra micro Chinese medicine powder mixing, add syrup and make granule, be dried to moisture≤6% again, add magnesium stearate, Pulvis Talci then, mixing is at ambient temperature 18-26 ℃, the condition lower sheeting of relative humidity 45-65%, last sugar coating or film-coat, promptly.
Medicine of the present invention has carried out acute toxicity test and long term toxicity test through ShanXi Chinese Medicine Academy pharmacology crude drug experimental center, and result of the test shows: main organs no abnormality seens such as mouse core, liver, spleen, lung, kidney, stomach change, non-toxic reaction.
The present invention compares than prior art, has following advantage:
(1) the present invention has carried out rational assembly to Chinese crude drug, its better efficacy;
(2) among the present invention, above-mentioned 14 flavor Chinese medicine raw materials are concocted pulverizing and then micronizing more earlier, concoct the toxicity that to eliminate or to reduce medicine on the one hand, strong or side effect, change the performance of medicine, make it more can be fit to state of an illness needs, be convenient to preparation and storage, remove impurity and non-medicinal part, make medicine pure, could consumption accurate, or be beneficial to and take, pulverizing micronizing on the other hand earlier can make the granule of Chinese medicine diminish again, granularity reduces, it is big that area becomes, simply say to be exactly that the specific surface area of Chinese medicine is significantly improved, thereby obviously improve the bioavailability of Chinese medicine, human body is significantly improved the absorbance of Chinese medicine; And micronizing can make the direct breaking cellular wall of Chinese medicine cell, is very beneficial for the direct absorption of human body to effective ingredient like this;
(3) among the preparation technology of the present invention to the moisture behind the particle drying, the environmental condition during tabletting has been carried out strict control, thus the preparations shaping of the prepared Chinese medicinal tablet of the present invention is better.
The specific embodiment
Below be the specific embodiment of the present invention, described embodiment is in order to describe the present invention in more detail, rather than restriction the present invention.
The preparation of [embodiment 1] tablet
Comprise following Chinese medicine raw material in the prescription of Chinese medicinal tablet:
Radix Aconiti Preparata 90g
Radix Aconiti Kusnezoffii Preparata 90g
Semen Strychni (processed) 6g
Rhizoma Pinelliae 25g
Rhizoma Arisaematis (processed) 13g
Pericarpium Citri Reticulatae 10g
Radix Cyathulae 6g
Fructus Chaenomelis 6g
Radix Codonopsis 10g
Ramulus Uncariae Cum Uncis 10g
Herba Dendrobii 6g
Radix Dipsaci 15.1g
Lapis Micae Aureus 4.5g
Pulvis Fumi Carbonisatus 4.5g
Chinese medicinal tablet is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder;
3) with behind the resulting Chinese medicine fine powder mixing, add syrup and make granule, dry back adds magnesium stearate, Pulvis Talci, and mixing, tabletting are promptly.
The preparation of [embodiment 2] tablet
Comprise following Chinese medicine raw material in the prescription of Chinese medicinal tablet:
Radix Aconiti Preparata 93g
Radix Aconiti Kusnezoffii Preparata 93g
Semen Strychni (processed) 9g
Rhizoma Pinelliae 32g
Rhizoma Arisaematis (processed) 16g
Pericarpium Citri Reticulatae 17g
Radix Cyathulae 8g
Fructus Chaenomelis 8g
Radix Codonopsis 17g
Ramulus Uncariae Cum Uncis 17g
Herba Dendrobii 8g
Radix Dipsaci 15.8g
Lapis Micae Aureus 4.8g
Pulvis Fumi Carbonisatus 4.8g
Chinese medicinal tablet is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule, wherein said coarse grained particle diameter is 0.84mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder, the particle diameter of wherein said Chinese medicine fine powder is 148 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing, the particle diameter of wherein said ultra micro Chinese medicine powder is 10 μ m;
4) with behind the resulting ultra micro Chinese medicine powder mixing, add syrup and make granule, be dried to moisture 6% again, add magnesium stearate, Pulvis Talci then, mixing, 26 ℃ of ambient temperatures, the condition lower sheeting of relative humidity 45% is promptly.
The preparation of [embodiment 3] tablet
Comprise following Chinese medicine raw material in the prescription of Chinese medicinal tablet:
Radix Aconiti Preparata 91g
Radix Aconiti Kusnezoffii Preparata 91g
Semen Strychni (processed) 7g
Rhizoma Pinelliae 28g
Rhizoma Arisaematis (processed) 14g
Pericarpium Citri Reticulatae 13g
Radix Cyathulae 7g
Fructus Chaenomelis 7g
Radix Codonopsis 13g
Ramulus Uncariae Cum Uncis 13g
Herba Dendrobii 7g
Radix Dipsaci 15.2g
Lapis Micae Aureus 4.6g
Pulvis Fumi Carbonisatus 4.6g
Chinese medicinal tablet is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule, wherein said coarse grained particle diameter is 0.80mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder, the particle diameter of wherein said Chinese medicine fine powder is 130 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing, the particle diameter of wherein said ultra micro Chinese medicine powder is 5 μ m;
4) with behind the resulting ultra micro Chinese medicine powder mixing, add syrup and make granule, be dried to moisture 5% again, add magnesium stearate, Pulvis Talci then, mixing is 18 ℃ of ambient temperatures, the condition lower sheeting of relative humidity 65%, last sugar coating or film-coat, promptly.
The preparation of [embodiment 4] tablet
Comprise following Chinese medicine raw material in the prescription of Chinese medicinal tablet:
Radix Aconiti Preparata 92.3g
Radix Aconiti Kusnezoffii Preparata 92.3g
Semen Strychni (processed) 7.7g
Rhizoma Pinelliae 30.8g
Rhizoma Arisaematis (processed) 15.4g
Pericarpium Citri Reticulatae 15.4g
Radix Cyathulae 7.7g
Fructus Chaenomelis 7.7g
Radix Codonopsis 15.4g
Ramulus Uncariae Cum Uncis 15.4g
Herba Dendrobii 7.7g
Radix Dipsaci 15.4g
Lapis Micae Aureus 4.7g
Pulvis Fumi Carbonisatus 4.7g.
Chinese medicinal tablet is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule, wherein said coarse grained particle diameter is less than 0.80mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder, the particle diameter of wherein said Chinese medicine fine powder is less than 75 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing, the particle diameter of wherein said ultra micro Chinese medicine powder is 8 μ m;
4) with behind the resulting ultra micro Chinese medicine powder mixing, add syrup and make granule, be dried to moisture 4% again, add magnesium stearate, Pulvis Talci then, mixing, 22 ℃ of ambient temperatures, the condition lower sheeting of relative humidity 45% is promptly.
The preparation of [embodiment 5] tablet
Prescription is with embodiment 4, and preparation technology is with embodiment 4 steps 2) in behind the resulting Chinese medicine fine powder mixing, add syrup and make granule, be dried to moisture 3% again, add magnesium stearate, Pulvis Talci then, mixing, 22 ℃ of ambient temperatures, the condition lower sheeting of relative humidity 45% promptly.
[embodiment 6] capsular preparation
The prescription of Chinese medicinal capsule is with embodiment 4, and preparation technology is with in incapsulating behind the particle drying of embodiment 4 described preparations, the mixing, promptly.
The preparation of [embodiment 7] granule
The prescription of Chinese medicine granules is with embodiment 4, and preparation technology divides in the bag of packing into, promptly after for the particle drying that embodiment 4 is prepared, mixing.
The preparation of [embodiment 8] granule
The prescription of Chinese medicine granules is with embodiment 4, and its preparation technology is prepared into Chinese medicine granules according to the preparation method of Chinese medicine granules with it after for the resulting prepared slices of Chinese crude drugs in the step 1) with embodiment 4 or coarse granule mixing.
The preparation of [embodiment 9] powder
The prescription of Chinese powder medicine and preparation technology are with embodiment 6.
The preparation of [embodiment 10] pill
The prescription of medicine pill is with embodiment 4, and its preparation technology is prepared into medicine pill according to the preparation method of medicine pill with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
The preparation of [embodiment 11] syrup
The prescription of Chinese materia medica syrup is with embodiment 4, and its preparation technology is prepared into Chinese materia medica syrup according to the preparation method of Chinese materia medica syrup with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
The preparation of [embodiment 12] syrup
The prescription of Chinese materia medica syrup is with embodiment 4, and its preparation technology is prepared into Chinese materia medica syrup according to the preparation method of Chinese materia medica syrup with it after for the resulting prepared slices of Chinese crude drugs in the step 1) with embodiment 4 or coarse granule mixing.
The preparation of [embodiment 13] mixture
The prescription of herb mixture is with embodiment 4, and its preparation technology is prepared into herb mixture according to the preparation method of herb mixture with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
The preparation of [embodiment 14] mixture
The prescription of herb mixture is with embodiment 4, and its preparation technology is prepared into herb mixture according to the preparation method of herb mixture with it after for the resulting prepared slices of Chinese crude drugs in the step 1) with embodiment 4 or coarse granule mixing.
The preparation of [embodiment 15] medicinal tea
The prescription of Chinese medicine medicinal tea is with embodiment 4, and its preparation technology is prepared into the Chinese medicine medicinal tea according to the preparation method of Chinese medicine medicinal tea with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
The preparation of [embodiment 16] medicinal tea
The prescription of Chinese medicine medicinal tea is with embodiment 4, and its preparation technology is prepared into the Chinese medicine medicinal tea according to the preparation method of Chinese medicine medicinal tea with it after for the resulting prepared slices of Chinese crude drugs in the step 1) with embodiment 4 or coarse granule mixing.
The preparation of [embodiment 17] emplastrum
The prescription of Chinese medicine patch unguentum is with embodiment 4, and its preparation technology is prepared into the Chinese medicine patch unguentum according to the preparation method of Chinese medicine patch unguentum with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
The preparation of [embodiment 18] plaster
The prescription of Chinese medicine plaster is with embodiment 4, and its preparation technology is prepared into Chinese medicine plaster according to the preparation method of Chinese medicine plaster with it after for resulting ultra micro Chinese medicine powder mixing in the step 3) with embodiment 4.
[test example 1] product tablet acute toxicity LD of the present invention
50Mensuration
Method and result
It is standby earlier the tablet of the embodiment of the invention 4 to be made the 30g% medicinal liquid with distilled water.
Get 15 of mices, 5 every group, divide three groups; That is: high, medium and low three dosage groups (0.4,0.2,0.1ml/10g).Fasting, can't help water 14h after, ig gives 1 time/d of test sample, predicts product tablet acute toxicity LD of the present invention
50
The result shows: none death behind the high dose group mice 3d, can not survey test sample LD
50So with product P OLD of the present invention
50Mensuration change and do maximum dosage-feeding (MTD) and measure.
Get 30 of mices, male and female half and half.Fasting, can't help behind the water 14h to predict that selected high dose group 0.4ml/10g gives test sample 1 time by an ig, observes 7d continuously.None death as a result.
7d viewing duration finding: give behind the test sample at ig that 30 mice independent activities obviously descend in the 24h, ingest, take the photograph that water is movable obviously reduces statvolt.Each mice independent activity is gradually normal behind the 24h, and Excreta, secretions no abnormality seen, weight increase also Non Apparent Abnormality change.Being tried mice after the observation expiration all survives.
Observe the execution of expiration back and all tried mice by a gross necropsy, as seen Non Apparent Abnormality case phases such as each important organ heart, liver, spleen, lung, kidney (bilateral), stomach, intestinal, testis/ovary change.
Brief summary: record maximum dosage-feeding (MTD) for the tablet of the mice ig embodiment of the invention 4 and be 12g/kg.d (quite primary crude drug 12g/kg.d).Be adult 240 times of (70kg) clinical consumption per day.
[test example 2] product tablet long term toxicity test of the present invention
Test sample: the strengthening the tendons and bones sheet physical behavior of the embodiment of the invention 4: chocolate brown powder
Specification: 12 * 3/ box content: 0.3g/ sheet (containing raw medicinal herbs 0.3g/ sheet)
Lot number: 030101 valid until: 200501
Authentication code: the accurate word Z20025061 of traditional Chinese medicines
The test sample unit of providing: Hanwang Pharmaceutical Industry Co., Ltd., Shanxi
Animal subject: SD strain rat in 8 age in week, body constitution amount 129.5 ± 13.59g, male and female half and half.Provide by Traditional Chinese Medicine Research Institute, Shanxi Province medical experiment animal center.The animal quality quality certification number: one grade of the moving card of Shan doctor word 08-25 number
Detectable
1, alkali phosphatase ALP (1) 10 * 10ml
Lot number: 020902
Effect duration: 030901
Beijing Zhongsheng Biological Engineering High Technology Company
(capital) is defended medicine and is given birth to the card No. 414 accurate word of traditional Chinese medicines of word (1999) D-117 number
2, glucose assays test kit (oxidation enzyme process)
Lot number: 021001
Effect duration: 030930
Shanghai Rongsheng Bioisystech Co., Ltd
The G-P5 medicine authorized No. is defended No. 06 in Shanghai
3, total protein TP 1 * 500ml
Lot number: 020801
Effect duration: 0300801
The card number: capital T20010069
Authentication code: (93) are defended the accurate word D-53-5 of medicine number
Beijing Zhongsheng Biological Engineering High Technology Company
4, albumin A IB 1 * 500ml
Lot number: 020822
Effect duration: 030822
The card number: capital T20010069
Authentication code: (93) are defended the accurate word D-53-5 of medicine number
Beijing Zhongsheng Biological Engineering High Technology Company
5, T-CHOL is measured test kit 1 * 100ml
Production number: 00011
Make lot number: 200281003
Useful life: 2003-8-10
(96) defend the accurate word D-01-2 of medicine number
East, Wenzhou bowl biological engineering company limited
6, glutamic oxaloacetic transaminase, GOT (AST/GDT) 1 * 500ml 2 * 50ml
Lot number: 020801
The card number: capital T20010069
Effect duration: 030801
Beijing Zhongsheng Biological Engineering High Technology Company
7, determination of urea nitrogen test kit BUN Diacetylmonoxime method
Lot number: 20021001
The card number: capital T20010069
Effect duration: 031001
Give birth to biological high-technology company in Beijing
8, glutamate pyruvate transaminase (ALT/GPT) Nai Shi method 1 * 300ml
Lot number: 20020901
The G-P5 medicine authorized No. is defended No. 06 in Shanghai
Shanghai Rongsheng Bioisystech Co., Ltd
9, total bilirubin determination reagent kit
Lot number: 020801
Effect duration: 030801
The G-P5 medicine authorized No. is defended No. 06 in Shanghai
Shanghai Rongsheng Bioisystech Co., Ltd
10, creatinine 2 * 100ml
Lot number: 020901
Effect duration: 030901
(capital) is defended medicine and is given birth to the card word No. 414
Beijing Zhongsheng Biological Engineering High Technology Company
Authentication code: the accurate word of traditional Chinese medicines (1999) D-58 number
11, hemoglobin standard liquid (100g/l)
Lot number: 021105
(river) defended medicine and given birth to the card word No. 168
Sichuan Mai Ke Science and Technology Ltd.
Blank medicine: 0.9% sodium chloride injection
Physical behavior: colourless transparent liquid specification: 500ml/ bottle
Lot number: 03031504 date of manufacture: 030314
Effect duration: half a year
Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine preparation management center
Detecting instrument: 1, Hisoon reaches Medical Instruments company on the SD811 biochemistry analyzer
2, GB-204 prunus mume (sieb.) sieb.et zucc. Teller electronic balance Switzerland
3, XDH-3 type electrocardiograph Shanghai Medical Electric Instrument Factory
Raising condition: experiment room temperature: 22-28 ℃ relative humidity: 75%-45%
Divide four groups at random with 80 rats, 20 every group, male and female are divided box.The laboratory lamp is fed.Regularly supply with every day and clean tap water, the raising of full price solid particle.2 timings are cleaned the Mus house, are cleaned the Mus box weekly, and spray the Mus house, soak Mus box 5min with 5% lysol.Morning every day, evening observe, and ventilation, in case duration of test rat infectious disease takes place.
Test period: 30d 8 ,-June 6 (administration phase) 2003 on May
14d 7 ,-June 20 (drug withdrawal convalescent period) 2003 on June
Method and result
After 80 rat adaptabilities are fed and are observed 7d, formal every day ig test sample medicinal liquid 30d.
Divide four groups at random with 80 rats, 20 every group, male and female half and half.That is: blank group (normal saline 2ml/100g.d), the strengthening the tendons and bones sheet of the embodiment of the invention 4 high, medium and low dosage group (19.44g, 9.72g, 4.86g/kg.d; 60 times, 30 times, 15 times amounts for therapeutic dose).Ig administration every day, 30d continuously.Weekly by group by only weighing once.And observe and ingest, take the photograph situations such as water, voluntary activity, the mental status and behavior, fur outward appearance, secretions, Excreta.Respectively organize rat 1/2 behind the 30d and do ECG detection, sacrificed by decapitation thereafter earlier.Blood sampling detects routine blood test, platelet count, clotting time, blood biochemical project, detects liver, renal function and the system's anatomic observation toxic reaction to important organs such as the heart, liver, spleen, lung, kidney, brain, stomach, duodenum, jejunum, colon, small intestinal, bladder, prostate, testis/ovary, uterus, adrenal gland, thymus, hypophysis, thyroid, and title weight in wet base, ask organ coefficient, do the tissue pathological slice microscopy.All the other 1/2 are respectively organized rat and also detect by above-mentioned every test item and method behind drug withdrawal 14d, observe the retardance toxic reaction that detects after the drug withdrawal and the target organ of test sample retention toxicosis.The result is as follows:
One, to the influence of general physiological activity and body weight gain
During the 30d ig strengthening the tendons and bones sheet medicinal liquid, each is organized, and rat ingests every day, to take the photograph water normal, and color hair light, movable agility, Excreta, secretions no abnormality seen also do not have that Mus is sick takes place and the symptom appearance of toxic reaction.Body weight increases day by day.High, medium and low dosage test sample body weight gain and blank group are relatively checked through t.The results are shown in Table 1.
Two, routine blood test, platelet count, clotting time detect
The test end, the sacrificed by decapitation rat, routine blood test, platelet count are done in blood sampling immediately, and clotting time detects.Check through t.The results are shown in Table 2.
The influence of table 2 pair routine blood test (X ± S)
Compare P＞0.05 with the blank group
The influence of table 3 pair platelet count, clotting time (X ± S)
Compare P＞0.05 with the blank group
The result shows: after the 30d ig administration the conventional every index of rat serum, platelet count, clotting time and blank group are compared the Non Apparent Abnormality influence.14d convalescent period clotting time does not more also have significantly unusual difference with blank group.
Three, blood parameters detects
1, the mensuration of plasma urea nitrogen, creatinine content
Survey respectively according to diacetyl-oxime development process, picric acid development process and respectively to organize rat plasma blood urea nitrogen, creatinine content.Check through t.The results are shown in Table 4.
The influence of table 4 pair plasma urea nitrogen, creatinine content (X ± S)
Compare P＞0.05 with the blank group
2, the mensuration of serum glutamic oxalacetic transaminase (AST), glutamate pyruvate transaminase (ALT), total bilirubin (T-BIL), total protein (TP), albumin (AIB).
Measure serum AST, ALT according to King's method; Measure serum T-BIL according to sodium benzoate-caffeine method; Measure serum T P according to biuret method; According to bromocresol green determination of color serum AIB.Check through t.The results are shown in Table 5.
The influence of table 5 pair blood parameters (X ± S)
Compare P＞0.05 with the blank group
The result shows after the 30d ig administration rat plasma BUN, Crea content relatively not to be had significantly unusual difference (P＞0.05) to rat blood serum AST, ALT, T-BIL, AIB, TP content and blank group.
3, the mensuration of alkali phosphatase (ALP), T-CHOL (T-CHO), blood glucose (GLU)
Measure ALP according to the disodium phenyl phosphate method; According to iron sulfate determination of color T-CHO; According to oxidation enzymatic assays GLU.Check through t.The results are shown in Table 6.
The influence of table 6 couple ALP, T-CHO, GLU (X ± S)
The blank group is P＞0.05 relatively
The result shows after the 30d ig administration rat ALP, T-CHO, GLU and blank group relatively not to be had the significance anomalous effects.
Four, to the influence of the dirty body ratio of rat
The experiment end, put to death rat, important organs such as system's anatomic observation heart, liver,spleen,kidney, brain, stomach, duodenum, jejunum, colon, small intestinal, bladder, prostate, adrenal gland, hypophysis, thymus, thyroid, testis/ovary, uterus, perusal, as seen each organs and tissues form and color and blank group relatively do not have remarkable abnormal change.Filter paper is inhaled dehematize liquid, body fluid.Each important organ is weighed and ask organ coefficient.Check through t.The results are shown in Table 7.
The influence (x ± sg or mg%) of the dirty body ratio of table 7 pair rat
The blank group is P＞0.05 relatively
The result shows, 30d ig administration and drug withdrawal 14d convalescent period relatively do not have significantly unusual difference (P＜0.05) to Rats Organs and Tissues coefficient and blank group.
Five, each important organ pathological section microscopy
After each Chinese medicine internal organs is finished in perusal, with internal organs 10% formaldehyde fixed, 99% ethanol dehydration, specimens paraffin embedding slices, HE dyeing, again through dewatering, add coverslip, after the gummy sealing, optical microscope is to each internal organs microscopy one by one of cutting into slices.
The result shows, 30d ig gives behind the test sample and drug withdrawal 14d high, medium and low dosage group and blank group finding relatively after convalescent period: this test sample is arranged and the change of morphosis Non Apparent Abnormality pathologic each vitals histiocyte such as the rat heart, liver,spleen,kidney, brain, stomach, duodenum, jejunum, colon, small intestinal, bladder, prostate, adrenal gland, hypophysis, thymus, thyroid, testis/ovary, uterus.
The preparation of other embodiment of the present invention has similar substantially result to this test example.
Claims (8)
1, the Chinese medicine preparation of a kind of dispelling wind and removing obstruction in the collateral, strengthening the tendons and bones is characterized in that, comprises following Chinese medicine raw material in the prescription of described preparation:
Radix Aconiti Preparata 90-95 part
Radix Aconiti Kusnezoffii Preparata 90-95 part
Semen Strychni (processed) 6-10 part
Rhizoma Pinelliae 25-35 part
Rhizoma Arisaematis (processed) 13-18 part
Pericarpium Citri Reticulatae 10-20 part
Radix Cyathulae 6-9 part
Fructus Chaenomelis 6-9 part
Radix Codonopsis 10-20 part
Ramulus Uncariae Cum Uncis 10-20 part
Herba Dendrobii 6-9 part
Radix Dipsaci 15.1-16 part
Lapis Micae Aureus 4.5-4.9 part
Pulvis Fumi Carbonisatus 4.5-4.9 part;
Described Chinese medicine preparation is by following prepared:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or particle diameter coarse granule less than 0.85mm;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder of particle diameter less than 150 μ m;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder that particle diameter is 5-10 μ m through micronizing;
4) the various preparation formulations of the administration that suits will be made again behind the resulting ultra micro Chinese medicine powder mixing according to the preparation method adding acceptable accessories of Chinese medicine preparation.
2, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 1, strengthening the tendons and bones is characterized in that: comprise in the prescription of described preparation:
Radix Aconiti Preparata 91-93 part
Radix Aconiti Kusnezoffii Preparata 91-93 part
Semen Strychni (processed) 7-9 part
Rhizoma Pinelliae 28-32 part
Rhizoma Arisaematis (processed) 14-16 part
Pericarpium Citri Reticulatae 13-17 part
Radix Cyathulae 7-8 part
Fructus Chaenomelis 7-8 part
Radix Codonopsis 13-17 part
Ramulus Uncariae Cum Uncis 13-17 part
Herba Dendrobii 7-8 part
Radix Dipsaci 15.2-15.8 part
Lapis Micae Aureus 4.6-4.8 part
Pulvis Fumi Carbonisatus 4.6-4.8 part.
3, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 2, strengthening the tendons and bones is characterized in that: comprise in the prescription of described preparation:
92.3 parts of Radix Aconiti Preparatas
92.3 parts of Radix Aconiti Kusnezoffii Preparatas
7.7 parts of Semen Strychni (processed)s
30.8 parts of the Rhizoma Pinelliaes
15.4 parts of Rhizoma Arisaematis (processed)
15.4 parts of Pericarpium Citri Reticulataes
7.7 parts of Radix Cyathulaes
7.7 parts of Fructus Chaenomeliss
15.4 parts of Radix Codonopsis
15.4 parts of Ramulus Uncariae Cum Uncis
7.7 parts of Herba Dendrobiis
15.4 parts of Radix Dipsacis
4.7 parts of Lapis Micae Aureuses
4.7 parts of Pulvis Fumi Carbonisatuss.
4, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 3, strengthening the tendons and bones is characterized in that, described preparation formulation is tablet, capsule, granule, powder, pill, syrup, mixture, medicinal tea, emplastrum or plaster.
5, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 4, strengthening the tendons and bones is characterized in that, the preparation method of described tablet comprises the steps:
1) above-mentioned Chinese medicine raw material is concocted respectively obtained the prepared slices of Chinese crude drugs or coarse granule;
2) prepared slices of Chinese crude drugs that above-mentioned steps is concocted or coarse granule again pulverize separately obtain the Chinese medicine fine powder;
3) above-mentioned steps is pulverized the Chinese medicine fine powder that obtains and obtained the ultra micro Chinese medicine powder through micronizing;
4) with behind the resulting ultra micro Chinese medicine powder of the step 3) mixing, add syrup and make granule, dry back adds magnesium stearate, Pulvis Talci, and mixing, tabletting are promptly.
6, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 5, strengthening the tendons and bones is characterized in that, the preparation method of described tablet also comprises sugar coating or film-coat.
7, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 6, strengthening the tendons and bones is characterized in that:
Coarse grained particle diameter is less than 0.85mm described in the step 1);
The particle diameter of the fine powder of Chinese medicine step 2) is less than 150 μ m;
The particle diameter of the Chinese medicine powder of ultra micro described in the step 3) is 5-10 μ m.
8, the Chinese medicine preparation of dispelling wind and removing obstruction in the collateral according to claim 7, strengthening the tendons and bones is characterized in that, in the step 4) with particle drying to moisture≤6%, described tabletting is at ambient temperature 18-26 ℃, the condition lower sheeting of relative humidity 45-65%.
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| CN105194344A (en) * | 2015-10-30 | 2015-12-30 | 吴小斌 | Traditional Chinese medicine pills for treating muscle and bone diseases and preparation method of traditional Chinese medicine pills |
| CN109646806A (en) * | 2018-12-17 | 2019-04-19 | 南京日光生物科技有限公司 | A kind of backbone patch and preparation method thereof with far infrared heating layer |
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| 中药微粉规范化研究之我见. 方道硕等.成都中医药大学学报，第25卷第1期. 2003 |
| 国家中成药标准汇编，中成药地方标准上升国家标准部分. 国家药品监督管理局编，606，国家药品监督管理局. 2002 |
| 浅谈超微细中药粉体. 骆苏芳等.中药材，第22卷第4期. 1999 |
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Address after: 723000 Yingbin West Road, Hantai District (North Economic Development Zone), Hanzhong City, Shaanxi Province Patentee after: Shaanxi Hanwang Pharmaceutical Co., Ltd Address before: 723000 Yingbin Road, North Zone, Hanzhoung Economic Development Zone, Shaanxi Patentee before: Hanwang Pharmaceutical Industry Co., Ltd., Shanxi |
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