CN103920010A - Medicinal composition with bleeding-stopping, pain-relieving and inflammation-diminishing effects, preparation method and application thereof - Google Patents
Medicinal composition with bleeding-stopping, pain-relieving and inflammation-diminishing effects, preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a medicinal composition with bleeding-stopping, pain-relieving and inflammation-diminishing effects, a preparation method and an application thereof. The medicinal composition is prepared from the following raw medicinal materials: cortex phellodendri, fructus forsythiae, sophora flavescens, lamiophlomis rotata, rhizoma bletillae, safflower, red halloysite, gallnut, dragon blood and menthol. The medicinal composition can generate a remarkable synergetic effect due to the compatibility of the raw medicinal materials, has remarkable bleeding stopping, pain relieving and inflammation diminishing effects due to experiment verification, and has good effects in the aspects of treating various bleeding, paining and inflammation symptoms, haemorrhoids and the like.
Description
Technical field
The invention belongs to pharmaceutical technology field, particularly a kind of pharmaceutical composition with hemostasis and pain-relieving and antiinflammatory action and its production and use.
Background technology
The diseases such as traumatic injury, digestive tract hemorrhage, hemorrhoid are conventionally with hemorrhage and pain symptom; sometimes also can be simultaneously with inflammatory symptoms; therefore in clinical, in considering hemostasis, pain relieving, conventionally also to consider to carry out anti-inflammatory treatment simultaneously, 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 stasis to stop bleeding, promoting blood circulation and stopping pain, but its antiinflammatory action not obvious.And for example the clinical MAYINGLONG MUSK HEMORRHOID UNGUENTUM that is usually used in treating hemorrhoid, has the effects such as heat clearing and damp drying, promoting blood circulation and detumescence, removing the necrotic tissue and promoting granulation, does not also have hemostasis, pain relieving and antiinflammatory action simultaneously.Therefore in the time of clinical middle situation about occurring simultaneously with hemorrhage, pain and inflammatory symptoms, the therapeutic effect of these medicines is unsatisfactory.
Summary of the invention
Main purpose of the present invention is to provide a kind of pharmaceutical composition simultaneously with hemostasis and pain-relieving and antiinflammatory action.
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, made by the crude drug of following weight parts proportioning:
Cortex Phellodendri 5-30 part, preferably 10-25 part, more preferably 15-20 part
Fructus Forsythiae 5-30 part, preferably 10-25 part, more preferably 15-20 part
Radix Sophorae Flavescentis 5-30 part, preferably 10-25 part, more preferably 15-20 part
Radix Lamiophlomidis Rotatae 5-30 part, preferably 10-25 part, more preferably 15-20 part
Pseudobulbus Bletillae (Rhizoma Bletillae) 1-20 part, preferably 5-15 part, more preferably 8-10 part
Flos Carthami 1-20 part, preferably 5-15 part, more preferably 8-10 part
Halloysitum Rubrum 1-10 part, preferably 2-7 part, more preferably 4-5 part
Galla Chinensis 1-10 part, preferably 2-7 part, more preferably 4-5 part
Sanguis Draxonis 1-10 part, preferably 2-7 part, more preferably 4-5 part
Mentholum 1-10 part, preferably 1.5-7 part, more preferably 2-4 part.
Each crude drug source of aforementioned pharmaceutical compositions is as follows respectively:
Cortex Phellodendri is the dry bark of rutaceae wampee Phellodendron chinense Schneid..Practise and claim " Cortex Phellodendri ".There is heat clearing and damp drying, pathogenic fire purging except effects such as steaming, detoxification sore treatments., hectic fever due to YIN-deficiency consumptive fever preesed for damp-heat dysentery, jaundice dark coloured urine, leukorrhagia pudendal pruritus, the puckery pain of pyretic stranguria, beriberi flaccidity, night sweat, seminal emission, sore swollen toxin, eczema eczema.
Fructus Forsythiae is the dry fruit of Oleaceae plants Fructus Forsythiae Forsythia suspensa (Thunb.) Vahl.There is the effects such as heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, dispelling wind and heat pathogens.Send out speckle, the puckery pain of pyretic stranguria for carbuncle, scrofula, acute mastitis, erysipelas, anemopyretic cold, epidemic febrile disease from the beginning of, warm Ren Ying, high hot excessive thirst, coma.
Radix Sophorae Flavescentis is the dry root of leguminous plant Radix Sophorae Flavescentis Sophora flavescens Ait..There is the effects such as heat clearing and damp drying, parasite killing, diuresis.For hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy, external treatment trichomonal vaginitis.
Radix Lamiophlomidis Rotatae is the dry aerial parts of labiate Radix Lamiophlomidis Rotatae Lamiophlomis rotate (Benth.) Kudo.There is the effect such as promoting blood circulation and hemostasis, wind-expelling pain-stopping.For traumatic injury, traumatic hemorrhage, rheumatic arthralgia, grasserie.
Pseudobulbus Bletillae (Rhizoma Bletillae) is the dry tuber of orchid Pseudobulbus Bletillae (Rhizoma Bletillae) Bletilla striata (Thunb.) Reiehb.f..There is the effect such as astringing to arrest bleeding, detumescence and promoting granulation.For spitting of blood, haematemesis, traumatic hemorrhage, sore swollen toxin, chapped skin.
Flos Carthami is the dried floral of feverfew Flos Carthami Carthamus tinctorius L..There is the effect such as promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain.Swell and ache for amenorrhea, dysmenorrhea, lochia, addiction abdominal mass mass in the abdomen, obstruction of qi in the chest and cardialgia, the stagnant stomachache of the stasis of blood, the twinge of the breast side of body, injury from falling down, skin infection.
Halloysitum Rubrum is silicates mineral halloysite family halloysite, main containing four water aluminium silicate [Al
4(Si
4o
10) (OH)
84H
2o].There is the effects such as astringing intestine to stop diarrhea, hemostasis, promoting tissue regeneration and ulcer healing.For chronic diarrhea chronic dysentery, hemorrhage, the bleeding not during menses of defecating, external treatment skin infection is burst for a long time and is not held back, eczema pus contamination.
Galla Chinensis is the insect gall on Anacardiaceae plant Fructus rhois chinensis Rhus chinensis Mill., blue or green bran poplar Rhus potaninii Maxim. or Radix Rhois Sinicae Rhus punjabensis.Stew.var.sinica (Diels) Rehd.Et wils. leaf, is mainly formed by melaphis chinensis Baker Melaphis chinensis (Bell) Baker parasitism.There is the effects such as the pathogenic fire reducing of astringing the lung, relieving diarrhea with astringents, arresting sweating, hemostasis, removing dampness sore.For chronic cough of deficiency lung, lung-heat phlegmatic cough, chronic diarrhea chronic dysentery, spontaneous sweating, quench one's thirst, have blood in stool hemorrhoidal bleeding, traumatic hemorrhage, carbuncle sore tumefacting virus, Skin wet and rotten.
Sanguis Draxonis is that the resin that oozes out of babassu Sanguis Draxonis Daemonorops draco Bl. fruit is through being processed into.There is the effects such as the analgesic therapy of invigorating blood circulation, removing stasis to stop bleeding, promoting tissue regeneration and ulcer healing.Do not hold back for traumatic injury, trusted subordinate's stasis of blood pain, traumatic hemorrhage, skin infection.
A kind of saturated cyclic alcohol that Mentholum is the fresh stem of labiate Herba Menthae Mentha haplocalyx Briq. and Ye Jing vapor distillation, freezing, recrystallization obtains is l-1-methyl-4-isopropyl cyclohexanol-3.
Aforementioned pharmaceutical compositions, can be any oral Pharmaceutical dosage forms such as capsule, tablet, pill, granule, oral solution, or any external used medicine dosage form such as spray, unguentum, suppository, patch, powder, powder, liniment, membrane, externally used solution agent.
According to a preferred embodiment of the invention, wherein pharmaceutical composition is by raw material is prepared according to the method processing comprising the following steps:
(1) get Cortex Phellodendri, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Flos Carthami in crude drug, adopt water extraction or ethanol-water solution (ethanol water of for example 60%-90%) 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) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum ground to form respectively to fine powder or break into respectively fine powder, then mixing, obtaining fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtaining 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, the pharmaceutical composition C in step (3) (for example, according to the conventional formulation preparation method of different dosage form medicine) is made to the medicine of corresponding dosage form.
According to another embodiment of the invention, the preparation method of aforementioned pharmaceutical compositions is provided, the method comprises following key step:
(1) get Cortex Phellodendri, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Flos Carthami in crude drug, adopt water extraction or ethanol-water solution (ethanol water of for example 60%-90%) 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) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum ground to form respectively to fine powder or break into respectively fine powder, then mixing, obtaining fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtaining 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 the conventional formulation method of different dosage form medicine) makes the medicine of corresponding dosage form.
Preferably, in said method: other described crude drug is carried out to extraction process i) respectively, refer to and get respectively each crude drug, add water or ethanol-water solution decocts extraction, filter, the concentrated rear extract that obtains each crude drug, and then each extract is mixed; Or, described other crude drug is merged and carries out extraction process ii), refer to all crude drug are combined by described proportioning, add water or ethanol-water solution decocts extractions, filter concentrated rear acquisition total extract.
In above-mentioned preparation method, the addition of water or alcoholic solution when water extraction or alcohol extraction, can be with reference to liquid addition conventional in extract drugs process, as according to crude 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 the medicine with hemostasis and pain-relieving and antiinflammatory action; For example can be used for the medicine of various hemorrhage, the pain of preparation treatment and inflammatory symptoms (as traumatic injury, digestive tract hemorrhage, hemorrhoid etc.).
Compared with prior art, the invention has the beneficial effects as follows:
Between each crude drug of pharmaceutical composition of the present invention, there is obvious synergistic function, confirm that by experiment it has significant hemostasis and pain-relieving and antiinflammatory action simultaneously, various hemorrhage, pain and inflammatory symptoms are had to good therapeutic effect.
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.Without departing from the idea case in the present invention described above, according to ordinary skill knowledge and customary means, make various replacements 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 crude 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 |
| Cortex Phellodendri | 5 | 10 | 15 | 20 | 20 | 25 | 30 |
| Fructus Forsythiae | 30 | 15 | 25 | 15 | 20 | 5 | 10 |
| Radix Sophorae Flavescentis | 10 | 25 | 30 | 15 | 20 | 5 | 5 |
| Radix Lamiophlomidis Rotatae | 25 | 30 | 5 | 20 | 20 | 10 | 15 |
| Pseudobulbus Bletillae (Rhizoma Bletillae) | 12 | 15 | 5 | 8 | 10 | 20 | 1 |
| Flos Carthami | 1 | 5 | 8 | 12 | 10 | 20 | 15 |
| Halloysitum Rubrum | 8 | 2 | 1 | 4 | 5 | 7 | 10 |
| Galla Chinensis | 10 | 7 | 8 | 5 | 4 | 1 | 2 |
| Sanguis Draxonis | 7 | 1 | 2 | 5 | 4 | 10 | 8 |
| Mentholum | 10 | 7 | 5 | 4 | 2 | 8 | 1.5 |
The preparation method of embodiment 1-3:
According to the crude drug proportioning of above-described embodiment 1-3, make respectively oral capsule, external spraying agent, externally-applied liniment by the method that comprises following key step:
(1) Cortex Phellodendri in crude drug, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), Flos Carthami are combined, adding percent by volume is 70% ethanol water, addition is according to crude drug weight: liquid volume=1g:10ml calculates, heating extraction, filter, by the concentrated filtrate extract A 1 that obtains;
(2) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum 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 method of different dosage form medicine, make the medicine of corresponding dosage form.
The preparation method of embodiment 4-7:
According to the crude drug proportioning of above-described embodiment 4-7, by comprising the method for following key step, make externally used paste:
(1) Cortex Phellodendri in crude drug, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), Flos Carthami are combined, adopt water extraction, add 8 times of weight in the water of crude drug weight, decoction is extracted 3 times, filters merging filtrate the concentrated rear extract A 1 that obtains;
(2) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum are broken into respectively to fine powder, then mix homogeneously, obtains 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 unguentum, make externally used paste.
Embodiment 8
For the further therapeutic effect of proved invention pharmaceutical composition, inventor taking above-described embodiment 4-7 totally four groups of pharmaceutical compositions carried out following experimental study as Experimental agents (being followed successively by Experimental agents 1-4).
For ease of observing the synergistic function between each crude drug, two have been increased with reference to medicine group: select at random seven kinds or eight kinds of crude drug (two groups) in pharmaceutical composition of the present invention simultaneously, make externally used paste with reference to weight portion proportioning of embodiment 4 pharmaceutical composition Raw medicines and preparation method thereof, 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 Cortex Phellodendris, 15 parts of Fructus Forsythiaes, 15 parts of Radix Sophorae Flavescentiss, 20 parts of Radix Lamiophlomidis Rotataes, 8 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 12 parts, Flos Carthami, 4 parts of Halloysitum Rubrums.
With reference to medicine 2: 15 parts of Radix Sophorae Flavescentiss, 20 parts of Radix Lamiophlomidis Rotataes, 8 parts of Pseudobulbus Bletillae (Rhizoma Bletillae), 12 parts, Flos Carthami, 4 parts of Halloysitum Rubrums, 5 parts of Galla Chinensiss, 5 parts of Sanguis Draxonis, 4 parts of Mentholums.
One, experiment material
1, laboratory animal
(1) hemostasis experiment is used
Clean level KM kind mice, 90, male and female half and half, body weight 20 ± 2g, by Chengdu, Da Shuo bio tech ltd provides, laboratory animal production licence number: SCXK (river) 2013-24, " the Quality of Experimental Animals quality certification " number: № 0014820.
(2) analgesic experiment is used
Clean level KM kind mice, 90, Quan Xiong, body weight 20 ± 2g, by Chengdu, Da Shuo bio tech ltd provides, laboratory animal production licence number: SCXK (river) 2013-24, " the Quality of Experimental Animals quality certification " number: № 0014819.
(3) antiinflammatory experiment is used
Clean level KM kind mice, 100, Quan Xiong, body weight 20 ± 2g, by Chengdu, Da Shuo bio tech ltd provides, laboratory animal production licence number: SCXK (river) 2013-24, " the Quality of Experimental Animals quality certification " 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 MUSK HEMORRHOID UNGUENTUM.
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, is produced by Kuming Nanjiang Pharmacy Co., Ltd, and batch number is C130205A, and valid until 2015.01, the date of manufacture is 2013.02.17;
Urethane (urethanes, analytical pure, AR): meet Q/C5411196-9, product batch number is 20100419, and Ke Long chemical reagent factory produces by Chengdu.
Glacial acetic acid (analytical pure, AR): meet GB/T676-2007, product batch number is 20120528, by Chengdu Ke Long chemical reagent factory, becomes 0.6% concentration with normal saline dilution, configuration 20ml is now with the current.
Dimethylbenzene (analytical 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 company limited;
Mouse cage (comprising kettle);
Syringe (1ml type);
Cotton swab;
Operating scissors;
Stopwatch;
Filter paper: 10mm
2, 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 of 10 animals, 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, model control 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 of 10 animals.
(3) grouping of animal in antiinflammatory experiment
100 animals (entirely male) are divided into 10 groups at random according to body weight, blank group, model control 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 of 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 experiment, owing to being subject to the restriction of medicine-feeding part, the dose-effect relationship of many Chinese medicine for external application is also not obvious; Zoopery topical dose in principle has one to be dose,equivalent with clinical external.For enepidermic feature, through test of many times and thinking, animals and human beings homalographic dosage is exactly unanimously dose,equivalent, instead of oral medicine animal consumption is the situation of the several times of people's consumption.
As in MAYINGLONG MUSK HEMORRHOID UNGUENTUM during for the treatment of the diseases such as hemorrhoid, anal fissure, anal eczema, adult's application area is estimated approximately 1～3cm
2, each consumption of being grown up is 9.6～13.9mg, within 1st, can smear repeatedly.
But being subject to animal in zoopery can, with the restriction of skin area, may be 1cm through the application area of prerun mouse tail
2; Ensureing that medicine fully absorbs under the prerequisite of not wasting, determining that each use amount of MAYINGLONG MUSK HEMORRHOID UNGUENTUM etc. is about 13.9mg ointment; Experimental agents of the present invention and with reference to the consumption of medicine the consumption with reference to MAYINGLONG MUSK HEMORRHOID UNGUENTUM.
(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; Blank group and model control group give appropriate normal saline (to be evenly coated with skin as degree, about 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 mice, and medicine-feeding part is mouse tail (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 under mouse web portion xiphoid-process around 2cm skin to the left; In mice caused by dimethylbenzene xylene ear swelling test, medicine-feeding part is on the skin on " two sides before and after auris dextra exterior feature ".
[administration area] application area is 1cm
2, because the unit's of being subject to skin absorbs quantitative limitation, ointment needn't be smeared too thick.
Table 2 dosage regimen
3, experimental procedure
2.3.1 the mice hemorrhage experiment of docking
In the room temperature environment of 15 DEG C, 30min after the administration of animal last, with sharp operating scissors cut off mouse tail long 1/4, treat that blood overflows beginning timing voluntarily, uses filter paper (10mm in good time
2, mg weighs) and sucking-off drop of blood, until blood stops (depletion of blood when filter paper is inhaled) naturally, calculate the bleeding time (BT, s), weigh 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 Mus gives dimension criteria lumbar injection 0.6% glacial acetic acid (glacial acetic acid) by 10ml/kg respectively; Observe " occurring first the time of writhing response " immediately that (writhing incubation period s), " writhing response number of times " (inferior) that occur in 15min, and is calculated the suppression ratio of medicine to writhing response.
Suppression ratio %=(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 smeared 0.9% normal saline with pipettor by 10 μ L/ faces (being two sides totally 20 μ L), and left ear is as own control; The mouse right ear of all the other each groups is smeared caused by dimethylbenzene xylene inflammation with pipettor 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, the card punch taking interior diameter as 6mm is got the auricle of left and right ear same area, weigh immediately, and the swelling (mg) taking left and right auricle weight difference as inflammation, and carry out statistical analysis.
Calculate average swelling (mg) and the inhibitory rate of intumesce (%) of each group by surveyed swelling.
The average swelling of inhibitory rate of intumesce=(the average swelling of average swelling-medication group of model control group)/model control group
4, sacrifice of animal
Animal is all used after urethane (concentration is 20g/100mL, and giving volume is 5mL/kg, gives dosage 1g/kg) intraperitoneal injection of anesthesia, and 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+SD
represent.
" the independent sample T inspection " of secondly, using SPSS17.0for windows software to provide carries out " significance test of mean difference " between medicine group and model control group.Carry out homogeneity test of variance with Levene inspection, in the time of P>0.05, show that variance is neat, observe corresponding T inspection P value; Vice versa.
Finally, there iing " the mean+SD of medicine group of significant difference
rear labelling " * ", represents that the difference between mean has significant statistical significance (P<0.05), and labelling " * * " represents that the 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 mice docking bleeding time
The average docking bleeding time of model control group mice is 602.33s.
With model control group comparison, the docking bleeding time of YUNNAN BAIYAO control group mice shortens (P<0.05) significantly.
With model control group comparison, there is the trend (P>0.05) of shortening in the docking bleeding time of MAYINGLONG MUSK HEMORRHOID UNGUENTUM control group mice.
With model control group comparison, the docking bleeding time that Experimental agents of the present invention is respectively organized mice shortens (P<0.05) significantly, and is better than with reference to medicine.
With model control group comparison, there is the trend (P>0.05) of shortening in the docking bleeding time of respectively organizing mice with reference to medicine
(2) mice docking amount of bleeding
The average docking amount of bleeding of model control group mice is 56.08mg.
With model control group comparison, the docking amount of bleeding of YUNNAN BAIYAO control group mice reduces (P<0.05) significantly.
With model control group comparison, the docking amount of bleeding of MAYINGLONG MUSK HEMORRHOID UNGUENTUM control group mice has the trend (P>0.05) of increase.
With model control group comparison, the docking amount of bleeding that Experimental agents of the present invention is respectively organized mice all reduces (P<0.05) significantly, and is better than with reference to medicine.
With model control group comparison, the docking amount of bleeding of respectively organizing mice with reference to medicine has the trend (P>0.05) of minimizing.
(3) brief summary
The average docking bleeding time of model control group mice is 602.33s, on average the amount of bleeding that docks is 56.08mg.
YUNNAN BAIYAO can shorten the mice docking bleeding time, and reduces mice docking amount of bleeding.
MAYINGLONG MUSK HEMORRHOID UNGUENTUM all affected less than obvious mice docking bleeding time and amount of bleeding.
Experimental agents of the present invention is respectively organized and can be shortened the mice docking bleeding time, and reduces mice docking amount of bleeding, and is better than with reference to medicine.
With model control group comparison, have and shorten the mice trend in docking bleeding time with reference to medicine, there is the trend that reduces mice docking amount of bleeding.
2, analgesic effect
(1) writhing incubation period
Be 220.50s average writhing incubation period of model control group mice.
With model control group comparison, the writhing of dexamethasone control group mice extends (P<0.05) incubation period significantly.
With model control group comparison, the writhing of MAYINGLONG MUSK HEMORRHOID UNGUENTUM control group mice has the trend (P>0.05) of prolongation incubation period.
With model control group comparison, Experimental agents of the present invention is respectively organized writhing all prolongations (P<0.05 or P<0.01) significantly incubation period of mice; And with the comparison of dexamethasone matched group, the writhing that Experimental agents of the present invention is respectively organized mice 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 mice control group mice with reference to medicine has the trend (P>0.05) of prolongation incubation period.
(2) writhing number of times
The average writhing number of times of model control group mice 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 MUSK HEMORRHOID UNGUENTUM control group mice obviously reduces (P<0.01).And with the comparison of dexamethasone matched group, the writhing number of times of MAYINGLONG MUSK HEMORRHOID UNGUENTUM control group mice 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 mice all obviously reduces (P<0.01); And with the comparison of dexamethasone matched group, the writhing number of times that Experimental agents of the present invention is respectively organized mice has the trend (P>0.05) of minimizing.
With model control group comparison, the writhing number of times of respectively organizing mice 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 mice.
Dexamethasone can reduce the number of times of " acetic acid cause mouse writhing reaction ", and extends mouse writhing incubation period.
MAYINGLONG MUSK HEMORRHOID UNGUENTUM can reduce the number of times of " acetic acid causes mouse writhing reaction ".
The number of times of " acetic acid causes mouse writhing reaction " is respectively organized and can be reduced to Experimental agents of the present invention, and extend 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 the preclinical trend of the mouse writhing of prolongation.
3, antiinflammatory action
(1) auricle swelling degree
With the comparison of blank group, obviously swelling of the auricle of model control group mice (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 MUSK HEMORRHOID UNGUENTUM control group mice has the trend of reduction (P>0.05).
With model control group comparison, the auricle swelling degree that Experimental agents of the present invention is respectively organized mice obviously reduces (P<0.01), and is better than with reference to medicine.
With model control group comparison, the auricle swelling degree of respectively organizing mice with reference to medicine has the trend (P>0.05) of reduction.
(2) brief summary
Dexamethasone can suppress mice caused by dimethylbenzene xylene auricle swelling degree.
MAYINGLONG MUSK HEMORRHOID UNGUENTUM xylol causes the not significantly impact of mice auricle swelling degree.
Experimental agents of the present invention is respectively organized xylol and is caused mice auricle swelling degree and all can suppress mice caused by dimethylbenzene xylene auricle swelling degree, 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 obvious 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 taking above-described embodiment 4-7 totally four groups of pharmaceutical compositions carried out following clinical experimental study as Experimental agents (being followed successively by Experimental agents 1-4).
For ease of observing the synergistic function between each crude drug, two have been increased with reference to medicine group, respectively identical with reference to medicine 1 and 2 with above-described embodiment 8 simultaneously.
(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 manual reduction.
(3) anus discomfort just time, or falling inflation.
2. inspection: anus edge hemorrhoid redness, while increasing abdominal pressure, blood stasis becomes large, and some patients were internal hemorrhoid is deviate from outside anus.
3. anoscopy: the bossed blood stasis 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 test case in.
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 anorectal academic conference in 1992, only record internal hemorrhoid, mixed hemorrhoid)
Clinical recovery: after an action of the bowels without hemorrhage, without prolapsus, it is normal that anoscopy hemorrhoid mucosa recovers, blood stasis atresia, curative effect rate 100%.
Effective: after an action of the bowels without hemorrhage, without deviating from, blood stasis redness obviously disappears, anoscopy, internal hemorrhoid mucosa mild hyperaemia, blood stasis 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 mucosa 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, 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, therapeutic effect is better, and the cure rate for the treatment of is more than 10%, and obvious effective rate is more than 80%; Take the patient with reference to medicine and control drug, cure rate and obvious effective rate entirety are lower than Experimental agents.
Claims (10)
1. there is a pharmaceutical composition for hemostasis and pain-relieving and antiinflammatory action, made by the crude drug of following weight parts proportioning:
Cortex Phellodendri 5-30 part, Fructus Forsythiae 5-30 part, Radix Sophorae Flavescentis 5-30 part, Radix Lamiophlomidis Rotatae 5-30 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 1-20 part, Flos Carthami 1-20 part, Halloysitum Rubrum 1-10 part, Galla Chinensis 1-10 part, Sanguis Draxonis 1-10 part, and Mentholum 1-10 part.
2. compositions according to claim 1, is characterized in that described crude drug proportioning is:
Cortex Phellodendri 10-25 part, Fructus Forsythiae 10-25 part, Radix Sophorae Flavescentis 10-25 part, Radix Lamiophlomidis Rotatae 10-25 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 5-15 part, Flos Carthami 5-15 part, Halloysitum Rubrum 2-7 part, Galla Chinensis 2-7 part, Sanguis Draxonis 2-7 part, and Mentholum 1.5-7 part.
3. compositions according to claim 1 and 2, is characterized in that described crude drug proportioning is:
Cortex Phellodendri 15-20 part, Fructus Forsythiae 15-20 part, Radix Sophorae Flavescentis 15-20 part, Radix Lamiophlomidis Rotatae 15-20 part, Pseudobulbus Bletillae (Rhizoma Bletillae) 8-10 part, Flos Carthami 8-10 part, Halloysitum Rubrum 4-5 part, Galla Chinensis 4-5 part, Sanguis Draxonis 4-5 part, and Mentholum 2-4 part.
4. according to the compositions described in any one in claim 1-3, it is characterized in that described pharmaceutical composition is oral drugs, be rendered as any one form in capsule, tablet, pill, granule, oral solution.
5. according to the compositions described in any one in claim 1-3, it is characterized in that described pharmaceutical composition is external used medicine, be rendered as any one form in spray, unguentum, suppository, patch, powder, powder, liniment, membrane, externally used solution agent.
6. according to the compositions described in any one in claim 1-5, wherein pharmaceutical composition is by raw material is prepared according to the method processing comprising the following steps below:
(1) get Cortex Phellodendri, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Flos Carthami in crude drug, adopt water extraction or ethanol-water solution (ethanol water of for example 60%-90%) 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) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum ground to form respectively to fine powder or break into respectively fine powder, then mixing, obtaining fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtaining 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. compositions according to claim 6, wherein, makes the pharmaceutical composition in step (3) medicine of corresponding dosage form.
8. a preparation method for compositions claimed in claim 1, comprises following key step:
(1) get Cortex Phellodendri, Fructus Forsythiae, Radix Sophorae Flavescentis, Radix Lamiophlomidis Rotatae, Pseudobulbus Bletillae (Rhizoma Bletillae), the Flos Carthami in crude drug, adopt water extraction or ethanol-water solution (ethanol water of for example 60%-90%) 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) Halloysitum Rubrum in crude drug, Galla Chinensis, Sanguis Draxonis, Mentholum ground to form respectively to fine powder or break into respectively fine powder, then mixing, obtaining fine powder mixture B1, or grind to form together fine powder or break into fine powder, obtaining 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 dosage form.
9. the purposes of the pharmaceutical composition described in any one in claim 1-7, by described pharmaceutical composition 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, the medicine by described pharmaceutical composition for the preparation for the treatment of traumatic injury, digestive tract hemorrhage, hemorrhoid.
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| CN113274455A (en) * | 2021-05-20 | 2021-08-20 | 郎中堂药业(厦门)有限公司 | Traditional Chinese medicine composition and application thereof |
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| CN113274455A (en) * | 2021-05-20 | 2021-08-20 | 郎中堂药业(厦门)有限公司 | Traditional Chinese medicine composition and application thereof |
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