CN101390961B - Medicine composition of aconitum pendulum non-alkaloids active site and preparation method thereof - Google Patents
Medicine composition of aconitum pendulum non-alkaloids active site and preparation method thereof Download PDFInfo
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Abstract
Disclosed is a medicine combination of effective fraction of aconitum pendulum non-alkaloid, and the preparation method thereof. The invention discloses a medicine combination of non-alkaloid effective fraction of aconitum pendulum, which is used for anti-inflammatory and analgesia, and the preparation method thereof; wherein, the non-alkaloid effective fraction of aconitum pendulum is extracted from the raw material of aconitum pendulum; the non-alkaloid effective fraction of aconitum pendulum has good anti-inflammation and analgesic effects; the non-alkaloid effective fraction of aconitum pendulum can be combined with pharmaceutical excipient to prepare medicine combination which can be made into capsules or tablets, etc.
Description
Technical field:
Pharmaceutical composition of aconitum pendulum non-alkaloids active site of the present invention and preparation method thereof, be a kind of ranunculaceae plant FUMAO aconitum pendulum non-alkaloids active site that is used for anti-inflammatory and antalgic, particularly aconitum pendulum non-alkaloids active site preparation of drug combination method.
Background technology:
Radix aconiti szechenyiani is the dried root of ranunculaceae plant FUMAO Radix aconiti szechenyiani Acontium flavum Hand-Mazz." Chinese dictionary " record: " Radix aconiti szechenyiani, blood circulation promoting and blood stasis dispelling, expelling wind and removing dampness, pain relieving, detumescence ", " Shaanxi Chinese herbal medicine " said: " Radix aconiti szechenyiani blood circulation promoting and blood stasis dispelling, wind-damp dispelling pain relieving, detumescence relieve internal heat, removing the necrotic tissue and promoting granulation, hemostasis ".The chemical constitution study of Radix aconiti szechenyiani concentrates on the alkaloids composition mostly, at present report has 8 kinds of alkaloids, is respectively that aconitine, 3-acetylaconitine, napellonine, 8-remove acetoxyl group-8-ethyoxyl-3-acetylaconitine, deoxyaconitine, 3-acetylaconitine and 12-table-anepline and 3-deoxyaconitine; With 3 kinds of non-alkaloids, be cupreol, 3-deoxyaconitine-8-linoleate and aconitine-8-linoleate.
The Radix aconiti szechenyiani pharmacological research comes from eighties of last century seventies, and has obtained certain progress in fields such as analgesia, antiinflammatory, rheumatisms.Utilize water for injection that FUMAO Radix aconiti szechenyiani total alkali is made into various concentration (pH is 7.4), 18～20 female white mice that restrain are carried out lumbar injection and survey its analgesia rate, respond well.Utilize the plant tuber to carry to such an extent that total alkaloids carries out pharmacological evaluation, in mice hot plate method, Cavia porcellus Pi Qiufa and rabbit eye drip method, prove powerful analgesia drawn game anaesthetic effect, but total alkali toxicity is higher, therapeutic index is lower.They have carried out the antiinflammatory experiment to 3-acetylaconitine and aconitine again afterwards, and the result has confirmed the alkaloidal antiinflammatory action of Radix aconiti szechenyiani.
At present, the chemical constituent that Radix aconiti szechenyiani is used for medicine also concentrates on alkaloids, not to the patent application of non-alkaloid constituents; The pharmacological research of Radix aconiti szechenyiani almost all concentrates on the alkaloids composition, and the pharmacological action of non-alkaloid constituents is not also had relevant report.
Summary of the invention:
Pharmaceutical composition of aconitum pendulum non-alkaloids active site of the present invention and preparation method thereof, goal of the invention is: at domestic and international pharmacological research present situation for Radix aconiti szechenyiani non-alkaloid constituents, with the Radix aconiti szechenyiani is that raw material carries out extraction separation, obtain having the aconitum pendulum non-alkaloids active site of anti-inflammatory and analgesic effect, find the preparation method of the extracting method and the anti-inflammation analgesis medicament of aconitum pendulum non-alkaloids active site.
Pharmaceutical composition of aconitum pendulum non-alkaloids active site of the present invention and preparation method thereof is achieved in that the preparation method of aconitum pendulum non-alkaloids active site composition of the present invention comprises following step:
A, the Radix aconiti szechenyiani pulverizing medicinal materials that will be dried to constant weight become coarse powder to cross 16 mesh sieves, and it is fixed to claim, adds 5～20 times of (mL/g) solvents and carries out reflux, extract, 1～3h.Cooling filters to get filtrate, and the solvent that filtering residue adds same amount repeats to extract merging filtrate 1～2 time.Concentrating under reduced pressure, to relative density be 1.5～2, concentrated solution.
B, concentrated solution is separated through macroporous adsorbent resin, water, concentration are that 30%～50% ethanol and concentration are that 80%～100% ethanol successively carries out eluting respectively, obtain washing position, 30%～50% ethanol position and 80%～100% ethanol position.
C, get 1～2mL washing position, 30%～50% ethanol position and 80%～100% ethanol position respectively, add 1～2 of bismuth potassium iodide test solution, whether to have orange-yellow flocculent deposit phenomenon to determine the non-alkaloid position.
D, concentrating under reduced pressure, to relative density be 1.5～2, reclaim solvent, obtain washing position, 30%～50% ethanol position fluid extract and 80%～100% ethanol position fluid extract respectively.
The extraction solvent that wherein is used to extract aconitum pendulum non-alkaloids active site can be the ethanol of water, acidic aqueous solution or 30%～95% concentration, the acidic ethanol of 30%～95% concentration.The liquid material ratio that wherein extracts solvent and medical material is 5～20 (mL/g); Its solvent extraction time is 1～3h; The solvent extraction number of times is 1～3 time; It is that 30%～50% ethanol and concentration are 80%～100% ethanol that the solvent that is used for the macroporous adsorbent resin eluting is respectively water, concentration; Determine that through the alkaloid precipitation aconitum pendulum non-alkaloids active site is that 95% ethanol is washed the position.Prepared aconitum pendulum non-alkaloids active site, it is clinical to be mainly used in antiinflammatory and analgesia.Described a kind of anti-inflammation analgesis medicament, it can be capsule or tablet, according to capsule or the conventional preparation technology of tablet, adds an amount of pharmaceutic adjuvant and is prepared from; Wherein the ratio of aconitum pendulum non-alkaloids active site and adjuvant is 1:10～1:500; Every in tablet contains aconitum pendulum non-alkaloids active site 0.2～2mg, and every of capsule contains aconitum pendulum non-alkaloids active site 0.2～2mg.
The anti-inflammatory and antalgic of the aconitum pendulum non-alkaloids active site extractum of the present invention's preparation explains:
One, antiinflammatory experiment
1. inflammatory model duplicates and experimentation
Get 40 of mices, male and female half and half are divided into 4 groups at random, 10 every group, are respectively the total extractum group of Radix aconiti szechenyiani 56.2mg (in crude drug)/kg; Aconitum pendulum non-alkaloids active site 2.4mg (in crude drug)/kg irritates stomach; Positive controls (indomethacin group) 20mg/kg irritates the stomach model matched group; The blank group.Adopt distilled water to prepare the total extractum group of Radix aconiti szechenyiani, aconitum pendulum non-alkaloids active site group respectively; Positive controls (being the indomethacin group) is with distilled water indomethacin to be made into the solution that concentration is respectively 1mg/mL; Model control group and blank group give the volumetrical distilled water of equivalent and irritate stomach.Each group was all irritated stomach 3 days, and the filling gastric capacity is 0.2mL/10g.After irritating stomach mice is placed cleaning level animal indoor feeding.Precision takes by weighing carrageenin, is made into 1% concentration with distilled water.After 1 hour, each group is all in mice metapedes sole of the foot portion subcutaneous injection carrageenin solution in last 1 gastric infusion, and dosage is 0.03mL/.In the line of mice ankle place, cause scorching front and back toes volume with self-control capillary tube measurement by magnification measurement device mice, cause the volumetrical difference of scorching forward and backward toes as the swelling degree with each mice.Toes volume * 100%. before swelling degree (%)=(cause scorching before toes volume * cause scorching back toes volume)/cause is scorching
2. date processing and experimental result
Experimental data is carried out statistical procedures, and represents with x ± s, and group difference relatively adopts the t check to add up.The result is as shown in table 1 below:
Table 1 different dosing component on Carrageenan causes the influence of mice foot swelling reaction
Annotate: compare with model group * P＜0.05
Experimental result shows that positive findings appears in model group, meets the inflammatory model requirement.Different dosing group (seeing Table 1), compare with model group, the significance of the total extractum group of Radix aconiti szechenyiani, aconitum pendulum non-alkaloids active site group reduces (P＜0.05), the total extractum group of Radix aconiti szechenyiani is described, aconitum pendulum non-alkaloids active site group on Carrageenan causes the mice foot swelling that inhibitory action is arranged.The result shows that the aconitum pendulum non-alkaloids active site on Carrageenan causes the mice foot swelling inhibitory action.
Two, analgesic experiment
1. the analgesic model duplicates and experimental study
Get 40 of mices, male and female half and half are divided into 4 groups at random, 10 every group, are respectively the total extractum group of Radix aconiti szechenyiani 56.2mg (in crude drug)/kg; Aconitum pendulum non-alkaloids active site 2.4mg (in crude drug)/kg irritates stomach; Positive controls (indomethacin group) 20mg/kg irritates the stomach model matched group; The blank group.Adopt distilled water to prepare the total extractum group of Radix aconiti szechenyiani, aconitum pendulum non-alkaloids active site group respectively; Positive controls (indomethacin group) is that indomethacin is made into the solution that concentration is 1mg/mL with distilled water; Model control group and blank group give the volumetrical distilled water of equivalent and irritate stomach once.Be subjected to the reagent thing after 1 hour, lumbar injection 0.6% acetic acid (HAC) solution 0.2mL, the number of times that writhing response appears in mice in the 30min behind the observation injection HAC calculates suppression ratio.Suppression ratio %=(matched group is turned round the several medication groups of body and turned round the body number)/matched group is turned round body number * 100%.
2. date processing and experimental result
Experimental data is carried out statistical procedures, and represents with x ± s, and group difference relatively adopts the t check to add up.The result is as shown in table 2 below:
Table 2 different dosing component Dichlorodiphenyl Acetate causes the influence (x ± s) of mouse writhing reaction
Annotate: * P＜0.05, compare with model control group; * P〉0.01 with positive controls relatively
Experimental result shows that positive findings appears in model group, meets the pain model requirement.Different dosing component (seeing Table 2) compares with model group, the significance of aconitum pendulum non-alkaloids active site group, the total extractum group of Radix aconiti szechenyiani raises (P＜0.05), illustrates that 5 aconitum pendulum non-alkaloids active site groups, the total extractum group of Radix aconiti szechenyiani Dichlorodiphenyl Acetate cause the mouse writhing reaction inhibitory action is arranged.Compare with positive controls, and aconitum pendulum non-alkaloids active site group there was no significant difference (P〉0.05), illustrate that the aconitum pendulum non-alkaloids active site group is suitable with positive controls medicine indomethacin analgesic effect.The result shows that the aconitum pendulum non-alkaloids active site Dichlorodiphenyl Acetate causes mouse writhing the suitable inhibitory action of indomethacin, and aconitum pendulum non-alkaloids active site has good antiinflammatory and analgesic activity.
The beneficial effect of pharmaceutical composition of aconitum pendulum non-alkaloids active site of the present invention and preparation method thereof: with the Radix aconiti szechenyiani is that raw material carries out extraction separation, has obtained having the extracting method of aconitum pendulum non-alkaloids active site of anti-inflammatory and analgesic effect and the preparation method of aconitum pendulum non-alkaloids active site anti-inflammation analgesis medicament.
The specific embodiment:
Embodiment 1
Get the Radix aconiti szechenyiani pulverizing medicinal materials that is dried to constant weight, cross 16 mesh sieves, take by weighing 100g, add 500mL70% alcohol reflux 1.5h, cooling filters, and filtering residue adds 500mL70% alcohol reflux 1.5h again, extracts so repeatedly 3 times, merges 3 times and extracts filtrate.Concentrating under reduced pressure is 1.5～2 fluid extract to relative density.According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 50% ethanol elution is colourless that 50% ethanol be washed the position until eluent with concentration, is that 95% ethanol carries out eluting and wash the position until colourless 95% ethanol that gets of eluent with concentration at last.Get 1～2mL washing position respectively, the position washed by 50% ethanol and 95% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 50% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 95% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that Radix aconiti szechenyiani non-alkaloid position is that 95% ethanol is washed the position.To wash position, 50% ethanol more respectively washes position and 95% ethanol and washes the position to be evaporated to relative density be 1.5 extractum.According to tablet producing technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves.Take by weighing 2kg, starch 55kg and microcrystalline Cellulose 35kg, fully mixing, it is an amount of to add 10%PVP ethanol liquid, the system soft material, with soft material with 16～20 mesh sieves, granulate, 40～80 ℃ of dryings add carboxymethyl starch sodium 6kg and magnesium stearate 2kg, mixing, 20 mesh sieve granulate are surveyed granule content, determine that sheet is heavy, tabletting, coating.Every contains Radix aconiti szechenyiani non-alkaloid 2mg.
Embodiment 2
With experimental example 1, wherein extracting solvent is 2000mL water, and reflux, extract, 3h extracts 2 times, merges 2 times and extracts filtrate, and concentrating under reduced pressure gets fluid extract.According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 30% ethanol elution is colourless that 30% ethanol be washed the position until eluent with concentration, is that 80% ethanol carries out eluting and wash the position until colourless 80% ethanol that gets of eluent with concentration at last.Get 1～2mL washing position respectively, the position washed by 30% ethanol and 80% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 30% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 80% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that aconitum pendulum non-alkaloids active site is that 80% ethanol is washed the position.To wash position, 30% ethanol more respectively washes position and 80% ethanol and washes the position to be evaporated to relative density be 1.5 extractum.According to tablet producing technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves.Take by weighing 0.2kg, starch 55kg and microcrystalline Cellulose 35kg, fully mixing, it is an amount of to add 10%PVP ethanol liquid, the system soft material, with soft material with 16～20 mesh sieves, granulate, 40～80 ℃ of dryings add carboxymethyl starch sodium 6kg and magnesium stearate 2kg, mixing, 20 mesh sieve granulate are surveyed granule content, determine that sheet is heavy, tabletting, coating.Every contains Radix aconiti szechenyiani non-alkaloid 0.2mg.
Embodiment 3
With experimental example 1, wherein extracting solvent is that the 500mLpH value is 2～6 aqueous acetic acid, and reflux, extract, 1h extracts 1 time.Concentrating under reduced pressure gets fluid extract.According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 40% ethanol elution is colourless that 40% ethanol be washed the position until eluent with concentration, is that 100% ethanol carries out eluting and wash the position until colourless 100% ethanol that gets of eluent with concentration at last.Get 1～2mL washing position respectively, the position washed by 40% ethanol and 100% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 40% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 100% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that aconitum pendulum non-alkaloids active site is that 100% ethanol is washed the position.To wash position, 40% ethanol more respectively washes position and 100% ethanol and washes the position to be evaporated to relative density be 1.5 extractum.According to capsule preparation technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves.Take by weighing 0.2kg, pregelatinized Starch is an amount of, and fully mixing is filled in the Capsules.Every contains Radix aconiti szechenyiani non-alkaloid 0.2mg.
Embodiment 4
With experimental example 1, wherein extracting solvent is that the 500mLpH value is 2～6 aqueous hydrochloric acid solution, and reflux, extract, 1h extracts 1 time.According to capsule preparation technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves.Take by weighing 2kg, pregelatinized Starch is an amount of, and fully mixing is filled in the Capsules.Every contains Radix aconiti szechenyiani non-alkaloid 2mg.
Embodiment 5
With experimental example 1, wherein extracting solvent is that the 600mLpH value is 2～6 acetic acid 70% alcoholic solution, and reflux, extract, 2h extracts 3 times.
Embodiment 6
With experimental example 1, wherein extracting solvent is that the 600mLpH value is 2～6 hydrochloric acid 30% alcoholic solution, and reflux, extract, 1.5h extracts 3 times.
Embodiment 7
With experimental example 1, wherein extracting solvent is that the 600mLpH value is 2～6 hydrochloric acid 95% alcoholic solution, and reflux, extract, 1.5h extracts 3 times.
Embodiment 8
With experimental example 1, wherein extracting solvent is that the 600mLpH value is 2～6 acetic acid 30% alcoholic solution, and reflux, extract, 1.5h extracts 3 times.
Embodiment 9
With experimental example 1, wherein extracting solvent is that the 600mLpH value is 2～6 acetic acid 95% alcoholic solution, and reflux, extract, 1.5h extracts 3 times.
Claims (3)
1. the pharmaceutical composition of aconitum pendulum non-alkaloids active site is characterized in that this pharmaceutical composition is prepared by the following method:
Get the Radix aconiti szechenyiani pulverizing medicinal materials that is dried to constant weight, cross 16 mesh sieves, take by weighing 100g, add 500mL 70% alcohol reflux 1.5h, cooling filters, filtering residue adds 500mL 70% alcohol reflux 1.5h again, extracts so repeatedly 3 times, merges 3 times and extracts filtrate; Concentrating under reduced pressure is 1.5～2 fluid extract to relative density; According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 50% ethanol elution is colourless that 50% ethanol be washed the position until eluent with concentration, is that 95% ethanol carries out eluting and wash the position until colourless 95% ethanol that gets of eluent with concentration at last; Get 1～2mL washing position respectively, the position washed by 50% ethanol and 95% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 50% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 95% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that Radix aconiti szechenyiani non-alkaloid position is that 95% ethanol is washed the position; To wash position, 50% ethanol more respectively washes position and 95% ethanol and washes the position to be evaporated to relative density be 1.5 extractum; According to tablet producing technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves; Take by weighing 2kg, starch 55kg and microcrystalline Cellulose 35kg, fully mixing, it is an amount of to add 10%PVP ethanol liquid, the system soft material, with soft material with 16～20 mesh sieves, granulate, 40～80 ℃ of dryings add carboxymethyl starch sodium 6kg and magnesium stearate 2kg, mixing, 20 mesh sieve granulate are surveyed granule content, determine that sheet is heavy, tabletting, coating; Every contains Radix aconiti szechenyiani non-alkaloid 2mg.
2. the pharmaceutical composition of aconitum pendulum non-alkaloids active site is characterized in that this pharmaceutical composition is to be prepared by the following method:
Get the Radix aconiti szechenyiani pulverizing medicinal materials that is dried to constant weight, cross 16 mesh sieves, take by weighing 100g, add 2000mL water reflux, extract, 3h, cooling filters, and filtering residue adds 2000mL water reflux, extract, 3h again, extracts so repeatedly 2 times, merges 2 times and extracts filtrate; Concentrating under reduced pressure is 1.5～2 fluid extract to relative density; According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 30% ethanol elution is colourless that 30% ethanol be washed the position until eluent with concentration, is that 80% ethanol carries out eluting and wash the position until colourless 80% ethanol that gets of eluent with concentration at last.Get 1～2mL washing position respectively, the position washed by 30% ethanol and 80% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 30% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 80% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that aconitum pendulum non-alkaloids active site is that 80% ethanol is washed the position; To wash position, 30% ethanol more respectively washes position and 80% ethanol and washes the position to be evaporated to relative density be 1.5 extractum; According to tablet producing technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves; Take by weighing 0.2kg, starch 55kg and microcrystalline Cellulose 35kg, fully mixing, it is an amount of to add 10%PVP ethanol liquid, the system soft material, with soft material with 16～20 mesh sieves, granulate, 40～80 ℃ of dryings add carboxymethyl starch sodium 6kg and magnesium stearate 2kg, mixing, 20 mesh sieve granulate are surveyed granule content, determine that sheet is heavy, tabletting, coating; Every contains Radix aconiti szechenyiani non-alkaloid 0.2mg.
3. the pharmaceutical composition of aconitum pendulum non-alkaloids active site is characterized in that this pharmaceutical composition is to be prepared by the following method:
Get the Radix aconiti szechenyiani pulverizing medicinal materials that is dried to constant weight, cross 16 mesh sieves, take by weighing 100g, adding 500mLpH value is 2～6 aqueous acetic acid reflux, extract, 1h, and cooling filters, and filtrate decompression concentrates, and is 1.5～2 fluid extract to relative density; According to taking by weighing this fluid extract with the macroporous adsorbent resin identical weight, separate through macroporous adsorbent resin, elder generation's water carries out eluting must wash the position until eluent is colourless, the back is that 40% ethanol elution is colourless that 40% ethanol be washed the position until eluent with concentration, is that 100% ethanol carries out eluting and wash the position until colourless 100% ethanol that gets of eluent with concentration at last; Get 1～2mL washing position respectively, the position washed by 40% ethanol and 100% ethanol is washed the position, add 1～2 of bismuth potassium iodide test solution respectively, wherein washing position, 40% ethanol washes the alkaloid precipitation at position and orange-yellow flocculent deposit occurs, 100% ethanol is washed the position and orange-yellow flocculent deposit do not occurred, illustrates that aconitum pendulum non-alkaloids active site is that 100% ethanol is washed the position; To wash position, 40% ethanol more respectively washes position and 100% ethanol and washes the position to be evaporated to relative density be 1.5 extractum; According to capsule preparation technology, get aconitum pendulum non-alkaloids active site extractum, spray drying is crossed 80 mesh sieves.Take by weighing 0.2kg, pregelatinized Starch is an amount of, and fully mixing is filled in the Capsules; Every contains Radix aconiti szechenyiani non-alkaloid 0.2mg.
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| CN101036681A (en) * | 2007-04-11 | 2007-09-19 | 杨伯涛 | Analgesic aconitum flavum |
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