CN101099765B - Preparation method of Chaihuang preparation - Google Patents
Preparation method of Chaihuang preparation Download PDFInfo
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- CN101099765B CN101099765B CN2006100213111A CN200610021311A CN101099765B CN 101099765 B CN101099765 B CN 101099765B CN 2006100213111 A CN2006100213111 A CN 2006100213111A CN 200610021311 A CN200610021311 A CN 200610021311A CN 101099765 B CN101099765 B CN 101099765B
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Abstract
The present invention discloses a Chinese medicine Chaihuang preparation. It is made up by using (by weight portion) 100-150 portions of bupleurum root, 6-12 portions of scutellaria root and proper quantity of auxiliary material through a certain preparation process. Besides, said invention also provides a quality control method of said Chailhuang preparation.
Description
Technical field
The present invention relates to a kind of Chaihuang preparation and method of quality control thereof.
Background technology
The yellow electuary of bavin (granule) is the treatment flu of approval listing at the beginning of the nineties, the Chinese patent medicine of fever, also has bavin pornographic movie, bavin yellow capsule, Chaihuang soft capsule, the yellow oral liquid of bavin etc. to change listing of agent kind or declaration in addition.
Present Chaihuang preparation is by crude drug Radix Bupleuri: (" Ministry of Public Health drug standard Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation " the 10th " yellow electuary of bavin " method of record) down that Radix Scutellariae extract (in baicalin) makes through following method with 125: 9 weight portion proportioning: get the Radix Bupleuri decocte with water 2 times; Each 2 hours, collecting decoction filtered; Filtrating is concentrated into the 1ml medicinal liquid and contains the about 5g of primary crude drug; Adding ethanol under stirring is 60% to containing the alcohol amount, leaves standstill more than 12 hours, filters; Filtrate recycling ethanol also is condensed into the Radix Bupleuri clear paste that relative density is about 1.30-1.33, and is subsequent use; Get Radix Scutellariae extract and be dissolved in water, the Radix Scutellariae clear paste, with above-mentioned Radix Bupleuri clear paste mixing, add right amount of auxiliary materials, process the medicine of required dosage form by the medicament method for preparing of routine, promptly get.
Wherein, the method for distilling of Radix Bupleuri is conventional decoction and alcohol sedimentation technique; Radix Scutellariae extract can extract from radix scutellariae medicinal materials through following method and make (" Radix Scutellariae extract " or " Ministry of Public Health drug standard Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation " the 10th " the yellow electuary of bavin " method of putting down in writing down of national drug standards Pharmacopoeia of the People's Republic of China version in 2005): get radix scutellariae medicinal materials, and decocte with water, collecting decoction filters; Filtrating adds hydrochloric acid and transfers pH value to 1-2, and 80 ℃ of insulations are left standstill, and filter; Taking precipitate adds suitable quantity of water and stirs, and transfers pH value to 7 with 40%NaOH solution, adds equivalent ethanol, fully stirs; Filter, filtrating adds hydrochloric acid actuator pH value to 1-2, and 60 ℃ or 80 ℃ of insulations are left standstill; Filter, the collecting precipitation thing is washed till pH value to 7 with suitable quantity of water and Different concentrations of alcohol successively; Wave most ethanol, cold drying promptly gets.Main component in the Radix Scutellariae extract is a baicalin, because the dissolubility of baicalin in water is smaller, and is insoluble in mineral acid; So it is also poor to contain the water solublity of Chaihuang preparation of Radix Scutellariae extract, especially granule will reconstitute with boiled water earlier before taking; Because its water solublity is relatively poor, usually make that there is one deck floating thing on the medicinal liquid surface that reconstitutes, neither attractive in appearance; Taste is also bitter, influences patient's compliance; And also be difficult for after taking absorbing, bioavailability is low.Though other dosage form such as tablet can change outward appearance, taste masking, improve patient's compliance, the problem that can not solve its poorly water-soluble, be difficult for absorption, bioavailability is low.
Also there is certain defective in present Chaihuang preparation aspect quality control; Except that qualitative identification; Present assay just adopts spectrophotography that content of baicalin in the preparation has been carried out limiting (" Ministry of Public Health drug standard Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation " the 10th " the yellow electuary of bavin " record down); Another component Radix Bupleuri in the preparation is not but set up corresponding content assaying method, so can not its quality of better controlled.
Summary of the invention
The purpose of this invention is to provide a kind of new Chaihuang preparation, the water solublity of this Chaihuang preparation is better, helps absorbing, and can improve bioavailability.
Another object of the present invention provides a kind of method of quality control of above-mentioned Chaihuang preparation; This method is set up a kind of feasible content assaying method to the contained main component saikoside of Radix Bupleuri in the Chaihuang preparation; Make the quality of Chaihuang preparation more controlled, help improving the quality and the curative effect of preparation.
The technical solution adopted for the present invention to solve the technical problems is: a kind of Chaihuang preparation, and it is made through the method that may further comprise the steps by the Radix Bupleuri of 100-150 weight portion and the Radix Scutellariae extract of 6-12 weight portion:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of said weight portion, the decoction and alcohol sedimentation technique extraction according to routine makes relative density and is the Radix Bupleuri clear paste of 1.10-1.35, and is subsequent use;
The decoction and alcohol sedimentation technique concrete steps are following: with Radix Bupleuri raw medicinal material decocte with water 2-3 time, and each 1-3 hour, collecting decoction; Filter, filtrating is concentrated into the 1ml medicinal liquid and contains the about 2-8g of primary crude drug, and stirring down, adding ethanol is 50-90% to containing the alcohol amount; Leave standstill more than 12 hours; Filter, filtrate recycling ethanol also is condensed into the Radix Bupleuri clear paste that relative density is 1.10-1.35, gets final product;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of said weight portion, add the water that 0.5-3 doubly measures, stir, it is an amount of to add sodium hydroxide solution or sodium bicarbonate solution that concentration is 5-40% again, transfers medicinal liquid PH to 5-8, the Radix Scutellariae clear paste;
(3) process preparation: with the Radix Bupleuri clear paste that makes of above-mentioned (1) step and the Radix Scutellariae clear paste mixing that (2) step makes, add appropriate amount of auxiliary materials, process the medicine of required dosage form, promptly get by the medicament method for preparing of routine.
The weight portion proportion optimization of Radix Bupleuri and Radix Scutellariae extract is 120-130: 8-10 in the above-mentioned Chaihuang preparation.
In above-mentioned (2) step preparation Radix Scutellariae clear paste process, the pH value of medicinal liquid is good to transfer to 5-7; The concentration of used sodium hydroxide solution or sodium bicarbonate solution is good with 10-20%.
The method of quality control of above-mentioned Chaihuang preparation; Except that " Ministry of Public Health drug standard Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation " the 10th " the yellow electuary of bavin " the qualitative identification and spectrophotometry content of baicalin put down in writing down, also can adopt following method to measure the wherein content of saikoside:
It is an amount of to get described Chaihuang preparation, and the back of accurately weighing adds the water that 1-5 doubly measures, and stirs and makes the formation suspension solution, to 5-8, filters water flushing deposition with adjusting ph values such as sour example hydrochloric acid, sulphuric acid; In deposition, add the water of 1-5 amount, stir, make the formation suspension; Regulate the ph value to 9-11 with solution such as alkali such as sodium hydroxide or sodium bicarbonate; Join in the macroporous resin column, it is colourless to be eluted to eluent with the alcoholic solution of 30-80%, with eluent concentrate, dry, weigh; Through simple computation, can obtain the weight of the contained saikoside of per unit Chaihuang preparation.
Wherein used macroporous adsorbent resin is optional to be that D101, DM130, HT-10, LSD-30, XDA-6 etc. are suitable for separating any one in the macroporous adsorbent resin of saponin from model.
Compared with prior art; The invention has the beneficial effects as follows: the present invention processes new Chaihuang preparation with improved method, before Radix Scutellariae extract mixes with Radix Bupleuri extract, adds sodium hydroxide solution or sodium bicarbonate solution, can significantly improve the water solublity of baicalin in the Radix Scutellariae extract; The new Chaihuang preparation water solublity of acquisition is obviously strengthened; In gastric juice, also be easy to dissolving, help absorbing, can improve bioavailability; And as far as granule, its water solublity increases; Also can make it in boiled water, be easy to dissolving when before taking, being in harmonious proportion, can not produce floating thing with boiled water, and can with the adjuvant mix homogeneously such as correctives in the granule; Not only increase its aesthetic appearance, and can improve taste, improve patient's compliance.In addition; The present invention has also set up a kind of new method of quality control to above-mentioned Chaihuang preparation; Promptly the contained main component saikoside of its component Radix Bupleuri is set up a kind of feasible content assaying method; Remedy the deficiency that only content of baicalin is limited in the prior art, made the quality of Chaihuang preparation more controlled, helped improving the quality and the curative effect of preparation.
The specific embodiment
Below in conjunction with the specific embodiment the present invention is made further detailed description.
Embodiment 1
The Chai huang granule of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 125 weight portions, add 10 times of amounts of water, 8 times of amounts respectively, decoct each 2 hours 2 times; Merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 5g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 70%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.30-1.35, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 9 weight portions, add the water of about 3 times of amounts, stir, it is an amount of to add concentration again and be 40% sodium hydroxide solution, transfers medicinal liquid PH to 5-5.5, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as an amount of sucrose, starch, process granule, promptly get by the process for producing granula of routine.
Embodiment 2
The bavin pornographic movie of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 125 weight portions, add 8 times of amounts of water, 6 times of amounts, 6 times of amounts respectively, decoct each 1 hour 3 times; Merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 2g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 50%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.10-1.15, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 9 weight portions, add the water of about 0.5 times of amount, stir, it is an amount of to add concentration again and be 5% sodium hydroxide solution, transfers medicinal liquid PH to 5.5-6, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as an amount of microcrystalline Cellulose, starch, process tablet, promptly get by the method for preparing tablet thereof of routine.
Embodiment 3
The bavin yellow capsule of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 130 weight portions, add 8 times of amounts of water, 6 times of amounts respectively, decoct each 1.5 hours 2 times; Merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 8g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 90%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.15-1.20, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 8 weight portions, add the water of about 2 times of amounts, stir, it is an amount of to add concentration again and be 10% sodium bicarbonate solution, transfers medicinal liquid PH to 6-6.5, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as appropriate amount of starch, process capsule, promptly get by the capsule preparation method thereof of routine.
Embodiment 4
The Chai huang granule of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 120 weight portions, add 10 times of amounts of water, 8 times of amounts respectively, decoct the 1st time 3 hours 2 times; The 2nd time 1 hour, merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 6g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 60%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.20-1.25, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 10 weight portions, add the water of about 1 times of amount, stir, it is an amount of to add concentration again and be 20% sodium bicarbonate solution, transfers medicinal liquid PH to 6.5-7, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as an amount of sucrose, dextrin, process granule, promptly get by the process for producing granula of routine.
Embodiment 5
The Chai huang granule of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 100 weight portions, add 10 times of amounts of water, 8 times of amounts respectively, decoct each 2 hours 2 times; Merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 3g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 80%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.25-1.30, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 12 weight portions, add the water of about 2 times of amounts, stir, it is an amount of to add concentration again and be 40% sodium bicarbonate solution, transfers medicinal liquid PH to 7-7.5, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as an amount of sucrose, starch, process granule, promptly get by the process for producing granula of routine.
Embodiment 6
The Chai huang granule of present embodiment for adopting following method to make:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of 125 weight portions, add 10 times of amounts of water, 8 times of amounts respectively, decoct each 2 hours 2 times; Merge decoction liquor, filter, filtrating is concentrated into the 1ml medicinal liquid contains the about 4g of primary crude drug; Add ethanol and make and contain the alcohol amount and reach approximately 75%, leave standstill more than 12 hours, filter; Be concentrated into relative density behind the filtrate recycling ethanol and be about 1.30-1.35, get the Radix Bupleuri clear paste, subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of 9 weight portions, add the water of about 2.5 times of amounts, stir, it is an amount of to add concentration again and be 20% sodium hydroxide solution, transfers medicinal liquid PH to 7.5-8, the Radix Scutellariae clear paste;
(3) process preparation: with above-mentioned (1) step Radix Bupleuri clear paste that makes and the Radix Scutellariae clear paste mixing that (2) step makes, add adjuvants such as an amount of lactose, corn starch, process granule, promptly get by the process for producing granula of routine.
With similar method, in each parameter area of the present invention, regulate different parameter values, add an amount of adjuvant commonly used be suitable for various dosage forms, the formulation method that adopts various pharmaceutical dosage form to use always can make the Chaihuang preparation of different dosage form, different size.
Embodiment 7
Present embodiment is a kind of method of quality control of the foregoing description 1 said Chai huang granule, except that carry out measuring the wherein content of saikoside according to following method qualitative identification and the content of baicalin mensuration according to the regulation in the existing national drug standards:
It is an amount of to get described Chai huang granule, and the back of accurately weighing adds the water of about 5 times of amounts, stirs and makes the formation suspension solution, regulates the ph value to about 5-6 with hydrochloric acid, filters, and precipitates with flushing with clean water; In deposition, add the water of about 5 amounts, stir, make the formation suspension solution; Regulate the ph value to about 9-10 with sodium hydroxide solution, join in the D101 macroporous resin column, it is colourless that the alcoholic solution with 80% is eluted to eluent; Collect eluent, reclaim concentrate behind the ethanol, dry, weigh, through calculating; Promptly get the weight of the contained saikoside of per unit Chai huang granule, be not less than 15mg/g.
With same method, in parameter area of the present invention, regulate different pH values, the macroporous adsorbent resin dress post with different model carries out eluting with Different concentrations of alcohol solution, all can record the content of saikoside in the Chaihuang preparation.
In order to confirm the beneficial effect of Chaihuang preparation of the present invention, the inventor has carried out following test and has investigated:
One, animal pharmacodynamics test
(1) extracorporeal bacteria inhibitor test
1. experiment material
1.1 strain: staphylococcus aureus CMCC (B) C, Sarcina lutea CMCC (B), escherichia coli CMCC (B), bacillus pyocyaneus CMCC (B) provide by Nat'l Pharmaceutical & Biological Products Control Institute.
1.2 medicine: Chai huang granule 1 (embodiment of the invention 1 described product), Chai huang granule 2 (according to the product of prior art production).
2. experimental technique and result
2.1 the preparation of culture medium: the broth medium of sterilization.
2.2 the preparation of experiment medicinal liquid: get two kinds of each 1g of Chai huang granule powder, add 10 milliliters in water respectively, the gained liquor strength is identical.
2.3 the mensuration of minimum inhibitory concentration (MIC): get 20 and sterilized and have the test tube of tampon, be divided into 1 group of Chai huang granule and 2 groups of Chai huang granules.Every pipe all adds 1 milliliter of common sterilization broth bouillon.With each 1 milliliter of above-mentioned two kinds of Chai huang granule medicinal liquid, add in the 1st pipe separately, mixing, sucking-off adds in the 2nd pipe for 1 milliliter ... So be diluted to the 9th pipe, take out 1 milliliter and discard.The 10th pipe is the blank pipe of drug not.Each adds 0.1 milliliter of the good experimental bacteria liquid of dilution in every pipe subsequently, and uniform mixing is cultivated 18-24h in 37 ℃ of calorstats.Observed result, and calculate the drug level in the bacterial growth test tube.Obtain the minimum inhibitory concentration (MIC) of medicine to experimental bacteria.The result sees table 1.
Two kinds of Chai huang granules of table 1 are to the inhibitory action of different strain
The result shows that the minimum inhibitory concentration of Chai huang granule 1 is lower than the Mlc of Chai huang granule 2, proves that under identical condition, the fungistatic effect of Chai huang granule 1 is better.
(2) antiinflammatory, antiallergic, antibacterial tests in the animal body
1. test articles for use
1.1 trial drug and reagent:
Chai huang granule A (embodiment of the invention 1 described product), Chai huang granule B (according to the product of prior art production).
Ovalbumin, pertussis vaccine, caseinhydrolysate agar (MHA), gentamycin paper granule (every granule contains gentamycin 10 μ g), Hb culture medium.Protein determination reagent: Coomassie brilliant blue G250,100mg are dissolved in 50 milliliter of 95% ethanol, add 100 milliliter of 85% (W/V) phosphoric acid, are diluted with water to 1000 milliliters, and be subsequent use.
1.2 animal and strain:
The Wistar rat, Balb/C mouse inbred lines, Kunming mouse, body weight 18-22g.Staphylococcus aureus CMCC (B), streptococcus pneumoniae CMCC (B), influenza blood bacillus CMCC (B), escherichia coli CMCC (B).
1.3 instrument: CMIA8.0 image analyzer.
2. test method and result
2.1 the abdominal cavity capillary permeability increases
60 of kunming mices, male and female half and half are divided into 6 groups at random; Be that blank group, model control group, Chai huang granule A1 group (dosage is 5 gram/kilograms), Chai huang granule A2 organize (dosage is 10 gram/kilograms), Chai huang granule B1 organizes (dosage is 5 gram/kilograms), Chai huang granule B2 (dosage is 10 gram/kilograms), after taking medicine 1 hour, inject 0.2 milliliter of 1% acetic acid/; Put to death animal after 20 minutes, with 2 ml physiological saline lavation abdominal cavities, sucking-off irrigating solution; Centrifugal, dilute 10 times, get 0.1 milliliter and add 5 milliliters of protein reagents; Fully vibration mixes, and adds 5 milliliters of protein reagent zeroings with 0.1 milliliter of distilled water after 2 minutes, in 595nm wavelength photometry density value; Obtain protein content from standard curve (through rectilinear regression, getting equation is Y=0.6135X+0.1025R2=0.9985).With protein content in the irrigating solution how much reflect inflammation the time mouse peritoneal capillary permeability variation.The result sees table 2.
Table 2 Dichlorodiphenyl Acetate causes the influence that the mouse peritoneal capillary permeability increases (x ± s)
The result shows, Chai huang granule A group and B group 5,10g/kg all can reduce protein concentration in the sepage of model mice abdominal cavity, shows that Chai huang granule has the effect of capillary permeability increase when reducing inflammation.But under the condition of same dose, Chai huang granule A group is higher than the suppression ratio of B group, compares P＜0.01 for two groups.
2.2 influence to the mouse ear skin hypersensitivity
4 of Mus great and mighty or powerful, 2 milliliters/kilogram of hind leg both sides intramuscular injection ovalbumin normal saline solutions, the lumbar injection pertussis vaccine is 2 * 1010/ simultaneously.Put to death rat after 14 days, blood sampling, separation of serum, put in the refrigerator-20 ℃ subsequent use.The Balb/C mice in former times of rat anti serum of left auricle subcutaneous injection 20 μ l/ only; Tail vein injection contains 0.5% azovan blue and 2 mg/ml ovalbumin solution for 0.20 milliliter after 48 hours, puts to death after 30 minutes, cuts left ear indigo plant and dyes part skin; Put in 5 milliliters of acetone-metabisulfite solutions and left standstill 48 hours; Get supernatant in 590nm place photometry density, with the acetone that do not soak skin-metabisulfite solution zeroing, the azovan blue amount of asking every mouse ear to ooze out from standard curve (regression equation Y=0.0354X-0.0069); With the degree that shows that the mouse ear capillary permeability increases, reflect the degree of skin allergy with the degree of its increase.
60 of Balb/C mices are divided 6 groups at random.Be that blank group, model control group, Chai huang granule A1 group (dosage is 5 gram/kilograms), Chai huang granule A2 organize (dosage is 10 gram/kilograms), Chai huang granule B1 organizes (dosage is 5 gram/kilograms), Chai huang granule B2 (dosage is 10 gram/kilograms); After the last administration; At left auricle subcutaneous injection normal saline 20 μ l/ only, quiet notes azovan blue ovalbumin solution after 1 hour.The result sees table 3:
The influence of table 3 pair mouse ear skin hypersensitivity (x ± s)
The result shows that the azovan blue when Chai huang granule A group and B group all can reduce mouse ear xenogenesis skin allergy oozes out, and explains that Chai huang granule has the effect of anti-I type allergy.But under identical condition, Chai huang granule A group is better than B group antianaphylaxis, compares P＜0.01 for two groups.
2.3KB method antibacterial tests
4 groups of 20 branches of rat, male and female half and half.Oral drugs or normal saline, 2 times/day, totally 5 days, after the last administration 2 hours; 30 milligrams of/kilogram anesthesia of injection pentobarbital sodium, the ventral aorta sterile blood sampling injects the sterile negative pressure blood taking tube; Centrifugal, separation of serum is divided into 2 parts with each group rat blood serum; Put for 1 part and preserve in-20 ℃ of refrigerators subsequent usely, another part behind 30 minutes deactivation complements, put equally and preserved subsequent use (when in a few days using) in-20 ℃ of refrigerators in 56 ℃ of water-baths.
With Xinhua's No. 1 filter paper preparation of granules sterile granules, be sub-packed in the sterile vials, 0.5 milliliter of pastille serum getting not deactivation, deactivation then respectively adds respectively and is equipped with in 50 particulate bottles of paper, soaks after 1 hour, and it is subsequent use to put in-20 ℃ of refrigerators preservation.
After bacterial strain brings back to life, on MHA flat board and MHA blood plate, cultivated 15 hours respectively, using physiological saline solution to wash and getting bacterium colony and be diluted to concentration is 1.5 * 108cfu/ml.Bacterium liquid is coated planar surface, and wherein pneumococcal vaccination is in the MHA blood plate, and escherichia coli and staphylococcus aureus are inoculated in the MHA flat board respectively; Hemophilus influenza is inoculated in clinical Hb chocolate culture medium; Slightly do, on mark position, stick two kinds of distinct methods preparations blank serum paper granule, contain the various dose and on the same group the serum paper granule of Chai huang granule not, each plate sticks the plain paper granule simultaneously; Above-mentioned plate is put 37 ℃ of incubators; Take out after 24 hours, gamma camera videotapes, and image analyzer is measured antibacterial circle diameter.The result is following:
The blank serum of deactivation does not have inhibitory action to hemophilus influenza and escherichia coli, shows to have the active substance that above-mentioned two kinds of antibacterials is had inhibition or killing action in the fresh rat serum.Chai huang granule A group and the also more blank serum group of Chai huang granule B group 12g/kg group pastille serum inhibition zone are obviously big; Relatively there was a significant difference for the two; Chai huang granule 6g/kg group pastille serum has obvious inhibition or killing action to hemophilus influenza; To colibacillary inhibition zone also greater than blank serum, but there was no significant difference.In addition, blank serum and pastille serum do not demonstrate bacteriostasis to staphylococcus aureus, streptococcus pneumoniae.The result sees table 4:
Table 4 Chai huang granule antibacterial tests result
The result shows that Chai huang granule all has the inhibitory action that shows the person to hemophilus influenza, escherichia coli, and the antibacterial circle diameter of Chai huang granule A2 group and B2 group is obviously bigger than blank serum group.Chai huang granule A group and Chai huang granule B organize antibacterial circle diameter P＜0.05 of comparing simultaneously, prove under identical condition, and Chai huang granule A group is better than B group fungistatic effect.
Can show that through above experiment Chai huang granule of the present invention has good antiinflammatory, antiallergic and antibacterial action, its effect is superior to the Chai huang granule of prior art.
Two, dissolubility test
In order to confirm that Chaihuang preparation of the present invention is in the improvement aspect the water solublity; The inventor compares the described Chaihuang preparation of embodiment of the invention 1-6 respectively with the Chai huang granule and the bavin pornographic movie of prior art; Respectively get the sample of same amount; Join in the water of same amount, observe its dissolubility situation, the result sees table 5.
Table 5 Chaihuang preparation dissolubility comparative test result
Show that by above each item result of the test Chaihuang preparation of the present invention has good water-solubility, medicine can be dispersed in the aqueous solution after water brews quickly and evenly.Therefore, behind the gastrointestinal tract that gets into human body, also be easier to be absorbed by the body, can improve bioavailability, thereby improve curative effect.
Claims (4)
1. the method for preparing of a Chaihuang preparation, said Chaihuang preparation is processed by the Radix Bupleuri of 100-150 weight portion and the Radix Scutellariae extract of 6-12 weight portion, and the method for preparing of said Chaihuang preparation may further comprise the steps:
(1) preparation Radix Bupleuri clear paste: get the Radix Bupleuri raw medicinal material of said weight portion, the decoction and alcohol sedimentation technique extraction according to routine makes relative density and is the Radix Bupleuri clear paste of 1.10-1.35, and is subsequent use;
(2) preparation Radix Scutellariae clear paste: get the Radix Scutellariae extract of said weight portion, add the water that 0.5-3 doubly measures, stir, it is an amount of to add sodium hydroxide solution or sodium bicarbonate solution that concentration is 5-40% again, transfers medicinal liquid PH to 5-8, the Radix Scutellariae clear paste;
(3) process preparation: with the Radix Bupleuri clear paste that makes of above-mentioned (1) step and the Radix Scutellariae clear paste mixing that (2) step makes, add appropriate amount of auxiliary materials, process the medicine of required dosage form, promptly get by the medicament method for preparing of routine.
2. the method for preparing of Chaihuang preparation according to claim 1, it is characterized in that: the weight portion proportioning of described Radix Bupleuri and Radix Scutellariae extract is 120-130: 8-10.
3. the method for preparing of Chaihuang preparation according to claim 1 is characterized in that: in described (2) step preparation Radix Scutellariae clear paste process, add sodium hydroxide solution or sodium bicarbonate solution medicinal liquid PH is transferred to 5-7.
4. the method for preparing of Chaihuang preparation according to claim 1 is characterized in that: in described (2) step preparation Radix Scutellariae clear paste process, the sodium hydroxide solution of adding or the concentration of sodium bicarbonate solution are 10-20%.
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|---|---|---|---|
| CN2006100213111A CN101099765B (en) | 2006-07-04 | 2006-07-04 | Preparation method of Chaihuang preparation |
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| 国家食品与药品监督管理局.柴黄冲剂.《国家药品中药标准中成药第十分册》.1995,第1卷141. * |
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