CN101244066B - New purpose of total steroidal saponin extract - Google Patents
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Abstract
The invention provides a new use of steroid total saponin extracts, in particular to a use for preparing a drug for curing heart neurosis. The invention also provides a drug composition for curing heart neurosis. The inventor finds that the steroid total saponin extracts have obvious function for curing heart neurosis, improving patient clinical symptoms, and provides a new, outstanding therapeutic effect drug selection through experimental studies, and has good economic and social benefits.
Description
Technical field
The present invention relates to the new pharmaceutical use of total extractives of steroid saponin, total extractives of steroid saponin is used for the treatment of purposes in the heart neurosis medicine in preparation specifically, belongs to technical field of Chinese medicines.
Background technology
Heart neurosis, once satisfactory nervus vasculairs disease, heart neurosis, functional heart discomfort etc., subjective symptom is not normal based on systema cariovasculare functional, merges the obstacle of psychological aspects, is neurosal a kind of specific type.Occur in the youth and the prime of life mostly, see at most with 20～40 years old person.The women is more than the male, and especially climacteric women sees, main suit's symptom is many and disperse, and (but the position is often fixing, and sustainable several seconds or a few hours are not waited to see cardiopalmus, dyspnea, precordial pain; How pain outbreak takes place when tranquillization with movable irrelevant, and the buccal nitroglycerin is invalid), fatigue and weak, and the symptom of some autonomic nervous dysfunctions,, two hand tremors cold, frequent micturition etc. as hyperhidrosis, brothers.With symptom occur more opposite be that health check-up often lacks positive sign, no organic heart disease foundation on the pathology.
At present the cause of disease about heart neurosis it be unclear that, and thinking may be relevant with body constitution, nerve, behavior, periphery environment, inherited genetic factors.Patient's neurotypes often is a weak type, and morbidity has clear and definite risk factor mostly, is upset in spirit or works when nervous, often can not make own this environment of adaptation and susceptible disease or make sx.The stimulation of spirit, environment etc. can cause various physiological changes, and mainly showing as sympathetic activity increases and epinephrine 17-hydroxy-11-dehydrocorticosterone secretion increasing.Clinical research shows that also this disease patient has abnormal response to motion, psychology test and pain stimulation.
Though heart neurosis has certain similarity with general neurosis in clinical manifestation, the two has nothing in common with each other in medical diagnosis on disease, treatment.Present heart neurosis clinically is the definite medicine of inefficacy still.Doctor trained in Western medicine is taked the principle of Comprehensive Treatment more to the treatment of heart neurosis.At first, pay attention to the psychotherapy, medical personnel must show loving care for and patient trust and cooperation to obtain him patient, carry out thought and explain, free one's mind of apprehensions, and it is believed there is no organic cardiovascular diseases, strengthen and cure confidence; Secondly, rationally make arrangements for the daily life, suitably participate in physical exertion and exercise, and suitably alleviate or adjustment work, but needn't lie up; Moreover, Drug therapy mitigation symptoms, tranquilizer such as available low dose of diazepam, chlordiazepoxide, meprobamate, beta-blockers such as Propranolol, bisoprolol, other also available oryzanol and Chinese medicine sedative etc.
The name of disease of not having direct correspondence at Chinese medicine cardiac neurosis, implement " provisions for new drugs approval " from China in 1985 and also do not produce national new Chinese medicine over more than 20 year through the treatment heart neurosis of systematic study, show that Chinese medicine is all very poor to the research of understanding, etiology and pathogenesis and the method for treatment of this disease essence, aspect experimentation, also do not have corresponding animal model and pharmacodynamics evaluation methodology.Brainstrust is pointed out should bring into play the advantage of China's Chinese medicine to still there not being the disease of particular treatment method, strengthens the research with such disease of Chinese medicine.Obtained preliminary curative effect with the Chinese medicine heart neurosis in recent years, the Zhu Cuiling report is used renal mass oral liquid treatment 60 routine cardiovascular neurosis patients, after 30 day course of treatment, to general curative effect and cardiopalmus, uncomfortable in chest, chest pain, insomnia, dyspnea and weak improvement, ST-T is unusual, the improvement of low flat, the electrocardiographic abnormalities such as the ST section is forced down, inversions of T ripple, premature beat of T ripple and the improvement of respiratory heart rate variance, the cardiac vegetative nerve function of peripheral indexs such as founding heart rate difference and Fa Shi index that crouch all obviously is better than matched group with the treatment group.Liu Shengjun etc. treat heart neurosis with step-length WENXIN KELI (compositions such as Radix Codonopsis, essence, Radix Et Rhizoma Nardostachyos, succinum, Radix Notoginseng) the associating peaceful sheet of the mind (compositions such as Semen Ziziphi Spinosae, Fructus Gardeniae, Radix Polygalae, Radix Glycyrrhizae, Poria, Massa Medicata Fermentata).Matched group adopts traditional stable aminoacyl heart amine that adds to treat two groups of each 32 examples, 2 months courses of treatment.The total effective rate of treatment group as a result is higher than matched group.Its other party medicine such as Radix Bupleuri add Os Draconis Concha Ostreae soup, Radix Et Caulis Acanthopanacis Senticosi injection, GUIPI TANG, mind tranquilizing and the heart calming drink, Shiwei Wendan Tang, XIAOYAO POWDER, the logical injection of painstaking effort, the resolving depression soup that nourishes heart etc. and have all obtained comparatively satisfied curative effect.(Qian Baichu. heart neurosis Chinese and western medicine research overview. Zhejiang combination of Chinese and Western medicine magazine, 2005,11 (15): 661～662) new Chinese medicine of the heart neurosis of research and development treatment has at present caused the attention of medical sci-tech circle.
Steroidal saponin is a class important biological material in the plant, also be the main active of Chinese medicine Dioscorea panthaica Prain et Burkill and Dioscorea nipponica Mak. Ningpo Yam Rhizome, 2005 editions one one of Pharmacopoeia of People's Republic of China disclose with DIAOXINXUE KANG (total steroidal saponin) be main component DIAOXINXUE KANG JIAONANG (main component is Dioscorea panthaica Prain et Burkill, Dioscorea nipponica Mak. Ningpo Yam Rhizome rhizome extract DIAOXINXUE KANG) the prevention and the treatment coronary heart disease, angina pectoris and blood-stasis internal-depression the thoracic obstruction, dizzy, breathe hard, cardiopalmus, uncomfortable in chest or the pain in purposes; Chinese invention patent ZL02128119.X discloses spirostane alcohols steroidal saponin and has been used for the treatment of purposes in the cardiovascular disease medicine in preparation; ZL02146284.4 discloses dioscin and has been used for the treatment of and prevents purposes in hyperlipemia, the anti thrombotic action medicine in preparation; CN02146797.8 discloses the purposes of dioscin in the preparation antitumor drug; Zhang Cunli etc. summarized steroidal saponin the pharmacologically active of aspects such as cardiovascular system, antitumor, enhance immunity, blood sugar lowering, antifertility, parasite killing, antifungal (Zhang Cunli etc. the bioactivity research progress of steroidal saponin. Xibei Forest College's journal, 2003,18 (2): 95～100).But do not find as yet that up to now total extractives of steroid saponin is used for the treatment of the new purposes of heart neurosis.
Summary of the invention
Technical scheme of the present invention provides total extractives of steroid saponin and is used for the treatment of purposes in the heart neurosis medicine in preparation.The present invention also provides a kind of pharmaceutical composition for the treatment of heart neurosis.
The invention provides the purposes of total extractives of steroid saponin in the medicine of preparation treatment heart neurosis.
Wherein, described total extractives of steroid saponin is the extract of DIAOXINXUE KANG or Dioscoreaceae plant Dioscorea panthaica Prain et Burkill DioscoreaPanthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome D.nopponica Makino rhizome.
Wherein, described total steroidal saponin is no less than 35.0% in total steroidal saponin unit.Further, described total steroidal saponin is no less than 65.0% in total steroidal saponin unit.
The present invention also provides a kind of pharmaceutical composition for the treatment of heart neurosis, and it is that total extractives of steroid saponin by effective dose is an active component, adds the medicament that acceptable accessories or complementary composition are prepared from.
Wherein, described total extractives of steroid saponin is the extract of DIAOXINXUE KANG or Dioscoreaceae plant Dioscorea panthaica Prain et Burkill DioscoreaPanthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome D.nopponica Makino rhizome.
Wherein, described total steroidal saponin is in total steroidal saponin unit, and percentage by weight is no less than 35.0%.Wherein, described total steroidal saponin is in total steroidal saponin unit, and percentage by weight is no less than 65.0%.
Wherein, described medicament is oral formulations, ejection preparation.
Described total extractives of steroid saponin can directly be that the crude drug DIAOXINXUE KANG of DIAOXINXUE KANG JIAONANG (is stated from the Pharmacopoeia of the People's Republic of China 2005 editions (an one), P430), also can be from Chinese medicine Dioscorea panthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome, to extract acquisition by the method for document record (CN200410040771.X).
The inventor is through experimental studies have found that total extractives of steroid saponin has significant treatment heart neurosis, improve the effect of patient's clinical symptoms, select for heart neurosis patient's clinical treatment provides a kind of medication new, that curative effect is outstanding, have good economic benefit and social benefit.
The specific embodiment of form by the following examples, foregoing invention content of the present invention is described in further details, but should not be construed as summary of the invention of the present invention and only limit to following examples, all inventions of making based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The preparation and the assay of embodiment 1 total extractives of steroid saponin
Take by weighing the dry rhizome 100kg of Chinese medicine Dioscorea nipponica Mak. Ningpo Yam Rhizome, pulverize, the alcohol reflux of adding 800ml75% 3 times, 3 hours for the first time, second and third time each 2 hours filters, and merge extractive liquid, reclaims ethanol, add water to 2g/ml, cold preservation 24 hours, centrifugal, supernatant is crossed HPD
300Macroporous adsorptive resins washes with water to effluent colourlessly earlier, uses 70% ethanol elution then, collects ethanol elution, reclaims ethanol, is concentrated into extractum, and vacuum drying promptly gets total extractives of steroid saponin.Get the about 0.3g of this product, the accurate title, decide, and puts in the 150ml round-bottomed flask, add sulphuric acid 40% alcoholic solution 50ml, put in the boiling water bath and refluxed 5 hours, put cold, add water 100ml, shake up, filter with 105 ℃ of No. 4 molten glass pots that hang down that are dried to constant weight, precipitation is washed with water to filtrate and does not show acid, 105 ℃ are dried to constant weight, calculate, and this product is pressed dry product and calculated, containing total steroidal saponin in the steroidal total aglycones, is 40%.
The preparation and the assay of embodiment 2 total extractives of steroid saponin
Take by weighing the dry rhizome 100kg of Chinese medicine Dioscorea panthaica Prain et Burkill, pulverize, the alcohol reflux of adding 1200ml95% 3 times, 3 hours for the first time, second and third time each 2 hours filters, and merge extractive liquid, reclaims ethanol, add water to 2g/ml, cold preservation 24 hours, centrifugal, supernatant is crossed macroporous adsorptive resins (HPD
100/ LD140=7:3 (W/W)), wash with water to effluent colourlessly earlier, use 70% ethanol elution then, collect ethanol elution, reclaim ethanol, be concentrated into extractum, vacuum drying promptly gets total extractives of steroid saponin.Calculate with reference to embodiment 3 detection methods, this product is pressed dry product and is calculated, and contains total steroidal saponin in the steroidal total aglycones, is 70%.
Below prove beneficial effect of the present invention by clinical trial.
The clinical research (one) of test example 1 di-ao-xin-xue-kang capsule in treating heart neurosis
Experimental subject: 56 routine cases all meet following diagnosis basis: 1. based on cardiovascular main suit symptom; 2. many with autonomic nervous dysfunction's symptom; 3. conventional cardiovascular diseases checks as X line, electrocardiogram, UCG prompting heart is normal or do not have specificity changes.Whole case anxiety self-appraisal scales (SAS)〉50 minutes
[1], HAMA is scale (HAMA) 18 minutes
[2], wherein male 20 examples, women 36 examples; 30～54 years old age; Random method is divided into 1,2 group of treatment, each 28 example, and two groups are at aspects such as age, sex, the course of disease, scale score values relatively, learn by statistics and handle there was no significant difference (P〉0.05).
Therapeutic Method: treat 1 group and take DIAOXINXUE KANG JIAONANG (capsule of DIAOXINXUE KANG through being processed into, every contains total steroidal saponin 100mg, Chengdu Diao Pharmaceutical Group Co., Ltd's production), every day 3 times, each 1, took for 8 weeks; Treat 2 groups and take DIAOXINXUE KANG JIAONANG, every day 3 times, each 2, took for 8 weeks.
1, efficacy assessment standard: two groups adopt respectively SAS, HANA scale before treatment, treatment afterwards respectively evaluates 1 time for the 2nd, 4,8 weekends, curative effect subtracts branch rate (T) evaluation with HANA: T 〉=75% is recovery from illness, 50%≤T＜75% is a produce effects, and 25%≤T＜50% is that effectively T＜25% is invalid.Subtract branch rate=(baseline branch-comment periodic score value)/baseline branch * 100.
The result: 1. treatment is treated 1 group of 7 example of fully recovering after 8 weeks, produce effects 9 examples, and effective 4 examples, invalid 8 examples, total effective rate is 71.43%; Treat 2 groups of 13 examples of fully recovering, produce effects 7 examples, effective 5 examples, invalid 2 examples, total effective rate is 92.86%; Treat 2 groups of general curative effects and be better than treating 1 group (P＜0.05).
2, treatment different times SAS scoring relatively sees Table 1.
Table 1 treatment different times SAS scoring is (x ± S) (n=28) relatively
Annotate: relatively preceding with treatment,
*P＜0.05,
*P＜0.01; Compare for 1 group with treatment:
#P＜0.05,
##P＜0.01, as follows
Table 1 result shows: relatively preceding with treatment, and treat 1 group, treat 2 groups of all significantly reductions of SAS scoring after 2 weeks of treatment, 4 weeks, 8 weeks, show that two groups all have therapeutical effect; Compare for 1 group with treatment: 2 weekends, 4 weekends, 2 groups of SAS scorings of treatment are lower than 1 group of treatment, but no difference of science of statistics, treat 2 groups of SAS scorings 8 weekends and significantly be lower than 1 group (P＜0.05) of treatment, show in equal administration time, increase with taking dose strengthens the main component total steroidal saponin of DIAOXINXUE KANG JIAONANG to the therapeutical effect of heart neurosis, has tangible dose-effect relationship.
3, treatment different times HAMA scoring relatively: see Table 2.
Table 2 treatment different times HAMA scoring is (x ± S) (n=28) relatively
Table 2 result shows: relatively preceding with treatment, and treat 1 group, treat 2 groups of all significantly reductions of HAMA scoring after 2 weeks of treatment, 4 weeks, 8 weeks, show that two groups all have therapeutical effect; Compare for 1 group with treatment: treat 2 groups of HAMA scorings 2 weekends and be lower than 1 group of treatment, but no difference of science of statistics, treat 2 groups of SAS scorings at 4 weekends, 8 weekends and significantly be lower than 1 group of treatment (P difference＜0.05 and 0.01), show in equal administration time, increase with taking dose strengthens the main component total steroidal saponin of DIAOXINXUE KANG JIAONANG to the therapeutical effect of heart neurosis, has tangible dose-effect relationship.
The clinical research (two) of test example 2 di-ao-xin-xue-kang capsule in treating heart neurosis
Experimental subject 84 routine cases, wherein male 35 examples, women 49 examples.All cases all meet " modern heart internal medicine "
[3]The diagnostic criteria of heart neurosis, and get rid of organic heart disease.21～54 years old age; Random method is divided into matched group, 1,2 group of each 28 example of treatment, and three groups at aspects such as age, sex, the course of disease, scale score values relatively, learns by statistics and handles there was no significant difference (P〉0.05).
The Therapeutic Method matched group is taken oryzanol tablets (Shanxi Taihang Medicine Stock Co., Ltd.), every day 3 times, each 30mg; Treat 1 group and take DIAOXINXUE KANG JIAONANG, every day 3 times, each 1, took for 8 weeks; Treat 2 groups and take DIAOXINXUE KANG JIAONANG, every day 3 times, each 2, took for 8 weeks.
The efficacy determination produce effects: all diseases alleviate, and it is normal that electrocardiogram recovers, not recurrence in 1 month after the drug withdrawal; Effectively: primary symptoms such as cardiopalmus, insomnia obviously alleviate or all diseases alleviate, not recurrence in the 10d after the drug withdrawal; Invalid: all disease opinions alleviate.
The result treats 8 all backs matched group produce effects 12 examples, effective 4 examples, and invalid 12 examples, total effective rate is 57.14%; Treat 1 group of produce effects 14 example, effective 5 examples, invalid 9 examples, total effective rate is 67.85%; Treat 2 groups of produce effects 19 examples, effective 6 examples, invalid 3 examples, total effective rate is 89.28%; The general curative effect for the treatment of 1 group, 2 groups all is better than matched group (P difference＜0.05 and 0.01), it is the strongest wherein to treat 2 groups of effects, increase with taking dose strengthens the main component total steroidal saponin that shows DIAOXINXUE KANG JIAONANG to the therapeutical effect of heart neurosis, shows tangible dose-effect relationship.
List of references:
[1] Shu Liang. self rating depressive scale. see Wang Xiangdong, Wang Xilin, Ma Hong writes. psychohygiene rating scale handbook, Chinese psychohygiene magazine, supplementary issue .194-195. in 1999
[2] Tang Yuhua. HAS. see Wang Xiangdong, Wang Xilin, Ma Hong writes. psychohygiene rating scale handbook, Chinese psychohygiene magazine, supplementary issue in 1999,253-255.
[3] Chen Guowei, Zheng Zonge. modern heart internal medicine [M]. Changsha: Hunan science tech publishing house, 1995.5
Claims (6)
1. the DIAOXINXUE KANG purposes in the medicine of preparation treatment heart neurosis separately.
2. purposes according to claim 1 is characterized in that described DIAOXINXUE KANG is the extract of Dioscoreaceae plant Dioscorea panthaica Prain et Burkill Dioscorea Panthaica Prain et Burkill or Dioscorea nipponica Mak. Ningpo Yam Rhizome D.nopponica Makino rhizome.
3. purposes according to claim 1 and 2 is characterized in that: described DIAOXINXUE KANG contains total steroidal saponin, in total steroidal saponin unit, is no less than 35.0%.
4. purposes according to claim 3 is characterized in that: described DIAOXINXUE KANG contains total steroidal saponin, in total steroidal saponin unit, is no less than 65.0%.
5. purposes according to claim 1 is characterized in that: the medicine of described treatment heart neurosis is that the DIAOXINXUE KANG by effective dose is an active component, adds the medicament that acceptable accessories is prepared from.
6. purposes according to claim 5 is characterized in that: described medicament is oral formulations, ejection preparation.
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| TR201708352T4 (en) * | 2005-10-28 | 2018-11-21 | Univ Industry Cooperation Group Kyung Hee Univ | The composition comprising the extract and the treatment of peripheral neuropathy of the Dioscoreaceae family. |
| CN103083513A (en) * | 2013-01-09 | 2013-05-08 | 大连医科大学 | Method for preparing high-purity dioscorea nipponica makino total saponin |
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| CN1362197A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Nano Diaoxinxuekang medicine and its preparation |
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| CN1362197A (en) * | 2001-01-02 | 2002-08-07 | 杨孟君 | Nano Diaoxinxuekang medicine and its preparation |
Non-Patent Citations (4)
| Title |
|---|
| 国家药典委员会.中华人民共和国药典2005年版一部 第1版.化学工业出版社,2005,第429-430页. |
| 国家药典委员会.中华人民共和国药典2005年版一部 第1版.化学工业出版社,2005,第429-430页. * |
| 潘延吉."86例心血管神经官能症的临床分析".邯郸医学高等专科学校学报16 5.2003,16(5),第471-472页. |
| 潘延吉."86例心血管神经官能症的临床分析".邯郸医学高等专科学校学报16 5.2003,16(5),第471-472页. * |
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