CN104491041B - Gegen Qinlian oral fluid and preparation method thereof - Google Patents

Gegen Qinlian oral fluid and preparation method thereof Download PDF

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CN104491041B
CN104491041B CN201410827524.8A CN201410827524A CN104491041B CN 104491041 B CN104491041 B CN 104491041B CN 201410827524 A CN201410827524 A CN 201410827524A CN 104491041 B CN104491041 B CN 104491041B
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周伟祥
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JIANGXI XINZHENG PHARMACEUTICAL CO Ltd
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Abstract

The present invention provides a kind of Gegen Qinlian oral fluid, and it is prepared by each bulk drug of following parts by weight：40 60 parts of the root of kudzu vine, 15 25 parts of the Radix Astragali, 15 25 parts of the coptis, 10 20 parts of honey-fried licorice root.Preparation method is as follows：Secondary, collecting decoction is first added water to cook, is filtered；Filtrate is taken to be concentrated into the 1.25g/cm of density 1.103, gradient alcohol precipitation is carried out, alcohol content is respectively 30 55% and 60 85%；Take supernatant to add stevioside, sodium benzoate, ethylparaben, EDTA 2Na and the honey of amount of preparation, add appropriate amount of water, adjust pH to 2.0 5.0, stand；Take supernatant to add appropriate amount of water, adjust pH to 5.5 7.0, stand, take supernatant to add the sodium pyrosulfite of amount of preparation 0.05 0.15%, mix, filling, sterilizing, you can.The Gegen Qinlian oral fluid cures mainly expelling pathogenic factors from muscles for clearing heat, antidiarrheal stop dysentery；For dysentery, the hot polydipsia of body, lower profit is smelly dirty.

Description

Gegen Qinlian oral fluid and preparation method thereof
Technical field
The present invention relates to oral preparation of Chinese traditional medicinal technical field, and in particular to a kind of Gegen Qinlian oral fluid, and the root of kudzu vine A kind of reed mentioned in ancient books connects the preparation method of oral liquid.
Background technology
Gegen qinlian decoction is first recorded in Zhang Zhongjing《The Treatise on Fevrile Diseases》, it is made up of four taste Chinese medicines, the root of kudzu vine is monarch, and a kind of reed mentioned in ancient books, company, radix glycyrrhizae are Assistant, its specially bright fleshy exterior of solution sun of anticipating, and in clearing stomach in heat, be the classic prescriptions of traditional Chinese medicine in this removing summer-heat and in inducing diaphoresis.The root of kudzu vine A kind of reed mentioned in ancient books in flakes, Gegen Qinlian oral fluid be gegen qinlian decoction different dosage forms, also recorded in Chinese Pharmacopoeia.
Paper《The research of gegen qinlian decoction Compatibility Law》(the phase 512-518 of the Chinese herbal medicines such as Luo Jiabo .2005 the 4th) refers to Go out：The root of kudzu vine and the coptis reduce the content of scutelloside, and the coptis reduces the content of glycyrrhizic acid, and the root of kudzu vine, radix scutellariae, radix glycyrrhizae make containing for jamaicin Amount reduces, i.e., the root of kudzu vine, radix scutellariae, the coptis, the different compatibilities of the taste Chinese medicine of honey-fried licorice root four will influence scutelloside, sweet in Gegen Qinlian prescription The content of the active ingredients such as oxalic acid, jamaicin, so as to influence drug effect.
Paper《Gegen qinlian decoction compatibility is studied with antipyretic medicine efficacy relation》(CHINA JOURNAL OF CHINESE MATERIA MEDICAs .2004 the 7th in remaining woods Phase 663-666) point out：The root of kudzu vine can strengthen the effect of radix scutellariae, the coptis and honey-fried licorice root then antagonism, reduce △ T values, main function medicine For radix scutellariae, the root of kudzu vine strengthens the effect of radix scutellariae, the effect of honey-fried licorice root and coptis antagonism radix scutellariae；In the antipyretic drug effect of gegen qinlian decoction In, its best of breed is radix scutellariae, the root of kudzu vine, it is seen that for different drug effects, need to use different Gegen Qinlian formulas.
Paper《Influence of the gegen qinlian decoction difference compatibility to puerarin content》(wear the Chinese herbal medicines such as karat gold .2003 the 6th Phase 506-509) point out：Containing caused by the coptis and the root of kudzu vine compatibility decocting liquid precipitation in may be relevant with the change of pH value containing Puerarin, That is the change of even pH value is also possible to influence the content of active ingredient in Gegen Qinlian prescription, and this shows Gegen Qinlian preparation Preparation method will also influence the content of active ingredient in final product.
The content of the invention
The technical problems to be solved by the invention are to provide a kind of Gegen Qinlian oral fluid, and the Gegen Qinlian oral fluid cures mainly Expelling pathogenic factors from muscles for clearing heat, antidiarrheal stop dysentery；For dysentery, the hot polydipsia of body, lower profit is smelly dirty.
The technical solution adopted in the present invention is：
A kind of Gegen Qinlian oral fluid, the oral liquid are prepared by each bulk drug of following parts by weight：Root of kudzu vine 40-60 Part, radix scutellariae 15-25 parts, coptis 15-25 parts, honey-fried licorice root 10-20 parts.
The preparation method of above-mentioned Gegen Qinlian oral fluid is as follows：
(1) bulk drug (root of kudzu vine, radix scutellariae, the coptis and honey-fried licorice root) of formulation by weight is weighed, adds water to cook secondary, 1 is small every time When, add 6-10 (quality) times water, second plus 5-8 (quality) times water, collecting decoction, filtering for the first time；
(2) it is 1.10-1.25g/cm to take filtrate to be concentrated into relative density3(80 DEG C), are cooled to room temperature, add ethanol to make containing alcohol Amount reaches 30-55%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, stands 24 hours；
(3) supernatant is taken, adds ethanol to alcohol content to reach 60-85%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, stands 24 hours；
(4) supernatant is taken, reclaims ethanol, adds amount of preparation (mass percent) 0.03-0.06% stevioside, 0.03- 0.06% sodium benzoate, 0.03-0.06% ethylparabens, 0.1-0.2%EDTA-2Na and 3-6% honey, add water weight To 0.5-1.5 times of bulk drug weight, boil, cool down, add salt acid for adjusting pH to stand 24-48 hours to 2.0-5.0；
(5) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, hydrogenation sodium oxide molybdena is adjusted PH to 5.5-7.0 is saved, is boiled, stands 24-48 hours；
(6) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, adjusts pH to 5.5- 7.0, boil, add amount of preparation (mass percent) 0.05-0.15% sodium pyrosulfites, mix, filling, sterilizing, you can.
Gegen Qinlian oral fluid of the present invention be brown color to the supernatant liquid of sepia, be long placed in a small amount of precipitation；Mildly bitter flavor, Sweet tea；Relative density is not less than 1.03, pH value 4.0-6.0.
Usage and dosage：Orally, each 10mL, 2 times a day.
The present invention is chosen the root of kudzu vine, radix scutellariae, the coptis and honey-fried licorice root and is carried out compatibility in specific proportions based on theory of traditional Chinese medical science, Make the drug effect between each taste Chinese medicine complement each other in the allotment of amount, bring out the best in each other so that Gegen Qinlian oral fluid tool of the present invention There is expelling pathogenic factors from muscles for clearing heat, antidiarrheal stop dysentery etc. to cure mainly function, for dysentery, the hot polydipsia of body, lower profit is smelly dirty.
In preparation method, the water extraction of (1) step, (2), (3) step gradient alcohol precipitation, for precipitating proteins, starch, colloid Deng macromolecular substances, set pH is advantageous to the precipitation of invalid components, is stood under (4), (5) step acid condition finally to precipitate Impurity, what is finally given produces liquid clear, and active constituent content is high, and impurity content is few.The sheet obtained by above step Invention Gegen Qinlian oral fluid active constituent content is high, and major function is inducing diaphoresis heat-clearing, is not solved to treat diseases caused by external factors exterior syndrome, heat evil In entering, the lower profit of body heat is shown as, excrement is smelly dirty, dysphoria with smothery sensation uncomfortable in chest, red tongue with yellowish fur, the illness of rapid pulse.Available for chordapsus, bacterium Property the category root of kudzu vine Siberian cocklebur such as dysentery, diarrhea connect disorder.
The present invention uses oral liquid formulations form, and convenient to take, mouthfeel is fine, is easily received by patient, absorbs completely, rises Effect is fast, and curative effect is high, and security is big during Clinical practice, suitable for promoting the use of for clinically relevant illness.
Embodiment
The present invention is further described in detail with reference to embodiments.It is noted that detailed description below is all to illustrate Property, it is intended to provide further instruction to the present invention.Unless otherwise indicated, all scientific and technical terms that the present invention uses With the identical meanings being generally understood that with the technical field of the invention personnel.
Embodiment 1：
The present embodiment Gegen Qinlian oral fluid is prepared by each bulk drug of following parts by weight：50 parts of the root of kudzu vine, radix scutellariae 18.75 parts, 18.75 parts of the coptis, 12.5 parts of honey-fried licorice root.It is prepared as follows to obtain：
(1) root of kudzu vine 500g, radix scutellariae 187.5g, coptis 187.5g, honey-fried licorice root 125g are weighed, adds water to cook secondary, 1 is small every time When, add 8 times of quality water, second plus 6.5 times of quality water, collecting decoction, filtering for the first time；
(2) it is 1.10-1.25g/cm to take filtrate to be concentrated into relative density3Between (80 DEG C), be cooled to room temperature (can be from So cooling, cooling circulating water can also be used to cool down), add ethanol alcohol content is reached 40%, hydrogenation sodium oxide molybdena adjust pH to In the range of 7.5-9.0,24 hours are stood；
(3) supernatant is taken, adds ethanol to alcohol content to reach 70%, hydrogenation sodium oxide molybdena is adjusted in the range of pH to 7.5-9.0, quiet Put 24 hours；
(4) supernatant is taken, adds amount of preparation (mass percent) 0.03-0.06% stevioside, 0.03-0.06% benzene Sodium formate, 0.03-0.06% ethylparabens, 0.1-0.2%EDTA-2Na and 3-6% honey, add water to 1000mL, boil, Cooling, salt acid for adjusting pH is added to stand 48 hours in the range of 2.0-5.0；
(5) supernatant is taken, is filtered, takes filtrate to add water to 1000mL, hydrogenation sodium oxide molybdena is adjusted in the range of pH to 5.5-7.0, Boil, stand 48 hours；
(6) supernatant is taken, is filtered, takes filtrate to add water to 1000mL, is adjusted in the range of pH to 5.5-7.0, is boiled, add preparation (mass percent) 0.05-0.15% sodium pyrosulfites are measured, are mixed, filling, sterilizing, you can.
Embodiment 2：
The present embodiment Gegen Qinlian oral fluid is prepared by each bulk drug of following parts by weight：60 parts of the root of kudzu vine, radix scutellariae 25 parts, 25 parts of the coptis, 20 parts of honey-fried licorice root.Root of kudzu vine 600g, radix scutellariae 250g, coptis 250g, honey-fried licorice root 200g are weighed, is configured to 1000mL Gegen Qinlian oral fluids, preparation method is the same as embodiment 1.
Embodiment 3：
The present embodiment Gegen Qinlian oral fluid is prepared by each bulk drug of following parts by weight：40 parts of the root of kudzu vine, radix scutellariae 15 parts, 15 parts of the coptis, 10 parts of honey-fried licorice root.Root of kudzu vine 400g, radix scutellariae 150g, coptis 150g, honey-fried licorice root 100g are weighed, is configured to 1000mL Gegen Qinlian oral fluids, preparation method is the same as embodiment 1.
Embodiment 4：The pharmacodynamic experiment of Gegen Qinlian oral fluid
Test medicine：
(1) Gegen Qinlian Tablets：Purchased from by Honghe Prefecture pharmaceutical factory；
(2) Gegen Qinlian oral fluid：Gained is prepared by the embodiment of the present invention 1.
Experimental animal：
Wistar big white mouse, Kun Ming mice, provided by laboratory animal room of Anhui Prov. Medical Science Inst..
(1) to the effect of big white mouse lactose diarrhoea
Take healthy Wistar male white rats, 160~180g of body weight.Be randomly divided into blank control group, Gegen Qinlian Tablets group, Gegen Qinlian oral fluid is big, middle dose group.Every group of 8 big white mouse.Before experiment, each big white mouse body weight and stool grade are recorded.It is real Each group is by corresponding group and dosage when testing, and 1 hour after gastric infusion, per mouse, gavage gives 50% lactose 1.5ml/100g bodies again Weight, twice a day, continuous 5 days.And (big white mouse is put in metabolic cage, respectively for observation big white mouse changes of weight and stool grade daily Record result).Stool grade：0 grade is normal stool；1 grade is the soft excrement of shaping；2 grades are non-forming soft excrement；3 grades are magma Close excrement；4 grades are watery stools, the results list 1,2.
The change of body weight after the different oral lactose of group big white mouse of table 1
The change of excrement after the different oral lactose of group big white mouse of table 2
The * P compared with blank control group<0.05, * * P<0.01.
Table 1,2 results prove：Gegen Qinlian oral fluid and Gegen Qinlian Tablets have anti-diarrhea effect to Rat Experimental diarrhoea, Compared with blank control group, there is notable difference.But the onset time of Gegen Qinlian oral fluid group is faster than Gegen Qinlian Tablets group.
(2) to the influence of small white mouse Intestinal propulsive rate
Take healthy Kun Ming mice, body weight 20~22g, ♀ ♂ half and half.It is random divide blank control group, Gegen Qinlian Tablets group, Gegen Qinlian oral fluid heavy dose group, Gegen Qinlian oral fluid middle dose group.Every group 14.Test fasted for one day prior.Every group is pressed 1 hour after corresponding group and dosage gastric infusion, charcoal end, 10% Arabic gum suspension 0.2ml/20g bodies per mouse gavage to 5% Weight.After 20 minutes animal is put to death with cervical dislocation.Cut open the belly immediately, alimentary canal is intactly extracted from orifice of the stomach to rectum end. It is not added with drawing, is laid on glass plate, survey its total length, and record charcoal end forward position to the distance of orifice of the stomach, it is complete with intestines and stomach calculates it Long percentage.The average value organized entirely is taken to be compared, statistical procedures, the results list 3.
Influence of the 3 different groups of table to small white mouse Intestinal propulsive rate
The * P compared with blank control group<0.05
As a result show：Gegen Qinlian oral fluid and Gegen Qinlian Tablets group, have and suppress mouse small intestine progradation, with blank Control group relatively has significant difference.
(3) to the influence of Mouse Stomach emptying
Take healthy Kun Ming mice, 20~22g of body weight, male and female half and half.It is randomly divided into blank control group, Gegen Qinlian Tablets Group, Gegen Qinlian oral fluid heavy dose group, Gegen Qinlian oral fluid middle dose group.Every group of 12 small white mouses.It is each to test the previous day Group was by fasting after corresponding group and dosage gastric infusion 24 hours.After 4 hours before experiment are administered once again, filled to every small white mouse The methyl orange aqueous solutions of stomach 0.2ml 0.1%.Put to death after 20 minutes, win stomach, be placed in beaker, add 10ml distilled water, it is big along stomach Curved scissors whets the appetite, and gastric content is fully washed in distilled water, uses NaHCO3Adjust PH to 6~6.5.Separation takes supernatant, with day This Shimadzu UV-240 type ultraviolet-visible photometers (wavelength 420um), 10ml distilled water is added to make with 0.1% methyl orange 0.2ml close Radix is spent, compares methyl orange trap in every Mouse Stomach of each group, and the average Stomach residue rate of each group is calculated by following equation. Statistical procedures.The results list 4.
Wherein：Methyl orange residual rate=(methyl orange trap/methyl orange trap radix in stomach) × 100 in stomach.
4 different groups of table are to influence (%) of the small white mouse to methyl orange gastric emptying
Group Mouse number (only) Dosage (g/kg) Methyl orange residual rate (X ± SD) in stomach
Blank control group 12 Distilled water 34.72±7.58
Gegen Qinlian Tablets group 12 5.2 24.92±6.75**
Root of kudzu vine a kind of reed mentioned in ancient books oral liquid group 12 5.2 17.96±4.01**
Root of kudzu vine a kind of reed mentioned in ancient books oral liquid group 12 5.2 24.88±4.43**
The * * P ＜ 0.01 compared with blank control group
The result of table 4 shows：Gegen Qinlian oral fluid, which has, promotes mouse gastric emptying, relatively has highly significant with control group Sex differernce.
(4) In vitro Bactericidal Experiments
1. method：Dilution method sensitization test.
2. culture medium：1. broth bouillon；2. 0.5% blood-bouillon culture medium；3. caseinhydrolysate liquid culture medium.
3. inoculum prepares：
1. shigella dysenteriae, Escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa：The strain of standard mattress is inoculated in into blood respectively to put down Single bacterium colony is isolated after plate again, several colony inoculations of homomorphosis 35 DEG C of 12h in meat soup pipe is then taken, uses physiological saline Bacterial concentration is corrected, makes its turbidity is identical with 0.5 Maxwell pipe (to use BaCl2System), content is about 1.5 × 108/ml。
2. streptococcus：Reference culture point is pure, take point pure bacterium colony kind 35 DEG C of mistakes in 0.5% blood-bouillon culture medium At night, concentration is corrected with salt solution, turbidity is same as above.
4. test procedure：10, test tube is arranged, wherein the first pipe plus caseinhydrolysate fluid nutrient medium 1.9ml, remaining each pipe Add 1ml, draw root of kudzu vine Siberian cocklebur and connect oral liquid and the root of kudzu vine Siberian cocklebur aqueous solution 0.1ml in flakes, add the mixing of the first pipe, suction out 1ml and add the Two pipes, by that analogy to the 9th pipe, it is control tube that the tenth pipe, which is not added with decoction, takes the bacterium solution 0.5ml for having corrected concentration to add and respectively contains Pencil and control tube, 35 DEG C overnight, observes result.
5. result：It is shown in Table 5 and table 6.
The root of kudzu vine Siberian cocklebur of table 5 connects the vitro antibacterial activity of oral liquid
Drug concentration (mg/ml)
The control strain control of 500mg 250mg 125mg 62.5mg 31.25mg 15.625mg medicines
Shigella dysenteriae ————————
Escherichia coli ————————
Hemolytic streptococcus ————————
Staphylococcus aureus ————————
Pseudomonas aeruginosa ————————
The vitro antibacterial activity of the root of kudzu vine Siberian cocklebur of table 6 aqueous solution in flakes
Drug concentration (mg/ml)
The control strain control of 500mg 250mg 125mg 62.5mg 31.25mg medicines
Shigella dysenteriae ———————
Escherichia coli ———————
Hemolytic streptococcus ———————
Staphylococcus aureus ———————
Pseudomonas aeruginosa ———————
"+" is to have bacteria growing, "-" asepsis growth.
Show from table 5,6 results：Gegen Qinlian oral fluid and Gegen Qinlian Tablets are to shigella dysenteriae, Escherichia coli, hemolytic Streptococcus and staphylococcus aureus have different degrees of inhibitory action.MIC is respectively 31.25,31.25,125 and 250mg/ ml。
(5) Xylose Content is tested in mouse serum
Take healthy Kun Ming mice, 20 ± 2g of body weight, male and female half and half.It is randomly divided into blank control group, Gegen Qinlian Tablets Group and two dosage groups of Gegen Qinlian oral fluid.Every group of 12 small white mouses.The previous day each group is tested to fill by corresponding group and dosage Stomach administration is secondary.The experiment same day gavages again to be administered once.After one hour, each group gavages 5%D- xylose solution 2.1g/kg body weight, After one hour, eye socket takes blood, prepares serum.And a mouse serum is taken, and add 8 parts of distilled water, 0.5 part of 0.3mol/1 sulfuric acid, 10% 0.5 part of sodium tungstate, with adding with shaking.Centrifugation removes protein, produces nonprotein filtrate, takes this filtrate 2ml, add 1% 2 antelope toluene reagent 2ml, mixes 1hr in rearmounted boiling water, and each pipe plus distilled water diluting mix to 25ml after cooling.Separately take 1 Branch blank tube adds distilled water 2ml, 2 each 2ml of xylose standard solution conduit (concentration is respectively 0.05mg/ml and 0.1mg/ml), its Remaining method is same as above, and its trap is surveyed at 630nm wavelength, calculates Xylose Content in mouse serum.The results list 7.
Influence of the 7 different groups of table to Xiaobao mouse serum Xylose Content
The P compared with blank control group>0.05
Xylose is thermally formed bran aldehyde in an acidic solution, and it is in green reaction that the latter can be acted on two antelope toluene.Can from upper table To find out：Root of kudzu vine Siberian cocklebur in flakes with oral liquid to small white mouse intestinal absorption without obvious facilitation.
(6) summarize
From pharmacodynamic results it can be seen that：Root of kudzu vine Siberian cocklebur connects oral liquid and had both remained the physiologically active of root of kudzu vine Siberian cocklebur in flakes, i.e., to breast The anti-diarrhea effect of sugared rat diarrhoea, to the inhibitory action of mouse enterocinesia, promotes small white mouse emptying and In Vitro Bacteriostasis Deng, and the agent in flakes of root of kudzu vine Siberian cocklebur is also substantially better than to mouse gastric emptying, the onset time of antidiarrheal is also faster than tablet control group.
Embodiment 5：The animal acute toxicity test of Gegen Qinlian oral fluid
Experimental animal：Kunming small white mouse, 20 ± 2g of body weight, male and female half and half, by animal housing of Anhui Prov. Medical Science Inst. There is provided.
Experimental drug：Root of kudzu vine Siberian cocklebur connects oral liquid, and gained is prepared by the embodiment of the present invention 1.
(1) mouth medication：
Above-mentioned healthy Kun Ming mice 20 is taken, each gavage of every small white mouse connects oral liquid 0.8ml/ to root of kudzu vine Siberian cocklebur 20g body weight (contains crude drug 0.8g), 4 times in every 6 hours 1 time, 24 hours, after administration in Continuous Observation 7 days, and small white mouse toxic reaction And death condition.As a result in seven days, freely, appetite and stool and urine are normal for small white mouse activity.Small white mouse toxic reaction is not found And death condition.It is computed：Root of kudzu vine Siberian cocklebur connect oral liquid gastric infusion hair, measure mini bus maximal tolerance dose more than 320 grams of crude drugs/ Kg, equivalent to 960 times of clinically people's dosage.
(2) intraperitoneal injection method：
Take above-mentioned specification small white mouse, random pair is divided into 5 groups, every group 10, by 1:0.8 grade is administered than anxious number, every small 0.2ml/20g body weight is injected intraperitoneally in white mouse, Continuous Observation seven days after administration, records each group mice dying number, and carry out in time Gross necropsy, lesion is not found, as a result see the table below 8.
Table 8
Use composite accounting：Try to achieve LD50=23.38g crude drugs/kg；LD5095% it is average it is credible be limited to 23.38 ± 1.98g/kg。
(3) summarize：
It is 320g crude drugs/kg that Gegen Qinlian oral fluid administration by gavage, which measures small white mouse maximal tolerance dose,；Intraperitoneal injection, which is surveyed, to be hindered Small white mouse LD5O=23.38g crude drugs/kg.
Embodiment 6：The long-term toxicity test for animals of Gegen Qinlian oral fluid
Experimental animal：Wistar big white mouse, body weight 150 ± 10g, ♂ ♀ half and half, by Anhui Prov. Medical Science Inst. animal Room provides.
Experimental drug：Embodiment 1 prepares gained root of kudzu vine Siberian cocklebur and connects oral liquid, every 10ml 10g containing crude drug, for ease of being administered, It is condensed into every 2 grams of milliliter contained amount.
(1) experimental method：
Healthy Wistar big white mouse 60 are selected in experiment, and 150 ± 10g of body weight, male and female half and half, random pair is divided into blank pair Connecting oral liquid heavy dose group according to group (daily gavage is to distilled water), root of kudzu vine Siberian cocklebur, (daily gavage connects oral liquid 40g/kg to root of kudzu vine Siberian cocklebur 120 times that dose is often used equivalent to Lin)；Root of kudzu vine Siberian cocklebur connects oral liquid small dose group, and (daily gavage connects oral liquid 9g/kg to root of kudzu vine Siberian cocklebur Equivalent to 27 times of clinical application amount)；Successive administration one month, during administration, survey body weight per week once, is adjusted by body weight and used Dose, and big white mouse activity, diet are observed daily and situations such as stool and urine, and record toxic reaction and dead animal number.Last After administration, fasting 12 hours, after the first thought-read electrograph of each group big white mouse, then take a blood sample and survey blood routine, hepatic and renal function, and dissect naked eyes Observe organ change, organ coefficient and main organs pathological examination.
(2) experimental result：
Above-mentioned big white mouse, activity, stool and urine and diet are normal during administration, body weight natural increase, have no obvious poison Property reaction, normal ECG, dissection internal organ also no abnormality seen, blood routine, hepatic and renal function in normal range (NR), the results detailed in Table 9, 10、11、12、13、14。
The root of kudzu vine Siberian cocklebur of table 9 connects influence of the oral liquid to big white mouse body weight
The root of kudzu vine Siberian cocklebur of table 10 connects influence of the oral liquid to blood picture
Group Number of animals (only) Dosage Hb(g/L) RBC×1012/L RBC×109/L
Blank control group 20 Distilled water 148.1±4.58 5.375±0.589 181.45±23.79
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 40g/kg 147±8.23 5.11±0.506 176±26.21
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 9g/kg 150±4.87 5.65±0.556 186.9±21.01
The root of kudzu vine Siberian cocklebur of table 11 connects influence of the oral liquid to blood picture
Group Number of animals (only) Dosage WBC(109/1) L (%) N (%)
Blank control group 20 Distilled water 6.31±3.22 39.6±3.72 60.4±.78
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 40g/kg 6.38±2.81 41.7±3.51 58.3±3.53
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 9g/kg 6.9±2.31 39.6±3.5 60.4±3.33
The root of kudzu vine Siberian cocklebur of table 12 connects influence of the oral liquid to Rat Liver function
Group Number of animals (only) Dosage TP(g/l) ALB(g/l) SGPT(μ) A/G
Blank control group 20 Distilled water 62.63±2.5 31.81±3.19 28.75±5.81 1.1：1
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 40g/kg 61.67±2.39 31.56±2.13 28.22±4.29 1.05：1
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 9g/kg 61.11±3.18 31.44±2.51 28.89±8.13 1.08：1
The root of kudzu vine Siberian cocklebur of table 13 connects influence of the oral liquid to renal function
Group Mouse number (only) Dosage BUN(mmol/L) Cr(μmol/L)
Blank control group 20 Distilled water 4.3±0.416 74.09±6
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 40g/kg 4.1±0.57 70.44±11.56
Root of kudzu vine Siberian cocklebur connects oral liquid group 20 9g/kg 4.52±0.447 75.44±7.28
The root of kudzu vine Siberian cocklebur of table 14 connects influence of the oral liquid to big white mouse organ coefficient
(3) summarize
Root of kudzu vine Siberian cocklebur connects oral liquid continuously to big white mouse gavage one month, dirty from blood routine, hepatic and renal function, electrocardiogram and whole body The results such as device pathological examination see do not occur toxic reaction.So security is big when root of kudzu vine Siberian cocklebur connects oral liquid Clinical practice.
Embodiment 7：Gegen Qinlian oral fluid treats dysentery clinical verification
(1) study subject
Selection institute of traditional Chinese medicine of Anhui Province is in hospital and outpatient 63, meets《Pharmacopeia》Regulation Gegen Qinlian Tablets cure mainly model To enclose, the dysentery of differential diagnosis in tcm category Gegen Qinlian card, doctor trained in Western medicine is diagnosed as bacillary dysentery person, and without severe malnutrition, severe Dehydration, without other general diseases, while except with the diseases such as de-, coma, bleeding, twitch of fainting dysentery, during observation not With in any antibiotic or other Chinese medicines, 63, male 33, women 30.The oldest person 63 years old, reckling 18 years old, put down At equal 36.06 ± 11.68 years old age, the course of disease is most short 1 day, most long 20 days.63 patients, it is divided into two groups, control group 32, takes Pueraria lobota Root a kind of reed mentioned in ancient books in flakes, validation group 31, takes Gegen Qinlian oral fluid, each group no difference of science of statistics (P in terms of sex, age, the course of disease ＞ 0.05).
(2) dialectical standard
1. dysentery diagnostic criteria
1. suffering from abdominal pain, being tenesmus, times of defecation, which increases, often has purulence blood is viscous to freeze；
2. being mainly in summer and autumn, having unhygienic diet history, acute attack can generate heat with malice；
3. positive rate of bacteria more than 80%.
2. the dialectical standard of Gegen Qinlian
1. defecating more than 3 times a day, increase (300 gram/day) with excrement amount and character changes (loose stools or watery stool, mucus Just, pus and blood stool)；
2. body is warm, slight chill, or headache, body Chu；
3. excrement it is smelly it is dirty, tripe door is scorching hot, diarrhea is urgent, or rushes down and not well；
4. dysphoria with smothery sensation, thirsty, scanty drak urine；
5. tongue is red, yellow tongue fur, rapid pulse；
6. or and borborygmus, stomachache it is or tenesmus.
All possess 1,2 and 3, wantonly 1 or more than 1 person in 4,5, can be used as primary election identifying object, and the 6th is or simultaneous Project.
(3) treatment method
Validation group takes the Gegen Qinlian oral fluid of the embodiment of the present invention 1,1 every time (10ml/ branch), twice a day.Control Group takes Gegen Qinlian Tablets, and 5 tablets once, twice a day, purchased from Honghe state, Yunnan Province pharmaceutical factory.
(4) observation index
1. the effect of observation of curative effect, treatment group, control group, compares.
2. each primary symptom onset time, recover the observation of normal time.
3. stool culture positive rate and negative conversion rate, the observation of bacterial species, White blood cell.
(5) result
1st, efficacy result
The observation of curative effect of table 15
As can be seen from Table 15, checking curative effect is higher than control group, is statistically analyzed, and total effective rate compares without significantly between group Sex differernce (p>0.05).
2nd, the observation of total white blood cells change
The observation (× 10 of the total white blood cells of table 16 change9/1)
Group n Before treatment After treatment
Control group 32 9.55±4.07 6.76±2.66#
Validation group 31 9.85±3.18 6.03±1.93#
(#P<0.01)
As can be seen from Table 16, control group and validation group can significantly reduce total white blood cells (#P<0.01), but between group compare Compared with there was no significant difference (#P>0.05)。
3rd, the observation of positive rate of bacteria and negative conversion rate
The observation of the positive rate of bacteria of table 17 and negative conversion rate
As can be seen from Table 17, the positive rate of bacteria of control group is slightly above validation group.After treatment, Bacteria Culture is turned out cloudy Rate validation group is higher than control group.From control group with from the point of view of validation group bacteria cultivation results, mattress name be mostly Shigella shigae and Shigella flexneri (accounts for 88.2%).
4th, each primary symptom onset time (h), the observation of recovery normal time (h) see the table below.
18 each primary symptom onset time (h) of table, the observation for recovering normal time (h)
(note：△P>0.05,#P>0.05)
Found out by table 18, validation group each primary symptom onset time and recovery normal time are smaller than control group.Times of defecation Onset time, recover that statistically there was no significant difference normal time (△P ＞ 0.05,#P ＞ 0.05).
(6) summarize
1st, validation group and control group have the effect of identical and attending scope, and efficacy result is shown, Gegen Qinlian oral fluid Curative effect is higher than Gegen Qinlian Tablets, but no difference of science of statistics (P ＞ 0.05).
2nd, validation group to improving, recovering clinical symptoms, the time of sign be smaller than control group, prompt validation group treating Imitate the time and recover rapid compared with control group on normal time.
3rd, the Bacteria Culture negative conversion rate of validation group is higher than control group, may easily be absorbed with novel form, and bioavilability improves It is relevant.
Generally speaking, the result shows, Gegen Qinlian oral fluid of the present invention has convenient to take, absorbs complete, works The advantages of fast.
Embodiment 8：Gegen Qinlian oral fluid treats diarrhea clinical verification
(1) study subject
Selection institute of traditional Chinese medicine of Anhui Province is in hospital and outpatient 80, meets《Pharmacopeia》Regulation Gegen Qinlian Tablets cure mainly model Enclose, Chinese medical discrimination belongs to damp and hot and hinders trencherman.Wherein man 8；Female 32；Age is minimum 18 years old, maximum 35 years old, average age 42.38 ± 13.28 years old.Disease includes chordapsus, chronic enteritis, chronic enteritis acute attack person.It is the course of disease most long January, most short 6 hours.Two groups are randomly divided into, control group 40, takes Gegen Qinlian Tablets；Validation group 40, take Gegen Qinlian mouth of the present invention Take liquid, two groups of no difference of science of statistics (P in terms of sex, age, disease, the course of disease>0.05).
(2) treatment method
1st, validation group：Take the Gegen Qinlian oral fluid of the embodiment of the present invention 1, each 10ml (containing crude drug 10g), daily two It is secondary；
2nd, control group：Gegen Qinlian Tablets (being purchased from Honghe Prefecture pharmaceutical factory) are taken, 5 tablets once (containing crude drug 10g), daily 2 times.
(3) observation index
1st, observe the symptoms and the pretherapy and post-treatment clinical change of sign, observation of curative effect and curative effect judge referring to《Clinical verification side Case》.
2nd, each cardinal symptom, sign, laboratory checking index recover the observation of normal time.
3rd, medicine has no toxic side effect during observation treatment.
(4) result
1st, efficacy result, 19 are shown in Table.
19 two groups of efficacy analysis of table
Validation group and control group therapeutic effect, are statistically analyzed, two medicine total effective rate no significant differences, Gegen Qinlian mouth It is consistent with Gegen Qinlian Tablets to take liquid curative effect, reaches《Pharmacopeia》Standard.
2nd, symptom, sign and laboratory examination recover normal time after treating：
20 two groups of recovery normal times (h) of table
Validation group Control group
Heating 74.70±49.89 84.0±46.98
Stomachache 101.09±43.17 103.71±47.13
It is tenesmus 75.43±40.23 82.29±53.41
Abdominal tenderness 98.40±45.17 103.30±41.82
Cardinal symptom and sign recover normal time, and validation group is slightly before control group.
(5) summarize
Gegen Qinlian oral fluid novel form has a good effect, works early, and mouthfeel is fair, it is convenient to take the advantages that, have preferably Clinical value, it is proposed that popularization and application.
While above example 4-8 experiments are carried out using embodiment 1, the scheme of embodiment 2,3 is also carried out simultaneously Parallel test, as a result approximate with the scheme works of embodiment 1, no longer burden description here.
The present embodiments relate to material, reagent and equipment, be to meet oral preparation of Chinese traditional medicinal unless otherwise instructed The commercially available prod of technical field.
It is described above, only the preferred embodiments of the present invention, it is noted that for those skilled in the art For, on the premise of the core technology of the present invention is not departed from, improvements and modifications can also be made, these improvements and modifications also should Belong to the scope of patent protection of the present invention.Any change in the implication and scope suitable with claims of the present invention, all It is considered as being included within the scope of the claims.

Claims (2)

  1. A kind of 1. application of Gegen Qinlian Chinese medicine compound prescription in oral liquid formulation is prepared, it is characterised in that：By following parts by weight Each bulk drug be prepared：Root of kudzu vine 40-60 parts, radix scutellariae 15-25 parts, coptis 15-25 parts, honey-fried licorice root 10-20 parts；
    The preparation method of the Gegen Qinlian oral fluid comprises the following steps,
    (1) weigh the bulk drug of formulation by weight, add water to cook it is secondary, 1 hour every time, for the first time plus 6-10 times of water, second plus 5-8 times of water, collecting decoction, filtering；
    (2) it is 1.10-1.25g/cm to take filtrate to be concentrated into relative density3, room temperature is cooled to, adds ethanol alcohol content is reached 30- 55%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, stand 24 hours；
    (3) supernatant is taken, adds ethanol to alcohol content to reach 60-85%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, it is small to stand 24 When；
    (4) take supernatant, reclaim ethanol, add amount of preparation 0.03-0.06% stevioside, 0.03-0.06% sodium benzoate, 0.03-0.06% ethylparabens, 0.1-0.2%EDTA-2Na and 3-6% honey, add water weight to the 0.5- of bulk drug weight 1.5 times, boil, cool down, add salt acid for adjusting pH to stand 24-48 hours to 2.0-5.0；
    (5) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, hydrogenation sodium oxide molybdena regulation pH To 5.5-7.0, boil, stand 24-48 hours；
    (6) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, adjusts pH to 5.5-7.0, Boil, add amount of preparation 0.05-0.15% sodium pyrosulfites, mix, filling, sterilizing, you can.
  2. 2. application of the Gegen Qinlian Chinese medicine compound prescription in oral liquid formulation is prepared described in claim 1, it is characterised in that：The root of kudzu vine The preparation method that a kind of reed mentioned in ancient books connects oral liquid formulation comprises the following steps,
    (1) weigh the bulk drug of formulation by weight, add water to cook it is secondary, 1 hour every time, for the first time plus 6-10 times of water, second plus 5-8 times of water, collecting decoction, filtering；
    (2) it is 1.10-1.25g/cm to take filtrate to be concentrated into relative density3, room temperature is cooled to, adds ethanol alcohol content is reached 30- 55%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, stand 24 hours；
    (3) supernatant is taken, adds ethanol to alcohol content to reach 60-85%, hydrogenation sodium oxide molybdena regulation pH to 7.5-9.0, it is small to stand 24 When；
    (4) take supernatant, reclaim ethanol, add amount of preparation 0.03-0.06% stevioside, 0.03-0.06% sodium benzoate, 0.03-0.06% ethylparabens, 0.1-0.2%EDTA-2Na and 3-6% honey, add water weight to the 0.5- of bulk drug weight 1.5 times, boil, cool down, add salt acid for adjusting pH to stand 24-48 hours to 2.0-5.0；
    (5) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, hydrogenation sodium oxide molybdena regulation pH To 5.5-7.0, boil, stand 24-48 hours；
    (6) supernatant is taken, is filtered, is taken filtrate, add water weight to 0.5-1.5 times of bulk drug weight, adjusts pH to 5.5-7.0, Boil, add amount of preparation 0.05-0.15% sodium pyrosulfites, mix, filling, sterilizing, you can.
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