CN1772122A - Indian stringbush prepn with antiphlogistic and detoxicating functions - Google Patents
Indian stringbush prepn with antiphlogistic and detoxicating functions Download PDFInfo
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- CN1772122A CN1772122A CN 200510100497 CN200510100497A CN1772122A CN 1772122 A CN1772122 A CN 1772122A CN 200510100497 CN200510100497 CN 200510100497 CN 200510100497 A CN200510100497 A CN 200510100497A CN 1772122 A CN1772122 A CN 1772122A
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Abstract
The present invention is Indian stringbush preparation with antiphlogistic and detoxicating functions and its preparation process. The Indian stringbush preparation has high solubility, high bioavailability and other features. The Indian stringbush preparation made of natural material is favorable to reducing the drug resistance of bacteria. The present invention also discloses the use of the Indian stringbush preparation in treating lung cancer.
Description
Technical field:
The present invention relates to field of medicaments, be specifically related to a kind of Radix Wikstroemae preparation and preparation method with antiinflammatory, detoxicating functions.
Background technology:
Radix Wikstroemae has another name called wikstroemia indica, latin name Wikstroemia indica (L) C.A.Mey.This medicine is because of treatment bullet, bamboo thorn incarnation, and traumatic injury is very imitated, and helps the man most, so gain the name " Radix Wikstroemae ".Motherland's medical science is thought: Radix Wikstroemae bitter in the mouth cold in nature, little suffering, tool heat-clearing and toxic substances removing, dispersing swelling and dissipating binds, preventing phlegm from forming and stopping coughing, the functions such as eliminating impediment, promoting urination to remove dampness of dispeling the wind.
This medical material standard is recorded 77 editions pharmacopeia in the People's Republic of China (PRC).Include the tablet of this product simultaneously.
The patent No. 98114403.9 " preparation method of anti-AIDS new drug Radix Wikstroemae extract " discloses a kind of extracting method with anti-AIDS function that Radix Wikstroemae is made.
Patent No. CN98114029.7 " a kind of chemical compound for the treatment of AIDS and preparation method thereof " discloses some and has had the preparation method of the active chemical compound of anti-AIDS.
The patent No. 200410023031.5 " a kind of indian stringbush root dispersion tablets " discloses a kind of method of Radix Wikstroemae extract being made dispersible tablet.
Capsule that open Herba Andrographis of number of patent application 20041002303.1 " a kind of Chinese medicinal capsule of eliminating inflammation and expelling toxin " and Radix Wikstroemae compositions are made and preparation method thereof.
Foregoing invention is all different with the present invention.The Radix Wikstroemae medical material has great toxic and side effects, the coordination problem of the toxicity physiologically active useful with it of unresolved this medical material in the prior art.
Pulmonary carcinoma be listed in malignant tumor because of first, early operation is the only resource of pulmonary carcinoma radical cure.China, the patient above 80% have belonged to late period when going to a doctor, in the face of large quantities of patients that lose the surgical engine meeting, radiation and chemotherapy becomes main treatment means.Yet chemicotherapy is when dwindling tumor, and its serious toxicity often brings great misery to the patient, makes physical function be subjected to serious strike.Seek lung cancer therapy medicine safely and effectively, improve the life quality of patients with lung cancer, have urgent reality needs.
Summary of the invention
The present invention makes the Radix Wikstroemae dry extract by Radix Wikstroemae through extraction, drop pill or the pharmaceutical dosage forms such as soft capsule or dispersible tablet or oral cavity disintegration tablet or effervescent tablet or micropill or suppository made by Radix Wikstroemae extract and pharmaceutically alleged adjuvant or substrate.
Can also contain Radix Astragali extract in the preparation of the present invention, wherein Radix Wikstroemae is formed with Radix Astragali ratio 1: 1～20 by weight.Said composition is used to make the preparation of treatment pulmonary carcinoma.
Said composition is used for the treatment of pulmonary carcinoma, can reduce its side effect in the performance Radix Wikstroemae extract.
The invention also discloses multiple Radix Wikstroemae effective site extracting method, the Radix Wikstroemae extract curative effect that this method makes is higher, and toxic and side effects is low.
The preparation soft capsule:
1. Radix Wikstroemae medicinal material extract: get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, or is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract;
2. modulate capsule liquid: get the Radix Wikstroemae medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating dissolving down, add additives such as glycerol, stir, after the degassing, insulation is left standstill, and makes the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
The disperse medium of making soft capsule is: Semen Coicis oil, olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or Oleum Cocois triglyceride; or the acetylizad monoglyceride of purification; or olein; or glyceryl linoleate, or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more.
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc.
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Its adjuvant can preferably use by following proportioning:
The supplementary product consumption of making soft capsule is: the described Radix Wikstroemae medicinal substances extract of claim 2 220g, with disperse medium 50～320g, suspending agent 0～60g, antiseptic 0～4.5g, modulation encystation liquid is made 1000 of soft capsules.
Its capsule material is: weight ratio is gelatin=41.5%, water=38.5%, and glycerol=18.5%, antiseptic: an amount of, pigment: an amount of, distilled water etc. are mixed and made into.Method for making: various raw materials in the glue are heated in changing the glue cylinder by technological requirement, mixing, vacuum is removed bubble, crosses 60 mesh sieves, elimination impurity.Sampling and measuring moisture and viscosity, insulation is standby down at 60～80 ℃ after the assay was approved.
The preparation dispersible tablet:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
Adjuvants such as adding disintegrating agent are made tablet, promptly get dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: 40% ethanol～95% alcoholic solution or starch slurry, or the alcoholic solution of polyvinylpyrrolidone or aqueous solution; Or 50～90% alcoholic solution of low-substituted hydroxypropyl cellulose;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.,
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
Its adjuvant can preferably use by following proportioning:
Its adjuvant can be preferably: the described Radix Wikstroemae extract 220g of claim 5, with filler 2～340g, disintegrating agent 2～175g, lubricant 0～100g proportioning; Make 1000 of dispersible tablets;
The preparation drop pill:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, or is dried to dry extract, promptly gets Radix Wikstroemae extract;
Get drop pill substrate heating and melting,, splash into coolant, make drop pill with above-mentioned Radix Wikstroemae extract mix homogeneously.
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: Polyethylene Glycol 8000: the mixture of poloxamer (10: 0.5: 0.5);
Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
Its adjuvant can preferably use by following proportioning:
Radix Wikstroemae extract 220g, with consumption be that the drop pill substrate of 70～550g is used, the best 460g that uses.Oral cavity disintegration tablet of the present invention is made like this:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
One or more adjuvants that add filler, disintegrating agent, fluidizer, correctives etc., compacting is in blocks, or coating is made coated tablet promptly again.
Its supplementary product consumption proportioning is: the described Radix Wikstroemae extract 220g of claim 10, filler 3～400g, disintegrating agent 3～145g, correctives 0～25g, lubricant 0.01～20g; Make 1000 of oral cavity disintegration tablets.
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described lubricant is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use stevioside and citric acid weight ratio 1: 1.5.
The preparation effervescent tablet:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
One or more adjuvants that add effervescent acid-base pair, filler, disintegrating agent, fluidizer, correctives etc. suppress in flakes promptly, or coating are made coated tablet again.
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., or the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 4: 3: 1.2: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: the mixture of low-substituted hydroxypropyl cellulose=5: 3.
Its supplementary product consumption proportioning is: Radix Wikstroemae medicinal substances extract 10～40g, filler 2～200g, disintegrating agent 1～55g, correctives 0～25g, effervescent acid-base pair 0.5～50g, lubricant 0～20g; Make 1000 of effervescent tablets; Micropill of the present invention or pellet capsule are made like this:
(1) get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly;
(2) get above-mentioned Radix Wikstroemae extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
220 parts of Radix Wikstroemae extracts, 5～220 parts of carboxymethyl starch sodium, 2～75 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones; Or be preferably: raw material medicated powder 220g, carboxymethyl starch sodium 70g, precoking starch 40g, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 8g, hydroxypropyl methylcellulose 35g, 90% alcoholic solution 200ml, Pulvis Talci 6g, magnesium stearate 2g, titanium dioxide 4～6g, Polyethylene Glycol
60004g, pigment 1～2g.
The preparation of Radix Wikstroemae-Milkvetch root composition of the present invention:
Wherein except that containing Radix Wikstroemae, also contain Semen Coicis oiliness extract, wherein Radix Wikstroemae extract is formed with Semen Coicis oiliness extract ratio 1: 0.05～30 by weight.Said composition can be used for preparation treatment or auxiliary treatment lung cancer drugs, and this medicine can be peroral dosage forms such as capsule, tablet, drop pill, also can be made into injecting medicine-feeding form.
Effect of the present invention:
Soft capsule of the present invention, dispersible tablet, oral cavity disintegration tablet can improve the bioavailability of principal agent in various degree.
Radix Wikstroemae-Milkvetch root composition of the present invention can obviously reduce the toxicity of Radix Wikstroemae, increases the tolerance degree of mice to Radix Wikstroemae.
Radix Wikstroemae extract is made the solution of 7.5g/ml, and preparation simultaneously contains the solution of Radix Wikstroemae extract and Radix Astragali extract; Contain Radix Wikstroemae 7.5g/ml in this solution, other contains Radix Astragali 15.0g/ml.Test mice is divided into two groups at random, irritates stomach to experiment mice continuously, each 2ml, every day 3 times.To 10% animal dead occurring.Observe hair color, state, the liver section of two groups of mices respectively.
The Radix Wikstroemae extract experimental group began to occur animal dead in 14 days, occur 10% animal dead in the time of the 16th day.Radix Wikstroemae-Radix Astragali extract experiment began to occur animal dead on 24th, and occurred 10% animal dead in the time of the 34th day.
Radix Wikstroemae-Milkvetch root composition of the present invention studies show that by serum pharmacological, aspect treatment pulmonary carcinoma, demonstrates the effect unique of not seen when the Radix Astragali, Radix Wikstroemae use separately.
Contain Chinese medicine Radix Wikstroemae-Milkvetch root composition rabbit anteserum and induce the human lung carcinoma cell Experimental study on apoptosis
1 materials and methods
1.1 experiment material
1.1.1 human lung cancer cell line: the low transfer subbreed LH7 (PGLH7) of people's giant cell carcinoma of lung is provided by medical board pathology system of Zhongshan University.
1.1.2 main agents: RPMI 1640 (U.S. GIBCO), trypsin U.S. SIGMA), Annexin V apoptosis reagent (Beijing Bao Sai company), all-trans-retinoic acid ((Chinese Huabang Pharmaceutical Co., Ltd., Chongqing produces), tetrazolium bromide (U.S. SIG), dimethyl sulfoxide (Beijing northization fine chemistry company).
1.1.3 capital equipment: high speed low temperature centrifugal machine (U.S. SIGMA), superclean bench (Beijing semiconductor equipment one factory); CO2 constant temperature incubator, the FACScan flow cytometer.
1.2 experimental technique
1.2.1 medication preparation and dosage: Radix Wikstroemae-Milkvetch root composition is made up of Radix Wikstroemae 25g, Radix Astragali 50g crude drug.
The Radix Astragali is added 9 times of amounts of water, decoct 2 times, each 1.5 hours, filter twice filtrate of merging, after concentrating, standby;
Radix Wikstroemae is put in the decoction container, and the decocting that adds 8 times of suitable medical material amounts boils twice, boils 5 hours; Merge with above-mentioned Radix Astragali extract concentrated solution;
Become to contain the water decoction of crude drug 2.40g/ml, 0.80g/ml, 0.27g/ml with the distilled water doubling dilution, irritate the stomach medicinal liquid as high, medium and low dosage respectively.Packing, sterilization, 4 ℃ of preservations are stand-by
All-trans-retinoic acid ATRA distilled water is made the Emulsion of 0.38mg/ml.
Radix Wikstroemae-Milkvetch root composition dosage standard: 4.0 (g/kg/ days); Middle dosage: be above-mentioned standard dose; High dose: be 3 times of standard dose; Low dosage: be 1/3 times of standard dose; All-trans-retinoic acid (ATRA): 1.90 (g/kg/ days).
1.2.2 the preparation of pastille serum:
24 of healthy rabbits, male, body weight 1.8～2.0kg.Divide 6 groups at random, 4 every group, body weight indifference between group.All animals keep fully drinking-water, plain particles forage feed 3 days.Fasting 10～12h before the administration can't help water.
Animal is divided 5 groups: blank group, Radix Wikstroemae-Radix Astragali low dose group, dosage group in Radix Wikstroemae-Radix Astragali, Radix Wikstroemae-Radix Astragali high dose group, ATRA matched group.Each organizes rabbit in morning every day, late each gastric infusion once, each 2.5ml/kg, totally 2 times.
Preparation pastille serum: administration every day 2 times, for three days on end; 1h etherization animal after the last administration, carotid artery is got blood under the aseptic condition, injects sterile tube immediately, and room temperature leaves standstill; Treat that blood coagulation is firm, after serum separates out, the sucking-off supernatant is centrifugal, draws supernatant again and is pastille serum; Serum mixes on the same group, puts deactivation 30min in 56 ℃ of water-baths, and the filtering with microporous membrane degerming with 0.22m places 20 ℃ of preservations standby.
Dosage serum group (middle dosage serum group), Radix Wikstroemae-Radix Astragali high dose serum group (high dose serum group), ATRA serum group in contrast rabbit anteserum group (control serum group), Radix Wikstroemae-Radix Astragali low dosage serum group (low dosage serum group), the Radix Wikstroemae-Radix Astragali.
1.2.3 the cultivation of human lung carcinoma cell: the PGLH7 cell strain, cultivate in 37 ℃, 5%CO2 incubator with the RPMI1640 that contains 10% hot deactivation fresh calf serum; Eugonic cell went down to posterity once in per 2 days.
1.2.4 flow cytometry detection by quantitative apoptosis: the PGLH7 cell inoculation that goes down to posterity in the 100ml culture bottle, is put in 37 ℃, 5%CO2 incubator with the RPMI 1640 that contains 10% deactivation calf serum and to be cultivated; Cultivate 24h to exponential phase, abandon culture fluid, add each 4ml of culture fluid that contains various dose pastille serum and control serum, put and cultivate 24h, 48h in the incubator.Collect the PGLH7 cell culture fluid that 24h, 48h pastille serum cultivate respectively, trypsinization, the phosphate buffered solution washing is inserted in the 10ml centrifuge tube centrifugally, abandons supernatant; Add the phosphate buffered solution 1ml of pre-cooling, light shaking makes cell suspension, 300 order nylon net filter cells; Centrifugal again, abandon supernatant; The PGLH7 cell precipitation is resuspended in the Binding Buffer of 200ul, adds 101AnnexinV-FITC, mixing gently, lucifuge reaction 15min; Add 5ul propidium iodide and 300ulBinding Buffer, go up machine testing immediately.Simultaneously with the PGLH7 cell that do not add Annex.in V-FITC and propidium iodide as negative control.
1.3 statistical procedures: date processing adopts variance analysis.
2 results:
Adopt Annex.inV-FITC and propidium iodide double labelling, flow cytometer detection by quantitative PGLH7 apoptosis to the results are shown in Table 1.
| Group | 24 hour cell apoptosis rates | 48 hour cell apoptosis rates |
| The control serum group | 15.21±0.72 | 15.82±1.54 |
| The low dosage serum group | 12.14±1.78 | 12.39±2.34 |
| Middle dosage serum group | 15.80±2.84 | 26.68±2.26 |
| The high dose serum group | 33.74±1.98 | 42.24±1.86 |
| The ATRA serum group | 16.45±2.12 | 10.60±1.75 |
Annotate: compare with same time point control serum group, P＜0.05, with 24h on the same group relatively, P＜0.05 as seen from Table 1: when pastille serum effect 24h, the apoptosis rate difference between Radix Wikstroemae-Radix Astragali high dose serum group and the control serum group then has statistical significance (P＜0.05); When pastille serum effect 48h, the apoptosis rate difference in Radix Wikstroemae-Radix Astragali between dosage, high dose serum group and the control serum group all has statistical significance (middle dosage group P＜0.05, high dose group P＜0.01).Simultaneously as can be seen, dosage in Radix Wikstroemae-Radix Astragali, high dose serum group are along with the prolongation of action time, and the shared ratio of apoptotic cell obviously increases, and significant difference (P＜0.05) is arranged.
The specific embodiment:
Embodiment 1: the extraction of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation:
Get Radix Wikstroemae, clean, add 8 times of water gagings, decoct twice, each 5.0 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract.
Embodiment 2: the extraction of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation:
Get Radix Wikstroemae, clean, clean, add 12 times of water gagings, decoct twice, each 5 hours, collecting decoction filtered, and it is 1.25 thick paste that filtrate is concentrated into 30 ℃ of relative densities, adds 6 times of amounts of water, stirs, leaves standstill 4 hours, filters.Filtrate concentrates, and is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract.
Embodiment 3: the extraction of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation:
Get Radix Wikstroemae, clean, add 8 times of water gagings, the pressurization of heating, temperature is 100 ℃, and pressure is 1.2 atmospheric pressure, and each 3.0 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract.
Embodiment 4: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae extract:
Get Radix Wikstroemae, clean, add 15 times of water gagings, decoct twice, each 5.0 hours, collecting decoction filters, and was centrifugal, gets supernatant, ultrafiltration, and ultrafiltrate concentrating under reduced pressure, 60 ℃ of cold drying filtrates are concentrated into thick paste, are dried to dry extract, promptly get the Radix Wikstroemae medicinal substances extract.Ultrafilter membrane relative molecular weight=5000 of damming.
Embodiment 5: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae-Milkvetch root composition:
Radix Wikstroemae-Milkvetch root composition: Radix Wikstroemae 200g, Radix Astragali 400g
Get Radix Wikstroemae, clean, add 8 times of water gagings, decoct twice, each 5.0 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, and is standby:
The Radix Astragali adds 6 times of amounts of ethanol reflux 3 hours, and backflow reclaims alcoholic acid thick paste, and is standby;
8 times of amounts of the continuous water of astragalus root dregs decocted 1.5 hours, filtered, and filtrate and above-mentioned thick paste and Radix Wikstroemae dry extract merge, and are dried to dry extract, promptly get the extract of Radix Wikstroemae-Milkvetch root composition.
Embodiment 6: a kind of antiinflammatory, antidotal Radix Wikstroemae soft capsule preparation:
Radix Wikstroemae extract 220g
Semen Coicis oil 60g
Oleum Arachidis hypogaeae semen 165g
Cera Flava 10g
Butyl p-hydroxybenzoate 1.5g
1. Radix Wikstroemae medicinal material extract: get the Radix Wikstroemae medical material, add 12 times of water gagings, decoct twice, each 5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract;
2. modulate capsule liquid: get the Radix Wikstroemae medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add additives such as glycerol, stir, after the degassing, insulation is left standstill, and makes the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Its capsule material is: weight ratio is gelatin=41.5%, water=38.5%, and glycerol=18.5%, antiseptic: an amount of, pigment: an amount of, distilled water etc. are mixed and made into.Method for making: various raw materials in the glue are heated in changing the glue cylinder by technological requirement, mixing, vacuum is removed bubble, crosses 60 mesh sieves, elimination impurity.Sampling and measuring moisture and viscosity, insulation is standby down at 60～70 ℃ after the assay was approved.
Embodiment 7: a kind of antiinflammatory, antidotal Radix Wikstroemae preparation soft capsule preparation:
Radix Wikstroemae extract 220g
Semen Coicis oil 150g
Oleum Arachidis hypogaeae semen 80g
Cera Flava 10g
Propylene glycol 1.5g
Make 1000.
Embodiment 8: a kind of antiinflammatory, antidotal Radix Wikstroemae preparation soft capsule preparation:
Radix Wikstroemae 150g
Semen Coicis oil 150g
Oleum Arachidis hypogaeae semen 300g
Cera Flava 10g
Propylene glycol 0.5g
Make 1000.
Radix Wikstroemae is made extract by embodiment 4, makes liposome with Semen Coicis oil, with Oleum Arachidis hypogaeae semen, Cera Flava, propylene glycol modulation encystation liquid, makes soft capsule.
Embodiment 9: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation dispersible tablet:
Radix Wikstroemae extract 220g
Microcrystalline Cellulose 80g
Lactose 25g
Crospolyvinylpyrrolidone 20g
Low-substituted hydroxypropyl cellulose 12g
70% alcoholic solution of low-substituted hydroxypropyl cellulose is an amount of
Make 1000.
Get above-mentioned medicinal substances extract; Add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
Embodiment 10: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation dispersible tablet:
Radix Wikstroemae extract 140g
Microcrystalline Cellulose 2g
Lactose 25g
Crospolyvinylpyrrolidone 20g
Low-substituted hydroxypropyl cellulose 12g
Cross-linked carboxymethyl cellulose sodium 13g
Sodium lauryl sulphate 1.5g
Micropowder silica gel 2.5g
70% alcoholic solution of low-substituted hydroxypropyl cellulose is an amount of
Make 1000.
Above-mentioned supplementary material is granulated, coating behind the tabletting, coating solution is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 10g, hydroxypropyl methylcellulose 15g, 90% alcoholic solution 200ml, Pulvis Talci 6g, magnesium stearate 2g, titanium dioxide 4～6g, Polyethylene Glycol
60004g, pigment 1～2g.
Embodiment 11: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation dispersible tablet:
Radix Wikstroemae extract 100g
Microcrystalline Cellulose 120g
Lactose 25g
Crospolyvinylpyrrolidone 20g
Low-substituted hydroxypropyl cellulose 12g
Cross-linked carboxymethyl cellulose sodium 13g
Sodium lauryl sulphate 1.5g
Micropowder silica gel 2.5g
70% alcoholic solution of low-substituted hydroxypropyl cellulose is an amount of
Make 1000.
Embodiment 12: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation drop pill:
Brother's extract 220g
Polyethylene Glycol
6000220g
Stearic acid 20g
Poloxamer 10g
Make 5000.
Get the Radix Wikstroemae medicinal substances extract; Get drop pill substrate heating and melting,, splash into coolant, make drop pill with said extracted thing mix homogeneously.
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: stearic acid: the mixture of poloxamer (11: 1: 0.5).
Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
Keep 95 centimetres of cooling column effective column lengths when dripping system, 5 ℃ of liquid coolants are dripped 60 on every part of clock of speed, dropper mouth external diameter 2.2mm, and internal diameter 2.0mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Embodiment 13: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation elaioplast drop ball:
Radix Wikstroemae extract 130g
Lecithin 60g
Cholesterol 45g
Polyethylene Glycol
6000150g
Stearic acid 8g
Poloxamer 4g
Make 5000.
By embodiment 4 Radix Wikstroemae is made extract, with the substrate Polyethylene Glycol
6000, stearic acid, poloxamer heat melt mixing, drip and make type, promptly.Maybe can continue coating, make coated drop pill.
Embodiment 14: a kind of Radix Wikstroemae-Radix Astragali extract preparation of soft capsule for the treatment of pulmonary carcinoma:
Radix Wikstroemae 2000g
Radix Astragali 4000g
Oleum Arachidis hypogaeae semen 200g
Cera Flava 10g
Propylene glycol 1.5g
Get Radix Wikstroemae, clean, add 8 times of water gagings, decoct twice, each 5.0 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, and is standby:
The Radix Astragali adds 6 times of amounts of ethanol reflux 3 hours, and backflow reclaims alcoholic acid thick paste, and is standby;
8 times of amounts of the continuous water of astragalus root dregs decocted 1.5 hours, filtered, and filtrate and above-mentioned thick paste and Radix Wikstroemae dry extract merge, and are dried to dry extract, promptly get the extract of Radix Wikstroemae-Milkvetch root composition.
1. modulate capsule liquid: get the extract of Radix Wikstroemae-Milkvetch root composition, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
2. get gelatin, water mixing, in heating in water bath dissolving down, add additives such as glycerol, stir, after the degassing, insulation is left standstill, and makes the capsule material;
3. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Its capsule material is: weight ratio is gelatin=41.5%, water=38.5%, and glycerol=18.5%, antiseptic: an amount of, pigment: an amount of, distilled water etc. are mixed and made into.Method for making: various raw materials in the glue are heated in changing the glue cylinder by technological requirement, mixing, vacuum is removed bubble, crosses 60 mesh sieves, elimination impurity.Sampling and measuring moisture and viscosity, insulation is standby down at 60～70 ℃ after the assay was approved.
Embodiment 15: a kind of preparation for the treatment of the Radix Wikstroemae preparation tablet of pulmonary carcinoma
Radix Wikstroemae 2000g
Radix Astragali 4000g
Microcrystalline Cellulose 200g
Lactose 25g
Low-substituted hydroxypropyl cellulose 12g
Cross-linked carboxymethyl cellulose sodium 13g
Sodium lauryl sulphate 1.5g
Micropowder silica gel 2.5g
75% alcoholic solution of low-substituted hydroxypropyl cellulose is an amount of
Make 1000.
Embodiment 16: a kind of preparation for the treatment of the Radix Wikstroemae parenteral solution of preparation of pulmonary carcinoma
Radix Wikstroemae 2000g
Radix Astragali 4000g
Get Radix Wikstroemae, clean, add 8 times of water gagings, decoct twice, each 5.0 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, and is standby:
The Radix Astragali adds 6 times of amounts of ethanol reflux 3 hours, and backflow reclaims alcoholic acid thick paste, and is standby;
8 times of amounts of the continuous water of astragalus root dregs decocted 1.5 hours, filtered, and filtrate and above-mentioned thick paste merge with the Radix Wikstroemae dry extract, and the adding purified water makes volume reach 18000ml, left standstill, cold preservation 24 hours filtration.Filtrate is concentrated into 1500ml, adds purified water and makes volume reach 3000ml, leaves standstill, cold preservation 24 hours, gets supernatant, ultrafiltration, and filtrate is distributed into every 3ml, sterilization, promptly.
Embodiment 17: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation oral cavity disintegration tablet:
Radix Wikstroemae extract 220g
Microcrystalline Cellulose 60g
Lactose 35g
Stevioside 10g
Citric acid 15g
Crospolyvinylpyrrolidone 40g
Low-substituted hydroxypropyl cellulose 25g
Cross-linked carboxymethyl cellulose sodium 15g
Sodium lauryl sulphate 1.5g
Micropowder silica gel 2.5g
70% alcoholic solution of low-substituted hydroxypropyl cellulose is an amount of
Get Radix Wikstroemae, clean, decoct with water secondary, 5 hours for the first time, 150 minutes for the second time, collecting decoction filtered, it is 1.1～1.2 (80 ℃) that filtrate is concentrated into relative density, is cooled to 40 ℃, adds ethanol and makes and contain alcohol amount and reach 60%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol to there not being the alcohol flavor, add ethanol and make and contain alcohol amount and reach 85%, stir evenly, left standstill 48 hours, filter, reclaim ethanol to nothing alcohol flavor, and be condensed into thick paste; Be the medicinal substances extract of preparation oral cavity disintegration tablet; Get above-mentioned medicinal substances extract; With filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again.
Embodiment 18: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation effervescent tablet:
Radix Wikstroemae extract 35g
Filler: lactose 15g
Mannitol 20g
Precoking starch 20g
Microcrystalline Cellulose 5g
Effervescent: sodium bicarbonate 45g
Tartaric acid 35g
Citric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 20g
Carboxymethyl starch sodium 10g
Lubricant: magnesium stearate 4g
Correctives: aspartame 0.5g
Get the Radix Wikstroemae medicinal substances extract; Get above-mentioned medicinal substances extract, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned medicinal substances extract,, make granule, add adjuvant mix homogeneously such as effervescent acid-base pair, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
Embodiment 19: the preparation of a kind of antiinflammatory, antidotal Radix Wikstroemae preparation micropill
Radix Wikstroemae extract 220g
Carboxymethyl starch sodium 320g
Precoking starch 50g
85% alcoholic solution of 11% polyvinylpyrrolidone is an amount of
Make 2000～3000.
Get the Radix Wikstroemae medicinal substances extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
Claims (13)
1, a kind of Radix Wikstroemae preparation with antiinflammatory, detoxicating functions is characterized in that: it is drop pill or the pharmaceutical dosage forms of mainly being made by Radix Wikstroemae extract and pharmaceutically alleged adjuvant or substrate such as soft capsule or dispersible tablet or oral cavity disintegration tablet or effervescent tablet or micropill or suppository.
2, have the Radix Wikstroemae preparation preparation of soft capsule method of antiinflammatory, detoxicating functions according to one kind of claim 1, it is characterized in that:
1. Radix Wikstroemae medicinal material extract: get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, or is dried to dry extract, promptly gets the Radix Wikstroemae medicinal substances extract;
2. modulate capsule liquid: get the Radix Wikstroemae medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating dissolving down, add additives such as glycerol, stir, after the degassing, insulation is left standstill, and makes the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
3, have the Radix Wikstroemae preparation soft capsule of antiinflammatory, detoxicating functions according to one kind of claim 2, it is characterized in that:
The supplementary product consumption of making soft capsule is: the described Radix Wikstroemae medicinal substances extract of claim 2 220g, with disperse medium 50～520g, suspending agent 0～60g, antiseptic 0～4.5g, modulation encystation liquid is made 1000 of soft capsules.
4, a kind of Radix Wikstroemae preparation dispersible tablet with antiinflammatory, detoxicating functions according to claim 1 is characterized in that this dispersible tablet preparation method is:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
Adjuvants such as adding disintegrating agent are made tablet, promptly get dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
5, according to a kind of Radix Wikstroemae preparation dispersible tablet described in the claim 4, it is characterized in that with antiinflammatory, detoxicating functions:
Its adjuvant can be preferably: the described Radix Wikstroemae extract 220g of claim 5, with filler 0～340g, disintegrating agent 5～175g, lubricant 0～100g proportioning; Make 1000 of dispersible tablets;
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
6, a kind of Radix Wikstroemae preparation drop pill with antiinflammatory, detoxicating functions according to claim 1 is characterized in that:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, or is dried to dry extract, promptly gets Radix Wikstroemae extract;
Get drop pill substrate heating and melting,, splash into coolant, make drop pill with above-mentioned Radix Wikstroemae extract mix homogeneously.
7, a kind of Radix Wikstroemae preparation drop pill with antiinflammatory, detoxicating functions described in according to Claim 8 is characterized in that:
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: Polyethylene Glycol 8000: the mixture of poloxamer (10: 0.5: 0.5);
Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
8, have the Radix Wikstroemae preparation oral cavity disintegration tablet of antiinflammatory, detoxicating functions according to one kind of claim 1, it is characterized in that:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
One or more adjuvants that add filler, disintegrating agent, fluidizer, correctives etc., compacting is in blocks, or coating is made coated tablet promptly again.
9, a kind of according to Claim 8 Radix Wikstroemae preparation oral cavity disintegration tablet with antiinflammatory, detoxicating functions is characterized in that:
Its supplementary product consumption proportioning is: the described Radix Wikstroemae extract 220g of claim 8, filler 3～400g, disintegrating agent 3～145g, correctives 0～25g, lubricant 0.01～20g; Make 1000 of oral cavity disintegration tablets;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described lubricant is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives can be selected: edible or medicinal correctivess such as A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid; Preferably use stevioside and citric acid weight ratio 1: 1.5.
10, have the Radix Wikstroemae preparation effervescent tablet of antiinflammatory, detoxicating functions according to one kind of claim 1, it is characterized in that:
Get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly gets Radix Wikstroemae extract;
One or more adjuvants that add effervescent acid-base pair, filler, disintegrating agent, fluidizer, correctives etc. suppress in flakes promptly, or coating are made coated tablet again.
11, have the Radix Wikstroemae preparation effervescent tablet of antiinflammatory, detoxicating functions according to one kind of claim 10, it is characterized in that:
Its supplementary product consumption proportioning is: the described Radix Wikstroemae extract 10～40g of claim 12, filler 2～200g, disintegrating agent 1～55g, correctives 0～25g, effervescent acid-base pair 0.5～50g, lubricant 0～20g; Make 1000 of effervescent tablets;
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 4: 3: 1.2: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: the mixture of low-substituted hydroxypropyl cellulose=5: 3.
12, have the Radix Wikstroemae preparation micropill of antiinflammatory, detoxicating functions according to one kind of claim 1, it is characterized in that:
(1) get the Radix Wikstroemae medical material, decoct with water twice, each 2.5～7.5 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is dried to dry extract, promptly;
(2) get above-mentioned Radix Wikstroemae extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
13, a kind of Radix Wikstroemae preparation with antiinflammatory, detoxicating functions according to claim 1 is characterized in that: wherein contain the Radix Astragali, Radix Wikstroemae is formed with Radix Astragali ratio 1: 1～20 by weight, and said composition is used to make the preparation of treatment pulmonary carcinoma.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510100497 CN1772122A (en) | 2005-10-20 | 2005-10-20 | Indian stringbush prepn with antiphlogistic and detoxicating functions |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510100497 CN1772122A (en) | 2005-10-20 | 2005-10-20 | Indian stringbush prepn with antiphlogistic and detoxicating functions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1772122A true CN1772122A (en) | 2006-05-17 |
Family
ID=36759373
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510100497 Pending CN1772122A (en) | 2005-10-20 | 2005-10-20 | Indian stringbush prepn with antiphlogistic and detoxicating functions |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1772122A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101601666B (en) * | 2009-07-10 | 2011-05-25 | 暨南大学 | Radix wikstroemae extractive and preparation method and application thereof |
| CN102988609A (en) * | 2012-11-29 | 2013-03-27 | 启东市隆腾电气有限公司 | Anti-inflammatory medicament |
| CN106668334A (en) * | 2015-11-06 | 2017-05-17 | 庞锦霞 | Wikstroemia indica tincture |
-
2005
- 2005-10-20 CN CN 200510100497 patent/CN1772122A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101601666B (en) * | 2009-07-10 | 2011-05-25 | 暨南大学 | Radix wikstroemae extractive and preparation method and application thereof |
| CN102988609A (en) * | 2012-11-29 | 2013-03-27 | 启东市隆腾电气有限公司 | Anti-inflammatory medicament |
| CN106668334A (en) * | 2015-11-06 | 2017-05-17 | 庞锦霞 | Wikstroemia indica tincture |
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