CN103920010B - There is pharmaceutical composition of hemostasis and pain-relieving and antiinflammatory action and its production and use - Google Patents
There is pharmaceutical composition of hemostasis and pain-relieving and antiinflammatory action and its production and use Download PDFInfo
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Abstract
The invention discloses a kind of pharmaceutical composition with hemostasis and pain-relieving and antiinflammatory action and its production and use, made by following bulk drug: golden cypress, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, safflower, red halloysite, Chinese gall, dragon's blood, menthol. The each bulk drug compatibility of pharmaceutical composition of the present invention can produce obvious synergistic function, and experiment confirms that it has significant hemostasis and pain-relieving and antiinflammatory action simultaneously, various hemorrhage, the pain for the treatment of the aspect such as inflammatory symptoms and hemorrhoid all there is good effect.
Description
Technical field
The invention belongs to pharmaceutical technology field, particularly a kind of medicine with hemostasis and pain-relieving and antiinflammatory action
Composition and method of making the same and purposes.
Background technology
The diseases such as traumatic injury, hemorrhage of digestive tract, hemorrhoid, conventionally with hemorrhage and pain symptom, also can sometimes
Simultaneously with inflammatory symptoms, in considering hemostasis, pain relieving, conventionally also to consider to enter in therefore clinical simultaneously
Row anti-inflammatory treatment, but at present clinically can with time there is the medicine of hemostasis and pain-relieving and antiinflammatory action few.
The medicine Yunnan Baiyao that is usually used in hemostasis and pain-relieving as clinical, has the effect such as removing blood stasis and hemostasis, promoting blood circulation and stopping pain, but
Its antiinflammatory action is also not obvious. And for example the clinical mayinglong shexiang zhichuang ointments that is usually used in treating hemorrhoid, has clearly
Hot eliminating dampness, activating blood circulation and reducing swelling, the effect such as remove necrosis and promote granulation do not have hemostasis, pain relieving and antiinflammatory action simultaneously yet.
Therefore in the time of clinical middle situation about occurring simultaneously with hemorrhage, pain and inflammatory symptoms, the treatment of these medicines
Effect is unsatisfactory.
Summary of the invention
Main purpose of the present invention is to provide a kind of drug regimen simultaneously with hemostasis and pain-relieving and antiinflammatory action
Thing.
Another object of the present invention is to provide the preparation method of aforementioned pharmaceutical compositions.
Another object of the present invention is to provide the purposes of aforementioned pharmaceutical compositions.
In order to realize foregoing invention object, the technical solution used in the present invention is as follows:
First there is a pharmaceutical composition for hemostasis and pain-relieving and antiinflammatory action, former by following weight parts proportioning
Material medicine is made:
Golden cypress 5-30 part, preferably 10-25 part, more preferably 15-20 part
Capsule of weeping forsythia 5-30 part, preferably 10-25 part, more preferably 15-20 part
Kuh-seng 5-30 part, preferably 10-25 part, more preferably 15-20 part
Lamiophlomis rotata 5-30 part, preferably 10-25 part, more preferably 15-20 part
Bletilla 1-20 part, preferably 5-15 part, more preferably 8-10 part
Safflower 1-20 part, preferably 5-15 part, more preferably 8-10 part
Red halloysite 1-10 part, preferably 2-7 part, more preferably 4-5 part
Chinese gall 1-10 part, preferably 2-7 part, more preferably 4-5 part
Dragon's blood 1-10 part, preferably 2-7 part, more preferably 4-5 part
Menthol 1-10 part, preferably 1.5-7 part, more preferably 2-4 part.
Each bulk drug source of aforementioned pharmaceutical compositions is as follows respectively:
Golden cypress is the dry bark of rutaceae wampee PhellodendronchinenseSchneid..
Practise and claim " CORTEX PHELLODENDRI CHINENSE ". There is heat-clearing and damp-drying drug, purging intense heat except effects such as steaming, detoxification sore treatments. For damp-heat dysentery,
Jaundice urine is red, the lower pruritus vulvae of band, heat are drenched puckery pain, beriberi impotence is preesed, hectic fever due to yin labor heat, night sweat, seminal emission, sore are swollen
Poison, the wet sore of eczema.
The capsule of weeping forsythia is the dry fruit of Oleaceae plants capsule of weeping forsythia Forsythiasuspensa (Thunb.) Vahl.
There is the effects such as clearing heat and detoxicating, dispersing swelling and dissipating binds, dispelling wind and heat from the body. For ulcer, scrofula, acute mastitis, erysipelas,
Anemopyretic cold, warm disease from the beginning of, warm Ren Ying, high hot polydipsia, coma send out spot, heat is drenched puckery pain.
Kuh-seng is the dry root of legume kuh-seng SophoraflavescensAit.. Have heat-clearing and damp-drying drug,
The effect such as desinsection, diuresis. For hot dysentery, have blood in stool, jaundice renal shutdown, leukorrhea with reddish discharge, swelling of vulva pruritus vulvae, eczema,
Wet sore, pruitus, mange leprosy, control trichomonas vaginitis outward.
Lamiophlomis rotata is the dry of labiate lamiophlomis rotata Lamiophlomisrotate (Benth.) Kudo
Aerial part. There is the effect such as promoting blood circulation and hemostasis, wind-expelling pain-stopping. For traumatic injury, traumatism and bleeding, rheumatism
Numbness pain, grasserie.
Bletilla is the dry tuber of orchid bletilla Bletillastriata (Thunb.) Reiehb.f..
There is the effect such as astringing to arrest bleeding, detumescence and promoting granulation. For spitting of blood, haematemesis, traumatism and bleeding, sore swollen toxin, skin
Skin is chapped.
Safflower is the dried floral of feverfew safflower CarthamustinctoriusL.. Have activating blood to promote menstruation,
The effects such as blood stasis removing analgesic. For through closing, dysmenorrhoea, lochia, addiction lump in the abdomen lump in the abdomen, chest impediment and cardialgia, the stagnant abdomen of the stasis of blood
Bitterly, the shouting pain of the chest side of body, injury from falling down, sore swell and ache.
Red halloysite is silicates mineral halloysite family halloysite, main containing four water alumina silicate
[Al4(Si4O10)(OH)8·4H2O]. There is the effects such as puckery intestines, hemostasis, regenerating tissue to heal wond. For rush down for a long time protracted dysentery,
Defecate under hemorrhage, uterine bleeding band, control outward sore burst for a long time do not hold back, wet sore pus contamination.
Chinese gall is Anacardiaceae plant Chinese sumac RhuschinensisMill., blue or green bran poplar Rhuspotaninii
Or redpunjab sumac root Rhuspunjabensis.Stew.var.sinica (Diels) Rehd.Etwils. Maxim.
Insect gall on leaf, is mainly formed by melaphis chinensis Baker Melaphischinensis (Bell) Baker parasitism.
Having astringes the lung falls the effects such as fire, relieving diarrhea with astringents, arrest sweating, hemostasis, hygroscopic sore. For chronic cough of deficiency lung, lung
Feverish cough, rush down protracted dysentery, spontaneous sweating for a long time, quench one's thirst, have blood in stool hemorrhoid blood, traumatism and bleeding, carbuncle sore tumefacting virus, skin
Wet rotten.
Dragon's blood is that the resin that babassu Sanguis Draxonis DaemonoropsdracoBl. fruit oozes out is made through processing
Become. There is the effects such as the analgesic therapy of invigorating blood circulation, removing blood stasis and hemostasis, regenerating tissue to heal wond. For traumatic injury, trusted subordinate's stasis of blood pain,
Traumatism and bleeding, sore are not held back.
Menthol is fresh stem and the Ye Jing steam of labiate peppermint MenthahaplocalyxBriq.
Distillation, a kind of saturated cyclic alcohol that freezing, recrystallization obtains are l-1-methyl-4-isopropyl cyclohexanol-3.
Aforementioned pharmaceutical compositions can be that capsule, tablet, pill, granule, oral solution etc. are any
A kind of oral Pharmaceutical dosage forms, or spray, paste, suppository, patch, powder, pulvis, liniment,
Any external used medicine formulations such as film, externally used solution agent.
According to a preferred embodiment of the invention, wherein pharmaceutical composition be by by raw material according to comprising
The method processing of following steps and preparation:
(1) get golden cypress, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, the safflower in bulk drug, adopt water extraction
Or ethanol-water solution (ethanol water of for example 60%-90%) extraction method, i) carry out respectively extraction process, obtain
Obtain extract separately, then mix, obtain extract A 1, or ii) merge and carry out extraction process, obtain
Extract A 1;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are ground to form respectively to fine powder or difference
Break into fine powder, then mix, obtain fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtain
Obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition C.
Further, by the pharmaceutical composition C in step (3) (for example, according to the conventional formulation system of different dosage form medicine
Preparation Method) make the medicine of corresponding formulation.
According to another embodiment of the invention, provide the preparation method of aforementioned pharmaceutical compositions, the method
Comprise following key step:
(1) get golden cypress, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, the safflower in bulk drug, adopt water extraction
Or ethanol-water solution (ethanol water of for example 60%-90%) extraction method, i) carry out respectively extraction process, obtain
Obtain extract separately, then mix, obtain extract A 1, or ii) merge and carry out extraction process, obtain
Extract A 1;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are ground to form respectively to fine powder or difference
Break into fine powder, then mix, obtain fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtain
Obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition C;
Optional (4), get the pharmaceutical composition C of above-mentioned steps (3), (for example, according to different dosage form medicine
Conventional formulation method) make the medicine of corresponding formulation.
Preferably, in said method: other described bulk drug is carried out to extraction process i) respectively, refer to
Get respectively each bulk drug, add water or ethanol-water solution decocts extraction, filter, obtain each raw material after concentrated
The extract of medicine, and then each extract is mixed; Or, other described bulk drug is merged and extracted
Process ii), refer to all bulk drugs are combined by described proportioning, add water or ethanol-water solution carries out
Decoct and extract, filter, the concentrated rear total extract that obtains.
In above-mentioned preparation method, the addition of water or alcoholic solution when water extraction or alcohol extracting, can extract with reference to medicine
Conventional liquid addition in journey, as according to bulk drug weight: liquid volume=1g:(6-12) ml etc.
In this application, " optional " represents to be with or without, and " optionally " expression is carried out or do not carried out.
According to another embodiment of the invention, provide aforementioned pharmaceutical compositions purposes, for the preparation of
There is the medicine of hemostasis and pain-relieving and antiinflammatory action; For example can be used for various hemorrhage, the pain of preparation treatment and inflammatory
The medicine of symptom (as traumatic injury, hemorrhage of digestive tract, hemorrhoid etc.).
Compared with prior art, the invention has the beneficial effects as follows:
Between each bulk drug of pharmaceutical composition of the present invention, there is obvious synergistic function, by experiment card
Real its has significant hemostasis and pain-relieving and antiinflammatory action simultaneously, and various hemorrhage, pain and inflammatory symptoms are had
Well result for the treatment of.
Detailed description of the invention
Below in conjunction with detailed description of the invention, foregoing invention content of the present invention is described in further detail.
But this should be interpreted as to the scope of the above-mentioned theme of the present invention only limits to following embodiment. Do not departing from this
Invent in above-mentioned technological thought situation, according to ordinary skill knowledge and customary means, make various replacing
Change and change, all should comprise within the scope of the invention.
Embodiment 1-7
Embodiment 1-7 is respectively the pharmaceutical composition of being made up of the bulk drug of weight portion proportioning shown in following table 1:
The raw material medicines in portions by weight proportioning of table 1 embodiment 1-7
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 | |
| Golden cypress | 5 | 10 | 15 | 20 | 20 | 25 | 30 |
| The capsule of weeping forsythia | 30 | 15 | 25 | 15 | 20 | 5 | 10 |
| Kuh-seng | 10 | 25 | 30 | 15 | 20 | 5 | 5 |
| Lamiophlomis rotata | 25 | 30 | 5 | 20 | 20 | 10 | 15 |
| Bletilla | 12 | 15 | 5 | 8 | 10 | 20 | 1 |
| Safflower | 1 | 5 | 8 | 12 | 10 | 20 | 15 |
| Red halloysite | 8 | 2 | 1 | 4 | 5 | 7 | 10 |
| Chinese gall | 10 | 7 | 8 | 5 | 4 | 1 | 2 |
| Dragon's blood | 7 | 1 | 2 | 5 | 4 | 10 | 8 |
| Menthol | 10 | 7 | 5 | 4 | 2 | 8 | 1.5 |
The preparation method of embodiment 1-3:
According to the bulk drug proportioning of above-described embodiment 1-3, make respectively by the method that comprises following key step
Become oral capsule, external spraying agent, externally-applied liniment:
(1) golden cypress in bulk drug, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, safflower are combined,
Adding percent by volume is 70% ethanol water, and addition is according to bulk drug weight: liquid volume=1g:10
Ml calculates, and heating is extracted, and filters, by the concentrated filtrate extract A 1 that obtains;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are mixed, break into fine powder,
Obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition C;
(4), get the pharmaceutical composition C of above-mentioned steps (3), according to the conventional formulation side of different dosage form medicine
Method, makes the medicine of corresponding formulation.
The preparation method of embodiment 4-7:
According to the bulk drug proportioning of above-described embodiment 4-7, by comprising the method for following key step, make
Externally used paste:
(1) golden cypress in bulk drug, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, safflower are combined,
Adopt water extraction, add 8 times of weight in the water of bulk drug weight, decoct and extract 3 times, filter, merge filter
Liquid the concentrated rear extract A 1 that obtains;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are broken into respectively to fine powder, then mixed
Close evenly, obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition C;
(4), get the pharmaceutical composition C of above-mentioned steps (3), according to the conventional formulation method of paste, make
Externally used paste.
Embodiment 8
For the result for the treatment of of further proved invention pharmaceutical composition, inventor is with above-described embodiment 4-7
Totally four groups of pharmaceutical compositions are that Experimental agents (being followed successively by Experimental agents 1-4) has carried out following experimental study.
For ease of observing the synergistic function between each bulk drug, increased by two with reference to medicine group simultaneously:
Random seven kinds or the eight kinds of bulk drugs (two groups) of selecting in pharmaceutical composition of the present invention, with reference to embodiment 4 medicines
Weight portion proportioning of composition Raw medicine and preparation method thereof is made externally used paste, as with reference to medicine 1 and 2.
Raw material medicines in portions by weight proportioning with reference to medicine 1 and 2 is as follows respectively:
With reference to medicine 1: 20 parts of golden cypresses, 15 parts of the capsules of weeping forsythia, 15 parts of kuh-sengs, 20 parts of lamiophlomis rotatas, 8 parts of bletillas,
12 parts, safflower, 4 parts of red halloysites.
With reference to medicine 2: 15 parts of kuh-sengs, 20 parts of lamiophlomis rotatas, 8 parts of bletillas, 12 parts, safflower, red halloysite 4
Part, 5 parts, Chinese gall, 5 parts of dragon's blood, 4 parts of menthols.
One, experiment material
1, animal used as test
(1) hemostasis experiment is used
Clean level KM kind mouse, 90, male and female half and half, body weight 20 ± 2g, reaches large biotechnology by Chengdu
Co., Ltd provides, animal used as test production licence number: SCXK (river) 2013-24, " Quality of Experimental Animals
The quality certification " number: № 0014820.
(2) analgesic experiment is used
Clean level KM kind mouse, 90, Quan Xiong, body weight 20 ± 2g, reaches large biotechnology by Chengdu limited
Company provides, animal used as test production licence number: SCXK (river) 2013-24, and " Quality of Experimental Animals is qualified
Card " number: № 0014819.
(3) anti-inflammatory experiment is used
Clean level KM kind mouse, 100, Quan Xiong, body weight 20 ± 2g, reaches large biotechnology by Chengdu limited
Company provides, animal used as test production licence number: SCXK (river) 2013-24, and " Quality of Experimental Animals is qualified
Card " number: № 0014818.
2, Experimental agents and control drug etc.
Experimental agents 1-4: the pharmaceutical composition that is followed successively by above-described embodiment 4-7.
With reference to medicine 1 and 2: above-mentioned with reference to medicine 1 and 2.
Positive control medicine 1: Yunnan Baiyao.
Positive control medicine 2: mayinglong shexiang zhichuang ointments.
Positive control medicine 3: dexamethasone acetate emulsifiable paste
3, main agents
Sodium chloride injection (0.9%): specification is 500ml:4.5g, authentication code is the accurate word H53020469 of traditional Chinese medicines,
Produced by Kuming Nanjiang Pharmacy Co., Ltd, batch number is C130205A, valid until 2015.01, raw
The product date is 2013.02.17;
Urethane (urethanes, analyze pure, AR): meet Q/C5411196-9, product batch number is
20100419, by Chengdu, Ke Long chemical reagent factory produces.
Glacial acetic acid (analyze pure, AR): meet GB/T676-2007, product batch number is 20120528, by becoming
City Ke Long chemical reagent factory, becomes 0.6% concentration with normal saline dilution, configuration 20ml is now with the current.
Dimethylbenzene (analyze pure, AR): meet: GB/T16494-1996, product batch number is 20120320, by
Chengdu Ke Long chemical reagent factory.
4, main equipment and equipment
Hygrothermograph: WS-2080B, Xinghai County of Beijing reaches industry and trade center instrument Watch Factory;
Electronic balance: BP-121S, Sai Duolisi Instrument Ltd.;
Electronic scale: BS-600L, Shanghai sound weighing apparatus Co., Ltd;
Mouse cage (comprising kettle);
Syringe (1ml type);
Cotton swab;
Operating scissors;
Stopwatch;
Filter paper: 10mm2, weigh (mg), about 255mg left and right;
Pipettor (5-50ul): Shanghai system 02220006, the good dutiful instrument plant of analysing in Shanghai;
Card punch: the about 6mm of internal diameter;
Eye scissors, ophthalmic tweezers etc.
Two, experimental technique
1, animal grouping
(1) grouping of animal in hemostasis experiment
90 animals (male and female half and half) are divided into 9 groups at random according to sex, body weight, model control group,
1 group of positive control, 2 groups of positive controls, Experimental agents 1-4 group, with reference to medicine 1-2 group; Every group 10
Animal, male and female half and half.
(2) grouping of animal in analgesic experiment
90 animals (entirely male) are divided into 9 groups at random according to body weight, i.e. model control group, positive control 2
Group, 3 groups of positive controls, Experimental agents 1-4 group, with reference to medicine 1-2 group; Every group of 10 animals.
(3) grouping of animal in anti-inflammatory experiment
100 animals (entirely male) are divided into 10 groups at random according to body weight, i.e. blank group, model contrast
Group, 2 groups of positive controls, 3 groups of positive controls, Experimental agents 1-4 group, with reference to medicine 1-2 group; Every group
10 animals.
2, dosage regimen
(1) Coming-of-Age Day is used determining of dosage
The third-class expert of Miao Ming thinks, in external application experiment owing to being subject to the restriction of medicine-feeding part, many Chinese medicine externals
The dose-effect relationship of preparation is also not obvious; Zoopery topical dose in principle has one to be equivalence with clinical external application
Dosage. For enepidermic feature, through test of many times and thinking, animals and human beings homalographic dosage
Be exactly unanimously dose,equivalent, instead of medicine for oral administration animal consumption is the situation of the several times of people's consumption.
As at mayinglong shexiang zhichuang ointments during for the treatment of the diseases such as hemorrhoid, anal fissure, perianal eczema, adult is coated with
The long-pending approximately 1～3cm that estimates wipes one's face2, each consumption of being grown up is 9.6～13.9mg, within 1st, can smear repeatedly.
But, in zoopery, be subject to animal can use the restriction of skin area, through smearing of prerun mouse tail
Area may be 1cm2; Ensureing that medicine fully absorbs under the prerequisite of not wasting, determine Ma Yinglong Moschus hemorrhoid
Each use amount of cream etc. is about 13.9mg ointment; Experimental agents of the present invention and with reference to the consumption of medicine with reference to horse
Answer the consumption of imperial Moschus acne cream.
(2) dosage regimen
Refer to following table 2.
[dosage] each positive controls, Experimental agents group, give the medicine of corresponding dosage with reference to medicine group
Thing; Blank group and model control group give appropriate physiological saline (to be evenly coated with skin as degree, approximately
0.03ml)。
[administration cycle] is every day 1 time (point in mornings 9), for three days on end.
[medicine-feeding part] docks in hemorrhage experiment mouse, and medicine-feeding part is that mouse tail is (apart from tail point 1/4
Place) skin (smearing the about 1cm of length); Cause in mouse writhing reaction experiment at acetic acid, medicine-feeding part is mouse
Under belly xiphoid-process around 2cm skin to the left; In mice caused by dimethylbenzene xylene ear swelling test, medicine-feeding part
On skin for " two sides before and after auris dextra exterior feature ".
[administration area] application area is 1cm2, because the unit's of being subject to skin absorbs quantitative limitation, ointment is not
Must smear too thick.
Table 2 dosage regimen
3, experimental procedure
2.3.1 the mouse hemorrhage experiment of docking
In the room temperature environment of 15 DEG C, 30min after the administration of animal last, cuts off little with sharp operating scissors
1/4 of mouse tail length, treats that blood overflows beginning timing voluntarily, uses filter paper (10mm in good time2, mg weighs) and sucking-off
Drop of blood, until blood stops while inhaling (filter paper without blood) naturally, calculates the bleeding time (BT, s), weighs blood volume
(mg). Note, forbid to push hemorrhage section.
2.3.2 acetic acid causes mouse writhing reaction experiment
In the room temperature environment of 20 DEG C, 30min after the administration of animal last, each mouse is pressed respectively 10ml/kg's
Give dimension criteria lumbar injection 0.6% glacial acetic acid (glacial acetic acid); Observe immediately and " occur first writhing response
Time " (writhing incubation period s), " writhing response number of times " (inferior) that occur in 15min, and is calculated medicine
The inhibiting rate of thing to writhing response.
Inhibiting rate %=(model control group writhing response mean-administration group writhing response mean) × 100%/model
Control group writhing response mean
2.3.3 mice caused by dimethylbenzene xylene ear swelling test
30min after last administration, the mouse right ear of blank group (is two sides with pipettor by 10 μ L/ faces
Totally 20 μ L) smear 0.9% physiological saline, left ear is as own control; The mouse right ear of all the other each groups is with moving
Liquid device is smeared caused by dimethylbenzene xylene inflammation by 10 μ L/ faces (being two sides totally 20 μ L), and left ear is as own control.
After 2h, animal is with after urethane intraperitoneal injection of anesthesia, and de-cervical vertebra is put to death. Cut two ears along auricle baseline,
Card punch taking interior diameter as 6mm is got the auricle of left and right ear same area, weighs immediately, with left and right auricle weight
The poor swelling (mg) for inflammation of amount, and carry out statistical analysis.
Calculate average swelling (mg) and the inhibitory rate of intumesce (%) of each group by surveyed swelling.
The contrast of inhibitory rate of intumesce=(the average swelling of average swelling-medication group of model control group)/model
The average swelling of group
4, sacrifice of animal
Animal is all used urethane (concentration is 20g/100mL, and giving volume is 5mL/kg, gives dosage 1g/kg)
After intraperitoneal injection of anesthesia, de-cervical vertebra is put to death.
5, statistical disposition
First, by each Sets of Measurement Data data (bleeding time, amount of bleeding, writhing incubation period, writhing response
Number of times, swelling) with " mean+SDRepresent.
" the independent sample T inspection " of secondly, using SPSS17.0forwindows software to provide carried out
" significance test of mean difference " between medicine group and model control group. With the Levene inspection side of carrying out
Poor test of homogeneity, as P > 0.05 time, show that variance is neat, observe corresponding T inspection P value; Vice versa.
Finally, there iing " the mean+SD of medicine group of significant differenceRear mark
" * ", represents that the difference between mean has significant statistical significance (P < 0.05), and mark " * * " represents
Difference between mean has the statistical significance (P < 0.01) of highly significant.
Three, experimental result
Refer to following table 3.
1, anastalsis
(1) the mouse docking bleeding time
The average docking bleeding time of model control group mouse is 602.33s.
With model control group comparison, the docking bleeding time of Yunnan Baiyao control group mice shortens significantly
(P<0.05)。
With model control group comparison, there is shortening in the docking bleeding time of mayinglong shexiang zhichuang ointments control group mice
Trend (P > 0.05).
With model control group comparison, the docking bleeding time that Experimental agents of the present invention is respectively organized mouse shortens significantly
(P < 0.05), and be better than with reference to medicine.
With model control group comparison, there is the trend of shortening in the docking bleeding time of respectively organizing mouse with reference to medicine
(P>0.05)
(2) mouse docking amount of bleeding
The average docking amount of bleeding of model control group mouse is 56.08mg.
With model control group comparison, the docking amount of bleeding of Yunnan Baiyao control group mice reduces significantly
(P<0.05)。
With model control group comparison, the docking amount of bleeding of mayinglong shexiang zhichuang ointments control group mice has increase
Trend (P > 0.05).
With model control group comparison, the docking amount of bleeding that Experimental agents of the present invention is respectively organized mouse all reduces significantly
(P < 0.05), and be better than with reference to medicine.
With model control group comparison, the docking amount of bleeding of respectively organizing mouse with reference to medicine has the trend of minimizing
(P>0.05)。
(3) brief summary
The average docking bleeding time of model control group mouse is 602.33s, on average the amount of bleeding that docks is
56.08mg。
Yunnan Baiyao can shorten the mouse docking bleeding time, and reduces mouse docking amount of bleeding.
Mayinglong shexiang zhichuang ointments all affected less than obvious mouse docking bleeding time and amount of bleeding.
Experimental agents of the present invention is respectively organized and can be shortened the mouse docking bleeding time, and reduces mouse docking amount of bleeding,
And be better than with reference to medicine.
With model control group comparison, have and shorten the mouse trend in docking bleeding time with reference to medicine, there is minimizing little
The trend of mouse docking amount of bleeding.
2, analgesic effect
(1) writhing incubation period
Be 220.50s average writhing incubation period of model control group mouse.
With model control group comparison, the writhing of dexamethasone control group mice extends incubation period significantly
(P<0.05)。
With model control group comparison, the writhing of mayinglong shexiang zhichuang ointments control group mice has prolongation incubation period
Trend (P > 0.05).
With model control group comparison, the writhing that Experimental agents of the present invention is respectively organized mouse all extends incubation period significantly
(P < 0.05 or P < 0.01); And with the comparison of dexamethasone control group, Experimental agents of the present invention is respectively organized turning round of mouse
Body all has the trend (P > 0.05) of prolongation incubation period, and is better than with reference to medicine.
With model control group comparison, the writhing of respectively organizing mouse control group mice with reference to medicine has prolongation incubation period
Trend (P > 0.05).
(2) writhing number of times
The average writhing number of times of model control group mouse is 34.5 times.
With model control group comparison, the writhing number of times of dexamethasone control group mice obviously reduces
(P<0.01)。
With model control group comparison, the writhing number of times of mayinglong shexiang zhichuang ointments control group mice obviously
Reduce (P < 0.01). And with the comparison of dexamethasone control group, the turning round of mayinglong shexiang zhichuang ointments control group mice
Body number of times has the trend (P > 0.05) of minimizing.
With model control group comparison, the writhing number of times that Experimental agents of the present invention is respectively organized mouse all obviously subtracts
Few (P < 0.01); And with the comparison of dexamethasone control group, Experimental agents of the present invention is respectively organized the writhing number of times of mouse
There is the trend (P > 0.05) of minimizing.
With model control group comparison, the writhing number of times of respectively organizing mouse with reference to medicine has obviously minimizing
(P<0.01)。
(3) brief summary
Be that 220.50s, average writhing number of times are 34.5 times average writhing incubation period of model control group mouse.
Dexamethasone can reduce the number of times of " acetic acid cause mouse writhing reaction ", and extends mouse writhing incubation period.
Mayinglong shexiang zhichuang ointments can reduce the number of times of " acetic acid causes mouse writhing reaction ".
Experimental agents of the present invention is respectively organized the number of times that can reduce " acetic acid causes mouse writhing reaction ", and extends mouse
Writhing incubation period, and suitable with the effect of dexamethasone.
The trend that has the number of times of minimizing " acetic acid causes mouse writhing reaction " with reference to each group of medicine, has prolongation mouse
The preclinical trend of writhing.
3, antiinflammatory action
(1) auricle swelling degree
With the comparison of blank group, obviously swelling of the auricle of model control group mouse (P < 0.01).
With model control group comparison, the auricle swelling degree of dexamethasone control group mice obviously reduces
(P<0.01)。
With model control group comparison, the auricle swelling degree of mayinglong shexiang zhichuang ointments control group mice has reduction
Trend (P > 0.05).
With model control group comparison, the auricle swelling degree that Experimental agents of the present invention is respectively organized mouse obviously falls
Low (P < 0.01), and be better than with reference to medicine.
With model control group comparison, the auricle swelling degree of respectively organizing mouse with reference to medicine has the trend of reduction
(P>0.05)。
(2) brief summary
Dexamethasone can suppress mice caused by dimethylbenzene xylene auricle swelling degree.
Mayinglong shexiang zhichuang ointments paraxylene causes the not significantly impact of mice auricle swelling degree.
Experimental agents of the present invention is respectively organized paraxylene and is caused mice auricle swelling degree and all can suppress mice caused by dimethylbenzene xylene ear
Wide swelling, and effect is better than with reference to medicine.
Four, experiment conclusion
Experimental agents of the present invention has obvious analgesic effect, and suitable with the effect of dexamethasone, and has bright
Aobvious hemostasis and antiinflammatory action, and whole structure is better than with reference to medicine.
Embodiment 9
In order further to investigate the clinical treatment effect of medicine of the present invention to hemorrhoid, inventor is with above-described embodiment
Totally four groups of pharmaceutical compositions of 4-7 is that Experimental agents (being followed successively by Experimental agents 1-4) has carried out following clinical testing
Research.
For ease of observing the synergistic function between each bulk drug, increased by two with reference to medicine group simultaneously,
Identical with reference to medicine 1 and 2 with above-described embodiment 8 respectively.
(1) diagnostic criteria
1. symptom
(1) podex is hemorrhage just time, or bleeds, or penetrates blood.
(2) just time or after fatigue, hemorrhoid are deviate from outside anus, can self-resetting, or need manipulative reduction.
(3) anus discomfort just time, or falling inflation.
2. visual examination: anus edge hemorrhoid redness, while increasing abdominal pressure, haemorrhoids becomes large, and some patients were internal piles is deviate from outside anus.
3. anoscopy: the bossed haemorrhoids of distal rectal, hemorrhoid mucous hyperemia, or companion is rotten to the corn.
In above-mentioned 3 all meeting (1) in 2 and (2), (3) 1, diagnosable.
(2) test case standard
1. include case standard in
Meet hemorrhoids diagnostic criteria, clinical manifestation is I, II, III phase, without incarceration, can include in
Test case.
2. health giving quality observation
(1) relevant symptoms, sign.
(2) rectal touch.
(3) anoscopy.
(3) curative effect determinate standard (formulate standard with reference to national analogy art meeting in 1992, only record internal piles,
Mixed hemorrhoid)
Clinical recovery: after an action of the bowels without hemorrhage, without prolapsus, it is normal that anoscopy hemorrhoid mucous membrane recovers, and haemorrhoids atrophy disappears
Lose curative effect rate 100%.
Effective: after an action of the bowels without hemorrhage, without deviating from, haemorrhoids redness obviously disappears, anoscopy, internal piles mucous membrane is light
Degree is congested, and haemorrhoids diminishes, curative effect rate >=75% < 100%.
Effective: still have after an action of the bowels hemorrhage on a small quantity, companion slightly prolapsus, anoscopy hemorrhoid mucous membrane mild hyperaemia, curative effect
Rate >=50% < 75%.
Invalid: sings and symptoms is treated front without improving, and even increases the weight of; Or curative effect rate <.
Integration=symptom score, physico-chemical examination divide, the summation of function of joint scoring.
(4) test method
1. test case
Include altogether 210 routine patients in, every group of 30 people.
2. test method
External application, 3 times on the 1st, medication 3 days. During treatment, patient does not do other processing.
(5) result of the test
Refer to following table 4.
Table 4 hemorrhoid treating clinical test results
The patient who takes Experimental agents of the present invention, result for the treatment of is better, and the cure rate for the treatment of is more than 10%, aobvious
Efficiency is more than 80%; Take the patient with reference to medicine and control drug, cure rate and obvious effective rate entirety are lower than reality
Test medicine.
Claims (10)
1. there is a pharmaceutical composition for hemostasis and pain-relieving and antiinflammatory action, by the raw material of following weight parts proportioning
Medicine is made:
Golden cypress 5-30 part, capsule of weeping forsythia 5-30 part, kuh-seng 5-30 part, lamiophlomis rotata 5-30 part, bletilla 1-20 part,
Safflower 1-20 part, red halloysite 1-10 part, Chinese gall 1-10 part, dragon's blood 1-10 part, and menthol 1-10
Part.
2. composition according to claim 1, is characterized in that described bulk drug proportioning is:
Golden cypress 10-25 part, capsule of weeping forsythia 10-25 part, kuh-seng 10-25 part, lamiophlomis rotata 10-25 part, bletilla
5-15 part, safflower 5-15 part, red halloysite 2-7 part, Chinese gall 2-7 part, dragon's blood 2-7 part, and peppermint
Brain 1.5-7 part.
3. composition according to claim 1 and 2, is characterized in that described bulk drug proportioning is:
Golden cypress 15-20 part, capsule of weeping forsythia 15-20 part, kuh-seng 15-20 part, lamiophlomis rotata 15-20 part, bletilla 8-10
Part, safflower 8-10 part, red halloysite 4-5 part, Chinese gall 4-5 part, dragon's blood 4-5 part, and menthol 2-4
Part.
4. according to the composition described in any one in claim 1-3, it is characterized in that described medicine group
Compound is oral drugs, is rendered as any one in capsule, tablet, pill, granule, oral solution
The form of kind.
5. according to the composition described in any one in claim 1-3, it is characterized in that described medicine group
Compound is external used medicine, is rendered as spray, paste, suppository, patch, powder, pulvis, liniment, film
Any one form in agent, externally used solution agent.
6. according to the composition described in any one in claim 1-5, wherein pharmaceutical composition is by will
Raw material preparation according to the method processing comprising the following steps below:
(1) get golden cypress, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, the safflower in bulk drug, adopt water extraction
Or ethanol-water solution extraction method, i) carry out respectively extraction process, obtain extract separately, then mix,
Obtain extract A 1, or ii) merge and carry out extraction process, extract A 1 obtained;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are ground to form respectively to fine powder or difference
Break into fine powder, then mix, obtain fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtain
Obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition.
7. composition according to claim 6, wherein, makes the pharmaceutical composition in step (3)
The medicine of corresponding formulation.
8. a preparation method for composition claimed in claim 1, comprises following key step:
(1) get golden cypress, the capsule of weeping forsythia, kuh-seng, lamiophlomis rotata, bletilla, the safflower in bulk drug, adopt water extraction
Or ethanol-water solution extraction method, i) carry out respectively extraction process, obtain extract separately, then mix,
Obtain extract A 1, or ii) merge and carry out extraction process, extract A 1 obtained;
(2) red halloysite in bulk drug, Chinese gall, dragon's blood, menthol are ground to form respectively to fine powder or difference
Break into fine powder, then mix, obtain fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtain
Obtain fine powder mixture B1;
(3), the fine powder mixture B1 of the extract A 1 of above-mentioned steps (1) and step (2) is mixed,
Obtain pharmaceutical composition C; Then, optionally, pharmaceutical composition C is made to the medicine of corresponding formulation.
9. the purposes of the pharmaceutical composition described in any one in claim 1-7, by described drug regimen
Thing is for the preparation of the medicine with hemostasis and pain-relieving and antiinflammatory action.
10. the purposes of the pharmaceutical composition described in any one in claim 1-7, by described medicine group
Compound is for the preparation of the medicine for the treatment of traumatic injury, hemorrhage of digestive tract, hemorrhoid.
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