CN104644655A - Applications of 20(R)-ginsenoside Rg3 in preparation of drugs for releasing or/and treating insomnia, and drugs for releasing or/and treating insomnia - Google Patents
Applications of 20(R)-ginsenoside Rg3 in preparation of drugs for releasing or/and treating insomnia, and drugs for releasing or/and treating insomnia Download PDFInfo
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- CN104644655A CN104644655A CN201310590365.XA CN201310590365A CN104644655A CN 104644655 A CN104644655 A CN 104644655A CN 201310590365 A CN201310590365 A CN 201310590365A CN 104644655 A CN104644655 A CN 104644655A
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Abstract
The present invention discloses new applications of 20 (R)-ginsenoside Rg3 in preparation of drugs for releasing or/and treating insomnia. According to the present invention, experimental results prove that the insomnia treatment effect of the 20 (R)-ginsenoside Rg3 is significant, the effect is rapid, the toxic-side effect is low, the drug is the insomnia treatment drug with characteristics of safety, efficiency, stability and simple preparation process, and the method is suitable for industrial production and is easy to spread; and the new drug source is provided for prevention and treatment of the insomnia and complications thereof.
Description
Technical field
The present invention relates to the same field, relate to a kind of medicine or health food for the treatment of of insomnia patients, the particularly application of a kind of Chinese medicine Radix Ginseng extract component in improvement and/or Cure for insomnia disease drug or health food.
Background technology
Insomnia is (English: sleeplessness) i.e. sleep disorder.Show as difficulty falling asleep, intermittently discontinuous, and wake up prematurely, can not continue again to sleep after waking up, do not have enough sleep, malaise, asthenia is felt, how because health condition is not good, pain, do not feel like oneself, circadian rhythm is upset, sleep environment impact etc., also has and is afraid of sleep and insomnia.Can take appropriate measures according to different reasons.
Insomnia is due to feelings will, diet internal injury, or after being ill and old, innate deficiency, the causes of disease such as timidness due to deficiency of the heart, cause lack of preservation of spirit or irritability, thus cause often obtaining the class disease that ortho sleep is feature.Main manifestations is the length of one's sleep, the deficiency of the degree of depth and can not allaying tiredness, regain one's strength and energy, the lighter's difficulty falling asleep, or sleep but not soundly, sometimes sleeping and sometimes waking, or can not sleep again after waking up, heavy then be insomnia all night.
Insomnia is one of common clinical disease, though do not belong to critical illness, hinders people orthobiosis, work, study and health, and can increase the weight of or bring out the diseases such as cardiopalmus, the thoracic obstruction, dizzy, headache, apoplexy.Obstinate insomnia, brings long-term misery to patient, even form the dependence to sleeping medicine, and the sleeping medicine of long-term taking can cause iatrogenic disease.
Insomnia is called " unable to close the eyes ", " insomnia ", " must not crouch " in "Nei Jing", and thinks that to mainly contain two kinds: one be other disorders affect to insomnia reason, as cough, vomiting, abdominal distention etc., makes people must not peacefully sleeping; Two is that negative and positive of qi and blood is become estranged, and people can not be fallen asleep.
Medicinal herbs most in use in Radix Ginseng Chinese medicine, modern medicine study shows that the primary efficacy of Radix Ginseng and effect have: for the effect of central nervous system, anticancer antitumor action, Immunologic Functions, diabetes effect, strengthens liver function effect, and cardiovascular and cerebrovascular vessel obstacle improves, arteriosclerosis effect, Blood pressure regulation, and climacteric obstacle and function of resisting osteoporosis, resisting fatigue, antioxidation, suppresses aging etc.Ginsenoside is as the principle active component of Radix Ginseng, be widely studied and use, wherein noticeable with 20 (R)-ginsenoside Rg3s, it is as the principle active component of Radix Ginseng, safety is good, has been made into improve immunologic function, resisting fatigue and antitumor oral drugs or health product are widely used in clinical.
The present inventor is by a large amount of modern scientific researches, adopt advanced separating and purifying technology from ginseng crude drug, extract effective ingredient 20 (the R)-ginsenoside Rg3 of its treatment of insomnia patients, the medicine or health product with good hypnotic effect can be provided for insomniac.
Summary of the invention
Primary and foremost purpose of the present invention is to provide 20 (R)-ginsenoside Rg3s and alleviates or/and the performance of Cure for insomnia disease and effect, and provide 20 (R)-ginsenoside Rg3s new pharmaceutical usage, the new opplication namely in the medicine treating, nurse one's health and alleviate insomnia or health food.
For achieving the above object, one aspect of the present invention provides a kind of 20 (R)-ginsenoside Rg3s to alleviate or/and application in Cure for insomnia disease drug or health product in preparation.
Have in the process of the active skull cap components for the treatment of of insomnia patients effect in screening, inventor finds that in the chemical composition of Radix Ginseng, 20 (R)-ginsenoside Rg3s have the effect of strong suppression insomnia.
Wherein, described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
Wherein, 20 described (R)-ginsenoside Rg3 content are 1% ~ 98%; Be preferably 30 ~ 80%, more preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, pharmaceutically acceptable carrier is used for this purpose by sanitarian's accreditation and usually as the non-active ingredient of medicament.About pharmaceutically acceptable carrier compilation can (Handbook of Pharmaceutical excipients, be edited by A.Wade and P.J.Weller by the 2nd edition in " handbook of pharmaceutical excipients "; American Pharmaceutical Association publishes, Washington and The PharmaceuticalPress, London, 1994) etc. find in reference book.
Especially, described carrier comprises excipient, as starch, water etc.; Lubricant, as magnesium stearate etc.; Disintegrating agent, as microcrystalline Cellulose etc.; Filler, as lactose etc.; Binding agent, as pregelatinized Starch, dextrin etc.; Sweeting agent; Antioxidant; Antiseptic, correctives, spice etc.;
Wherein, described medicine exists with tablet, capsule, pill, powder, granule, syrup form.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
The present invention provides on the other hand a kind of alleviation containing 20 (R)-ginsenoside Rg3s or/and the medicine of Cure for insomnia disease or health product.
Wherein, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably 1% ~ 98%; Be preferably 30 ~ 80%, be further preferably 60%.
Particularly, 20 described (R)-ginsenoside Rg3 content >=1%, are preferably >=30%, more preferably >=60%, be further preferably >=80%, be more further preferably >=98%.
Particularly, the described weight of 20 (R)-ginsenoside Rg3s is 0.01-10:100 with the ratio of the gross weight of described external preparation, is preferably 0.1 ~ 10:100, more preferably 1 ~ 10:100.
Particularly, Semen Ziziphi Spinosae, Semen oryzae sativae, Radix Glycyrrhizae, Radix Polygalae, Semen Nelumbinis, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant thereof is also comprised in described medicine or health product.
Described medicine can adopt method well known in the art to make various dosage form, as tablet, capsule, pill, powder, granule, syrup etc.
Present invention also offers a kind of method of Cure for insomnia disease, comprise the pharmaceutical composition giving 20 (the R)-ginsenoside Rg3s treating effective dose to experimenter, its treatment effective dose is 0.06 ~ 12mg/kg.d, be preferably 1 ~ 6mg/kg.d, more preferably 1.5 ~ 3mg/kg.d.
Unless otherwise indicated, term used herein " treatment effective dose " is for needing the consumption of the medicine producing useful effect; " treatment effective dose " can adjust and change, and is finally determined by medical worker, and its factor considered comprises character and the order of severity of the character of route of administration and preparation, the ordinary circumstance such as body weight, age of receiver and institute's disease therapy.
Compared with prior art, the present invention has following obvious advantage:
1, the present invention has excavated new medical value to known compound 20 (R)-ginsenoside Rg3, use it for alleviation, treatment of insomnia patients, and alleviation and/or the medicine for the treatment of of insomnia patients or health food can be prepared into, thus open up a new field for the application of ginseng crude drug.
2, campaign of the present invention research proof 20 (R)-ginsenoside Rg3 has effect of significant alleviation, treatment of insomnia patients, can length of one's sleep of significant prolongation insomniac, significantly improves sleep quality.
3,20 (R)-ginsenoside Rg3 pharmacological actions of the present invention are strong, for alleviate, nurse one's health and treatment of insomnia patients effect significantly, instant effect, toxic and side effects are little, safety good, can long-term taking, have good prospect in medicine.
4, product preparation process of the present invention is simple, can be made into various dosage form, and dosing is little, easy to use, is therefore easy to promote.
5, the present invention both can adopt 20 (R)-ginsenoside Rg3 active fraction preparations alleviations of single component and the medicine for the treatment of of insomnia patients, 20 (R)-ginsenoside Rg3s and other active component (Semen Ziziphi Spinosae, Semen oryzae sativae, Radix Glycyrrhizae, Radix Polygalae, Semen Nelumbinis, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant) thereof common prescription can be adopted again, prepare the compound medicine for the treatment of of insomnia patients.
Detailed description of the invention
Further describe the beneficial effect of formula of the present invention below by detailed description of the invention, these embodiments include 20(R of the present invention) capsule of-ginsenoside Rg3, tablet, soft capsule pharmacodynamics test.These embodiments are only exemplary, do not form any restriction to scope of the present invention.It will be understood by those skilled in the art that and do not departing under formula thinking of the present invention, purposes scope and can modify to the details of technical solution of the present invention and form or replace, but these amendments and replacement all fall within the scope of protection of the present invention.
Embodiment 1Rg3 tablet
Rg3 tablet is prepared according to following proportioning:
Embodiment 2Rg3 capsule
Rg3 capsule is prepared according to following proportioning:
Ginsenoside Rg3's (content 98%) 100g
Starch 1000g
Make 10000
Embodiment 3Rg3 granule
Rg3 granule is prepared according to following proportioning:
Ginsenoside Rg3's (content 63%) 300g
Starch 1000g
Make 10000 bags
Embodiment 4Rg3 tablet
Rg3 tablet is prepared according to following proportioning:
Embodiment 5Rg3 capsule
Rg3 capsule is prepared according to following proportioning:
Embodiment 6Rg3 granule
Rg3 granule is prepared according to following proportioning:
Embodiment 7Rg3 oral liquid
1, Rg3 oral liquid is prepared according to following proportioning:
2, get ginsenoside Rg3, Radix Polygoni Multiflori extract, Semen Sesami Nigrum extract, add deionized water to 100% with after dissolve with ethanol, to obtain final product.
Test example 120 (R)-ginsenoside Rg3 anti-insomnia pharmacodynamic experiment is studied
1 experiment material
1.1 medicines and reagent
20 (R)-ginsenoside Rg3s (purity > 98%), Dalian Fu Sheng natural drug development corporation, Ltd. produces, lot number: 20120316; The standard control provided with Nat'l Pharmaceutical & Biological Products Control Institute also carries out HPLC mensuration, and content meets calibration value, and assay value is 98.2%.
Positive control drug: stable, pharmaceutical factory, Anhui BBCA Pharmaceuticals Co., Ltd. Tushan, lot number: 20120507.
Pentobarbital sodium: chemical experimental factory of Foshan City produces, lot number: 20120312.
1.2 instrument
Mice ambulatory activity count instrument: thing instrument (Beijing) Science and Technology Ltd., model: wi79243.
1.3 animal
Kunming mouse male and female half and half, body weight 15 ~ 20g, all purchased from Dalian Medical Univ's Experimental Animal Center, laboratory animal credit number: SCXK(the Liao Dynasty) 2004-0017.
2 experimental techniques
2.1Rg3 is on the impact of mice autonomic activities
Select Kunming mouse 110, body weight 18 ~ 22g, male and female half and half, are divided into 5 groups at random, i.e. blank group, the high, medium and low dosage group of Rg3, and positive drug stabilizes matched group, often organize 22.Gastric infusion: dosage is according to the conversion of adult's dosage, and Rg3 high dose is 6mg/kg, middle dosage is 3mg/kg, low dosage 1.5mg/kg; The dosage that positive drug stabilizes gastric infusion is 1mg/kg; The isopyknic tap water of blank group gastric infusion.Successive administration 5 days, after last administration 30 minutes, is placed in mice ambulatory activity count instrument, adapts to after 5 minutes by animal, record the movable number of times of mice in 10 minutes.Every treated animal divides 11 countings, 2/time, and the counting that hockets between each group is observed.
2.2Rg3 is on the impact of pentobarbital sodium induced mice sleep effect
Kunming mouse 7O only, body weight 18 ~ 22g, male and female half and half, be divided into 5 groups at random, often organize 14, according to such as 2.1 method administrations, after last administration 30 minutes, by weight lumbar injection pentobarbital sodium inj (0.04g/kg), then with righting reflex loss or revert to index, observed and recorded mice time for falling asleep and the length of one's sleep.
3. experimental result
3.1Rg3 is on the impact of mice autonomic activities
Experimental result is as shown in table 1, and result of the test shows: Rg3 can make mice autonomic activities number obviously reduce, and compares, have significant difference with blank group, and Rg3 high dose group organizes therapeutic equivalence with stable.
Table 1Rg3 is on the impact (X ± s) of mice autonomic activities
Note: compare with blank group, middle dosage group P<0.05, high dose group P<0.01.
3.2Rg3 is on the impact of pentobarbital sodium induced mice sleep effect
Experimental result is as shown in table 2, result of the test shows: Rg3 obviously can shorten the time for falling asleep after injected in mice pentobarbital sodium, extend its length of one's sleep simultaneously, show that rg3 can be calm and strengthen pentobarbital sodium to the central inhibitory action of mice, the therapeutic equivalence of dosage group and stable matched group in Rg3, the curative effect of Rg3 high dose group is better than stable matched group.
Table 2Rg3 is on the impact (X ± s) of pentobarbital sodium induced mice sleep effect
Note: compare with blank group, middle dosage group * P<0.05, high dose group * * P<0.01.
Claims (10)
1.20 (R)-ginsenoside Rg3s for the preparation of alleviating or/and application in the medicine for the treatment of of insomnia patients or health product.
2. application according to claim 1, is characterized in that described medicine is made up of 20 (R)-ginsenoside Rg3s and pharmaceutically acceptable carrier.
3. application according to claim 1 and 2, is characterized in that described medicine exists with tablet, capsule, pill, powder, granule, syrup, solution form.
4. application according to claim 1 and 2, is characterized in that content >=1% of 20 described (R)-ginsenoside Rg3s.
5. application according to claim 4, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is 1% ~ 98%.
6. alleviate or/and the medicine of Cure for insomnia disease or health product, it is characterized in that containing 20 (R)-ginsenoside Rg3s.
7. medicine according to claim 6, is characterized in that the ratio of the gross weight of the weight of described 20 (R)-ginsenoside Rg3s and described medicine or health product is 0.01-10:100.
8. medicine according to claim 6, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is >=1%.
9. medicine according to claim 8, is characterized in that the content of 20 described (R)-ginsenoside Rg3s is 1% ~ 98%.
10. medicine according to claim 6, is characterized in that also comprising Semen Ziziphi Spinosae, Semen oryzae sativae, Radix Glycyrrhizae, Radix Polygalae, Semen Nelumbinis, Semen Sesami Nigrum extract, Rhizoma Zingiberis Recens extract, Semen Vitis viniferae extract, Semen Granati extract, plants essential oil, arbutin, vitamin C and derivant thereof or vitamin E and derivant thereof.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111358803A (en) * | 2020-04-24 | 2020-07-03 | 陕西巨子生物技术有限公司 | Pharmaceutical composition containing rare ginsenoside Rg6 and F4 for improving sleep |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947704A (en) * | 2006-08-30 | 2007-04-18 | 富力 | Medicinal water-soluble compositions contg. 20(R)-ginsenoside (Rg3), and its prepn. method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947704A (en) * | 2006-08-30 | 2007-04-18 | 富力 | Medicinal water-soluble compositions contg. 20(R)-ginsenoside (Rg3), and its prepn. method |
Non-Patent Citations (1)
| Title |
|---|
| BYUNG-HWAN LEE 等: "Ginsenoside Rg3 regulates GABAA receptor channel activity：Involvement of interaction with the r2 subunit", 《EUROPEAN JOURNAL OF PHARMACOLOGY》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111358803A (en) * | 2020-04-24 | 2020-07-03 | 陕西巨子生物技术有限公司 | Pharmaceutical composition containing rare ginsenoside Rg6 and F4 for improving sleep |
| CN111358803B (en) * | 2020-04-24 | 2021-05-07 | 陕西巨子生物技术有限公司 | Pharmaceutical composition containing rare ginsenoside Rg6 and F4 for improving sleep |
| WO2021213502A1 (en) * | 2020-04-24 | 2021-10-28 | 陕西巨子生物技术有限公司 | Sleep-improving pharmaceutical composition containing rare ginsenosides rg6 and f4 |
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