CN1355028A - Medicine prepared from extract of pubescent holly root for treating erection disfunction and preparing process thereof - Google Patents
Medicine prepared from extract of pubescent holly root for treating erection disfunction and preparing process thereof Download PDFInfo
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- CN1355028A CN1355028A CN 00127593 CN00127593A CN1355028A CN 1355028 A CN1355028 A CN 1355028A CN 00127593 CN00127593 CN 00127593 CN 00127593 A CN00127593 A CN 00127593A CN 1355028 A CN1355028 A CN 1355028A
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Abstract
A medicine in the form of particles, capsule, table, oral liquid or injection for treating erection disfunction is prepared from the extract of pubescent holly root (5-80%) and medicinal additive (20-95%). Its advantages include high curative effect, no any toxic by-effect and low cost.
Description
The present invention relates to the Chinese medicine preparation preparation method, be specifically related to a kind of Radix Ilicis Pubescentis extract preparation and preparation method for the treatment of disorder of erection function.
In history male sexual dysfunction is referred to as " sexual impotence ".Medical circle changes and is called " erection disturbance " in recent years, and English is Erectile Dysfunction, is called for short ED.The method of treatment ED is a lot, at present, clinically based on physical therapy and Drug therapy, and more welcome in the Drug therapy with oral drugs.Citric acid former times polyphenol (Sildenafil citrate, commodity are called Viagra, are commonly called as viagra) is former to be the anginal new drug of treatment of Pfizer Inc.'s exploitation in 1992, in clinical trial, its curative effect to treat angina pectoris is average, and evident in efficacy to ED, is a kind of arteria penis expander.Through declaring new purposes again, U.S. FDA is in March, 1997 approval listing.At present, this medicine be generally acknowledge in the world, successful ED medicine.Bayer, the Schering-Plough of Germany and Zonagen lnc. and Eli Lily and ICOS Corp. are also at cooperative development ED medicine.Can expect that the product that is similar to viagra in a few years from now on will go on the market in succession.
Although viagra rapid-action, effective percentage is higher, gets consumer reception, its is same to exist weakness that other synthetic drug had.The report that 500 many cases death have been arranged in 2 years since listing in succession is so medical circle thinks that viagra has toxicity, side effect.Countries such as Britain take strict control to the sale of viagra, and concerning consumer, this is undoubtedly a kind of negative effect.Obviously, seek effect and be similar to viagra, and have no side effect or the medicine of low side effect, especially natural drug attracts tremendous attention.
Radix Ilicis Pubescentis (Ilex pubescens Hook.et Arm.) is a kind of southern evergreen shrubs of China that grows in, and is used as medicine with root etc.Be Chinese medicine, medicinal history is remote.The Radix Ilicis Pubescentis master contains compositions such as flavone, Saponin, and blood vessel dilating and antibacterial and anti-inflammation functions are arranged, and is mainly used in crown animal hardening heart disease, thromboangitis obliterans, central serous chorioretinopathy, infantile pneumonia etc.Up to the present, Radix Ilicis Pubescentis does not see that it has obvious poison, side reaction, does not more have the bibliographical information of treatment ED.
The objective of the invention is to provide a kind of Radix Ilicis Pubescentis extract preparation for the treatment of the high activity component content of disorder of erection function.
Granule, capsule, tablet, oral liquid and injection that the Radix Ilicis Pubescentis extract preparation of high activity component content disclosed by the invention is made up of 5～80% Radix Ilicis Pubescentis extract extractum and 95～20% pharmaceutic adjuvants, wherein Radix Ilicis Pubescentis extract contains total flavones and total Saponin 〉=50%.
Pharmaceutic adjuvant of the present invention is common medicinal supplementary material such as dextrin, starch, lactose, calcium carbonate, ethylene glycol, benzoic acid, sodium chloride, sucrose, sorbic acid, aspartame, cyclamate, citric acid, low-substituted hydroxypropyl cellulose, swollen speed, magnesium stearate, white carbon black, Pulvis Talci, titanium dioxide, modified starch, hydroxypropyl emthylcellulose, water, ethanol etc.
Another object of the present invention is the preparation method that will disclose above-mentioned Radix Ilicis Pubescentis extract preparation.
The preparation of Radix Ilicis Pubescentis extract preparation of the present invention comprises the following steps:
(1) preparation of active ingredient extractum
Exsiccant Radix Ilicis Pubescentis is cut into decoction pieces, add water or hydrophilic solvent that primary dose 10-20 doubly measures, flood after 2 hours, reflux, heat is carried 1-2 time, each 1 hour, after the cooling, left standstill 24 hours, filter, filtrate is not by being chromatographic column 1-2 time of carrier with the separating medium of ion-exchange group, water and water-pure mixed solvent eluting is collected eluent, concentrating under reduced pressure under＜60 ℃ of temperature again, make the extractum that contains total flavones and total Saponin 〉=50% after the drying, it is 1.5～3% that extractum extracts yield.
(2) contain the preparation of Radix Ilicis Pubescentis extract preparation
Get 5～80% above-mentioned active ingredient extractum and 95～20% pharmaceutic adjuvants routinely formulation method make granule, capsule, tablet, oral liquid and injection.
Hydrophilic solvent described in the inventive method is aliphatic lower alcohol or lower ketones; The separating medium with ion-exchange group is not macroporous adsorbent resin, silica gel, aluminium oxide, polyamides saddle silicon, kieselguhr, active carbon or cellulose etc., and these media can single use also can mix use.
Alcohol in water described in the inventive method-pure intermixture is aliphatic lower alcohol, and water is the arbitrary proportion of water: alcohol=99-1: 1-99 with the mixed proportion of alcohol.
A further object of the present invention is the application of open Radix Ilicis Pubescentis active ingredient extract formulation in treatment erection function sexual disorders disease.
Contain with of the present invention that Radix Ilicis Pubescentis active ingredient extract formulation carries out animal experiment and clinical research shows, the same with viagra, incubation period is significantly shortened (P＜0.01) in the erection of the basic, normal, high dosage group of Radix Ilicis Pubescentis extract castrated rats, and the rat penis significantly improves the irritability of outside stimulus after the administration.40 routine ED patients are after the pubescent holly root preparation treatment of a course of treatment, and clinical symptoms is clearly better, and international erection disturbance index significantly improves, and total effective rate is 82.5%.
The therapeutic dose of product of the present invention is the oral preparation that is equivalent to Radix Ilicis Pubescentis active ingredient extractum 1.5～3g every day, and taking 1 month continuously is 1 course of treatment.
Radix Ilicis Pubescentis is the root of Aquifoliaceae Ilicis Purpureae vegetable hair Ilicis Purpureae (Ilex pubescens Hook.Et Arn.), has blood circulation and channel invigorating, heat-clearing and toxic substances removing, the effect of reducing swelling and alleviating pain.Be Drugs for Cardiovascular Diseases, blood vessel dilating and antibacterial and anti-inflammation functions are arranged.This plant contains flavonoid, Saponin class, sterol, aminoacid, phenoloid, tannin, triterpenoid compound etc., and it is usually used in the treatment of coronary atherosclerotic heart disease, thromboangiitis obliterans, central serous chorioretinopathy and infantile pneumonia.
It is reported, former times the pharmacological action mechanism of polyphenol be, by suppressing phosphodiesterase-5 (PDE-5), reduce cyclic guanylic acid (cGMP) degraded, cause the diastole of cavernous body of penis vascular smooth muscle, blood flow increases, thereby makes erection.Our experimental result prompting, the existing effect to the penis blood vessel of the pharmacology mechanism of Radix Ilicis Pubescentis extract also may be passed through other approach onset.
Existing pubescent holly root preparation has tablet, capsule, injection etc., and used Radix Ilicis Pubescentis extract is aqueous extraction-alcohol precipitation technology, and some active ingredients are a large amount of the loss with the macromolecular compound precipitation, its main active ingredient total flavones＜30%.Technology of the present invention is that the water extract adsorbs through the post layer, and enrichment micromolecule effective ingredient then, with a certain proportion of alcohol solvent eluting, desorbing effective ingredient, after drying, is equipped with appropriate amount of auxiliary materials, makes tablet, capsule, granule or injection after the mixing.Post layer absorption method can overcome the loss of effective ingredient effectively, thereby improved content of effective in the extract.The content of main active ingredient flavone and Saponin is improved greatly, can reach 〉=50% level.
Carry out pharmacology and clinical trial with Radix Ilicis Pubescentis extract extractum of the present invention, concrete outcome is as follows: one, pharmacological testing () experiment material I animal: the SD rat, and male, body weight 180-200g, the quality certification number is provided by Shanghai west pul-Bi Kai company: Shanghai is moving closes the card word No. 152.The ICR mice, each 10 of male and female, body weight 18-22g is provided by Shanghai west pul-Bi Kai company, the quality certification number: Shanghai is moving closes the card word No. 153.Raising condition: raise by the inbred animal requirement.The II instrument: JL-B type electrostimulator Shanghai good dragon religion instrument factory makes.III medicine (I) Radix Ilicis Pubescentis extract powder: be the light brown yellow pulverulent solids, lot number: 20000428, water is made into the solution for standby of debita spissitudo during use.(II) testosterone propionate injection: Shanghai the 9th pharmaceutical factory; Lot number: 990401; Oleum Arachidis hypogaeae semen dilution back is standby.(III) citric acid former times polyphenol (Sildenafil citrate): purity 99.12% is configured to suspension with 1%CMC before using.(2) experimental technique and result 1, to the preclinical influence of castrated rats erection:
(4%, 40mg/kg ip) anaesthetizes sterilization skin of scrotum down to animal, extracts bilateral testes, postoperative intramuscular injection scotcil 20,000/kg at pentobarbital sodium.
The castration operation was divided into 6 groups at random with rat after 3 days.The third testis group subcutaneous injection androlin 1.25mg/1ml/kg makes positive control; 3 groups of administration groups are irritated stomach respectively and are given and Radix Ilicis Pubescentis extractum 0.15,0.45 and 1.35/10ml/kg; Model group is irritated stomach distilled water 10ml/kg.More than the equal successive administration of 5 treated animals 20 days, every day 1 time.The viagra group was given and citric acid former times polyphenol in the test precontract in 40 minutes, as positive control.Other gets 10 the not castrated rats raisings same period, as the normal control group.
7 treated animals are all on 21st, place rat penis position with the electrode of electrostimulator, give and local electricity irritation, and current intensity is 4mA.Record begins to the time (erecing incubation period) that penis erects from stimulation.
The result shows (seeing Table 1), under local electricity irritation effect, with the positive control androlin and former times polyphenol the same, incubation period is significantly shortened (P＜0.01) in the erection of the basic, normal, high dosage group of Radix Ilicis Pubescentis extractum castrated rats, and the rat penis significantly improves the irritability of outside stimulus after the administration.
Table 1 Radix Ilicis Pubescentis extractum influences group number of animals dosage incubation period to the erection of electricity irritation castrated rats is preclinical
(n) (mg/kg) (normal control group 10 5.50 ± 1.71* castration model group 8 26.13 ± 5.38 third testis group 9 1.25 4.80 ± 0.73* former times polyphenol groups 8 90 7.64 ± 1.32* administration group 9 150 12.77 ± 4.13* of mean ± SDs)
8 450 7.60±1.76*
8 1,350 6.42 ± 1.60**: compare P＜0.01 with the castration model group.2, to the influence of rat copulation:
1. female rats is prepared: get body weight and be 120 of the sexual maturity rats of 200-300g, male and female half and half.60 female rats under etherization, the row bilateral oophorectomy, postoperative intramuscular injection penicillin 20,000 U/kg, totally 3 days with infection.Oophorectomize two Zhou Houke experimentize.Only test before 48 hours subcutaneous injection estradiol benzoate 20 μ g/, only injected progesterone injection 500 μ g/ before 4 hours once more.
2. male rat is prepared: 60 male rats are divided into 6 groups at random, and every day, gastric infusion was 1 time, continuous 7 days.
3. mating test observational technique: male rat is put into 54.5 * 39.5 * 20cm cage separately, after it is conformed, every cage adds 1 female Mus, begin to clock and write down pounce on catch incubation period (be fed into male Mus from female Mus and pounce on the time of catching between the female Mus for the first time), ejaculation latency (be fed into male Mus from female Mus the time between the ejaculation for the first time takes place), male Mus pounces on the number of times of catching female Mus, the number of times of male Mus ejaculation in 20 minutes in 20 minutes.Above-mentioned observed result is carried out statistics (t-test between group) and is handled.
The result shows, with the blank group relatively, give with Radix Ilicis Pubescentis extract after, the pouncing on of rat catches incubation period and ejaculation latency obviously shortens, and pounces on to catch number of times and ejaculation frequency obviously increases.Especially the increase of ejaculation frequency has significance meaning (P＜0.01).Prompting: Radix Ilicis Pubescentis extract can improve libido and the mating ability of rat.
Table 2 Radix Ilicis Pubescentis extract is pounced on to catch to pounce on incubation period and is caught number of times ejaculation latency ejaculation frequency the drug dose number of animals that influences of rat copulation
(mg/kg) (n) (min) (inferior) (Min) (inferior) blank 9 2.73 ± 1.60 17.6 ± 9.6 7.92 ± 7.56 2.56 ± 2.19 former times polyphenol 30 8 2.24 ± 1.60 22.0 ± 10.4 3.56 ± 3.35 5.50 ± 4.81 Testosterone Propionate 68 0.56 ± 0.39
*23.5 ± 8.2 0.97 ± 0.50
*6.50 ± 3.63
*
120 9 1.65 ± 0.88 20.3 ± 5.6 2.70 ± 1.38 8.00 ± 3.50
*Radix Ilicis Pubescentis extract 240 9 2.00 ± 2.06 23.0 ± 6.5 3.25 ± 2.24 8.33 ± 4.90
*
480 8 2.49 ± 2.24 22.3 ± 12.9 2.96 ± 2.60 8.63 ± 5.15
* *: P＜0.05,
*: P＜0.01. two, Radix Ilicis Pubescentis acute toxicity tests of extractum
The healthy mice of selecting and weigh, each 10 of male and female are irritated stomach and are given Radix Ilicis Pubescentis extractum aqueous solution 0.4ml/10g with 54% concentration, and dosage is 21.6g/kg, is equivalent to 360 times of clinical dosage.Response situation behind the observation mouse stomach, continuous 7 days.
The result:after the administration diet of mice and activity all normal, animal dead is not also seen in the reaction of no abnormality seen in 7 days observation period.The toxicity of prompting Radix Ilicis Pubescentis extractum is lower.Three, clinical observation on the therapeutic effect (1) object and the method I object of observation of Radix Ilicis Pubescentis treatment penile erectile function obstacle:andropathy, age 20-59 year (average 39.65 ± 10.25 years old), course of disease January-17 year (average 3.35 ± 4.32 months) .The II administrated method:every day, oral extractum was 1 time, each 3.6g, and continuous 1 month was 1 course of treatment.III curative effect judging standard:according to international erectile dysfunction standard of index of Chinese medical discrimination (table 3) (table 4) etc.; Judge that criterion of therapeutical effect is as follows:the indifferent sexual desire of principal characteristic wish reduces that idol is sexual to be required the no couple of impotence ejaculation to have frequent outbreak to continue to occur the soreness and weakness of waist and knees idol to have outbreak repeatedly to show effect to continue to show effect in the table 3 differential diagnosis in tcm mild symptoms; It is One's spirits are drooping to be difficult for alleviating One's spirits are drooping lassitude; The international erectile dysfunction standard of index of table 4 slow in reacting standards of grading 0 minute 1 minute 2 minutes 3 minutes 4 minutes 5 minutes to obtain and keep very low in the Confidence of contour very high erection erected by sexual stimulus after without sexuality almost do not have or far fewer than approximately half more than half almost always how many times can insert when not having half or always sexual intercourse fully, how many times do not attempt almost not having or far fewer than approximately half more than half almost always can keep the erectile condition sexual intercourse do not have half fully or always keep erect until property do not attempt difficulty greatly the very large difficulty of difficulty have a few the or not friendship of difficulty finish degree of difficulty sexual intercourse sexual intercourse have how many times not have trial almost not have or far fewer than about half more than half almost always feel to satisfy sexual intercourse do not have fully half or always
Cure in the recent period: after a course of treatment, clinical symptom disappearance, erection is greater than 90 °, success rate of sexual intercourse＞70%, international erection disturbance index＞20.
Produce effects: after a course of therapy, clinical symptoms is obviously improved (more than the secondary), erection＞90 °, success rate of sexual intercourse＞50%, international erection disturbance index＞20.
Effectively: after a course of therapy, clinical symptoms takes a turn for the better, and erection has improvement, success rate of sexual intercourse＞25%.
Invalid: symptom does not have improvement.(2) I clinical efficacy as a result: through the treatment of a course of treatment, cure 8 examples, account for 20.0%; Produce effects 11 examples account for 27.5%; Effective 14 examples account for 35.0%; Invalid 7 examples account for 17.5%.Total effective rate is 82.5% (seeing Table 5).
40 8/20.0 11/27.5 14/35.0 7/17.5 33/82.5II clinical symptoms change are organized in the treatment of the clinical total effects of table 5 (routine %) group example number clinical recovery produce effects enabledisable total effective rate: after the treatment of a course of treatment, and patient's clinical symptoms be clearly better (seeing Table 6).Clinical symptoms change (example) before and after the table 6 40 routine patient treatments
The international erection disturbance index of treatment back P value libido unable 18 15＜0.05 soreness of the waist and knees, 15 3＜0.01 lethargy, the 27 12＜0.05III of indifferent 24 7＜0.01 ejaculation before the treatment
40 routine patients significantly improve (seeing Table 7) through treating the international dysfunction index that rises.
The international erection disturbance index variation of table 7 situation (mean ± SD)
Treatment back index score value 13.38 ± 6.36 22.48 ± 2.85** before treating: relatively preceding with treatment, P＜0.01.
The generation of ED is relevant with age growth, and investigation of the U.S. shows that among the male in 40-50 year, ED once took place 40% people; The male in 70-80 year then is 70%.But ED is not aged inevitable outcome, but other age-related disease comprises the result that psychosomatic disease causes.Estimate that recently the U.S. has 4,000 ten thousand ED patients approximately, the whole world has 100,000,000 above patients approximately.Can predict that with the quickening pace of modern life and social senilization, ED patient will increase year by year.
The present invention contain the active extractum of Radix Ilicis Pubescentis the preparation for treating disorder of erection function curative effect and former times polyphenol suitable, but life-time service is not found any toxic and side effects, is a kind of safe, inexpensive, reliable All Pure Nature medicine of curative effect, has huge social and economic benefit.
Embodiment 1,
Get Radix Ilicis Pubescentis decoction pieces 20kg, add water 200kg, heating, reflux, reflux, extract, 2 hours is emitted medicinal liquid, add water 150kg in the residue again, reflux, extract, 1 hour, merge extractive liquid, then, after partial concentration, cross one and the stainless steel column of macroporous resin (D-101) is housed (Φ 200 * 1000mm), after the washing of 10kg pure water, respectively with each the 20kg washing of 20%, 50% and 95% ethanol, collect 50% and 95% ethanol elution,, obtain extract 0.4kg through concentrated, dry.
Embodiment 2,
Get Radix Ilicis Pubescentis 10kg, add 50% ethanol 100kg, reflux 2 hours, emit medicinal liquid, add 50% ethanol 80kg in the residue again, reflux 2 hours, merge extractive liquid, then, after partial concentration, crossing one is equipped with the stainless steel column of polyamide (Φ 150 * 800mm), use 20%, 40% and 95% washing with alcohol successively, collect 95% ethanol elution, through concentrated, dry, obtain extract 0.2kg.
Embodiment 3,
Get the extract 1kg that embodiment 1 method obtains, in add lactose 0.75kg and starch 0.75kg, after fully mixing, cross 60 mesh sieves, dry-pressing is granulated then, granulate obtains evengranular granule 2.5kg, is packaged into bag, every bag is 1.5g.
Embodiment 4,
Get the extract 1kg that embodiment 2 methods obtain, in add dextrin 0.5kg, starch 0.5kg crosses 60 mesh sieves through fully mixing the back, wet granulation then, dry back filling capsule is made every capsule that weighs 0.4g.
Embodiment 5,
Get and add microcrystalline Cellulose 0.667kg, starch 0.333kg and swollen fast 0.167 in the extract 2kg that embodiment 1 method obtains, after fully mixing, cross dusting cover, granulate.In granule, add magnesium stearate and white each 33g of carbon black then, make 0.49 special-shaped tablets after the mixing, behind film coating, obtain heavily being the tablet of 0.5g.
Embodiment 6,
Get the extract 1kg that embodiment 1 method obtains, add the injection water and make every ml contain extract 50mg, regulate pH value, filtration, embedding, sterilization promptly get every 2ml dress injection.
Claims (6)
1, a kind of Radix Ilicis Pubescentis extract preparation for the treatment of disorder of erection function, it is characterized in that said preparation is by 5～80%, granule, capsule, tablet, oral liquid and injection that Radix Ilicis Pubescentis extract extractum and 95～20% pharmaceutic adjuvants are formed, wherein Radix Ilicis Pubescentis extract contains total flavones and total Saponin 〉=50%.
2, a kind of preparation method of Radix Ilicis Pubescentis extract preparation of treatment disorder of erection function as claimed in claim 1 is characterized in that this method comprises the following steps:
(1) preparation of active ingredient extractum
Exsiccant Radix Ilicis Pubescentis is cut into decoction pieces, add water or hydrophilic solvent that primary dose 10-20 doubly measures, flood after 2 hours, reflux, heat is carried 1-2 time, each 1 hour, after the cooling, left standstill 24 hours, and filtered, filtrate is not by being chromatographic column 1-2 time of carrier with the separating medium of ion-exchange group, water and water-pure mixed solvent eluting again, collect eluent, concentrating under reduced pressure under＜60 ℃ of temperature makes the extractum that contains total flavones and total Saponin 〉=50% after the drying;
(2) contain the preparation of Radix Ilicis Pubescentis extract preparation
Get 5～80% above-mentioned active ingredient extractum and 95～20% pharmaceutic adjuvants routinely formulation method make granule, capsule, tablet, oral liquid and injection.
3, a kind of preparation method of Radix Ilicis Pubescentis extract preparation of treatment disorder of erection function as claimed in claim 2 is characterized in that wherein said hydrophilic solvent is aliphatic lower alcohol or lower ketones.
4, a kind of preparation method of Radix Ilicis Pubescentis extract preparation of treatment disorder of erection function as claimed in claim 2, it is characterized in that wherein said is not macroporous adsorbent resin, silica gel, aluminium oxide, polyamides saddle silicon, kieselguhr, active carbon or cellulose etc. with the separating medium of ion-exchange group, and these media can single use also can mix use.
5, a kind of preparation method of Radix Ilicis Pubescentis extract preparation of treatment disorder of erection function as claimed in claim 2, it is characterized in that the alcohol in wherein said water-pure intermixture is aliphatic lower alcohol, water is the arbitrary proportion of water: alcohol=99-1: 1-99 with the mixed proportion of alcohol.
6, the application of a kind of Radix Ilicis Pubescentis extract preparation as claimed in claim 1 in the treatment disorder of erection function, it is characterized in that said preparation can be used for treating disorder of erection function, therapeutic dose is the oral preparation that is equivalent to Radix Ilicis Pubescentis active ingredient extractum 1.5～3g every day, and taking 1 month continuously is 1 course of treatment.
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| CN101474381B (en) * | 2009-01-10 | 2011-10-26 | 广东顺峰药业有限公司 | Medicament for treating acute and chronic rhinitis as well as preparation method thereof and nasal cavity medicine delivery device |
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| CN101474381B (en) * | 2009-01-10 | 2011-10-26 | 广东顺峰药业有限公司 | Medicament for treating acute and chronic rhinitis as well as preparation method thereof and nasal cavity medicine delivery device |
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