CN1994353A - A superfine powdered Chinese medicinal composition and preparation method thereof - Google Patents

Abstract

The invention relates to a Chinese drug composite, especially a micro powder, wherein it is formed by calculus bovis, moschus to be prepared into mastic, myrrh, etc. And it can treat influx and cancer, etc. The invention also provides relative production.

Description

A kind of superfine powder Chinese medicine composition and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition, especially a kind of is the Chinese medicine composition of raw material with the Chinese medicine ultra-fine powder, belongs to the field of Chinese medicines.The preparation method that also relates to this Chinese medicine composition simultaneously.

Background technology

One, 'Xihuang ' selected topic foundation

The 9th Chinese patent medicine kind-XIHUANG WAN of recording of " Ministry of Health of the People's Republic of China's ministry standard " Chinese traditional patent formulation preparation; by Calculus Bovis; Moschus; Olibanum (system); (Myrrha (processed) wherein is Myrrha (processed) to Myrrha (processed) four Chinese medicine composition; Olibanum (system) is Olibanum (processed)); similarly preparation also has Calculus Bovis from Northwest of China capsule (recording in the 17th in " Ministry of Health of the People's Republic of China's ministry standard " Chinese traditional patent formulation preparation); enhanced Xihuang ball (recording) in the 3rd in " Ministry of Health of the People's Republic of China's ministry standard " Chinese traditional patent formulation preparation; mainly be to have changed drug ratio; the enhanced Xihuang ball has also increased Venenum Bufonis (system); but its effect is all with detoxicating and resolving stagnation of pathogens, and reducing swelling and alleviating pain is main.Be used for the malicious stasis of blood and tie mutually, ulcer sores, carbuncle of yin nature swells and ache, the carbuncle furunculosis, scrofula, multiple abscess, diseases such as cancerous protuberance have been widely used in clinically, and comparatively ideal effect is arranged.But also there is following deficiency:

1, Calculus Bovis, Moschus are animal medicinal material, and Olibanum, Myrrha are the resinae medical material, and effective ingredient is indeterminate in the medicine; be used as medicine rationally with medicated powder, but this product is bigger owing to resinae pulverizing medicinal materials granularity, pill is easy disintegrating not; cause bioavailability not high, the medical material waste.

2, drug technique content is low, and the medical material dose is big, and square Chinese crude drug price is more expensive, brings difficulty for the popularization and application of this product.

To sum up,, just can greatly improve and stay the powder medical surfaces long-pending, improve bioavailability, save medical material, reduce cost, solve the deficiency that commercially available Calculus Bovis from Northwest of China class preparation exists if utilize the ultra micro vibromill that Calculus Bovis from Northwest of China compound medicine micronizing is mixed.

Two, micronizing progress

1 micronizing principle and meaning

Superfine communication technique is the machining process that makes the fine and super-refinement of material, provides one of important means of ultrafine powder.Over nearly 20 years, this technology obtains to develop rapidly, has been widely used in industrial circles such as metallurgy, pottery, weaving and Aero-Space abroad, and the nanotechnology of domestic inorganic matter (as the tape magnetic powder) has obtained development faster.The Chinese medicine industry is introduced the micropowder notion and is started from late 1990s, though start late, but since pulverize be Chinese medicine production and use in basic process technology, so micronizing also more and more causes people's attention, superfine communication technique has manifested distinctive advantage and wide application prospect.

In the crushing process of Chinese crude drug, 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 traditional Chinese medicine medicated powder (chemical constituent is present in the complete cell wall), 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, conventionally relatively at present pulverize, decocting boils or method such as organic solvent extraction has incomparable advantage.Especially for the resinae medical material; animal drugs and valuable medicinal such as Sanguis Draxonis; Hirudo; Moschus; Calculus Bovis etc.; because composition is indeterminate in these medical materials; should not extract; after pulverizing, routine goes into the diffusing application of ball mostly; and behind the introducing superfine communication technique; to bring the influence of generation to traditional preparation process; make original material be in a kind of " new state " of ultramicro powder; give full play to the micropowders unique physical and chemical properties; Effective Components of Chinese Herb not only can not lose or reduce; but also can fully be absorbed by human body, the characteristic of Chinese medicine will obtain bigger performance.

The problem of the broken existence of 2 Chinese medicine ultra-fine powders

Although the broken research of Chinese medicine ultra-fine powder has become upsurge, but some problem with practical application meaning or difficult problems are arranged, so far do not have to such an extent that effectively solve, these problems or a difficult problem comprise: in the pulverizing medicinal materials process, along with reducing of grain diameter, the energy of required further pulverizing constantly increases (1), after grain diameter acquires a certain degree, crush efficiency obviously reduces (2) both just after pulverizing is finished and since particle diameter reduce still cause easily: surface energy increases, and granule is played pendulum; Mobile poor, easily assemble forming false bulky grain; Wettability increases, easily the moisture absorption; Adsorptivity increases, easily the impurity in the absorbed air.(3) because the existence of above problem, cause that the Chinese medicine micropowder occurs in the preparation process that powder fluidity is poor, divided dose is inaccurate, the easy moisture absorption, tablet technical problem such as easy-formation not, have a strong impact on the practical application of Chinese medicine micropowder, become the bottleneck that broken technology of Chinese medicine ultra-fine powder or Chinese medicine ultra-fine powder and Chinese medicine preparation are connected mutually.

At other industrial circles, also there is above similar problem, as the production of magnetic powder or ink powder, solution is broken with pigment exactly, and the fine powder of generation is distributed to rapidly in the water, weakens its aggregation, after treating that pulverizing is finished, again water is got rid of, dried, promptly obtain careful uniform magnetic powder or ink powder.But this method can not directly transplanting to the field of Chinese medicines because the former is a mineral, character is relatively stable, both water fasts is heated and can not destroys, and does not also have the process of preparation; Chinese medicine is then different, and ingredient complexity, character have nothing in common with each other, if also liquid feeding is pulverized, the solid-liquid separation process after pulverizing so (no matter being to filter or heat to concentrate) will damage the composition in the liquid.Therefore, at the field of Chinese medicines, the method for liquid feeding (referring generally to water) micronizing is considered to infeasible always.

So, do not have a kind of superfine powder Chinese medicine truly now, there is not the feasible superfine grinding method of real industry yet

Summary of the invention

The object of the present invention is to provide a kind of new superfine grinding method, especially be applied to the superfine grinding method of Chinese crude drug, can obtain the superfine powder of medium particle diameter less than 20 μ m.

The present invention seeks to realize like this:

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.

At this moment, crude drug of the present invention is:

10～80 parts of 10～20 parts of Moschus superfine powders of Calculus Bovis superfine powder

400～600 parts of 400～600 parts of Myrrha (processed) superfine powder of Olibanum (processed) superfine powder

In addition as required, 1～5 part of system Venenum Bufonis superfine powder can also be arranged in the crude drug, so the crude drug after finally preferred is:

15 parts of [prescription 1] 15 parts of Moschus superfine powders of Calculus Bovis superfine powder

550 parts of 550 parts of Myrrha (processed) superfine powder of Olibanum (processed) superfine powder

75 parts of [prescription 2] 15 parts of Moschus superfine powders of Calculus Bovis superfine powder

500 parts of 500 parts of Myrrha (processed) superfine powder of Olibanum (processed) superfine powder

75 parts of [prescription 3] 15 parts of Moschus superfine powders of Calculus Bovis superfine powder

500 parts of 500 parts of Myrrha (processed) superfine powder of Olibanum (processed) superfine powder

2.4 parts of system Venenum Bufonis superfine powder

The medium particle diameter of above superfine powder is all less than 20 μ m.

Need be pointed out that once more, " about using the notice of natural Moschus, the relevant matters of artificial Moschus in the Chinese medicine prescription " of issuing according to State Food and Drug Administration, requirement is for containing Moschus in the national drug standards prescription, but the manufacturing enterprise of this kind or this kind excludes No. 3 bulletin, with the Moschus in the prescription with the use that feeds intake of artificial Moschus's equivalent, Moschus feeds intake with the artificial Moschus in will writing out a prescription according to this regulation, so the Moschus that relates in this product prescription also can be the artificial Moschus.In addition, the Calculus Bovis in the prescription also can be the artificial Calculus Bovis.

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:

A. get dry clean medical material, routine was pulverized 20～100 mesh sieves, added 0.01～5 times of solid dispersion medium that amount is suitable, used vibromill micronizing 10～60 minutes, promptly.

B. get dry clean medical material, routine was pulverized 20～100 mesh sieves, added 0.2～5 times of amount appropriate liquid disperse medium, used vibromill micronizing 10～60 minutes, promptly.

In such scheme, involved disperse medium can be divided into two big classes by pulverizing the back mixture state, is specially:

Solid dispersion can be selected from but be not limited to the combination of following one or more: Polyethylene Glycol, micropowder silica gel, microcrystalline Cellulose, cyclodextrin, magnesium stearate, Pulvis Talci, starch, carboxymethylstach sodium, acrylic resin.

Liquid dispersant can be selected from but be not limited to the combination of following one or more: soybean oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, rapeseed oil, Semen Maydis oil, Oleum sesami, safflower oil, ethyl oleate, Oleum Cocois esters, Oleum helianthi monoglyceride, Cera Flava, polyethylene glycols, glycerol, propylene glycol, sorbitol, phospholipid, cholesterol, tween, span, Pa Luoshamu.

At last, this ultra micro compositions can be made any in the following dosage form: the application in the preparations such as pill, powder, tablet, granule, soft capsule, hard capsule, oral gel, solid/semisolid preparation capable of permeating skin and Orally taken emulsion, the especially application in preparation Chinese medicinal soft capsule, hard capsule capsule liquid.

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.

Beneficial effect

Technical scheme of the present invention is considered from practical angle, in conjunction with the needs of preparation, adds suitable disperse medium micronizing and prepares semi-finished product, directly makes required preparation.Thereby selected disperse medium is not a water, but multiple pharmaceutic adjuvant, this method has solved micronizing to a certain extent and has been applied to adaptability problem in the Chinese medicine preparation, broken through tired the scratching of technology that conventional micronizing efficient constantly reduces, broken the first powder process thinking model of preparation again, also abandoned the traditional view that Chinese medicine can not add the medium micronizing, this method has been crossed the broken bottleneck that is connected mutually with Chinese medicine preparation of Chinese medicine ultra-fine powder, be with the optimised process of pulverizing with the preparation perfect adaptation, will greatly promote superfine communication technique at the Chinese medicine single medicinal material, compound recipe is the application in the compound recipe especially, be the new trend that superfine communication technique is used in Chinese drugs agentia, reach the saving medical material, simplify the doulbe-sides' victory effect of preparation process.Specifically, this patent method is removed has the raising grinding particle size, improves bioavailability, outside the advantages such as saving medical material, also has following advantage:

1. take into full account medical material character medical material: plant medicine material, mineral substance medical material, though toughness is strong as Ganoderma spore, but general micronizing can reach crushing effect, and the resinae medical material, very easily " return thick " or problems such as the deliquescing of being heated, albuminous degeneration in the common process crushing process, tangible tablet is arranged, in the ground product due to extruding between the rod iron; And as easy as rolling off a log regrouping in the put procedure.And according to medical material character, adding suitable substrate carries out micronizing, has the following advantages: a. has avoided poly-again phenomenon in the crushing process fully, is disperseed rapidly in the medicine crushing process, avoids glutinous and connects, gathers again; B. improved the granularity of medical material greatly, wherein added solid disperse medium gained mixture 90% particle diameter in 20 μ m, its medium particle diameter is in 12 μ m; Add the liquid disperse medium, thinner with the waterproof pulverization granularity, gained mixture 90% particle diameter is in 10 μ m, and its medium particle diameter improves with interior more conventional micronizing granularity greatly at 4 μ m; C. adopt to add the disperse medium comminuting method, pulverize time ratio and shortened originally, crush efficiency is than improving greatly originally; D. the more important thing is, adopt the operation of this method, can avoid mince polymerization in put procedure of superfine powder, solve the problem of poor stability in this constituents storage.

2. take into full account need combining of preparation with pulverizing with preparation, angle from preparation, consider the factors such as raising of stability of formulation, bioavailability, select suitable disperse medium, for example if be prepared into capsule, the micropowder silica gel of normal selection adding 5～10% is pulverized, and the gained stabilized with mixture is good, mobile strong, can be directly used in capsule charge; Be equipped with soft capsule if draw up, can select to add vegetable oil or PEG400, other adds pharmaceuticss such as suitable suspending agent, stabilizing agent adjuvant commonly used, pulverizes in the lump, and gained fluid or semifluid are directly used in the filling soft capsule.

3. do not have subsequent technique, have problems in the solution explained hereafter:, therefore do not exist liquid, solid to be difficult to problems such as separation because this technology is directly made preparation after pulverizing; Added disperse medium again in pulverizing, the flowability of ultrafine powder is improved greatly, hygroscopicity reduces, and makes the easier molding of preparation, stable, has avoided the inherent defective of ultrafine powder.

4. the advantage of adjuvant itself is to improving the effect of micronizing

1. the application of micropowder silica gel

Have another name called white carbon, its odorless, tasteless, water insoluble; Do not react with most medicines, good flowability and adhesive force are arranged; Lubricant is made in short disintegrate, can increase stripping, solid dispersion, because of its light weight, volume are big, good fluidity as disperse medium, can significantly improve the flowability of superfine powder, avoid intermolecular reunion, guarantee the weight differential of preparation, its application value in the micronizing process is great.

2. the application of PEG400

Recommend to use the soft capsule adjuvant as American Pharmacopeia, be incorporated in the micronizing, further high degree of dispersion can improve bioavailability greatly, and effect is more outstanding, and this point has report in pharmacological testing; In the medicine crushing process, directly add PEG400, can make it in time, combine with ingredient fully, its in conjunction with effect be tradition " pulverize afterwards earlier and mix " method can not compare.

3. the application of cyclodextrin

Add an amount of hydroxypropyl cyclodextrin or beta-schardinger dextrin-in the disperse medium; can treat and pulverize that the volatile oil composition has direct bag and effect in medical material such as Moschus, Borneolum Syntheticum or the medical material; and envelop rate and bag and efficient height; can effectively protect volatility or the strong composition of sublimability, improve the stability of specific examples of such components in preparation.

5, make things convenient for preparation, improve preparation stability

Adopt the method that adds suitable disperse medium micronizing, gained ultra micro mixture can directly be made preparation according to clinical needs, and gained mixture height uniformly emulsify, granularity is little, good stability, no lamination, available this method solves stays the powder medical material to prepare the difficult problem of long-term puzzlement such as the easy layering of soft capsule, precipitation, equally also can improve stability as other preparation ultrafine powders such as capsule, powders, and preparation technology is simple and easy to do, be with the optimised process of pulverizing, will in ultra micro preparation production from now on, be promoted with the preparation perfect adaptation.

6, single medical material, Chinese medicine compound all can

This patent institute proposition method, be not only applicable to the processing of Chinese crude drug, can also be used to contain animal drugs, resin medicine, valuable medicine and stay the further development and use of the Chinese medicine compound of powder, as the former preparation 'Xihuang ' of the present invention, its annual sales volume be used to buy Chinese crude drug more than 40%, add the disperse medium micronizing if adopt, on the basis that guarantees curative effect, decrement is used, and can save about 50% medical material, its direct economy income is considerable, so this technology has boundless market prospect.

For further specifying the obtained beneficial effect of the present invention, the inventor describes from crushing effect, ultra micro stabilized with mixture and pharmacological testing three aspects:

One, crushing effect

(prescription consists of Calculus Bovis, Moschus, Olibanum (processed with vinegar), Myrrha (processed with vinegar) to XIHUANG WAN; wherein Olibanum (processed with vinegar), Myrrha (processed with vinegar) are the resinae medical material;) be representative; carry out conventional micronizing respectively and add 1 times of amount PEG-propylene glycol (9: 1) micronizing; pulverize separately 30 minutes; adopt the WJ9200 laser particle analyzer to measure granularity respectively, the results are shown in Table 1.

As seen from Table 1, the XIHUANG WAN maximum particle diameter of conventional micronizing is about 200 μ m (fragment for multiple poly-accounts for 4～6%, but screening examination), and medium particle diameter is about 24 μ m; After adding the liquid disperse medium, maximum particle diameter is about 21 μ m, and medium particle diameter is about 4 μ m; Therefore, add disperse medium after, improved the granularity of medical material greatly, effect is remarkable.

Two, preparation stability

The more conventional micronizing of test objective and add the half-finished stability of medium micronizing gained

Trial drug

1. the conventional superfine powder of XIHUANG WAN prepares soft capsule content: get clean XIHUANG WAN medical material, and after the precomminution, micronizing, the gained micropowder adds 1.5 times of amount PEG400-propylene glycol (9: 1) and makes substrate, makes soft capsule content, uses for stability test;

2. XIHUANG WAN adds disperse medium and directly pulverizes the preparation soft capsule content: get clean XIHUANG WAN medical material, after the precomminution, add 1.5 times of amount PEG400-propylene glycol (9: 1) and make substrate, and micronizing, the gained mixture is made soft capsule content, makes stability test and uses.

Test method

Centrefuge experiment is got the 5g sample respectively and is put in the centrifuge tube, and with the centrifugal 20min of 3000rpm, observation has or not lamination, and result of study sees Table 2.

Cold-resistant heat-resistant experiment is got an amount of sample respectively and is put low temperature 2-5 ℃, 30d; And high temperature 50-53 ℃, 24h, the color and luster of observation sample, denseness, uniformity have no change, and result of study sees Table 2.

Sample thief is an amount of respectively for room temperature reserved sample observing method, respectively adorns three tool plug test tubes, adopts room temperature reserved sample observing method working sample after 3 months, and whether appearance character is stable, and result of study sees Table 2.

As seen from the experiment, with new approaches micronizing gained mixture, good stability, no lamination can tentatively be determined to stay the powder medical material to prepare the difficult problem of long-term puzzlement such as the easy layering of soft capsule, precipitation with this method solution.

Three, pharmacological testing checking

Pharmaceutical preparation of the present invention has heat-clearing and toxic substances removing and battalion's repercussive function, is used for the carbuncle furunculosis, scrofula, multiple abscess, treatment of diseases such as cancerous protuberance.The inventor also cures mainly according to its function, sets about this product pharmacodynamics is studied from esophageal carcinoma, hepatocarcinoma, gastric cancer three big tumors and relevant pharmacodynamics.

Be subjected to the reagent thing: the ultra micro 'Xihuang ', dosage is by suitable crude drug amount conversion, 1/3 (1 group of superfine powder), 1/2 (2 groups of superfine powder), 2/3 (3 groups of the superfine powder) of the quite common XIHUANG WAN dosage of design dosage.

XIHUANG WAN: the natural pharmaceutcal corporation, Ltd in Jiu Zhaigou, lot number: 030305.

Animal subject: Wistar rat, male and female dual-purpose, 150～210g; Kunming mouse, male and female half and half, 18～22g; Provide by Shandong Medical University's Experimental Animal Center.

Key instrument: 3F-3 type high speed microcentrifuge, wheel company of Huaxing produces; Binocular is inverted reading microscope, Changchun No.1 optical Instrument Plant production; TF photo-thermal dolorimeter, institute of Materia Medica,Chinese Academy of Medical Sciences production; Electronic balance, AEL-200 type, Japanese SHIMADZU company product.

Test 1: antitumor action experimental study

Test method: get hepatocarcinoma (HepA) mouse ascites of inoculation 7d, with sterile saline by dilution in 1: 4, every Mus abdominal cavity inoculation 0.2ml (about 25 * 106 cells/ml), the 2nd day random packet in inoculation back, every day gastric infusion once, amount to 9d.The mice time-to-live respectively organized in record then, and calculate increase in life span.

Increase in life span (%)=administration group natural law/matched group natural law * 100% of on average surviving of on average surviving.

Get murine sarcoma (S180) the tumor piece of inoculation 7-10d, added sterile saline homogenate by 1: 4 and become cell suspension, inoculate 0.2ml (about 25～28 * 106 cancerous cell/ml) respectively at the right oxter of every Mus.The 2nd day random packet in inoculation back, administration every day amounts to 9d, and 10d puts to death mice, peel off the tumor piece weighs, and calculates the heavy suppression ratio of tumor.

The average tumor of the average tumor weight/matched group of tumour inhibiting rate=1-administration group heavy * 100%.The results are shown in Table 3.

Table 3 is the result show, XIHUANG WAN and this product superfine powder 1,2,3 all can prolong the life cycle of ascitic type liver cancer mice in various degree, can suppress the growth of mice S180 solid tumor, have compared the significance difference with matched group.Its antitumor action this product superfine powder 2 is suitable with XIHUANG WAN.

Table 4 is the result show, XIHUANG WAN and this product superfine powder 1,2,3 can make the peritoneal macrophage phagocytic index increase, and phagocytic activity improves.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

In sum, this product preparation can suppress the growth of murine sarcoma (S180) and hepatocarcinoma (HepA).Tumor-bearing mice gastric infusion, tumour inhibiting rate are all greater than 30%, and increase in life span is all greater than 130%, and curative effect is better.Experiment shows that also this medicine can obviously improve Turnover of Mouse Peritoneal Macrophages phagocytic percentage and phagocytic index, increases macrophage phagocytic function.

Test 2: microcirculation improvement experimental study

1. to the effect of rat blood rheological characteristic

Get the Wistar rat, modeling the results are shown in Table 5 to the therapeutical effect of stasis syndrome rat model.

Table 5 is the result show, XIHUANG WAN and this product superfine powder 1,2,3 can significantly reduce fibrinogen content, erythrocyte sedimentation rate and the platelet adhesion reaction rate of rat model.The change of blood relative viscosity shows that it mainly reduces whole blood viscosity by reducing plasma viscosity before and after the administration, thereby significantly improves the rat blood circulation.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

2. to the microcirculatory effect of rat intestine cell membrane

Get 60 of healthy rats, after water 12h is can't help in fasting, with 20% urethane (0.4ml/100g) intraperitoneal injection of anesthesia, back of the body position is fixing, cut the otch that is about 3～4cm in a sidewall, pull out the preparation administration that resets after the duodenal intubation ligation, pull out one section jejunum again, be tiled in the special lucite perfusion pond, with pin intestinal tube is fixed, mesentery is tiled in the 15ml Rockwell nutritional solution perfusion pond of filling with 30 ℃, amplifies 80 times with the binocular inverted microscope and observes measurement (micrometer is housed in the microlens).Test is divided into 6 groups, 10 every group.Result of the test sees Table 6.

Table 6 is the result show, XIHUANG WAN and this product superfine powder all can show increase rat intestine cell membrane blood capillary caliber and blood capillary flow velocity for 1,2,3 groups, and this product superfine powder 2 is suitable with the XIHUANG WAN effect.

In sum, this product preparation can reduce the high sticking high rat blood viscosity of coagulating, and reduces hematoblastic quantity, also may reduce its adhesion rate, can reach the purpose of blood circulation promoting and blood stasis dispelling by this effect.This product preparation also can make mesentery vasodilation in addition, and the hemocyte flow velocity is accelerated, and the open number of blood capillary increases, and explanation can improve the mesentery microcirculation.

Test 3: enhancing immunity experimental study

1. to S37 sarcoma mouse immune organ weight's influence

Get 50 of mices, 10 every group, begin administration, every day 1 time next day after the strain of inoculation S37 tumor, successive administration 10 days, and after drug withdrawal next day mice taken off neck cause death, take out spleen, thymus, use the filter paper suck dry moisture, torsion balance is weighed, and calculates spleen index and thymus index.The results are shown in Table 7.

Table 7 is the result show, 1,2,3 groups of spleen index and thymus indexs that all can significantly improve S37 sarcoma mice of XIHUANG WAN and this product superfine powder promote its immunologic function.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

2. to the influence of lotus S37 sarcoma Turnover of Mouse Peritoneal Macrophages phagocytic function

Get 50 mices after the inoculation S37 sarcoma, be divided into five groups at random, medication is the same, successive administration 10 days, after administration early in the 10th day, every Mus lumbar injection 5% chicken red blood cell suspension 0.4ml takes off neck and puts to death after 10 hours, weigh, sterilization pneumoretroperitoneum injection 2.5mlHank ' s liquid (pH7.0～7.2) is gently rubbed abdominal part, cuts an osculum on abdominal wall, draw peritoneal fluid 2ml and place test tube, behind the mixing, inhale a little on microscope slide, slide is placed in the enamel tray that is covered with wet gauze, putting into 37 ℃ of incubators hatched 30 minutes, remove to be attached to the cell of surface of glass slide with normal saline flushing, blot, methanol is fixed 5 minutes, with Wright's stain dyeing 10 minutes, water flushing removal floating color dries then, and microscopically is observed, calculate macrophage phagocytic percentage rate and phagocytic index, the results are shown in Table 8.

Table 8 is the result show, XIHUANG WAN and this product superfine powder all can improve phagocytic percentage and phagocytic index for 1,2,3 groups significantly.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

In sum, this product preparation can strengthen special and nonspecific cell of mice and humoral immune function.

Test 4: the research of test such as analgesia, antiinflammatory

Xylol induced mice ear swelling influence experimental study: 50 of mices are divided into 5 groups, 10 every group at random; Administration every day 1 time, for three days on end; 30min after the last administration, mice left side ear is coated with dimethylbenzene 0.05ml/ and only causes inflammation, and auris dextra compares; Taking off the neck mortar behind the 15min puts to death, cut ears along the auricle baseline, sweep away auricle with the 6mm corneal trephine in left and right sides ear same position, on electronic analytical balance, weigh (being accurate to 0.1mg), left side ear weight deducts the difference (unit: mg) be the swelling degree of auris dextra weight, calculate and respectively organize average swelling degree and obtain inhibitory rate of intumesce (%), the results are shown in Table 9.

Table 9 is the result show, XIHUANG WAN and this product superfine powder 1,2,3 all can reduce the scorching mice auricle swelling rate of caused by dimethylbenzene xylene, illustrate that it has certain antiinflammatory action.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

2. photo-thermal is caused the influence of pain method induced mice pain threshold

Select for use on TF photo-thermal dolorimeter the prediction pain threshold 52 of the female mices of 3～10s scope, body weight 22～26g is divided into 5 groups at random, 10～11 every group, after measuring administration on the TF photo-thermal dolorimeter 30,60,120min respectively organizes the pain threshold of mice, the results are shown in Table 10.

Table 10 is the result show, the pain threshold that different time is measured after 1,2,3 groups of mice administrations of XIHUANG WAN and this product superfine powder all than before the administration or matched group certain prolongation trend is arranged, pain threshold has been compared significant difference with matched group behind the medicine.This product superfine powder 2 is suitable with the XIHUANG WAN effect.

In sum, this product preparation can reduce the scorching mice auricle swelling rate of caused by dimethylbenzene xylene, illustrates that it has certain antiinflammatory action; And can obviously improve the pain threshold that mice photo-thermal causes pain, illustrate that it has good analgesic activity.

Test 5: acute toxicity test in mice

Give mouse stomach this product preparation 85g/kg in one day, be equivalent to more than 145 times of clinical 70kg people's per kilogram of body weight consumption per day, observed continuously seven days, mice generally in order, none death illustrates this product low toxicity, safety.

Test 6: rat long term toxicity test

Get the Wistar rat, stablized before the test 7 days, observe general situation: situations such as body weight, feed, feces, activity are all no abnormal, be divided into four groups at random by body weight, blank group and superfine powder high dose group, middle dosage group, low dose group, 30 every group, 5 in every cage, begin administration then, press heavy timing every day of 1ml/100g Mus gastric infusion.Surveyed a body weight in per 7 days and press body weight change adjustment dosage, successive administration 45 days notes observing situations such as animal activity, hair color feces, feed, body weight change during the administration.Water is eaten, decided to body weight of weighing weekly surely weekly, claims surplus after 24 hours, and the difference of addition and surplus is daily diet, daily drink amount.After the administration 21 days, water 12h is can't help in fasting, carries out hematology, the biochemical check of blood, gets 20 sacrifice of animal for every group and carries out pathological anatomy and histopathologic examination.All the other rats are cooked 10 day convalescent period and observe the repetition measurement These parameters

Successive administration 21 days, general situation such as the activity of rat, behavior, feed, drinking-water, hair color, fecaluria is not seen appreciable impact, and none death, the hematology of rat, blood biochemical learn and important organ pathological tissue index does not all have remarkable change, recovered to observe through 10 days after administration finishes, do not observe other the back something lost and the toxicity of secondary and give birth to effect.Safety, the low toxicity of prompting ultrafine preparation.

By above results of pharmacodynamic test, except that its therapeutical effect of proof, also further specify its need 1/2 recipe quantity, can meet or exceed the effect of former prescription, illustrate that the variation of matter has taken place this medical substance, be a kind of new medical substance.

The specific embodiment:

Below further specify technical process of the present invention by specific embodiment, but do not limit the present invention:

Embodiment one:

Prescription: Calculus Bovis 10g Moschus 85g

Olibanum (processed) 400g Myrrha (processed) 600g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 40 mesh sieves, added the micropowder silica gel of 0.2 times of amount and made dispersant with micronizing under the vibromill low temperature 45 minutes, made the ultra micro mixture of medium particle diameter less than 10 μ m, use water pill, put aeration-drying place and dry in the shade, promptly get the ultra micro pill.

Embodiment two:

Prescription: Calculus Bovis 20g Moschus 10g

Olibanum (processed) 600g Myrrha (processed) 400g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 80 mesh sieves, added the micropowder silica gel of 0.2 times of amount and made dispersant with micronizing under the vibromill low temperature 20 minutes, made the ultra micro mixture of medium particle diameter less than 10 μ m, encapsulated, promptly get the ultra micro capsule.

Embodiment three:

Prescription: Calculus Bovis 10g Moschus 10g

Olibanum (processed) 550g Myrrha (processed) 600g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, added 0.5 times of amount decanoyl/octanoyl glycerides and made substrate, and micronizing is 30 minutes under the usefulness vibromill low temperature, make the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment four:

Prescription: Calculus Bovis 15g Moschus 15g

Olibanum (processed) 550g Myrrha (processed) 550g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, add 1.5 times of amount PEG400-propylene glycol (9: 1) mixture and make substrate, micronizing is 30 minutes under the usefulness vibromill room temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment five:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 40 mesh sieves, added the micropowder silica gel of 0.2 times of amount and made dispersant with micronizing under the vibromill low temperature 30 minutes, made the ultra micro mixture of medium particle diameter less than 10 μ m, use water pill, put aeration-drying place and dry in the shade, promptly get the ultra micro pill.

Embodiment six:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 80 mesh sieves, add 0.4 times of amount micropowder silica gel-Macrogol 4000 (2: 1) and make dispersant, micronizing is 45 minutes under the usefulness vibromill low temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, encapsulated, promptly get the ultra micro capsule.

Embodiment seven:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, add 0.5 times of amount decanoyl/octanoyl glycerides-Tween 80 (9: 1) and make substrate, micronizing is 30 minutes under the usefulness vibromill room temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment eight:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, add 1.5 times of amount PEG400-propylene glycol (9: 1) mixture and make substrate, micronizing is 30 minutes under the usefulness vibromill low temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment nine:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

System Venenum Bufonis 2.4g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 40 mesh sieves, added the micropowder silica gel of 0.2 times of amount and made dispersant with micronizing under the vibromill low temperature 30 minutes, made the ultra micro mixture of medium particle diameter less than 10 μ m, use water pill, put aeration-drying place and dry in the shade, promptly get the ultra micro pill.

Embodiment ten:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

System Venenum Bufonis 2.4g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 80 mesh sieves, add 0.4 times of amount micropowder silica gel-Macrogol 4000 (2: 1) and make dispersant, micronizing is 45 minutes under the usefulness vibromill low temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, encapsulated, promptly get the ultra micro capsule.

Embodiment 11:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

System Venenum Bufonis 2.4g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, add 0.5 times of amount decanoyl/octanoyl glycerides-Tween 80 (9: 1) and make substrate, micronizing is 30 minutes under the usefulness vibromill low temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment 12:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

System Venenum Bufonis 2.4g

Method for making: get above-mentioned medical material, dry, clean, mix, routine was pulverized 20 mesh sieves, add 1.5 times of amount PEG400-propylene glycol (9: 1) mixture and make substrate, micronizing is 30 minutes under the usefulness vibromill low temperature, makes the ultra micro mixture of medium particle diameter less than 10 μ m, the dress soft capsule promptly gets the ultra micro soft capsule.

Embodiment 13:

Prescription: Calculus Bovis 15g Moschus 75g

Olibanum (processed) 500g Myrrha (processed) 500g

System Venenum Bufonis 2.4g

Method for making: method for making: get above-mentioned medical material, dry, clean, to mix, routine was pulverized 40 mesh sieves, added the micropowder silica gel of 0.2 times of amount and made dispersant with micronizing under the vibromill low temperature 30 minutes, made the ultra micro mixture of medium particle diameter less than 10 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 ultra micro mixture, 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.

Subordinate list:

The different superfine grinding method grinding particle size of table 1 check table

Project	Calculus Bovis from Northwest of China Ball
			Maximum particle diameter (μ m)	Medium particle diameter (μ m)
	Conventional micronizing	194.28			21.36
Adding medium pulverizes			19.53	4.54

Table 2 results of stability table

The investigation project	Conventional micronizing	Adding disperse medium pulverizes
			Centrefuge experiment	Slight lamination is arranged	No lamination
Cold-resistant heat-resistant experiment	The upper strata color is shallow, rarer, and lower floor's color depth is thick	Sample is stable
			Reserved sample observing	As seen appearance character has obvious lamination upper strata rare, and lower floor is thick	Appearance character is stable, no lamination

Table 3 couple transplantability mouse tumor S180 and HepAInhibitory action (x ± S, n=10)

Group	Dosage (g/kg)	HepA		S180
						Life cycle (d)	Increase in life span (%)	Tumor heavy (g)	Anti-ratio of outflow (%)
		Negative control group	-	13.5±4.2	-					2.35±0.63	-
The common flour group	0.78					21.3±2.6**	157.8	0.87±0.68**	62.98
		Superfine powder 1	0.26	18.9±3.7**	140.0					1.12±0.568**	52.34
Superfine powder 2	0.39					21.8±3.1**	161.5	0.86±0.75**	63.40
		Superfine powder 3	0.52	23.6±2.6**	174.8					0.78±0.87**	66.81

Annotate: compare * P＜0.05, * * P＜0.01 with matched group

The influence of table 4 pair Turnover of Mouse Peritoneal Macrophages phagocytic function (x ± S, n=10)

Group	Dosage (g/kg)	Phagocytic percentage (%)	Phagocytic index
				Negative control group	-	51.53±8.67	2.76±0.63
The common flour group	0.78	67.10±7.13*	4.36±0.5**
				Superfine powder 1	0.26	58.17±8.06**	3.26±0.64*
Superfine powder 2	0.39	67.25±8.34**	4.37±0.37**
				Superfine powder 3	0.52	70.39±9.66**	4.53±0.49**

Annotate: compare * P＜0.05, * * P＜0.01 with matched group

Table 5: to acute blood The stasis of bloodThe research of rat model blood viscosity influence (x ± s)

Experiment parameter	Normal group	Model group	The common flour group	Superfine powder 1	Superfine powder 2	Superfine powder 3
							High shear rate viscosity ( mPs·s)	4.83± 0.35	6.36± 0.70	4.53± 0.46**	4.89± 0.62*	4.52± 0.56**	4.36± 0.67**
The low shear rate viscosity ( mPs·s)	3.65± 0.33	4.68± 0.55	3.25± 0.52**	3.59± 0.82*	3.26± 0.62**	3.18± 0.64**
							The blood plasma viscosity ( mPs·s)	10.5± 1.21	15.66± 1.89	8.30± 0.80**	9.21± 1.26**	8.22± 1.65**	8.10± 1.80**
Erythrocyte sedimentation rate (mm/h)	7.60± 3.60	7.70± 3.90	4.60± 3.20**	5.20± 1.80*	4.50± 2.60**	4.10± 3.10**
							Packed cell volume (%)	38.7± 2.60	40.70± 3.50	38.50± 1.90	39.60± 3.60	38.10± 2.70	38.00± 1.60
Fibrinogen content (g/L)	2.45± 0.66	4.56± 0.76	2.56± 0.45**	3.16± 0.03*	2.60± 0.11**	2.39± 0.93**
							Total number of blood platelet (ten thousand/mm 2)	18.50 ±2.70	15.60± 2.90	13.20± 2.30*	14.60± 3.00*	13.20± 3.20*	12.70± 2.10*
Platelet adhesion reaction rate (%)	27.00 ±3.10	28.70± 3.60	23.18± 5.35**	25.27± 4.39*	23.68± 3.07**	23.08± 4.60**
							Whole blood reduced viscosity (%)	9.80± 1.72	13.21± 1.73	8.35± 1.26**	9.37± 1.79**	8.37± 1.54**	8.12± 1.45**
Blood relative viscosity (%)	0.48± 0.12	0.42± 0.15	0.48± 0.14*	0.49± 0.19*	0.48± 0.13*	0.47± 0.12*

Annotate: compare with model group: * P＜0.05, * * P＜0.01.

Table 6 pair is big Mus intestinal cell membraneMicrocirculatory effect (x ± S, n=10)

Group	Dosage (g/kg)	Blood capillary caliber (μ m)		Blood capillary flow velocity (μ m/s)
						Before the medicine	Behind the medicine	Before the medicine	Behind the medicine
		The normal saline group	-	0.77±0.12	0.78±0.12					7.85±0.88	7.94±0.76
The common flour group	0.54					0.76±0.09	1.03± 0.13**	8.06±0.63	10.45± 1.85**
		Superfine powder 1	0.18	0.75±0.13	0.88±0.15*					7.78±0.92	9.58±2.01*
Superfine powder 2	0.27					0.74±0.08	1. 03± 0.16**	8.22±0.86	10.46± 1.26**
		Superfine powder 3	0.36	0.71±0.14	1.04± 0.18**					7.69±0.77	10.49± 1.67**

Annotate: self compare before and after each organizes administration: * P＜0.05, * * P＜0.01.

Table 7 couple S37 sarcoma mouse immune organ weight's influence (x ± S, n=10)

Group	Dosage (g/kg)	SpleenIndex (mg/ 10gBody weight)	Thymus index(mg/ 10gBody weight)
				The normal saline group	-	191.35±18.26	8.56±1.68
The common flour group	0.78	245.67±23.69**	11.35±1.35**
				Superfine powder 1	0.26	214.46±34.51*	10.02±1.29*
Superfine powder 2	0.39	247.07±24.83**	11.53±2.18**
				Superfine powder 3	0.52	251.55±40.12**	12.53±3.01**

Annotate: * P＜0.05, compare with NS * * P＜0.01

The influence of table 8 pair lotus S37 sarcoma Turnover of Mouse Peritoneal Macrophages phagocytic function (x ± S, n=10)

Group	Dosage (g/kg)	Phagocytic percentage (%)	Phagocytic index
				The normal saline group	-	56.35±3.08	0.96±0.12
The common flour group	0.78	66.27±5.86**	1.17±0.22**
				Superfine powder 1	0.26	60.10±3.35*	1.07±0.16*
Superfine powder 2	0.39	66.72±4.12**	1.18±0.09**
				Superfine powder 3	0.52	68.00±7.13**	1.21±0.10**

Annotate: * P＜0.05, * * P＜0.01, compare with NS * * * P＜0.001

The influence of table 9 xylol induced mice ear swelling (X ± s)

Group	Dosage (g/kg)	Swelling degree (mg)	Suppression ratio (%)
				The normal saline group	-	10.3±2.11	-
The common flour group	0.78	6.2±3.01*	39.8
				Superfine powder 1	0.26	8.5±2.37*	17.5
Superfine powder 2	0.39	6.3±3.15*	38.8
				Superfine powder 3	0.52	5.2±2.46*	49.5

Annotate: compare * P＜0.05 with matched group

Table 10 pair photo-thermal causes the influence (X ± s) of pain method induced mice pain threshold

Group	Dosage (g/kg)	Pain threshold before the administration	Different time pain threshold (s) after the administration
						30min	60min	120min
			The normal saline group	-	5.6±1.7				6.2±2.0	5.8±2.5	6.2±1.7
The common flour group	0.78	5.4±1.7				9.0±2.1	8.9±2.6	8.3±3.0
			Superfine powder 1	0.26	5.5±1.6				8.1±2.2	7.1±1.6	7.0±2.1
Superfine powder 2	0.39	5.4±1.9				9.1±2.5	8.9±3.1	8.3±2.5
			Superfine powder 3	0.52	5.3±1.7				9.5±2.4	9.2±2.2	8.8±2.1

Annotate: compare * P＜0.05 with matched group

Claims (10)

1. Chinese medicine composition is characterized in that this Chinese medicine composition made by following parts by weight of Chinese traditional medicine superfine powder: 10～20 parts of Calculus Bovis superfine powder, 10～80 parts of Moschus superfine powders, 400～600 parts of Olibanum (processed) superfine powder, 400～600 parts of Myrrha (processed) superfine powder.

2. Chinese medicine composition according to claim 1 is characterized in that the optimum ratio of each crude drug is: 15 parts of Calculus Bovis superfine powder, 15 parts of Moschus superfine powders, 550 parts of Olibanum (processed) superfine powder, 550 parts of Myrrha (processed) superfine powder.

3. Chinese medicine composition according to claim 1 is characterized in that the optimum ratio of each crude drug is: 15 parts of Calculus Bovis superfine powder, 75 parts of Moschus superfine powders, 500 parts of Olibanum (processed) superfine powder, 500 parts of Myrrha (processed) superfine powder.

4. as claim 1,2 or 3 described Chinese medicine compositions, it is characterized in that to have in the crude drug 1～5 part of system Venenum Bufonis superfine powder.

5. as Chinese medicine composition as described in the claim 4, it is characterized in that the optimum ratio of each crude drug is: 15 parts of Calculus Bovis superfine powder, 75 parts of Moschus superfine powders, 500 parts of Olibanum (processed) superfine powder, 500 parts of Myrrha (processed) superfine powder, 2.4 parts of system Venenum Bufonis superfine powder.

6. as arbitrary described Chinese medicine composition in the claim 1 to 5, it is characterized in that this Chinese medicine composition can make any in the following dosage form: pill, powder, tablet, granule, soft capsule, hard capsule, oral gel, solid/semisolid preparation capable of permeating skin and Orally taken emulsion.

7. the preparation method of Chinese medicine composition as claimed in claim 6 is characterized in that it can being in the following method any one:

A. get dry clean medical material, routine was pulverized 20～100 mesh sieves, added 0.01～5 times of solid dispersion medium that amount is suitable, used vibromill micronizing 10～60 minutes, promptly got each medical material superfine powder, again these superfine powder was made required dosage form.

B. get dry clean medical material, routine was pulverized 20～100 mesh sieves, added 0.2～5 times of amount appropriate liquid disperse medium, used vibromill micronizing 10～60 minutes, promptly got each medical material superfine powder, again these superfine powder was made required dosage form.

8. preparation method as claimed in claim 7 is characterized in that used solid dispersion medium among the method a can be selected from but is not limited to the combination of following one or more: solid polyethylene glycol, micropowder silica gel, microcrystalline Cellulose, cyclodextrin, magnesium stearate, Pulvis Talci, starch, carboxymethylstach sodium, acrylic resin.

9. preparation method as claimed in claim 7 is characterized in that used liquid dispersion medium among the method b can be selected from but is not limited to the combination of following one or more: soybean oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, rapeseed oil, Semen Maydis oil, Oleum sesami, safflower oil, ethyl oleate, Oleum Cocois esters, Oleum helianthi monoglyceride, Cera Flava, liquid macrogol, glycerol, propylene glycol, sorbitol, phospholipid, cholesterol, tween, span, Pa Luoshamu.

10. be used for the treatment of the malicious stasis of blood as Chinese medicine composition as described in arbitrary in the claim 1 to 5 in preparation and tie mutually, ulcer sores, carbuncle of yin nature swells and ache, carbuncle furunculosis, scrofula, multiple abscess, the application in the medicine of diseases such as cancerous protuberance.