CN103520417A - External preparation for treating traumatic injury, stasis, gall and soft tissue contusion - Google Patents
External preparation for treating traumatic injury, stasis, gall and soft tissue contusion Download PDFInfo
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Abstract
The invention discloses an external preparation for treating of traumatic injury, stasis swelling and pain. The preparation is extracted and prepared from dragon's blood, radix paeoniae rubra, Rhizoma Corydalis, safflower, Radix Clematidis, Lycopodii herb, rhubarb, Cape jasmine, frankincense, myrrh, Radix Aconiti Preparata, prepared kusnezoff monkshood root, clove, radix angelica, asarum, camphor and borneol. Acidic ethanol infiltration and percolation extraction are employed to retain to the maximum and improve the utilization rate of effective component of dragon's blood. The product has the advantages of stable performance, accurate packaging measurement, convenience for use and improved medication compliance.
Description
Technical field
The invention belongs to field of traditional Chinese, specifically a kind of Chinese medicine for outer use by Chinese drug preparations such as Sanguis Draxonis, Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, Herba Asari, Camphora, Borneolum Syntheticums.
Background technology
Extremity and each joint are human body activities of daily living scope one of positions the most frequently; and while undertaking hard work in daily routines or vigorous exercise improper; cause turn round press or the chance of external force crush injury many; often because of the damage or acute injury produces muscle, tendon, ligament fibers trace repeatedly ruptures and hemorrhage of being overworked for a very long period year in year out such as shoulder, elbow, cervical region joint, thereby form gradually swelling or aseptic inflammation, adhesion and the contracture of subcutaneous tissue and muscle.At present the Chinese medicine preparation of the diseases such as treatment traumatic injury is more, and external preparation is quite a few, but some belongs to and cure the symptoms, not the disease, and some uses expensive Chinese crude drug, and some interrupts using because of unsatisfactory curative effect.
The present invention has overcome the defect of prior art, and a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect are provided.
The summary of experience of the inventor based on modern Chinese medicine pharmaceutical research and clinical case, to limbs, joint promoting blood circulation and stopping pain, changes the Therapeutic Principle of the detumescence of becoming silted up in conjunction with motherland's medical science, on the basis of clinical treatment proved recipe, increase invigorate blood circulation, all taste Chinese medicine of pain relieving, be prepared into a kind of by Sanguis Draxonis 10g, Radix Paeoniae Rubra 10g, Rhizoma Corydalis 15g, Flos Carthami 10g, Radix Clematidis 10g, Herba Lycopodii 10g, Radix Et Rhizoma Rhei 10g, Fructus Gardeniae 10g, Olibanum 10g, Myrrha 10g, Radix Aconiti Preparata 10g, Radix Aconiti Kusnezoffii Preparata 10g, Flos Caryophylli 5g, Radix Angelicae Dahuricae 5g, Herba Asari 5g, Camphora 7g, Borneolum Syntheticum 5g extracts the Chinese patent medicine preparation being prepared from through acid ethanol solution.
In side, Sanguis Draxonis is sweet salty flat, and there is scattered silt and invigorate blood circulation, the effect of tissue regeneration promoting pain relieving, owner controls traumatic injury, the key medicine of promoting tissue regeneration and wound healing, the pungent temperature of Rhizoma Corydalis, micro-hardship, is blood circulation promoting and blood stasis dispelling, promoting the circulation of QI analgesic, two medicines are worked in coordination with silt releasing and analgesia, make its effectiveness multiplication, are all the monarch drug in we; Olibanum regulating qi and activating blood, the pain relieving of Myrrha circulation of qi promoting scattered silt, share in the contracture of muscle arteries and veins, and traumatic injury, is ministerial drug; Assistant is with Radix Paeoniae Rubra, Flos Carthami, and Radix Clematidis, the scattered silt of all tastes such as Herba Lycopodii is invigorated blood circulation, the merit of broken silt tissue regeneration promoting; Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata pain relieving, spasmolytic; And Herba Asari, Flos Caryophylli, Camphora, the stagnated fire of Borneolum Syntheticum open hole powder, is and makes medicine, outstanding kind controls all diseases due to swelling and pain due to blood stasis.Should control in traumatic injury congestion disease and the double acute soft tissue injury person such as swell and ache.
Various drug ratio of the present invention rationally, reliably, and make external preparation using dosage accurately, pack easy, its end product quality detects controlled, method is reliable, overcome the shortcomings such as decoction volume is large, use amount is many, decocting time is long and loaded down with trivial details and be not easy to carry, greatly improved the compliance of medication.
Summary of the invention
The object of the present invention is to provide a kind of clinical efficacy definite, toxic and side effects is little, and quality control is reliable, the Chinese medicine for external application of activating blood circulation to dissipate blood stasis, alleviating pain and detumescence.
The present invention seeks to be achieved through the following technical solutions: a kind of traumatic injury for the treatment of, congestion swells and ache, the external preparation of soft tissue contusion, its raw material of Chinese medicine medicine by following weight proportion is prepared from:
Sanguis Draxonis 8～12g, Radix Paeoniae Rubra 8～12g, Rhizoma Corydalis 10～20g, Flos Carthami 8～12g, Radix Clematidis 8～12g, Herba Lycopodii 8～12g Radix Et Rhizoma Rhei 8～12g, Fructus Gardeniae 8～12g, Olibanum 8～12g, Myrrha 8～12g, Radix Aconiti Preparata 8～12g, Radix Aconiti Kusnezoffii Preparata 8～12g, Flos Caryophylli 3～8g, the Radix Angelicae Dahuricae 3～8g, Herba Asari 3～8g, Camphora 3～8g,, Borneolum Syntheticum 3～8g
Preferably, its raw material of Chinese medicine medicine by following weight proportion is prepared from:
Sanguis Draxonis 10g, Radix Paeoniae Rubra 10g, Rhizoma Corydalis 15g, Flos Carthami 10g, Radix Clematidis 10g, Herba Lycopodii 10g, Radix Et Rhizoma Rhei 10g, Fructus Gardeniae 10g, Olibanum 10g, Myrrha 10g, Radix Aconiti Preparata 10g, Radix Aconiti Kusnezoffii Preparata 10g, Flos Caryophylli 5g, Radix Angelicae Dahuricae 5g, Herba Asari 5g, Camphora 7g, Borneolum Syntheticum 5g,
In more than forming, weight is calculated with crude drug, and above composition can be made into the pharmaceutical preparation of available 1-7 days.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production, can take kilogram is unit, Huo Yidunwei unit, small-scale production also can be take milligram as unit, weight can increase or reduce, but the constant rate of each raw medicinal herbs weight proportion between forming.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount can corresponding adjustment forming, increases or reduces being no more than 100%, and drug effect is constant.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming, also can be replaced by the suitable Chinese medicine with the identical property of medicine, and its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine preparation of the present invention, is that the raw material of Chinese medicine by above-mentioned formula is formed is processed through extraction or other modes, makes pharmaceutically active substance, subsequently, take this material as raw material, while needing, add medicine acceptable carrier, according to the routine techniques of galenic pharmacy, make external preparation.Described active substance can obtain by extracting respectively raw material of Chinese medicine, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverizing, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the method such as ketone is carried, chromatography obtains, these active substances can be the material of extractum form, can be that dry extract can be also fluid extract, according to the difference of preparation, need to determine to make different concentration.
Pharmaceutically active substance in Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.01-99.99%, all the other are medicine acceptable carrier.
The present invention is external preparation preferably, as unguentum, and powder, patch, lotion, spray, tincture, aerosol, spray etc.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, as smeared every day three times.
Chinese medicine preparation of the present invention, pharmaceutically active substance wherein, preferred preparation method is as follows:
Above-mentioned formula, except Camphora, Borneolum Syntheticum, outside Sanguis Draxonis, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolation pot, with 50% alcoholic solution 200ml, add acetic acid 50ml and stir, soak more than 12 hours, with 65% alcoholic solution 700ml, with 2ml/min speed, carry out percolation, obtain percolate, camphorate, Borneolum Syntheticum, Sanguis Draxonis, is stirred to dissolve and get final product.
Take this material as raw material, while needing, add medicine acceptable carrier, according to the routine techniques of galenic pharmacy, make external preparation, be preferably the preparation of smearing use, as varnish, or spray, the preparation method of described spray agent is as follows: get above-mentioned active substance, add ethanol to 1000ml, mix homogeneously, be filled in spray device and can use, as be prepared into 10 bottles of the sprays of mono-bottle of 100ml, also can be prepared into 100 bottles of the sprays of mono-bottle of 10ml.
Described spray, it is used as power with compressed air or noble gas, dosage form medicinal liquid being sprayed with nonmetal aerosol apparatus.
The present invention also can be prepared into liniment, as is prepared into 10 bottles of the liniments of mono-bottle of 100ml, during use, opens bottledly, is applied to injury.
Also can be prepared into aerosol, as wherein added propellant.
External preparation of the present invention, its function cure mainly into: treatment traumatic injury, congestion swells and ache, soft tissue contusion.
Technique of the present invention is the improvement to traditional handicraft, and traditional handicraft generally adopts water-boiling method, and the present invention selects 50% ethanol to add the innovation technique of acetum infiltration, 65% ethanol percolate extraction.In this patent by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, after the coarse powder such as Herba Asari mix, first through 50% ethanol, add acetum and infiltrate 12～24 hours, then add 65% ethanol percolate extraction, tetrahydropalmatine, alkali in its extracting solution, safflower oil, pigment, Radix Angelicae Dahuricae element, eugenol, the active constituent contents such as asaricin improve greatly, obtained beyond thought effect, had significantly differently from general simple decocting process method, its medicine for external use dosage is greatly reduced.
The present invention is through experimental study, according to the screening of the characteristic of medicine and extracting method, selecting 50% ethanol to add acetum infiltrates, add again 65% ethanol extraction, the active constituent content of extract is improved greatly, avoid Sanguis Draxonis, Rhizoma Corydalis, Flos Carthami, the Radix Angelicae Dahuricae, Herba Asari, the loss of effective components that Flos Caryophylli etc. cause because decocting boils, because effective ingredient, content and medical material utilization rate improve greatly, the active constituent content diversity of extracting between batch is little, and technology stability is good.
External preparation of the present invention, owing to using acidic ethanol extraction technique, improve effective ingredient extraction ratio, rationally utilize, increase acetum, make the Chinese medicine in prescription fully leach with percolation and extract at acid ethanol solution, effective ingredient improves greatly, simultaneously as selecting short penetrating agent, increases skin to the expansion of medicine and absorption, utilization.The present invention, through screening, has selected Camphora, and Borneolum Syntheticum, as Percutaneous absorption enhancer, has improved the stability of medicine, same, and ethanol acetate also plays the effect that promotes that medicine absorbs from skin.In addition, owing to having reduced the solid amount of extract, therefore the unit dose package amount of medicine greatly reduces, make drug use, carry all more convenient.
In addition, it is good that preparation of the present invention also has therapeutic effect, few side effects, and instant effect, the quality guarantee period of medicament phase is long, and cost is low, and preparation technology is simpler, has saved and has decocted the plurality of advantages such as time of preparing medicine.
The present invention is based on Chinese medicine and decoct principle, consider Sanguis Draxonis, Camphora, Borneolum Syntheticum is dissolved in the volatile characteristic of ethanol, in order to improve the utilization rate of active components such as Rhizoma Corydalis, Flos Carthami, the Radix Angelicae Dahuricae, Flos Caryophylli, Herba Asari, by innovation impurity removal process, directly adopt acidic ethanol infiltration, percolation to extract, significantly reduced the solid content in leaching process, and guarantee that drug effect is not lowered, improved tetrahydropalmatine, alkali, safflower oil, pigment, Radix Angelicae Dahuricae element, the yield of the effective ingredient such as eugenol.
By extracting tetrahydropalmatine in medicine, paeoniflorin, eugenol content and pharmacological testing comparison and pilot sample study on the stability, toxicity, the test of pesticide effectiveness and clinical observation result, in conjunction with modern science and technology, percolation extractive technique being applied to Chinese crude drug, to extract separation be also feature of the present invention: the cell interior of the Chinese crude drug that acidic ethanol is infiltrated through be extracted by percolation extractive technique, increase the extracts active ingredients amount of medicine and extract effectiveness, directly by Sanguis Draxonis, Camphora, Borneolum Syntheticum dissolves, can reduce and avoid when extracting percolation because other Chinese medicinal powder cause Sanguis Draxonis to factors such as its absorption, Camphora, the loss of content of bornyl alcohol, make main component Sanguis Draxonis glycoside, tetrahydropalmatine, alkali, safflower oil, color element, Radix Angelicae Dahuricae element, asaricin, eugenol etc. are able to maximum reservation and extraction and application, ethanol acetate also increases the absorption of skin to medicine, diffusion, owing to adopting above-mentioned modern science and technology pharmaceutical technology and hands section, improved the utilization rate of medicine and guaranteed the effectiveness that this patent pharmaceutical dosage form is applied.
Below data further illustrate beneficial effect of the present invention by experiment:
The spray that wherein Experimental agents used is prepared according to the embodiment of the present invention 1 method (is called: grieved spirit).
Effect to rat acute soft tissue injury:
With tape preliminary election, measure every rat (221 ± 17g) right hind impact site girth, then rat be fixed on plank,
Getting an internal diameter is 1.4cm, long 100cmPVC hollow pipe is placed in outside Rat Right lower limb on soft tissue, (test first 1 day part and shave hair), then 1 blunt nosed ferrum pestle of heavy 80g from top to bottom freely falling body impact outside Rat Right lower limb soft tissue totally 3 times, cause the about 4cm2 size of area to have the non-open soft tissue injury model of obvious subcutaneous hemorrhage and swelling, modeling 1 hour, with tape, again measure impact site girth, according to swelling degree, sex and body weight are divided into 5 groups, it is blank solvent group, (the traumatology spirit of positive group, for Guizhou Heng Ba pharmaceutcal corporation, Ltd marketed drugs), grieved spirit is large, in, small dose group, every group 10, male and female half and half.Then by group, in rat right hind leg swelling place, be coated with relative medicine.Be coated with the each 0.5ml/200g body weight of dose, upper and lower noon administration, matched group is coated with equivalent solvent.Within 3,5,7 days after administration, measure respectively damage location girth, calculate the difference of administration front and back, do t check.After within the 7th day, measuring girth, each group rat is put to death, get damage location tissue and fix 24 hours with 10% formalin, specimens paraffin embedding slices, HE dyeing, checks under light microscopic, and presses classification: "-" changes without obvious histopathology; "+" subcutaneous and muscle fiber Mild edema, congestion, rarely seen inflammatory cell infiltrations such as neutrophil that are dispersed in; Intermediate edema between " ++ " subcutaneous and muscle fiber, a little muscle fiber is downright bad, has the inflammatory cell infiltrations such as obvious neutrophil; Severe edema between " +++ " subcutaneous and muscle fiber, a large amount of myofibrosis necrosis and inflammatory cell infiltration or inflammatory granulation tissue hyperplasia.The results are shown in Table 1, table 2:
The swelling impact of the grieved spirit of table 1 on rat acute soft tissue injury
mm, n=10
T check is compared * P (0.05, * * P ﹤ 0.01 with blank group
The grieved spirit of table 2 Microscopic observation is on the impact of rat acute soft tissue injury (n=10)
Data Ridit method is processed administration group and is compared with blank group.
Result shows the heavy dose of group of grieved clever spray and middle dosage group damage location is subcutaneous and muscle fiber between edema and inflammatory cell obviously alleviate, rarely seen a little myofibrosis necrosis and inflammatory cell infiltration,
2. grieved clever spray detumescence test
Mice is divided into 5 groups at random by body weight, and group of solvents, positive group, grieved clever heavy dose of group, middle dosage group, small dose group, 10 every group, male and female half and half.The left ear of each Mus of administration group is only coated with respective concentration medicinal liquid 0.5ml/, positive group is only coated with traumatology spirit 0.05ml/, solvent control group is coated with equivalent solvent, the toluene solvant being coated with after 15 minutes only causes inflammation to 0.05ml/, after causing scorching 20 minutes, put to death, with internal diameter 9mm card punch, get 2 auricles and weigh, with left and right auricle difference, do t check, the results are shown in Table 3
The impact of the grieved clever xylol induced mice ear swelling of table 3 (
mm, n=10)
With solvent control group comparison: * P ﹤ 0.05, * * P ﹤ 0.01
Result shows that the mice ear due to the big or middle dosage xylol of grieved spirit has significant inhibitory action.
The analgesic activity of 3 grieved spirits
A. writhing method
Get 50 of mices, body weight 20 ± 2g, is divided into 5 groups at random, male and female half and half, and minute blank solvent matched group, positive group, grieved clever large, medium and small dosage group, each is organized mouse back and is coated with corresponding medicinal liquid 0.5ml/20g.Matched group is to equivalent solvent, and after medication 30 minutes, every Mus lumbar injection 0.7% glacial acetic acid 0.25ml/ only, recorded the writhing number of times in 20 minutes, and between organizing, t checks.The results are shown in Table 4
The impact of the grieved clever Dichlorodiphenyl Acetate induced mice writhing number of table 4 (
n=10)
| Group | Dosage g/kg | Writhing number (inferior) in 20 minutes |
| Solvent control group | — | 50.7±18.32 |
| Traumatology spirit group | 5ml | 27.8±12.18** |
| Grieved clever group | 1.6 | 26.1±16.06** |
| Grieved clever group | 0.8 | 31.9±14.18* |
| Grieved clever group | 0.4 | 35.7±17.97 |
With solvent control group comparison: * P ﹤ 0.05, * * P ﹤ 0.01
Result shows: the big or middle dosage group of grieved spirit significantly reduces the writhing number of mice.
B. hot plate method
Use hot plate dolorimeter, 55 ± 0.5 ℃ of constant temperature, first choose qualified animal and (with mice, put into hot plate to occurring licking metapedes, the time occurring is this Mus pain threshold) respectively organize mice two metapedes and be coated with the every foot of corresponding tested material 0.05ml/, after 1 hour, survey its pain threshold, with different time record pain threshold organize between t check, the results are shown in Table 5
The grieved spirit of table 5 on the impact of mice pain threshold (
)
With blank group comparison: * P ﹤ 0.05, * * P ﹤ 0.01
Above result shows: grieved clever spray suppresses edema between subcutaneous and muscle fiber that rat acute soft tissue injury causes significantly, the infiltration of inflammatory cell, the hypertrophy of muscle fiber necrosis and inflammatory granulation tissue, mice ear is had to good detumescence effect, and analgesic experiment shows that grieved spirit has stronger analgesic activity.Above-mentioned experimental result matches with the function that cures mainly of grieved spirit, confirms that grieved clever spray has blood circulation promoting and blood stasis dispelling, the effect of reducing swelling and alleviating pain.
Spray safety test.
A. acute toxicity test: get 20 of healthy new zealand rabbits, male and female dual-purpose, body weight 2.05 ± 0.12kg, the depilation of ridge both sides, back, the about 150cm2 of area, after depilation 24h, depending on skin conditions, be divided into blank solvent group, the large small dose group of the large low dose of combination damaged skin of intact skin, totally 5 groups, every group 4, female, male half and half, damaged skin group is drawn skin " well " font with No. 8 sterilization syringe needles after the sterilization of depilation district, take oozing of blood as degree, administration treated animal is coated with corresponding medicinal liquid (1ml/ only) in depilation district, blank group is coated with equivalent solvent, after slightly dry, with oilpaper, cover gauze wrapping, fixing single cage is raised, after 24 hours, throw off binder, the activity of rabbit in 1h and 24h to 7d after observation removal tested material, diet, fur color pool, body weight and death condition, within continuous 7 days, observe, each treated animal extremity are movable normal, behavior is active, breathe steadily, pupil size is normal, eye is without rushing blood and secretions increase, animal wool coloured light profit, have no feces abnormal, the variation of the weight of animals growth and dietary amount, between group, nothing is significantly abnormal, and without death.Show that grieved spirit is in the complete and damaged skin test through rabbit of 15.7% and 31.4% concentration, there is not obvious toxicity and dead generation in animal, therefore this medicine is safer in this test dose scope.The results are shown in Table 6
The grieved clever spray the acute toxicity tests of table 6
B. the sensitivity test of grieved clever spray
Get 30 of Cavia porcelluss, be divided at random administration, blank group and positive group, 10 every group, male and female half and half, shave hair by guinea pig back lateral symmetry, the about 3*3cm2 of area, the grieved spirit of administration group is applied to depilation district, left side, every 0.2ml, and blank solvent group is coated with equivalent solvent, positive controls is coated with 1%2,4-dinitrochlorobenzene, every 0.2ml, each covers gauze wrapping with oilpaper after organizing administration, single cage is raised, and after contact 6h, removes residue, and 7d and 14d repeat sensitization.After last administration 14d, in depilation district, Cavia porcellus right side, administration group is coated with the grieved spirit of 0.2ml, and blank solvent group is coated with equivalent solvent, positive controls is coated with 0.1%2,4-dinitrochlorobenzene 0.2ml, after contact 6h, remove residue, at once observe, then in 24,48,72h observes skin allergy situation again, while recording each, react, and by " standards of grading " scoring, the results are shown in Table 7
The grieved spirit of table 7 is to guinea pig skin sensitivity test result
Result shows: positive controls produces obvious erythema after exciting contact 6h, its sensitization rate is 90%: and grieved spirit has no Cavia porcellus generation erythema after exciting contact 24h, without edema, the serious anaphylaxiss such as asthma, shock, its sensitization rate is zero, for reacting without sensitization.
C. the dermatologic irritation test of grieved clever spray
1. single applies the irritation test of grieved spirit to rabbit intact skin
By the depilation of rabbit back vertebra lateral symmetry, area 150cm2, depilation 24h backsight skin conditions is divided into intact skin group and damaged skin group, and 4 every group, female, hero half and half.Damaged skin group, will lose hair or feathers after district's skin degerming, with No. 8 sterilization syringe needles, at depilation zoning " well " font, take Shan blood as degree, make damaged degree basically identical, the clever 1ml/ of the pain of injury is only applied to depilation district, left side, right side is coated with the blank solvent of equivalent, after slightly dry, oilpaper covers, and wrapping is fixing, and single cage is raised.After administration 24h, with warm water, wash away residue, perusal 1,24,72h coating position erythema and edema, and with the comparison of offside matrix group, by " skin irritation standards of grading " scoring, the results are shown in Table 8
The grieved clever single coating of table 8 is to irritation test result
Result shows that grieved clever single-dose has no erythema, edema generation to rabbit intact skin and damaged skin, and its average response value is 0, is vacuum response.
2. apply the irritation tests of grieved spirit to rabbit intact skin for many times
Get 8 of rabbits, grouping and medication are the same, and successive administration 7d observes skin erythema after medicine, edema, the colour of skin, petechia, skin fineness and the situation such as poor, and Continuous Observation 7d, the results are shown in Table 9
The grieved spirit of table 9 repeatedly applies irritation test result
Result shows: grieved spirit 7d medication continuously, produces slight erythema to the damaged skin of rabbit; Each group is without edema generation, pigmentation and petechia, and skin is without coarse and poor variation.Histological examination result: the epidermis of each treated animal, pilosebaceous unit etc., all without ANOMALOUS VARIATIONS, in dermis of skin, all have a small amount of eosinophilic granulocyte and neutrophil infiltration, and damaged skin is compared with intact skin weight.Administration group and the comparison of blank solvent group, skin histology structural change no significant difference.
Conclusion: grieved spirit through skin single and repeatedly medication irritation test be nonirritant medicine.
Grieved clever spray study on the stability:
By 3 batches of the clever sprays of the pain of injury, lot number 020102, lot number 020108, lot number 020109 is put and under normal temperature condition, is carried out 3-6 month study on the stability, and result is as following table:
| Lot number 020102 | January 22 | March 21 | April 20 | May 20 |
| Character | Up to specification | Up to specification | Up to specification | Up to specification |
| Differentiate Borneolum Syntheticum | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Flos Caryophylli | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Sanguis Draxonis | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Containing alcohol amount | 56.7% | 56.5% | 57.0% | 56.7% |
| Emitted dose | > 0.12g/ time | - | - | - |
| Loading amount | 30ml/ bottle | - | - | - |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification |
| Lot number 020108 | January 22 | March 21 | April 20 | May 20 |
| Character | Up to specification | Up to specification | Up to specification | Up to specification |
| Differentiate Borneolum Syntheticum | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Flos Caryophylli | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Sanguis Draxonis | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Containing alcohol amount | 57.4% | 56.8% | 56.6% | 56.6% |
| Emitted dose | > 0.12g/ time | - | - | - |
| Loading amount | 30ml/ bottle | - | - | - |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification |
| Lot number 020109 | January 22 | March 21 | April 20 | May 20 |
| Character | Up to specification | Up to specification | Up to specification | Up to specification |
| Differentiate Borneolum Syntheticum | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Flos Caryophylli | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Sanguis Draxonis | Be positive reaction | Be positive reaction | Be positive reaction | Be positive reaction |
| Containing alcohol amount | 56.6% | 56.8% | 56.7% | 56.3% |
| Emitted dose | > 0.12g/ time | - | - | - |
| Loading amount | 30ml/ bottle | - | - | - |
| Microbial limit | Up to specification | Up to specification | Up to specification | Up to specification |
Study on the stability result: three batches of indices are all up to specification
Grieved clever clinical treatment efficacy evaluation
This group patient is totally 24 examples, male's 12 examples wherein, women's 12 examples, age: maximum 53 years old, minimum 2 years old, average 33 ± 2.1 years old, the course of disease the longest was 1 month, and the shortest is 2 days.
Result: this is organized 24 examples and follows up a case by regular visits to, follows up a case by regular visits to 2 weeks time, and 3 examples of fully recovering, account for 12.5%,
Effective 18 examples, account for 75.0%
Effective 2 examples, account for 8.3%
Invalid 1 example, accounts for 4.2%
The total effective rate 95.8% of grieved clever spray.
The specific embodiment
Further illustrate by the following examples the present invention, but not as limitation of the present invention.
Example 1
Prescription: Sanguis Draxonis 10g, Radix Paeoniae Rubra 10g, Rhizoma Corydalis 15g, Flos Carthami 10g, Radix Clematidis 10g, Herba Lycopodii 10g, Radix Et Rhizoma Rhei 10g, Fructus Gardeniae 10g, Olibanum 10g, Myrrha 10g, Radix Aconiti Preparata 10g, Radix Aconiti Kusnezoffii Preparata 10g, Flos Caryophylli 5g, Radix Angelicae Dahuricae 5g, Herba Asari 5g, Camphora 7g, Borneolum Syntheticum 5g, acetum 50ml, appropriate amount of ethanol.
Method for making:
Prescription Chinese medicine, except Sanguis Draxonis, Camphora, outside Borneolum Syntheticum, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolator, with 50% alcoholic solution 200ml, adding acetic acid 50ml stirs, soak more than 12 hours, with 65% alcoholic solution, with 2ml/min speed, carry out percolation, get percolate 950ml, camphorate, Borneolum Syntheticum, Sanguis Draxonis (pulverizing 100 orders), after being stirred to dissolve, add ethanol to 1000ml, standing 7 days, get supernatant liquid filtering, divide and install in the sprayer unit of 30ml, obtain 33 bottles of spray finished products.
Example 2
Prescription: Sanguis Draxonis 8g, Radix Paeoniae Rubra 8g, Rhizoma Corydalis 10g, Flos Carthami 8g, Radix Clematidis 8g, Herba Lycopodii 8g Radix Et Rhizoma Rhei 8g, Fructus Gardeniae 8g, Olibanum g, Myrrha 8g, Radix Aconiti Preparata 8g, Radix Aconiti Kusnezoffii Preparata 8g, Flos Caryophylli 3g, Radix Angelicae Dahuricae 3g, Herba Asari 3g, Camphora 3g,, Borneolum Syntheticum 3g, acetum 50ml, appropriate amount of ethanol.
Method for making:
Prescription Chinese medicine, except Sanguis Draxonis, Camphora, outside Borneolum Syntheticum, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolator, with 50% alcoholic solution 200ml, adding acetic acid 50ml stirs, soak more than 12 hours, with 65% alcoholic solution, with 2ml/min speed, carry out percolation, get percolate 950ml, camphorate, Borneolum Syntheticum, Sanguis Draxonis (pulverizing 100 orders), after being stirred to dissolve, add ethanol to 1000ml, standing 7 days, get supernatant liquid filtering, divide and install in the sprayer unit of 30ml, obtain 33 bottles of spray finished products.
Example 3
Prescription: Sanguis Draxonis 12g, Radix Paeoniae Rubra 12g, Rhizoma Corydalis 20g, Flos Carthami 12g, Radix Clematidis 12g, Herba Lycopodii 12g Radix Et Rhizoma Rhei 12g, Fructus Gardeniae 12g, Olibanum 12g, Myrrha 12g, Radix Aconiti Preparata 12g, Radix Aconiti Kusnezoffii Preparata 12g, Flos Caryophylli 8g, Radix Angelicae Dahuricae 8g, Herba Asari 8g, Camphora 8g, Borneolum Syntheticum 8g, acetum 50ml, appropriate amount of ethanol.
Method for making:
Prescription Chinese medicine, except Sanguis Draxonis, Camphora, outside Borneolum Syntheticum, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolator, with 50% alcoholic solution 200ml, adding acetic acid 50ml stirs, soak more than 12 hours, with 65% alcoholic solution, with 2ml/min speed, carry out percolation, get percolate 950ml, camphorate, Borneolum Syntheticum, Sanguis Draxonis (pulverizing 100 orders), after being stirred to dissolve, add ethanol to 1000ml, standing 7 days, get supernatant liquid filtering, divide and install in the sprayer unit of 30ml, obtain 33 bottles of spray finished products.
Embodiment 4
The method of quality control of grieved clever spray preparation:
[Sanguis Draxonis discriminating] gets this product 10ml, puts evaporating dish and volatilizes, and residue adds chloroform 1ml to be made to dissolve, as need testing solution.Separately get Dracoalban's reference substance, add chloroform and become solution that 1ml contains 1mg product solution in contrast, according to thin layer chromatography (2010 editions appendix VIB of Chinese Pharmacopoeia) test, draw each 4 μ l of above-mentioned two kinds of solution and put respectively on same silica gel g thin-layer plate, take chloroform: methanol (19:1) is developing solvent, launch, take out, dry, natural light is inspected, in test sample chromatograph, in the corresponding position of reference substance chromatograph on, the punctation of aobvious same color.
[Flos Caryophylli discriminating] got this product 0.1ml and added normal hexane 1ml, shakes up, as need testing solution.Separately get eugenol reference substance, add normal hexane and make every 1ml containing the reference substance solution of 0.2mg eugenol, according to gas chromatography (2010 editions appendix VIE of Chinese Pharmacopoeia), test, (110 ℃/min5 minute of column temperature, with 10 ℃/min, rise to 220 ℃, retain 20 minutes, PEG-20M quartz capillary column), draw each 3 μ l of above-mentioned two kinds of solution, inject gas chromatograph, carries out gas chromatographic analysis respectively, records chromatogram, in test sample chromatograph, present with the reference substance of eugenol and retain neural chromatographic peak.
[Borneolum Syntheticum discriminating] gets Borneolum Syntheticum reference substance, adds normal hexane and makes every 1ml containing the reference substance solution of 2mg Borneolum Syntheticum, draws reference substance solution 1 μ l, and [discriminating] 2 lower need testing solution 3 μ l, according to test under differentiating 2, carry out respectively gas chromatographic analysis, record chromatogram.In test sample chromatograph, present the chromatographic peak identical with the reference substance retention time of Borneolum Syntheticum.
Claims (10)
1. treat a traumatic injury, congestion swells and ache, and the external preparation of soft tissue contusion is characterized in that it is to be made by the raw material of Chinese medicine medicine of following weight proportion: Sanguis Draxonis 8～12g, Radix Paeoniae Rubra 8～12g, Rhizoma Corydalis 10～20g, Flos Carthami 8～12g, Radix Clematidis 8～12g, Herba Lycopodii 8～12g Radix Et Rhizoma Rhei 8～12g, Fructus Gardeniae 8～12g, Olibanum 8～12g, Myrrha 8～12g, Radix Aconiti Preparata 8～12g, Radix Aconiti Kusnezoffii Preparata 8～12g, Flos Caryophylli 3～8g, the Radix Angelicae Dahuricae 3～8g, Herba Asari 3～8g, Camphora 3～8g,, Borneolum Syntheticum 3～8g.
2. external preparation as claimed in claim 1, is characterized in that it is to be made by the raw material of Chinese medicine medicine of following weight proportion: Sanguis Draxonis 10g, Radix Paeoniae Rubra 10g, Rhizoma Corydalis 15g, Flos Carthami 10g, Radix Clematidis 10g, Herba Lycopodii 10g, Radix Et Rhizoma Rhei 10g, Fructus Gardeniae 10g, Olibanum 10g, Myrrha 10g, Radix Aconiti Preparata 10g, Radix Aconiti Kusnezoffii Preparata 10g, Flos Caryophylli 5g, Radix Angelicae Dahuricae 5g, Herba Asari 5g, Camphora 7g, Borneolum Syntheticum 5g.
3. external preparation as claimed in claim 1, is characterized in that being selected from: unguentum, powder, patch, lotion, spray, tincture, aerosol or spray.
4. external preparation as claimed in claim 1, is characterized in that being selected from: spray, aerosol or spray.
5. external preparation as claimed in claim 1, is characterized in that being selected from: spray.
6. the preparation method of external preparation claimed in claim 1, is characterized in that, raw material of Chinese medicine is processed through extraction or other modes, make pharmaceutically active substance, subsequently, take this material as raw material, while needing, add medicine acceptable carrier, according to the routine techniques of galenic pharmacy, make external preparation.
7. according to the preparation method of claim 6, it is characterized in that, described active substance can obtain by extracting respectively raw material of Chinese medicine, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverizing, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the method such as ketone is carried, chromatography obtains, these active substances can be the material of extractum form, can be that dry extract can be also fluid extract, according to the difference of preparation, need to determine to make different concentration.
8. according to the preparation method of claim 6, it is characterized in that, described active substance preparation method is as follows: except Camphora, Borneolum Syntheticum, outside Sanguis Draxonis, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolation pot, with 50% alcoholic solution 200ml, adding acetic acid 50ml stirs, soak more than 12 hours, with 65% alcoholic solution 700ml, with 2ml/min speed, carry out percolation, obtain percolate, camphorate, Borneolum Syntheticum, Sanguis Draxonis, be stirred to dissolve and get final product.
9. according to the preparation method of claim 6, it is characterized in that, preparation method is as follows: except Sanguis Draxonis, Camphora, outside Borneolum Syntheticum, by Radix Paeoniae Rubra, Rhizoma Corydalis, Flos Carthami, Radix Clematidis, Herba Lycopodii, Radix Et Rhizoma Rhei, Fructus Gardeniae, Olibanum, Myrrha, Radix Aconiti Preparata, Radix Aconiti Kusnezoffii Preparata, Flos Caryophylli, the Radix Angelicae Dahuricae, the 14 taste medicated powder such as Herba Asari are broken into coarse powder, in percolator, with 50% alcoholic solution 200ml, adding acetic acid 50ml stirs, soak more than 12 hours, with 65% alcoholic solution, with 2ml/min speed, carry out percolation, get percolate 950ml, camphorate, Borneolum Syntheticum, pulverizing 100 bleeding of eye exhausts, after being stirred to dissolve, add ethanol to 1000ml, standing 7 days, get supernatant liquid filtering, packing, obtain finished product.
10. the external preparation of claim 1 is in preparation treatment traumatic injury, and congestion swells and ache, the application in the medicine of soft tissue contusion.
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Application publication date: 20140122 |