CN102319400A - Traditional Chinese drug composition for blood cooling, hemostasis, yin nourishing, blood stasis dissipating, liver nourishing and eyesight improving, and preparation method thereof - Google Patents
Traditional Chinese drug composition for blood cooling, hemostasis, yin nourishing, blood stasis dissipating, liver nourishing and eyesight improving, and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a traditional Chinese drug composition for blood cooling, hemostasis, yin nourishing, blood stasis dissipating, liver nourishing and eyesight improving, and a preparation method thereof. The traditional Chinese drug composition is prepared from the following nineteen traditional Chinese drugs: cattail pollen, salvia miltiorrhiza, rehmannia, eclipta, chrysanthemum, baikal skullcap root (charred radix scutellariae), obtuseleaf senna seed, asiatic plantain seed, common motherwort fruit, glossy privet fruit, common selfheal spike, Chinese gentian root, wenchow turmeric root tuber, common scouring rush, red peony root, tree peony root-bark, hawthorn, angelica and szechwan lovage rhizome. The traditional Chinese drug composition has effects of blood cooling, hemostasis, yin nourishing, blood stasis dissipating, liver nourishing and eyesight improving, and is mainly applicable for yin deficiency, liver hyperactivity, and subhyaloid hemorrhage caused by collateral thermal injury. Compared to the prior art, the clinical pharmacodynamics test effects of the traditional Chinese drug composition provided by the present invention are significantly increased, the bioavailability of the traditional Chinese drug composition provided by the present invention is high, and the traditional Chinese drug composition provided by the present invention does not cause any toxic and side-effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition that is used for cooling blood for hemostasis, YIN nourishing blood stasis dispelling, nourishing the liver to improve visual acuity and preparation method thereof, belong to the pharmaceutical technology field.
Technical background
The eyes pathological changes of bringing out along with factor such as the increase of the pollution of environment, life stress, the tired anxiety of people's spirit in recent years is more and more, has seriously influenced daily life, has brought great misery to people.The medicine that uses clinically at present is a lot, but curative effect is undesirable mostly." and XUEMINGMU PIAN " under WS-10062 (ZD-0062)-2002 in " the national standard for traditional Chinese medicines compilation ophthalmology department of otorhinolaryngology department of dermatologry fascicle " of State Food and Drug Administration's in December, 2002 promulgation discloses its prescription and method for making; The inventor is through years of researches; Find that the preparation that makes with its technology exists: curative effect is desirable not enough; Technology is thicker, and poor stability is prone to defectives such as the moisture absorption goes bad.
For solving above-mentioned existing in prior technology defective, in the time in recent years, we are through excavating the abundant Chinese medicine resource of motherland; In conjunction with the lots of clinical pharmacodynamic study, we grope through a large amount of experiments on the basis of original and XUEMINGMU PIAN technology; Discovery with the water in its technology carry make into 6 times the amount 60% ethanol extractions after, extraction ratio of effective constituents significantly improves, its clinical pharmacodynamic experiment effect significantly improves; Good stability, and safe without toxic side effect; We have processed tablet, capsule, granule, soft capsule or drop pill by common process; Most preferred dosage form is a tablet.
Summary of the invention
The objective of the invention is to: Chinese medicine composition that a kind of curative effect is used for cooling blood for hemostasis, YIN nourishing blood stasis dispelling, nourishing the liver to improve visual acuity more significantly and preparation method thereof is provided.
Chinese medicine composition of the present invention, its prescription is formed as follows:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; Filtrate decompression concentrates (0.08MPa; 80 ℃) be the thick paste of 1.35～1.39 (60 ℃) to relative density; Add above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry are ground into fine powder; Add each dosage form proper auxiliary materials, process tablet, capsule, granule, soft capsule or drop pill by each dosage form common process.
1, the method for preparing of Chinese medicine composition tablet of the present invention is following:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add dextrin, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate adds magnesium stearate, mixing; Be pressed into 1000, coating promptly gets tablet.
2, the method for preparing of Chinese medicinal composition capsules agent of the present invention is following:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add starch, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate, promptly gets capsule by encapsulated 1000.
3, the method for preparing of Chinese medicinal composition granules of the present invention is following:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, the adding dextrin is an amount of, processes granule with 85% ethanol, 60 ℃ of oven dry; Granulate makes granule 1000g, promptly gets granule.
4, Chinese medicine composition soft capsule method for preparing of the present invention is following:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; It is an amount of to get the adjuvant soybean oil, adds the Cera Flava of 4-6%, after heating makes dissolving, adds above-mentioned hybrid medicine fine powder, stirs, and colloid mill grinds well, and processes 1000 of soft capsules, promptly gets soft capsule.
5, Chinese medicine composition drop pill method for preparing of the present invention is following:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; Macrogol 4000 put in the water-bath heat, melt the back and add above-mentioned hybrid medicine fine powder, stirring is transferred to reservoir, airtight and in 70 ℃ of insulations, is coolant with the methyl-silicone oil, processes drop pill, promptly gets drop pill.
Stability experiment
(1) experiment material:
1. medicine:
1. tablet group A of the present invention: the method preparation according to the embodiment of the invention 1, get tablet A, be assigned to desired concn with normal saline during experiment.
2. matched group B: just following with the concrete method for preparing of XUEMINGMU PIAN agent group:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors were soaked 30 minutes, the reflux, extract, secondary, and each 2 hours, collecting decoction filtered; Filtrate decompression is concentrated into the thick paste that relative density is 1.35～1.39 (60 ℃), adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, adds dextrin 30g; Process granule with 85% ethanol, 60 ℃ of oven dry, granulate adds magnesium stearate 1.5g; Mixing, tabletting, sugar coating promptly gets tablet B.
2. animal: Japan large ear rabbit.
(2), method and result:
1, test method: above sample is positioned in 4-6 ℃, 20-25 ℃, 35-38 ℃ the calorstat, makes regular check on stability indicator according to time of repose, the criterion that its result observes is following:
0 does not have deposition 1 does not have muddy 2 little turbid 3 muddy 4 depositions
2. result of the test: result of the test is seen table 2
Table 2 stability test
3. conclusion (of pressure testing): can know that through this result of the test tablet group A of the present invention does not have muddiness, deposition produces; Contrast tablet group B has muddiness, deposition to produce.
(3), brief summary: show through the study on the stability test: under identical condition, tablet group A of the present invention is more stable than comparison film agent group B.
The present invention program is through inventor's repetition test repeatedly, updates that adjustment sums up out, and the method for preparing of the invention described above tablet group is best method for preparing, and clinical pharmacodynamic experiment effect significantly improves.
With tablet of the present invention is example, and Pharmacodynamic test of active extract result proves: with the present invention " method for preparing: above 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add dextrin, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate adds magnesium stearate, mixing; Be pressed into 1000, coating promptly gets tablet of the present invention " with former invention " (and XUEMINGMU PIAN) method for preparing: above 19 flavor medical materials; Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors were soaked 30 minutes, the reflux, extract, secondary, and each 2 hours, collecting decoction filtered; Filtrate decompression is concentrated into the thick paste that relative density is 1.35～1.39 (60 ℃), adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder; Add dextrin 30g, process granulation with 85% ethanol, 60 ℃ of oven dry, granulate; Add magnesium stearate 1.5g, mixing, tabletting; Sugar coating promptly gets " to compare, results of pharmacodynamic test has significance to improve.
Pharmacodynamic test of active extract
One, the preparation of experiment medicine:
1, tablet group of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add dextrin, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate adds magnesium stearate, mixing; Be pressed into 1000, coating promptly gets.
1, positive controls (and XUEMINGMU PIAN):
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors were soaked 30 minutes, the reflux, extract, secondary, and each 2 hours, collecting decoction filtered; Filtrate decompression is concentrated into the thick paste that relative density is 1.35～1.39 (60 ℃), adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, adds dextrin 30g; Process granule with 85% ethanol, 60 ℃ of oven dry, granulate adds magnesium stearate 1.5g; Mixing, tabletting, sugar coating promptly gets.
Two: process of the test and result of the test
Experiment purpose: through to sheet of the present invention and with pharmacological experiment studies such as the hemostasis of XUEMINGMU PIAN, blood coagulation, inhibition capillary permeability, microcirculation improvement, human body immunity improving power; Compare experiment with sheet group of the present invention with XUEMINGMU PIAN, observe the power of its pharmacological action.
Test method: sheet of the present invention and with the influence of XUEMINGMU PIAN to the mice docking bleeding time; Influence to the rat platelet number; Influence to the heparinization clotting time of mice; Influence to the multiple calcium clotting time of rabbit; To the phagocytotic influence of Turnover of Mouse Peritoneal Macrophages; Influence to the mice capillary permeability; To the microcirculatory influence of tame lagophthalmos conjunctiva; To effect of immunologic function.
Experimental result: sheet of the present invention and with XUEMINGMU PIAN can obviously shorten the mice bleeding time; The platelet count of rat obviously increases; Shorten the clotting time of experimental disorders of hemostasis animal; The multiple calcium clotting time of rabbit is obviously shortened; Obviously improve the phagocytic index of Turnover of Mouse Peritoneal Macrophages, promote the absorption of congestion; Suppressing the abdominal cavity capillary permeability increases, and stops hemocyte to ooze out and is beneficial to hemostasis; Promote the speed of tame lagophthalmos conjunctiva microcirculation blood flow; Obviously increase the content of hemolysin in the serum, improve humoral immune function.
Conclusion: pharmacological actions such as the hemostasis of sheet ratio of the present invention and XUEMINGMU PIAN, blood coagulation, inhibition capillary permeability, microcirculation improvement, human body immunity improving power are strong; Therefore; Sheet group ratio of the present invention and XUEMINGMU PIAN are used for deficiency of YIN liver-yang hyperactivity, and the caused retinal hemorrhage clinical efficacy of thermal burn channels is good.
One, to the mice influence in docking bleeding time
Experiment material
1, animal: Kunming mouse, male and female have concurrently, body weight 18～22g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 3.6,1.8,0.9g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 3.6g crude drug/kg.Successive administration 7d, every day 1 time, each 20ml/kg.Behind the last administration 30min, it is cross-section respectively each to be organized Mus back range tail point 5mm place, treats that blood overflows the back voluntarily and picks up counting with stopwatch, and every dehematizing with the filter paper suction at a distance from 30s dripped 1 time.Overflow and pick up counting with Mus tail section blood, the mice bleeding time respectively organized in record as the bleeding time depletion of blood time when inhaling section with filter paper.
Experimental result: see table 1
The influence
in table 1 pair mice docking bleeding time
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and with the XUEMINGMU PIAN group can obviously shorten the mice bleeding time, compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that the anastalsis of sheet group ratio of the present invention and XUEMINGMU PIAN group is strong.
Two, to the influence of rat platelet number
Experiment material
1, animal: the SD rat, male and female have concurrently, body weight 180～220g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
50 of SD rats, male and female half and half, body weight 180～220g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 2.4,1.2,0.6g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 2.4g crude drug/kg.Successive administration 7d, every day 1 time, 2h gets blood system platelet rich plasma after the last administration, with microscopy method direct count platelet count.
Experimental result: see table 2
The influence of table 2 pair rat platelet number
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and can obviously increase the platelet count of rat with the XUEMINGMU PIAN group, compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that sheet group ratio of the present invention and XUEMINGMU PIAN group anastalsis are strong.
Three, to the influence of heparinization clotting time of mice
Experiment material
1, animal: Kunming mouse, male and female have concurrently, body weight 18～22g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
60 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 6 groups at random, 10 every group.Blank group and model group are irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 3.6,1.8,0.9g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 3.6g crude drug/kg.Successive administration 7d, every day 1 time, each 20ml/kg, 15min before the last administration, except that the blank group, each organizes mice tail vein injection 7u/ml heparin-saline 0.1ml/10g modeling respectively.Each organizes 30min behind the mice last gastric infusion; Extract eyeball blood sampling 0.5ml; Splash in the test tube of long 10cm, internal diameter 9mm (37 ℃ of constant temperature water baths); Whether whenever subsequently observe blood and flow at a distance from slowly tilt test tube 30 degree 1 time of 30s, the record autoblood splashes into test tube and rises to test tube to tilt for 90 immobilising times of blood (clotting time) when spending.
Experimental result: see table 3
The influence of table 3 pair clotting time of mice
Compare * * P＜0.01 with model group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and have the clotting time effect of shortening experimental disorders of hemostasis animal with the XUEMINGMU PIAN group, compared utmost point significant difference (P＜0.01) with model group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that sheet group ratio of the present invention and XUEMINGMU PIAN group Blood clotting are strong.
Four, to the rabbit influence of calcium clotting time again
Experiment material
1, animal: rabbit, male and female have concurrently, body weight 1.8～2.2kg.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
50 of rabbit, male and female half and half, body weight 1.8～2.2kg is divided into 5 groups at random, 10 every group.Respectively organize tame rabbit ear arteria comitans nervi mediani blood sampling 2.7ml adding before the administration and fill 3.8% sodium citrate 0.3ml in advance in vitro; Getting 0.1ml blood plasma behind the centrifugal 10min of 1000rpm respectively adds in 5 long 10cm, the internal diameter 9mm test tube; And in every test tube, add the 0.1ml normal saline; Incubation 1min in 37 ℃ of water-baths adds 0.28%CaCl again in every test tube
20.1ml, put into water-bath behind the mixing and begin to clock, every behind the 1min at a distance from slowly tilt test tube 1 time of 10s, motionless (fibrin formations) time of liquid level during record inclination test tube, get 5 test tube fibrin formation time averages as calcium clotting times again.Respectively organize the rabbit gastric infusion subsequently, matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 1.6,0.8,0.4g crude drug/kg respectively; With the thin gastric infusion 1.6g of XUEMINGMU PIAN crude drug/kg.Successive administration 7d, every day 1 time, each 15ml/kg.Once more from tame rabbit ear arteria comitans nervi mediani blood sampling 2.7ml, measure the multiple calcium clotting time of blood plasma behind the last administration 45min, obtain clotting time and shorten percentage rate [value before 100 * (being worth after value-administration before the administration)/administration].
Experimental result: see table 4
The influence
of the multiple calcium clotting time of table 4 pair rabbit
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and have the effect of shortening the multiple calcium clotting time of rabbit with the XUEMINGMU PIAN group, compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that the Blood clotting of sheet group ratio of the present invention and XUEMINGMU PIAN group is strong.
Five, to the phagocytotic influence of Turnover of Mouse Peritoneal Macrophages
Experiment material
1, animal: Kunming mouse, male and female have concurrently, body weight 18～22g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine
Before experiment, dispose gastric infusion with distilled water.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 3.6,1.8,0.9g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 3.6g crude drug/kg.Successive administration 7d, every day 1 time, lumbar injection 5% chicken red blood cell (CRBC) immediately after the last administration, every 0.5mL; Put to death mice behind the 4h, lumbar injection 0.9% sodium chloride injection, every 2mL gently rubs mouse web portion 1min; Draw the abdominal cavity drop on two slides, 37 ℃ of temperature are incubated 30min, and 0.9% sodium chloride solution rinsing is dried; Methanol is fixed, and the oily sem observation in back is dried in 4%Giemsa-Wright dyeing.Count 100 macrophages, calculate phagocytic index.(CRBC number/100 macrophage number * 100% that phagocytic index=quilt is engulfed)
Experimental result: see table 5
The phagocytotic influence of table 5 pair Turnover of Mouse Peritoneal Macrophages
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and all possibly obviously improve the phagocytic index of Turnover of Mouse Peritoneal Macrophages with the XUEMINGMU PIAN group, compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that the effect that sheet group ratio of the present invention and XUEMINGMU PIAN group promote blood stasis to absorb is strong.
Six, to the influence of mice capillary permeability
Experiment material
1, animal: Kunming mouse, male and female have concurrently, body weight 18～22g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
50 of kunming mices, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 3.6,1.8,0.9g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 3.6g crude drug/kg.Successive administration 7d behind the last administration 1h, gives mouse tail vein injection 0.5% ivens blue 5ml/kg every day 1 time, and the 5min pneumoretroperitoneum is injected 0.5% acetic acid 10ml/kg.Take off vertebra behind the 30min and put to death, cut open the belly and use the distilled water flushing abdominal cavity, flushing liquor is diluted to 10ml, adds 0.1mol/L NaOH 0.1ml, places 30min.Divide spectrophotometer (590nm) colorimetric with 721 types.
Experimental result: see table 6
The influence of table 6 pair mice capillary permeability
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and all significantly suppress the abdominal cavity capillary permeability with the XUEMINGMU PIAN group and increase; Improve capillary permeability; The antagonism nonspecific inflammation; Ooze out thereby suppress hemocyte effectively, help hemostasis, compare the difference (P＜0.01) that utmost point significance is arranged with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that the effect of the inhibition capillary permeability of sheet ratio of the present invention and XUEMINGMU PIAN is strong.
Seven, to the microcirculatory influence of tame lagophthalmos conjunctiva
Experiment material
1, animal: rabbit, male and female have concurrently, body weight 1.8～2.2kg.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
Adopt tame lagophthalmos conjunctiva blood capillary fluorimetry.50 of rabbit, male and female half and half, body weight 1.8～2.2kg is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 1.6,0.8,0.4g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 1.6g crude drug/kg.Successive administration 7d, every day 1 time, each 15ml/kg, 1h after the last administration, the uranin normal saline solution 1ml/kg (being equivalent to fluorescein 100mg/kg) of ear vein injection 10%, the time of fluorescence appears in the record rabbit conjunctival.
Experimental result: see table 7
The table 7 pair microcirculatory influence of tame lagophthalmos conjunctiva
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and obviously quicken tame lagophthalmos conjunctiva microcirculation blood flow with the XUEMINGMU PIAN group, promote the eye microcirculation, and improve the ocular blood flow supply, compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that the microcirculation improvement effect of sheet group ratio of the present invention and XUEMINGMU PIAN group is strong.
Eight, to effect of immunologic function
1, animal: Kunming mouse, male and female have concurrently, body weight 18～22g.
2, medicine: with XUEMINGMU PIAN 0.84g crude drug/sheet; Large, medium and small three the dose groups 0.84g crude drug/sheets of sheet of the present invention.Medicine disposes with distilled water before experiment, gastric infusion.
Experimental technique
50 of Kunming mouses, male and female half and half, body weight 18～22g is divided into 5 groups at random, 10 every group.Matched group is irritated the normal saline of stomach with volume; Sheet group of the present invention is gastric infusion 3.6,1.8,0.9g crude drug/kg respectively; With XUEMINGMU PIAN group gastric infusion 3.6g crude drug/kg.Successive administration 7d, every day 1 time, each 20ml/kg.Behind the administration 2d, each organizes the equal lumbar injection of mice 5: 3, and (V: V) the red born of the same parents' suspension of the sheep 0.2ml/ of dilution only carries out immunity.Continue administration 5d, behind the last administration 1h, pluck eyeball respectively and get blood, separation of serum, the content of mensuration hemolysin.
Experimental result: see table 8
Table 8 pair effect of immunologic function
Compare * * P＜0.01 with matched group; With with the XUEMINGMU PIAN group than △ P＜0.05.
The result shows: sheet group of the present invention and can obviously increase the content of hemolysin in the serum with the XUEMINGMU PIAN group, improve mouse humoral immune power, and compared utmost point significant difference (P＜0.01) with matched group; The heavy dose of group of sheet of the present invention with and the XUEMINGMU PIAN group significant difference (P＜0.05) of having compared.It is thus clear that it is strong that sheet group ratio of the present invention and XUEMINGMU PIAN group improve immunity function.
Conclusion: pharmacological actions such as the hemostasis of sheet ratio of the present invention and XUEMINGMU PIAN, blood coagulation, inhibition capillary permeability, microcirculation improvement, human body immunity improving power are strong; Therefore; Sheet group ratio of the present invention and XUEMINGMU PIAN are used for deficiency of YIN liver-yang hyperactivity, and the caused retinal hemorrhage clinical efficacy of thermal burn channels is good.
Toxicological experiment:
Acute toxicity testing is the result show: with tablet Cmax of the present invention, maximum volume gastric infusion, successive administration is 3 times in 24h, each 4h at interval, and accumulation medicine total amount reaches 38g crude drug/kg, is equivalent to 211.1 times of the clinical plan consumption of people.After the administration in the 7d, mice is movable, feed, drain all normal, well-grown, the hair color light, its average body weight average increases with the prolongation of test period.8d puts to death every mice perusal heart of back dissection, liver, spleen, lung, kidney, brain, thymus, stomach, intestinal etc. and does not all find color and paramophia, fails to measure LD
50Show that tablet of the present invention does not have acute toxic reaction.
Long term toxicity test is the result show: tablet ingredients of the present invention is that basic, normal, high dosage is respectively 4,8,16g crude drug/kg/d; Be equivalent to 22.2,44.4,88.9 times of clinical dosage; Gastric infusion is after 12 weeks; Tablet of the present invention does not all have tangible influence to general situation, hematological indices, the blood parameters of animal, the yet no abnormal pathological change of system's dissection, organ coefficient and histopathological examination.2 weeks of drug withdrawal are not seen obvious change yet.Tablet of the present invention is not found overt toxicity reaction and delayed toxicity reaction in long term toxicity test.It is thus clear that, tablet non-toxic reaction of the present invention, long-term prescription is safe and reliable.
The specific embodiment
1, the preparation of tablet of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add dextrin, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate adds magnesium stearate, mixing; Be pressed into 1000, coating promptly gets tablet.
2, the preparation of capsule of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add starch, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate, promptly gets capsule by encapsulated 1000.
3, the preparation of granule of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, the adding dextrin is an amount of, processes granule with 85% ethanol, 60 ℃ of oven dry; Granulate makes granule 1000g, promptly gets granule.
4, the preparation of soft capsule of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; It is an amount of to get the adjuvant soybean oil, adds the Cera Flava of 4-6%, after heating makes dissolving, adds above-mentioned hybrid medicine fine powder, stirs, and colloid mill grinds well, and processes 1000 of soft capsules, promptly gets soft capsule.
5, the preparation of drop pill of the present invention:
Prescription:
Method for preparing is:
More than 19 flavor medical materials, Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; Macrogol 4000 put in the water-bath heat, melt the back and add above-mentioned hybrid medicine fine powder, stirring is transferred to reservoir, airtight and in 70 ℃ of insulations, is coolant with the methyl-silicone oil, processes drop pill, promptly gets drop pill.
Claims (9)
1. Chinese medicine composition that is used for cooling blood for hemostasis, YIN nourishing blood stasis dispelling, nourishing the liver to improve visual acuity is characterized in that the prescription of said Chinese medicine composition consists of:
2. according to the method for preparing of the said Chinese medicine composition of claim 1, it is characterized in that the prescription of said Chinese medicine composition consists of:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; Filtrate decompression concentrates (0.08MPa; 80 ℃) be the thick paste of 1.35～1.39 (60 ℃) to relative density; Add above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry are ground into fine powder; Add each dosage form proper auxiliary materials, process tablet, capsule, granule, soft capsule or drop pill by each dosage form common process.
3. according to claim 1 or 2 said Chinese medicine compositions, it is characterized in that the dosage form of said Chinese medicine composition is: tablet, capsule, granule, soft capsule or drop pill.
4. according to claim 1 or 2 said Chinese medicine compositions, it is characterized in that said Chinese medicine composition most preferred dosage form is: tablet.
5. according to the method for preparing of claim 1 or 2 said Chinese medicine compositions, it is characterized in that the prescription of said Chinese medicine composition consists of:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add dextrin, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate adds magnesium stearate, mixing; Be pressed into 1000, coating promptly gets tablet.
6. according to the method for preparing of claim 1 or 2 said Chinese medicine compositions, it is characterized in that the prescription of said Chinese medicine composition consists of:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, add starch, process granule with 85% ethanol, 60 ℃ of oven dry; Granulate, promptly gets capsule by encapsulated 1000.
7. according to the method for preparing of claim 1 or 2 said Chinese medicine compositions, it is characterized in that the prescription of said Chinese medicine composition consists of:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, 60 ℃ of oven dry; Be ground into fine powder, the adding dextrin is an amount of, processes granule with 85% ethanol, 60 ℃ of oven dry; Granulate makes granule 1000g, promptly gets granule.
8. according to the method for preparing of claim 1 or 2 said Chinese medicine compositions, it is characterized in that the prescription of said Chinese medicine composition consists of:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; It is an amount of to get the adjuvant soybean oil, adds the Cera Flava of 4-6%, after heating makes dissolving, adds above-mentioned hybrid medicine fine powder, stirs, and colloid mill grinds well, and processes 1000 of soft capsules, promptly gets soft capsule.
9. according to the method for preparing of claim 1 or 2 said Chinese medicine compositions, it is characterized in that the prescription group of said Chinese medicine composition. become:
Method for preparing is: above 19 flavor medical materials, and Flos Chrysanthemi, charcoal Radix Scutellariae, Semen Plantaginis (half amount), Pollen Typhae (half amount), mixed powder is broken into fine powder, and is subsequent use; Residue Semen Plantaginis, Pollen Typhae and all the other each flavors add 60% soak with ethanol 30 minutes, the reflux, extract, secondary, and each 2 hours, add 6 times of amounts of 60% ethanol for the first time, add 6 times of amounts of 60% ethanol for the second time, merge extracted twice liquid, filter; It is the thick paste of 1.35～1.39 (60 ℃) that filtrate decompression concentrates (0.08MPa, 80 ℃) to relative density, adds above-mentioned fine powder mix homogeneously, and 60 ℃ of oven dry are ground into fine powder, gets the hybrid medicine fine powder, subsequent use; Macrogol 4000 put in the water-bath heat, melt the back and add above-mentioned hybrid medicine fine powder, stirring is transferred to reservoir, airtight and in 70 ℃ of insulations, is coolant with the methyl-silicone oil, processes drop pill, promptly gets drop pill.
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| CN108815389A (en) * | 2018-08-16 | 2018-11-16 | 贵州苗之源苗药中药饮片有限公司 | A kind of Chinese medicine composition to nourish the liver to improve visual acuity |
| CN108815390A (en) * | 2018-08-16 | 2018-11-16 | 贵州苗之源苗药中药饮片有限公司 | A kind of Chinese medicine composition and preparation method thereof improving eyesight |
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Denomination of invention: Traditional Chinese drug composition for blood cooling, hemostasis, yin nourishing, blood stasis dissipating, liver nourishing and eyesight improving, and preparation method thereof Effective date of registration: 20151130 Granted publication date: 20121128 Pledgee: The Bank of Xi'an branch of Limited by Share Ltd Pledgor: Beilin Pharmaceutical Co., Ltd., Xi'an Registration number: 2015990001065 |
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