CN101244060A - Leonurus heterophyllus alkaloid composition and method of preparing the same - Google Patents
Leonurus heterophyllus alkaloid composition and method of preparing the same Download PDFInfo
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- CN101244060A CN101244060A CNA2007100802407A CN200710080240A CN101244060A CN 101244060 A CN101244060 A CN 101244060A CN A2007100802407 A CNA2007100802407 A CN A2007100802407A CN 200710080240 A CN200710080240 A CN 200710080240A CN 101244060 A CN101244060 A CN 101244060A
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- herba leonuri
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- leonurine
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Abstract
The invention relates to a leonurus-japonicus alkaloid composition, belonging to the technical field of pharmacy; wherein, the proportion of the parts by weights of stachydrine and leonurine is 10 to 20:1; and both of stachydrine and leonurine have synergistic interaction and better pharmacologic effects.
Description
Technical field
The invention belongs to the pharmaceutical technology field, relate to a kind of Herba Leonuri alkaloid composition specifically.
Technical background
Herba Leonuri (Herba leonuri) is the fresh or dry aerial parts of labiate Herba Leonuri (Leonurus japonicus Houtt.), and the beginning is stated from Shennong's Herbal, another name Herba Leonuri Chinese mugwort, Herba vallisneriae Spiralis, Herba Leonuri etc., its acrid in the mouth, little hardship, cold nature.Return liver, pericardium channel, have promoting blood flow to regulate menstruation, the effect of inducing diuresis to remove edema.
Herba Leonuri has following main pharmacological: 1, to the effect in uterus.Herba Leonuri has stronger uteri excitation effect, can increase shrinkage amplitude, frequency and the tension force in uterus; 2, to cardiovascular effect.Herba Leonuri can be treated myocardial ischemia reperfusion injury; 3, antiplatelet aggregative activity; 4, reduce blood viscosity and resisting blood coagulation effect; 5, to the effect of kidney.Herba Leonuri has certain therapeutical effect to acute tubular necrosis; 6, to the effect of T, bone-marrow-derived lymphocyte, cellular immune function that can enhancing body.
Herba Leonuri is used for treatment of diseases such as menoxenia, silt in puerperal pain, cardiovascular and cerebrovascular disease, hematopathy clinically.And the alkaloids effective ingredient in the Herba Leonuri mainly comprises leonurine and stachydrine, is its main effective ingredient.
For the extraction of the alkaloid effective ingredient in the Herba Leonuri, document [An Weijian.The progress of Chinese medicine Herba Leonuri extracts active ingredients and assay method.The Tianjin pharmacy, 2003,15 (3): 68] report has: 1, pot group type dynamic countercurrent extraction; 2, supercritical extraction; 3, ultrasonic extraction; 4, method such as different solvents extraction.
20 in Chinese medicine promulgated by the ministries or commissions of the Central Government has been included the Herba Leonuri injection, and its method for making is: the Herba Leonuri water extract-alcohol precipitation, and activated carbon decolorizing obtains; Application number is the preparation method that the patent documentation of CN02148608.5 discloses a kind of Herba Leonuri total alkaloids, its preparation method is: Herba Leonuri extractum passes through storng-acid cation exchange resin after being dissolved in sour water, washing, ammonia solution and/or acid solution eluting, concentrating under reduced pressure, vacuum drying promptly gets Herba Leonuri total alkaloids, and content is greater than 50%; Application number is the patent documentation of CN02117432.6 extraction process of disclosing the Herba Leonuri total alkali and uses thereof, its extraction process is: the Herba Leonuri water extract-alcohol precipitation, acid solution is crossed storng-acid cation exchange resin, washing, the pickle adjust pH, concentrate extracts with high concentration ethanol, promptly gets Herba Leonuri total alkaloids; Application number is preparation method and the new medicine use thereof that the patent application document of CN02123967.3 discloses Herba Leonuri total alkaloids, its preparation method is: the Herba Leonuri water extract-alcohol precipitation, acid solution is crossed cation exchange resin, washing, acid solution or alkali liquor eluting concentrate, and are drying to obtain, alkaloid is greater than 50%, and stachydrine content is greater than 20%; Application number is the extraction process of the open class Herba Leonuri total alkali of patent documentation of CN03100594.2, its extraction process is: water is carried, behind the precipitate with ethanol, acidify upper prop, behind the 1-4% hydrochloric acid eluting with behind the sodium hydroxide neutralization/1-4% sulphuric acid eluting with quicklime or calcium hydroxide neutralization; Application number is that the open class fresh Herba Leonuri of the patent documentation of CN03118828.1 extracts Herba Leonuri total alkali technology and motherwort total alkali preparation, its extraction process is: extracting juice, precipitate with ethanol, filtration, acid solution peracidity cation exchange resin column, washing, pickling or alkali wash water are transferred neutral, concentrate drying, use ethanol extraction, concentrate, drying, promptly.
Above-mentioned preparation method generally adopts water extract-alcohol precipitation and the bonded method of storng-acid cation exchange resin that alkaloid is extracted and purification.Leonurine is the very strong alkaloid of alkalescence, directly with storng-acid cation exchange resin purification Herba Leonuri total alkaloids, for the strong leonurine of alkalescence is irreversible dead absorption, basic eluting does not get off, and makes only to contain in the final Herba Leonuri total alkaloids even not contain leonurine on a small quantity.
Summary of the invention
At the deficiencies in the prior art, research worker of the present invention has been prepared the Herba Leonuri alkaloid composition that contains stachydrine and leonurine through a large amount of experiments.The stachydrine in the Herba Leonuri alkaloid composition of the present invention and the weight part ratio of leonurine are 10-20: 1, and both have good synergistic effects.The Herba Leonuri alkaloid composition that obtains can be used for the preparation of various oral formulations and ejection preparation.
Technical problem to be solved by this invention just provides a kind of Herba Leonuri alkaloid composition that contains stachydrine and leonurine.
Herba Leonuri alkaloid composition of the present invention, the stachydrine wherein and the weight part ratio of leonurine are 10-20:, have good synergistic effects at 1 o'clock.
Preferably, above-mentioned Herba Leonuri alkaloid composition, the stachydrine wherein and the weight part ratio of leonurine are 12-16: synergistic function was obvious in 1 o'clock; The weight part ratio of stachydrine and leonurine is 15: 1 o'clock, has better synergistic function.
Will be according to the purity that prior art for preparing becomes higher leonurine and stachydrine, be 10-20 according to the weight part ratio of stachydrine and leonurine: 1 is mixed with mixture, also has good synergistic effects.
Preferably, will be according to the purity that prior art for preparing becomes higher leonurine and stachydrine, be 12-16 according to the weight part ratio of stachydrine and leonurine: 1, be mixed with mixture in more preferably 15: 1, have better synergistic function.
The pure product of stachydrine can be according to document [He Liqin, Wang Xiaoshan.The synthesising process research of stachydrine.The West China pharmaceutical journal.2005,20 (1): 50-51] method in is synthetic.
The pure product of leonurine can be that method in the CN02138364.2 patent documentation is synthetic according to application number.
Described Herba Leonuri alkaloid composition can be prepared into oral formulations and ejection preparation; Wherein oral formulations comprises tablet, capsule, pill, syrup, granule, oral solution, oral suspensions or Orally taken emulsion, and ejection preparation comprises small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder.
Also contain pharmaceutically acceptable pharmaceutic adjuvant in the pharmaceutical preparation of described Herba Leonuri alkaloid composition.
Be used to regulate the isoosmotic adjusting agent of osmotic pressure, be usually used in intravenous injection and infusion solutions, for example, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, sodium lactate, glucose, xylitol, sorbitol and dextran etc. are preferably sodium chloride and/or glucose.Can add excipient in the powder pin, for example, mannitol, glucose etc.
In tablet, can add filler, wetting agent, binding agent, disintegrating agent, lubricant etc. as required.Filler can be starch, microcrystalline Cellulose, pregelatinized Starch etc.Wetting agent can be water and/or ethanol.Binding agent can be polyvidone, starch slurry, cellulose etc.Disintegrating agent can be polyvinylpolypyrrolidone, CC-Na, starch or CMC-Na etc.Lubricant can be Pulvis Talci, stearic acid, magnesium stearate calcium, magnesium stearate etc.
In granule, can add filler, wetting agent, binding agent etc. as required.
Can add antiseptic, correctives in the solution type liquid agent.
Also should add dense aqueous sucrose solution in the syrup.
Can add suspending agent, wetting agent, flocculating agent etc. as required in the suspensoid.Suspending agent can be arabic gum, sodium alginate, agar, polyvidone, cellulose family, carbopol, sodium acrylate.
Can add emulsifying agent, antiseptic, correctives etc. in the Orally taken emulsion.
The used in the preparation Herba Leonuri medical material of Herba Leonuri alkaloid composition of the present invention must meet " the pertinent regulations under Chinese pharmacopoeia version Herba Leonuri in 2005 the medical material item.
Above-mentioned Herba Leonuri alkaloid composition can also adopt the preparation method of using weak-acid cation-exchange resin, storng-acid cation exchange resin, neutral alumina purification Herba Leonuri extracting solution successively to obtain.
Specifically, the preparation method of above-mentioned Herba Leonuri alkaloid composition may further comprise the steps:
(1) weak-acid cation-exchange resin purification; With weak-acid cation-exchange resin post on the Herba Leonuri extracting solution, water is eluted to colourless, and it is standby to collect water lotion; Reuse 2%-5% ammonia spirit eluting is collected the ammonia eluent, merges, and obtains eluent A;
(2) storng-acid cation exchange resin purification; It is to go up strong acid cation exchange resin column behind the 1-3 that above-mentioned reserve liquid is acidified to pH value, be washed to colourless after, discard; Reuse 2%-5% ammonia spirit or ammonia: ethanol (20: 80) eluant solution, collect eluent, merge, obtain eluent B;
(3) neutral alumina column purification; Above-mentioned eluent A and eluent B are merged, and it is neutral regulating pH value, concentrates, and drying is used 95% dissolve with ethanol, crosses the neutral alumina post, uses 95% ethanol elution, collects eluent, concentrates, and drying promptly gets the Herba Leonuri alkaloid composition.
Above-mentioned Herba Leonuri extracting solution can be by adopting decoction and alcohol sedimentation technique or ethanol extract from water precipitation or acid extraction method to obtain the Herba Leonuri medical material.
Certainly, above-mentioned Herba Leonuri extracting solution also can obtain by methods such as the pot group type dynamic countercurrent extraction method in the open source literature, super critical extraction, ultrasonic extraction.
In particular, above-mentioned Herba Leonuri extracting solution can adopt following any one method preparation:
(1) with the Herba Leonuri pulverizing medicinal materials, the alcoholic solution reflux, extract, of the 60%-95% that doubly measures with 10-15 1-3 time, each 1-2 hour, merge extractive liquid, filters, after filtrate decompression is concentrated into and does not have the alcohol flavor, add entry to medical material: solution is 1: 1, and is centrifugal, and supernatant is extracting solution;
(2) with the Herba Leonuri pulverizing medicinal materials, the water boiling and extraction of doubly measuring with 10-15 1-3 time, each 1-2 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into medical material: solution is 1: 1, adds ethanol and makes that determining alcohol is 70%-90%, leaves standstill, filter, filtrate decompression is concentrated into medical material: solution is 1: 1, leaves standstill, and supernatant is extracting solution;
(3) with the Herba Leonuri pulverizing medicinal materials, sour water with 10 times of amounts decocts extraction 1-3 time, and each 1-2 hour, merge extractive liquid,, filter, filtrate decompression is concentrated into medical material: solution is 1: 1, and adjust pH is 70%-90% for neutral back adding ethanol makes determining alcohol, leaves standstill, filter, filtrate decompression is concentrated into medical material: solution is 1: 1, and is centrifugal, and supernatant is extracting solution; Sour water wherein is hydrochloric acid or vitriolic aqueous solution, and pH value is 1-3.
Above-mentioned weak-acid cation-exchange resin can be a kind of in the D151 of Nankai type, Nankai's 101 types.
Above-mentioned storng-acid cation exchange resin can be a kind of in Nankai's 001 * 1 type, Nankai's 001 * 2 type, Nankai's 001 * 3 type, Nankai's 001 * 14.5 type, D151 type, D018 type, D019 type, D020 type, YWD12V type, nuclear Yadong 732 types.
Containing in the Herba Leonuri alkaloid composition of the present invention mainly in the Herba Leonuri has effective alkaloid---leonurine and a stachydrine, and both have the effect of Synergistic, thereby have better therapeutical effect.
Herba Leonuri alkaloid composition of the present invention has following main pharmacological: 1, to the effect in uterus.Have stronger uteri excitation effect, can increase shrinkage amplitude, frequency and the tension force in uterus; 2, to cardiovascular effect.Can treat myocardial ischemia reperfusion injury; 3, antiplatelet aggregative activity; 4, reduce blood viscosity and resisting blood coagulation effect; 5, to the effect of kidney.Acute tubular necrosis there is certain therapeutical effect; 6, to the effect of T, bone-marrow-derived lymphocyte, cellular immune function that can enhancing body.
Herba Leonuri alkaloid composition of the present invention is used for treatment of diseases such as menoxenia, silt in puerperal pain, cardiovascular and cerebrovascular disease, hematopathy clinically.
For the effect of verifying that stachydrine in the Herba Leonuri alkaloid composition of the present invention and leonurine have Synergistic, research worker of the present invention has been carried out pharmacological experiment to the influence of rat endometrium dystopy disease to it.
Positive control drug is according to document [He Liqin, Wang Xiaoshan.The synthesising process research of stachydrine.The West China pharmaceutical journal.2005,20 (1): 50-51] method in is synthesized stachydrine, and purity is 97.4%; According to application number is the synthetic leonurine of method in the CN02138364.2 patent documentation, and purity is 99.2%.Medicine of the present invention is the described compositions of embodiment 1-5.
Get female sd inbred rats, random packet, 10 every group.Be followed successively by 1 group-5 groups of normal group, model group, positive controls, the present invention.Except that normal group, all the other each treated animals are selected rutting period, set up the EMT animal model.With rat with 3% pentobarbital sodium 40mg/kg intraperitoneal injection of anesthesia, do a vertical incision in the lower abdomen center, choose the right side cornua uteri, the uterus of excision 7mm, separating uterus inner membrance in normal saline, get the intrauterine diaphragm of 3mm * 3mm size, make its superficial epithelium facing to stomach wall, four jiaos are sewed up with abdominal wall muscle, and the uterus butt joint of right side dialysis is sewed up, the conventional abdomen that closes is sterilized, and injection penicillin 10,000 units/kg.Sham operated rats only hysterectomizes, not with its dystopy.Every day is timing gastric infusion (0.5g/kg) according to dosage, and successive administration was got blood to rat eye socket posterior vein after 1 month, and separation of serum is used radioimmunoassay method E
2Level is observed different Herba Leonuri total alkaloidss to endometriosis rat gonadal hormone E
2Influence.The results are shown in Table 3.
Table 3 Herba Leonuri alkaloid composition is to endometriosis rat gonadal hormone E
2Influence
Annotate:
*Expression and model group compare: P＜0.01.
By above-mentioned experimental result as can be seen: the E of endometriosis rat
2Tangible rising is arranged; Positive controls and 1-5 of the present invention organize in administration after 1 month, for E
2Rising tangible reduction effect is all arranged; And 1-5 group of the present invention is for E
2The reduction effect obviously be better than positive controls, especially best with 1 group of the present invention's effect.The effect that stachydrine in the Herba Leonuri alkaloid composition of the present invention and leonurine have good Synergistic is described, pharmacological effect is better than stachydrine under identical dosage; And when the weight portion proportioning of stachydrine in the Herba Leonuri alkaloid composition of the present invention and leonurine was 15: 1, effect was best.
The specific embodiment
Further describe the present invention with embodiment below, help understanding, but described embodiment only is used to illustrate the present invention rather than restriction the present invention the present invention and advantage thereof, better effects if.
Embodiment 1-5
According to document [He Liqin, Wang Xiaoshan.The synthesising process research of stachydrine.The West China pharmaceutical journal.2005,20 (1): 50-51] method in is synthesized stachydrine, and purity is 97.4%.According to application number is the synthetic leonurine of method in the CN02138364.2 patent documentation, and purity is 99.2%.
| Embodiment | The weight portion proportioning of stachydrine and leonurine |
| Embodiment 1 | 15∶1 |
| Embodiment 2 | 20∶1 |
| Embodiment 3 | 16∶1 |
| Embodiment 4 | 12∶1 |
| Embodiment 5 | 10∶1 |
Embodiment 6
With the Herba Leonuri pulverizing medicinal materials, with 70% alcoholic solution reflux, extract, of 12 times of amounts 3 times, each 1.5 hours, merge extractive liquid, filtered, and after filtrate decompression was concentrated into and does not have the alcohol flavor, add entry to medical material: solution is 1: 1, and was centrifugal, and supernatant is the Herba Leonuri extracting solution.
With the D151 of Nankai type weak-acid cation-exchange resin post on the Herba Leonuri extracting solution, water is eluted to colourless, and it is standby to collect water lotion; Reuse 5% ammonia spirit eluting is collected the ammonia eluent, merges, and obtains eluent A.
It is that Nankai's 001 * 2 type strong acid cation exchange resin column is gone up in 1 back that above-mentioned reserve liquid is acidified to pH value, be washed to colourless after, discard; Reuse 3.5% ammonia spirit eluting is collected eluent, merges, and obtains eluent B.
Above-mentioned eluent A and eluent B are merged, and it is neutral regulating pH value, concentrates, and drying is used 95% dissolve with ethanol, crosses the neutral alumina post, uses 95% ethanol elution, collects eluent, concentrates, promptly.
Claims (5)
1. a Herba Leonuri alkaloid composition is characterized in that, the stachydrine wherein and the weight part ratio of leonurine are 10-20: 1.
2. Herba Leonuri alkaloid composition according to claim 1 is characterized in that, the stachydrine wherein and the weight part ratio of leonurine are 12-16: 1.
3. Herba Leonuri alkaloid composition according to claim 2 is characterized in that, the stachydrine wherein and the weight part ratio of leonurine are 15: 1.
4. according to the described Herba Leonuri alkaloid composition of one of claim 1-3, it is characterized in that, can be prepared into oral formulations and ejection preparation; Wherein oral formulations comprises tablet, capsule, pill, syrup, granule, oral solution, oral suspensions or Orally taken emulsion, and ejection preparation comprises small-volume injection, bulk capacity injection, injectable powder and lyophilized injectable powder.
5. according to the described Herba Leonuri alkaloid composition of claim, it is characterized in that, also contain pharmaceutically acceptable pharmaceutic adjuvant in the described pharmaceutical preparation.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103073474A (en) * | 2012-12-13 | 2013-05-01 | 大兴安岭林格贝有机食品有限责任公司 | Manufacturing technology for leonurus stachydrine |
| WO2019196835A1 (en) * | 2018-04-09 | 2019-10-17 | 青岛海洋生物医药研究院股份有限公司 | Proline derivative and application thereof in preparing drug for treating cardiovascular and cerebrovascular disease |
| CN111374967A (en) * | 2018-12-29 | 2020-07-07 | 复旦大学附属妇产科医院 | Application of leonurine in preparation of medicine for improving infertility pregnancy outcome |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1364468A (en) * | 2001-01-19 | 2002-08-21 | 赵国林 | Wall breaking and extracting method for Chinese herbal medicine and formulation |
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2007
- 2007-02-15 CN CN2007100802407A patent/CN101244060B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103073474A (en) * | 2012-12-13 | 2013-05-01 | 大兴安岭林格贝有机食品有限责任公司 | Manufacturing technology for leonurus stachydrine |
| CN103073474B (en) * | 2012-12-13 | 2016-06-01 | 大兴安岭林格贝寒带生物科技股份有限公司 | The production technique of a kind of Motherwort Herb stachydrine |
| WO2019196835A1 (en) * | 2018-04-09 | 2019-10-17 | 青岛海洋生物医药研究院股份有限公司 | Proline derivative and application thereof in preparing drug for treating cardiovascular and cerebrovascular disease |
| CN110357800A (en) * | 2018-04-09 | 2019-10-22 | 青岛海洋生物医药研究院股份有限公司 | Proline derivative and its application in preparation treatment cardiovascular and cerebrovascular diseases medicament |
| CN110357800B (en) * | 2018-04-09 | 2022-07-26 | 青岛海生洋润生物科技有限公司 | Proline derivative and application thereof in preparing medicine for treating cardiovascular and cerebrovascular diseases |
| CN111374967A (en) * | 2018-12-29 | 2020-07-07 | 复旦大学附属妇产科医院 | Application of leonurine in preparation of medicine for improving infertility pregnancy outcome |
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