CN1436554A - Bupleurum-skullcap dripping pills - Google Patents
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- CN1436554A CN1436554A CN 02110821 CN02110821A CN1436554A CN 1436554 A CN1436554 A CN 1436554A CN 02110821 CN02110821 CN 02110821 CN 02110821 A CN02110821 A CN 02110821A CN 1436554 A CN1436554 A CN 1436554A
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Abstract
The bupleurum-skullcap pills consists of bupleurum root extractive, obtained with bupleurum root and through decoction, concentration, alcohol precipitation, centrifugation and concentration of the supernatant; skullcap root extractive, obtained with skullcap root and through decoction, acidification, precipitation, basification, alcoholization, sucking filtering, precipitation, drying and crushing; and matrix polyglycol or sodium stearate. The present invention is one kind of Chinese medicine with fast effect, small dosage and carrying convenience.
Description
Technical field
The present invention relates to a kind of Traditional Chinese Medicine Dropping Pill for the treatment of flu, particularly a kind of bupleurum-skullcap dripping pills.
Background technology
Flu is a kind of disease common, the most occurred frequently, and light fever and cough then is heavy then high fever causes multiple pathological changes, and no matter men and women, old and young all can fall ill, throughout the year especially with the winter and spring pilosity.Therefore, the demand of coldrex is very huge.At present, the coldrex of Shi Yonging mostly contains chemical drugs clinically, and the different toxic and side effects of degree is all arranged.For example, the preparation that contains phenylpropanolamine (PPA) causes allergy easily because of it, arrhythmia, hypertension etc. and disabled; The preparation that contains chlorphenamine is out of favour because of tangible drowsiness side effect.The Chinese medicine curative effect is affirmed, non-evident effect ought to become the main force that treatment is caught a cold, but because present Chinese medicine preparation exists onset slow, dosage is big, takes shortcomings such as carrying inconvenience, causes the market share little.Therefore, utilize modern technologies that the Chinese medicinal formulae of determined curative effect is developed to the novel form that meets modern society's needs, very necessary.
" the bavin pornographic movie " that Radix Bupleuri and scutellaria dispensing are made, it is existing historical for many years to be used for the treatment of flu clinically, determined curative effect, non-evident effect.But adopted part crude drug fine powder tabletting in " bavin pornographic movie " preparation process, and sugar coating, cause taking dose big, onset is slow.No active constituent content measuring method and index in the quality standard of said preparation cause product quality uncontrollable.
Summary of the invention
The objective of the invention is to overcome the shortcoming that prior art exists, a kind of Radix Bupleuri of flu and novel form---bupleurum-skullcap dripping pills that scutellaria dispensing is made of being used for the treatment of is provided.
Purpose of the present invention is achieved through the following technical solutions:
Prescription: Radix Bupleuri (Radix Bupleuri) is 1 with the ratio of Radix Scutellariae: 1-1: 3 or 1: 1-3: 1 (preferred proportion is 1: 1); The extract of Radix Bupleuri and Radix Scutellariae and the ratio of substrate are 1: 0.5～1: 3 (preferred proportion is 1: 1).
Technology (routine techniques): get Radix Bupleuri (Radix Bupleuri), decocting concentrates, precipitate with ethanol, and centrifugal, supernatant concentration becomes extractum.Get Radix Scutellariae, decocting, acidify, the precipitation alkalization adds alcohol, acidify, sucking filtration, the precipitation drying is pulverized.Get substrate (Polyethylene Glycol or sodium stearate), hot melt adds Radix Scutellariae extract and Radix Bupleuri extractum, and mixing drips and makes drop pill.
By above-mentioned technology, comprise the saikoside composition in the Radix Bupleuri extractum, comprise the baicalin composition in the Radix Scutellariae extract.
Novel form provided by the invention---bupleurum-skullcap dripping pills, its advantage is rapid-action, takes easy to carryly, can carry out the qualitative, quantitative quality control.
The specific embodiment
Embodiment 1
Get Radix Bupleuri 300g and decoct with water secondary, the decocting liquid concentrating under reduced pressure, adding ethanol is 60% to containing the alcohol amount, leaves standstill, centrifugal, the supernatant concentrating under reduced pressure becomes extractum.
Get Radix Scutellariae 300g and decoct with water secondary, decocting liquid is transferred pH to 1.0～2.0 with hydrochloric acid, separates out precipitation, gets precipitation and adds an amount of hot water suspendible, transfer pH to 6.0～7.0 with 20% sodium hydroxide, add equivalent ethanol, filter, filtrate adds hydrochloric acid and transfers pH to 1.0～2.0, sucking filtration, precipitation water and ethanol are washed, and 60 ℃ of dryings are pulverized.
Press medicine (two kinds of extracts) weight and 1: 1 taking polyethylene glycol of substrate, hot melt adds Radix Scutellariae extract and Radix Bupleuri extractum, and mixing drips and makes 1000 drop pill.
Embodiment 2
Get Radix Bupleuri 100g and decoct with water secondary, the decocting liquid concentrating under reduced pressure, adding ethanol is 60% to containing the alcohol amount, leaves standstill, centrifugal, the supernatant concentrating under reduced pressure becomes extractum.
Get Radix Scutellariae 300g and decoct with water secondary, decocting liquid is transferred pH to 1.0～2.0 with hydrochloric acid, separates out precipitation, gets precipitation and adds an amount of hot water suspendible, transfer pH to 6.0～7.0 with 20% sodium hydroxide, add equivalent ethanol, filter, filtrate adds hydrochloric acid and transfers pH to 1.0～2.0, sucking filtration, precipitation water and ethanol are washed, and 60 ℃ of dryings are pulverized.
Press medicine (two kinds of extracts) weight and 1: 2 taking polyethylene glycol of substrate, hot melt adds Radix Scutellariae extract and Radix Bupleuri extractum, and mixing drips and makes 600 drop pill.
Embodiment 3
Get Radix Bupleuri 300g and decoct with water secondary, the decocting liquid concentrating under reduced pressure, adding ethanol is 60% to containing the alcohol amount, leaves standstill, centrifugal, the supernatant concentrating under reduced pressure becomes extractum.
Get Radix Scutellariae 100g and decoct with water secondary, decocting liquid is transferred pH to 1.0～2.0 with hydrochloric acid, separates out precipitation, gets precipitation and adds an amount of hot water suspendible, transfer pH to 6.0～7.0 with 20% sodium hydroxide, add equivalent ethanol, filter, filtrate adds hydrochloric acid and transfers pH to 1.0～2.0, sucking filtration, precipitation water and ethanol are washed, and 60 ℃ of dryings are pulverized.
Get sodium stearate at 1: 3 by medicine (two kinds of extracts) weight and substrate, hot melt adds Radix Scutellariae extract and Radix Bupleuri extractum, and mixing drips and makes 600 drop pill.
Embodiment 4
Get Radix Bupleuri 300g and decoct with water secondary, the decocting liquid concentrating under reduced pressure, adding ethanol is 60% to containing the alcohol amount, leaves standstill, centrifugal, the supernatant concentrating under reduced pressure becomes extractum.
Get Radix Scutellariae 300g and decoct with water secondary, decocting liquid is transferred pH to 1.0～2.0 with hydrochloric acid, separates out precipitation, gets precipitation and adds an amount of hot water suspendible, transfer pH to 6.0～7.0 with 20% sodium hydroxide, add equivalent ethanol, filter, filtrate adds hydrochloric acid and transfers pH to 1.0～2.0, sucking filtration, precipitation water and ethanol are washed, and 60 ℃ of dryings are pulverized.
Press medicine (two kinds of extracts) weight and 1: 0.5 taking polyethylene glycol of substrate, hot melt adds Radix Scutellariae extract and Radix Bupleuri extractum, and mixing drips and makes 800 drop pill.
The thin layer chromatography of saikoside is differentiated in embodiment 5 bupleurum-skullcap dripping pills
The preparation of reference substance solution: get saikoside a and saikoside d reference substance, add methanol and make the mixed solution that every ml comprises 0.5mg, promptly.
The preparation of need testing solution: get 10 of this product, add water 30ml ultrasonic dissolution, filter, filtrate is extracted 3 times with water-saturated n-butanol, each 30ml.Merge the alcohol layer, with the NaOH solution washing of 0.1mol/L 3 times, each 60ml merges the alcohol layer, and evaporated under reduced pressure adds the 10ml dissolve with methanol.
Draw above-mentioned two kinds of each 5ul of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with ethyl acetate-alcohol-water (8: 2: 1), launches, take out, dry, spray is with 40% sulfuric acid solution of 2% paradime thylaminobenzaldehyde, and 60 ℃ to be heated to the speckle colour developing clear, put respectively under daylight and the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle or the yellow fluorescence speckle of same color.
Content of baicalin is measured in embodiment 6 bupleurum-skullcap dripping pills
The preparation of reference substance solution: precision takes by weighing at 4 hours baicalin reference substance of 60 ℃ of drying under reduced pressure an amount of, adds methanol and makes the solution that every 1ml contains 0.06mg, promptly.
The preparation of need testing solution: get 20 of this product, the accurate title, decided weight, gets wherein 5, the accurate title, decide, put in the 100ml round-bottomed flask, add 70% ethanol 50ml, reflux 3 hours, filter, filtrate is put in the 100ml measuring bottle, and with a small amount of 70% ethanol gradation washing container, washing liquid is incorporated in the same measuring bottle, add 70% ethanol to scale, shake up.The accurate 5ml that draws puts in the 50ml measuring bottle, adds methanol and is diluted to scale, shakes up, and filters with the 0.20um microporous filter membrane, promptly.
Accurate reference substance solution 5ul and the need testing solution 10ul of drawing injects chromatograph of liquid, measures, and every of this product contains Radix Scutellariae with baicalin (C
21H
18O
11) meter, must not be less than 4.0mg.
The test of embodiment 7 bupleurum-skullcap dripping pills extracorporeal antivirus effects
Get the culture plate that grows up to cell monolayer, outwell culture fluid, inoculate 100 TCID
50Different virus liquid 50 μ l in cell hole, cell plates of each virus inoculation, stay delegation not virus inoculation do normal cell contrast.Put 37 ℃ of 5%CO
2Absorption is 1 hour in the incubator, outwells viral liquid, after keeping liquid and wash cell face 3 times with the Eagl é s that does not contain calf serum, adds each medicinal liquid (comprising the contrast medicine) 100 μ l/ holes of 6 concentration of doubling dilution.Establish virus control, normal cell contrast simultaneously, fluid infusion is to 200 μ l/ holes.Put 37 ℃ of 5%CO
2Cultivated 3-4 days in the incubator, mouthful every day is microscopy CPE progress under inverted microscope.
Table 1 bupleurum-skullcap dripping pills extracorporeal antivirus effect exercising result
| Virus | Bupleurum-skullcap dripping pills EC 50?????????TI ??(mg/ml)???(TC50＝1.77mg/ml) | Virazole (0.179mg/ml) |
| ????RSV | ????0.27?????????6.6 | ????+ |
| ????HVJ | ????0.37?????????4.8 | ????+ |
| ????ADV 3 | ????0.37?????????4.8 | ????+ |
| ????ADV 7 | ????0.37?????????4.8 | ????+ |
Annotate: EC in the table
50Be 50% valid density, TI is therapeutic index=TC
50/ EC
50"-" unrestraint effect, "+" has inhibitory action.
The result shows that bupleurum-skullcap dripping pills is to respiratory syncytial virus (RSV), parainfluenza virus (HVJ), adenovirus type III (ADV
3), adenovirus type VII (ADV
7) the obvious suppression effect all arranged.
Embodiment 8 bupleurum-skullcap dripping pills are to the protective effect of bacterial infection dead mouse
Get the 18-20g mice, be divided into 5 groups at random, irritate stomach respectively and give bupleurum-skullcap dripping pills high, medium and low three dosage groups, the positive control drug penicillin by body weight.Test group begins administration the previous day in bacterial infection, every day 2 times, infect the same day, staphylococcus aureus 2-18 strain is increased bacterium be diluted to 0.6 hundred million/ml with normal saline after 24 hours, animal dead number in 48 hours is observed and added up to the bacteria suspension of lumbar injection 0.5ml/20g mice, calculates survival rate, carry out statistical procedures, relatively between administration group and the matched group there was no significant difference is arranged.
Table 2 bupleurum-skullcap dripping pills is to the dead protective effect result of bacterial infection mice
The dosage Mus is counted the death toll protective rate
Group
The P value
(g/kg) (only) (only) (%)
Contrast-20 18 10
Penicillin 0.005 20 2 90＜0.01
Bupleurum-skullcap dripping pills 8.0 20 10 50＜0.05
4.0???????20??????12??????40????＞0.05
2.0???????20??????16??????20????＞0.05
The result shows that bupleurum-skullcap dripping pills 8.0g crude drug/kg can make the golden Portugal of infection bacterium mortality of mice obviously reduce, and survival rate obviously improves, and compares with infecting matched group, and significant difference is arranged.
The refrigeration function test of embodiment 9 bupleurum-skullcap dripping pills
Get healthy rabbits, in testing the normal rectal temperature of before measurement 2 times.Select the animal of body temperature about 39.0 ℃ to be for experiment.4 group is established in test altogether, 8 every group (the test branch carries out for 2 times).Matched group is irritated the distilled water of stomach with volume, three dosage groups of bupleurum-skullcap dripping pills high, medium and low (2.0,1.0,0.5g/kg).Morning on the same day was surveyed the animal basal body temperature earlier in test, after injecting to tame rabbit ear vein with typhoid fever, paratyphoid fever, the second triple vaccine of 0.5ml/kg, irritated stomach medicinal liquid or water respectively by group.Per hour respectively survey the anus temperature once behind the medicine, totally 4 times, surveyed anus temperature and basic anus using warming therapy difference with different time, be the index of body temperature variation.
Table 3 bupleurum-skullcap dripping pills is to the refrigeration function result of vaccine pyrogenicity rabbit
Different time body temperature changing value behind the dosage medicine (℃, X ± SD) group
G/kg 1h 2h 3h 4h 5h matched group--1.28 ± 0.14 1.43 ± 0.17 1.23 ± 0.26 1.05 ± 0.18 0.72 ± 0.26
2.0 0.95 ± 0.30
*0.86 ± 0.32
*0.730.28
*0.69 ± 0.30
*0.39 ± 0.23
*The bavin Huang
1.0 1.06 ± 0.21
*0.93 ± 0.34
*0.84 ± 0.42
*0.76 ± 0.38 0.49 ± 0.30 drop pill
0.5???1.09±0.23???1.11±0.30
**?1.00±0.30????0.88±0.28???0.57±0.29
Annotate: number of animals is 8; Compare with matched group
*P＜0.05
*P＜0.01
The result shows that bupleurum-skullcap dripping pills causes that to vaccine the fervescence of rabbit has the obvious suppression effect.
The antiinflammatory action of embodiment 10 bupleurum-skullcap dripping pills
Get the 18-20g mice, be divided into 4 groups at random, irritate stomach and give bupleurum-skullcap dripping pills high, medium and low three dosage groups by body weight.Mice is pressed the body weight random packet, gastric infusion, and the normal control group gives the distilled water of equal volume.Behind the medicine after one hour, the blue liquid 0.2ml/20g of tail vein injection 0.5% ivens, pneumoretroperitoneum was injected 1.0% acetic acid 0.2ml/20g in 10 minutes, 10 minutes pneumoretroperitoneum injection 5ml normal saline solutions, put to death mice, gently rub abdominal part 50 times, cut off skin, draw peritoneal fluid with suction pipe, photometry density under wavelength 590nm.
Table 4 bupleurum-skullcap dripping pills antiinflammatory action result
Dosage number of animals optical density suppression ratio
Group
(g/kg) (only) (X ± SD) (%)
Matched group--10 0.48 ± 0.15
8.0??????10?????0.30±0.06
**?????36.26
Bupleurum-skullcap dripping pills 4.0 10 0.30 ± 0.07
*37.15
2.0??????10?????0.34±0.13
*??????28.00
Annotate: compare with matched group
*P＜0.05
*P＜0.01
The result shows that with the bupleurum-skullcap dripping pills single administration, each dosage group all can obviously suppress increasing of mouse peritoneal capillary permeability.
The comparison of comparing embodiment bupleurum-skullcap dripping pills and bavin pornographic movie disintegration time
Get 6 of test samples, place lift disintegration tester hanging basket, immerse in the 1000ml beaker, and when regulating the hanging basket position it being descended apart from beaker bottom 25mm, fill temperature in the beaker and be 37 ℃ ± 1 ℃ water, screen cloth is at underwater 25mm when regulating height of water level hanging basket being risen.The metal rack of lifting moves up and down distance and is 55mm, and round frequency is per minute 30～32 times.
The result: bavin pornographic movie disintegration time is 58 minutes; Bupleurum-skullcap dripping pills disintegrate (molten loosing) time is 6 minutes.Fast nearly 10 times of bupleurum-skullcap dripping pills than bavin pornographic movie.
Claims (4)
1. bupleurum-skullcap dripping pills, its prescription is Radix Bupleuri, Radix Scutellariae and substrate, wherein the proportioning of Radix Bupleuri and Radix Scutellariae is 1: 1-1: 3 or 1: 1-3: 1, the extract of Radix Bupleuri and Radix Scutellariae and the proportioning of substrate are 1: 0.5-1: 3, this substrate is Polyethylene Glycol or sodium stearate, Radix Bupleuri extract be by Radix Bupleuri through decocting, concentrate, precipitate with ethanol, centrifugal, get supernatant concentration and form; Radix Scutellariae extract be by Radix Scutellariae through decocting, acidify, precipitation alkalization, add alcohol, acidify, sucking filtration, precipitation and pulverize after drying and form.
2. bupleurum-skullcap dripping pills according to claim 1, the preferred proportion that it is characterized in that this Radix Bupleuri and Radix Scutellariae is 1: 1.
3. bupleurum-skullcap dripping pills according to claim 1 is characterized in that the extract of this Radix Bupleuri and Radix Scutellariae and the preferred proportion of substrate are 1: 1.
4. bupleurum-skullcap dripping pills according to claim 1 is characterized in that containing in this Radix Bupleuri extract saponin constituent recklessly, contains the baicalin composition in this Radix Scutellariae extract.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110821 CN1436554A (en) | 2002-02-08 | 2002-02-08 | Bupleurum-skullcap dripping pills |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110821 CN1436554A (en) | 2002-02-08 | 2002-02-08 | Bupleurum-skullcap dripping pills |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100430045C (en) * | 2004-06-30 | 2008-11-05 | 天津天士力制药股份有限公司 | Radix bupleuri dripping pill and its preparing method |
| CN1872161B (en) * | 2005-06-01 | 2010-12-15 | 天津天士力制药股份有限公司 | Drop pills of Chaihuang, and preparation method |
| CN104127491A (en) * | 2014-07-29 | 2014-11-05 | 成都乾坤动物药业有限公司 | Pharmaceutical composition with fever relieving effect and preparation method and application thereof |
| CN109568387A (en) * | 2017-09-29 | 2019-04-05 | 复旦大学 | A kind of Chinese medicine composition for antipyretic and anti-inflammatory |
-
2002
- 2002-02-08 CN CN 02110821 patent/CN1436554A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100430045C (en) * | 2004-06-30 | 2008-11-05 | 天津天士力制药股份有限公司 | Radix bupleuri dripping pill and its preparing method |
| CN1872161B (en) * | 2005-06-01 | 2010-12-15 | 天津天士力制药股份有限公司 | Drop pills of Chaihuang, and preparation method |
| CN104127491A (en) * | 2014-07-29 | 2014-11-05 | 成都乾坤动物药业有限公司 | Pharmaceutical composition with fever relieving effect and preparation method and application thereof |
| CN109568387A (en) * | 2017-09-29 | 2019-04-05 | 复旦大学 | A kind of Chinese medicine composition for antipyretic and anti-inflammatory |
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Owner name: SHANGHAI PHARMACEUTICAL( GROUP ) CO., LTD. Free format text: FORMER OWNER: SHANGHAI HUATUO MEDICINE SCI-TECH DEVELOPMENT CO., LTD. Effective date: 20050812 |
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Effective date of registration: 20050812 Address after: 200020 No. 200, Taicang Road, Shanghai Applicant after: Shanghai Pharmaceutical (Group) Co., Ltd. Address before: 200093 No. 90, Shulan Road, Shanghai, Yangpu District Applicant before: Shanghai Huatuo Medicine Sci-Tech Development Co., Ltd. |
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