CN103083623A - Application of compound traditional Chinese medicine preparation in Parkinson disease treatment drug preparation - Google Patents
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Abstract
The present invention discloses an application of a compound traditional Chinese medicine preparation in Parkinson disease treatment drug preparation. The compound traditional Chinese medicine preparation is prepared from the following bulk drugs, by weight, 65-85 parts of yanhusuo tuber, 10-26 parts of hindu datura flower, 100-135 parts of salvia miltiorrhiza, 10-26 parts of cassia bark, 10-26 parts of radix aconiti lateralis preparata, 22-42 parts of agalloch eaglewood, 32-52 parts of costusroot, 10-26 parts of dried ginger, 10-26 parts of whitefruit amomum fruit, 10-26 parts of ginseng, 70-110 parts of pearl powder, 65-85 parts of peach seed, 65-85 parts of safflower, 65-85 parts of angelica, and 30-50 parts of szechwan lovage rhizome. With treatment of the Parkinson disease by using the compound traditional Chinese medicine preparation, advantages of definite and significant treatment, unique effect, safety, reliability, stable condition, low toxic-side effect and the like are provided. In addition, important significances are provided for meeting of clinical medical requirements and market requirements.
Description
Technical field
The present invention relates to the new purposes of a kind of compound Chinese medicinal preparation (listing Chinese patent medicine Jinan-Tai'an sheet), relate in particular to the application of a kind of compound Chinese medicinal preparation in the Parkinsonian medicine of preparation treatment.
Background technology
Parkinson disease (Parkinson disease, PD), have another name called Parkinsonism, it is a kind of chronic neurodegenerative diseases, its pathological characters is that the degeneration of substantia nigra of midbrain striatum system dopaminergic neuron is dead, cause reduction of Dopamine minimizing in brain, the clinical manifestations such as static tremor, muscular rigidity and hypokinesia occur.
Follow social senilization, PD becomes serious Medicine and society problem of China just day by day, needs to be resolved hurrily.The sickness rate of PD is about 4.5-16/100000 people/year.PD affects all races, and the male is susceptible slightly.The PD average age of onset is and mid-term early stage at 60 years old mainly, wherein approximately has 5-10% patient initial symptom to occur between 21-40 year.Research report shows, China over-65s PD prevalence, and the male 1.7%, and the women 1.6%, occupies old nervous system degenerative disease second.It is stiff that PD patient can be developed to whole body late period, can not get up, and under health status is all with day, often dies from last various complication.
Pharmacotherapy is the primary treatment measure of PD, still lacks desirable PD medicine but at present China is clinical.The PD needs of patients is accepted long-term Drug therapy, levodopa is always as the leading medication of clinical treatment, yet the serious side reactions such as unusual fluctuation disease, agent end phenomenon and " switch " phenomenon can appear in this medicine prolonged application, and can increase free radical generation in brain, damage dopamine neuron.Benserazide, pramipexole, bromocriptine methanesulfonate, pergolide, selegiline, entacapone, piribedil etc., equal taking convenience, but different approaches, control symptom to some extent, mitigate the disease, but the multiformity of PD etiology and pathogenesis and uncertainty have determined that single chemical drugs is many without definite curative effect; And the neurotrophic agents such as injection GM1 can promote the reparation of dopamine (DA) serotonergic neuron, but price is high, medication is inconvenient, is unfavorable for patient's prolonged application.In addition, from intellectual property, domestic PD medicine is almost imitated kind entirely, the famine independent intellectual property right.
The Jinan-Tai'an sheet is the pure Chinese medicinal drug withdrawal medicine that the applicant produces, it be Mr. Yang Jitai according to one of bright clear Hubei Province east four large well-known doctors at Qing Dynasty's road light, the secret recipe in ancient times of giving up Opium drug addiction of ruling together and creating between year, for contemporary drugs characteristic, use modern science and technology, adopt the advanced technologies flow process, through clinical verification in more than ten years, what develop did not contain any anesthetis, can not produce the drug rehabilitation proprietary Chinese medicine of drug dependence.The Jinan-Tai'an sheet obtained the invention patent certificate that State Intellectual Property Office issues (patent No. is: ZL99116602.7) and the pharmaceutical production of State Food and Drug Administration's approval criticize code, also listed in China public security system compulsory rehabilitation center medication catalogue by the Ministry of Public Security simultaneously.
The Jinan-Tai'an sheet is mainly made by Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Semen Persicae, Flos Carthami, Margarita powder, Radix Aconiti Lateralis Preparata, Cortex Cinnamomi, Radix Ginseng, Rhizoma Zingiberis, the Radix Aucklandiae, Fructus Amomi Rotundus, Lignum Aquilariae Resinatum, Flos Daturae ten Chinese medicine of the five flavours, do not contain dependency material and any anesthetis, without any synthetic yet.Function with blood-activating and qi-promoting, dispersing cold for relieving pain, warming the kidney and strengthening the spleen, clearing away heart-fire for tranquillization.Be mainly used in alleviating opiates medicine addict's detoxification treatment, application in other respects and treatment have no report.
Summary of the invention
The object of the invention is to open up the new purposes of the old medicine of ancient prescription, the Jinan-Tai'an sheet is reused Rhizoma Corydalis, Radix Salviae Miltiorrhizae is monarch, and merit is arrogated to oneself blood-activating and qi-promoting; Radix Angelicae Sinensis, Rhizoma Chuanxiong can strengthen blood-activating and qi-promoting, the wind dispelling relieving convulsion; Radix Aconiti Lateralis Preparata (system), Cortex Cinnamomi, Rhizoma Zingiberis, Fructus Amomi Rotundus and Radix Ginseng, strongly invigorating primordial QI Yuanyang, but promoting the flow of QI-blood by warming the meridian, cold expelling spasmolytic; The Radix Aucklandiae, Lignum Aquilariae Resinatum promoting QI circulation for relieving depression, pain relieving in accent is minister altogether; Margarita powder can help the Radix Salviae Miltiorrhizae clearing away heart-fire for tranquillization, is assistant; The Flos Daturae relieving spasm to stop pain can lead all medicines sick institutes that goes directly, for making.All medicines share, but treating both the principal and secondary aspects of a disease is brought into play warming the kidney and strengthening the spleen, blood-activating and qi-promoting, wind dispelling spasmolytic function jointly.Utilize the effect of the aspects such as its blood-activating and qi-promoting, clearing away heart-fire for tranquillization, be applied to treatment of Parkinson disease, increase its indication.
The invention provides the new purposes of a kind of compound Chinese medicinal preparation (being the Jinan-Tai'an sheet), the i.e. application of this compound Chinese medicinal preparation in the Parkinsonian medicine of preparation treatment, described compound Chinese medicinal preparation is made by the crude drug of following weight portion: Rhizoma Corydalis 65-85, Flos Daturae 10-26, Radix Salviae Miltiorrhizae 100-135, Cortex Cinnamomi 10-26, Radix Aconiti Lateralis Preparata 10-26, Lignum Aquilariae Resinatum 22-42, Radix Aucklandiae 32-52, Rhizoma Zingiberis 10-26, Fructus Amomi Rotundus 10-26, Radix Ginseng 10-26, Margarita powder 70-110, Semen Persicae 65-85, Flos Carthami 65-85, Radix Angelicae Sinensis 65-85, Rhizoma Chuanxiong 30-50.
The Parkinsonian medicine of described treatment comprise be used to improve Parkinson disease progress and late period motor complication medicine and the medicine that is used for alleviating the symptom of using the Parkinsonian that L-3,4 dihydroxyphenylalanine treats.
With Jinan-Tai'an sheet treatment parkinson disease, concrete instructions of taking and consumption are:
In the present invention, the Jinan-Tai'an sheet is used for the treatment of Parkinsonian consumption and can appropriately adjust the course for the treatment of according to patient's age, the light and heavy degree of disease, but one is oral 2～3 times of every day, and each 1～2, every 0.4 gram, but life-time service.
Find through pharmacodynamic study, Jinan-Tai'an of the present invention sheet shows obvious improvement effect in the mice that arecoline and 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. cause is trembled model.As seen, (1) Jinan-Tai'an sheet can be used for improving Parkinson disease (PD) progress and late period motor complication; (2) to can be used for alleviating the PD patient's who uses the L-3,4 dihydroxyphenylalanine treatment symptom be the treatment of purpose to the Jinan-Tai'an sheet.Jinan-Tai'an of the present invention sheet treatment parkinson disease have that determined curative effect is remarkable, and effect is unique, and is safe and reliable, stable disease, the advantage such as toxic and side effects is little.Therefore, the Parkinsonian medicine of research and development treatment has good social benefit and optimistic market prospect, and is for satisfying medical clinical demand and the market demand, significant.
The specific embodiment
Below by test example, beneficial effect of the present invention is further elaborated:
Test example 1
Jinan-Tai'an sheet (being called for short JTP) causes the pharmacodynamic study that trembles to arecoline
1, experiment purpose
Parkinsonian's clinical manifestation the most intuitively is the static tremor of muscle.Arecoline is the M-cholinergic receptors agonist, can cause the violent contraction of muscle, can simulate well clinical PD patient's the performance of trembling.Therefore arecoline muscular tremor model is selected in this part, estimates the improvement effect of JTP to trembling.
2, experiment material
Animal: Kunming mouse, body weight 23 ± 1g is available from Chinese Academy of Medical Sciences's Experimental Animal Center.Cleaning level, the quality certification number: SCXK (capital) 2009-0007.The raising condition: barrier level Animal House is raised, and raises 5, every box in credit number: SYXK (capital) 2009-0004, feeding standard box.
Tested medicine: Jinan-Tai'an sheet tablet (JTP), Shanghai Traditional Chinese Medicine Pharmaceutical Technology Co., Ltd, the accurate word of traditional Chinese medicines: Z20044197, adopt the patent No. to be: the disclosed prescription of the description of ZL99116602.7 and method make.
Positive control drug L-DOPA: madopar (Benserazide sheet), Shanghai Roche Group company limited, the accurate word H10930198 of traditional Chinese medicines, lot number: SH0895; Trihexyphenidyl (Trihexyphenidyl, benzhexol hydrochloride): Tianjin Lisheng Pharmaceutical Co., Ltd., the accurate word H12020224 of traditional Chinese medicines.
Arecoline hydrochlorate: Sigma company product, article No.: SZB710VX.
3, experimental technique
Grouping: Normal group, vehicle group, model group, JTP low dose group, dosage group in JTP, JTP high dose group, dosage group in L-DOPA37.5mg/kg+JTP, L-DOPA75mg/kg positive controls and trihexyphenidyl 15mg/kg group, every group of 10 mices.
The in advance administration in 7 days of each dosage group of JTP and positive drug, tail vein injection arecoline 1.25mg/kg after the 7th day last administration 1h.Record mice and give arecoline to the time that begins to occur trembling, be designated as incubation period, record the time of mice from beginning to occur to tremble and finish to trembling, for trembling the persistent period.The observation time upper limit that trembles is 120s.
4, experimental result
Medicine causes the tremble impact of incubation period and persistent period of mice to arecoline
After Normal group injected in mice normal saline, atremia occurs, and other group mouse tail vein injection arecoline begins to occur trembling.The JTP high dose group is trembled and is compared obvious raising (P＜0.01) incubation period with model group, and the persistent period is obviously reduced (P＜0.01).Dosage in JTP (P＜0.01), JTP+L-DOPA (P＜0.01) can obviously reduce mice and tremble the persistent period, but to having no significant effect the incubation period of trembling.All without the improvement effect, the positive drug trihexyphenidyl can obviously improve mice and tremble incubation period (P＜0.01) positive drug L-DOPA to tremble incubation period and persistent period, shortens tremble the persistent period (P＜0.01) (table 1).
Table 1.JTP on arecoline cause the impact of trembling (
N=9～10)
*P＜0.01vs.Control mice,
#P＜0.05,
##P＜0.01vs. arecoline model mice
5, brief summary
The mice that JTP causes arecoline is trembled and improves significantly.Prompting, JTP may be the M-cholinergic receptors blocker.L-DOPA does not report to have the m receptor blocking effect clinically, does not observe in this experiment the effect of L-DOPA group yet.The positive control medicine trihexyphenidyl that this experiment is used is to be used for clinically the m receptor blocker of disturbances in patients with Parkinson disease, finds in this experiment, and trihexyphenidyl has significant protective effect to trembling due to arecoline, proves that this experimental result is reliable.
Test example 2
Jinan-Tai'an sheet (being called for short JTP) causes the pharmacodynamic study that trembles to 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne.
1, experiment purpose
1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. is the M-cholinergic receptors agonist that synthesizes, and acts on similar arecoline, but action intensity is than the strong several times of arecoline.This part adopts 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. muscular tremor model to estimate the improvement effect of JTP to trembling.
2, experiment material
Animal: Kunming mouse, body weight 23 ± 1g is available from Chinese Academy of Medical Sciences's Experimental Animal Center.Cleaning level, the quality certification number: SCXK (capital) 2009-0007.The raising condition: barrier level Animal House is raised, and raises 5, every box in credit number: SYXK (capital) 2009-0004, feeding standard box.
Tested medicine: Jinan-Tai'an sheet tablet (JTP), Shanghai Traditional Chinese Medicine Pharmaceutical Technology Co., Ltd, the accurate word of traditional Chinese medicines: Z20044197.
Positive control drug L-DOPA: madopar (Benserazide sheet), Shanghai Roche Group company limited, the accurate word H10930198 of traditional Chinese medicines, lot number: SH0895.Trihexyphenidyl (Trihexyphenidyl, benzhexol hydrochloride): Tianjin Lisheng Pharmaceutical Co., Ltd., the accurate word H12020224 of traditional Chinese medicines.
1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. fumarate: Sigma company product, article No.: 119K4613V.
3, experimental technique
Grouping: Normal group, vehicle group, model group, JTP low dose group, dosage group in JTP, JTP high dose group, dosage group in L-DOPA37.5mg/kg+JTP, L-DOPA75mg/kg positive controls and trihexyphenidyl 15mg/kg group, every group of 10 mices.
The in advance administration in 7 days of each dosage group of JTP and positive drug, tail vein injection 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. 0.25mg/kg after the 7th day last administration 1h.Record mice and give 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. to the time that begins to occur trembling, be designated as incubation period.Record the time of mice from beginning to occur to tremble and finish to trembling, for trembling the persistent period.The observation time upper limit that trembles is 1200s.After the 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. injection, 30min and 1h observe sialorrhea and the situation of shedding tears and sialorrhea are marked with shedding tears.Sialorrhea and its degree of looking of shedding tears are divided into 6 grade scorings, are up to 5 minutes, and sialorrhea not occurring and shedding tears is 0 minute.
4, experimental result
4.1 medicine causes the tremble impact of incubation period and persistent period of mice to 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne.
After Normal group injected in mice normal saline, atremia occurs, and begins to occur trembling after other group mouse tail vein injection 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne..In JTP, the dosage group can obviously extend tremble incubation period (P＜0.05), and on the not impact of persistent period of trembling.But JTP high dose group significant prolongation mice is trembled incubation period (P＜0.05), shortens the persistent period (P＜0.01).All without the improvement effect, the positive drug trihexyphenidyl can obviously extend mice and trembles incubation period (P＜0.01) and shorten the persistent period (P＜0.01) (table 2) positive drug L-DOPA to tremble incubation period and persistent period.
Table 2.JTP on 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. cause the impact of trembling (
N=9～10)
*P＜0.01vs.Control mice,
#P＜0.05,
##P＜0.01vs. 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. model mice.
4.2 medicine causes mice sialorrhea and the impact of shedding tears to 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne.
1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. can stimulate the periphery m receptor, and glandular secretion is increased, and sialorrhea occurs and sheds tears, and can be used as the index of estimating the m receptor excitement.Occur sialorrhea after the injected in mice 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. and shed tears, the JTP low dose group is compared obviously with model group at the 60min sialorrhea and is weakened, and scoring reduces (P＜0.01), can obviously improve shed tears (P＜0.01) during 30min.The scoring (P＜0.05, P＜0.01) that in JTP, dosage, JTP high dose, JTP+L-DOPA and positive drug trihexyphenidyl group all can obviously reduce sialorrhea and shed tears when 30min and 60min.Sialorrhea and the obviously improvement effect (table 3) of nothing of shedding tears that positive drug L-DOPA causes 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne..
Table 3.JTP on 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. cause mice sialorrhea and the impact of shedding tears ((
N=9～10)
*P＜0.01vs.Control mice,
#P＜0.05,
##P＜0.01vs. 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. model mice.
5, brief summary
The mice that JTP causes 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne. is trembled and improves significantly, and sialorrhea obviously weakens with having shed tears.Prompting JTP may be the M-cholinergic receptors blocker.L-DOPA does not report to have the m receptor blocking effect clinically, does not observe in this experiment the effect of L-DOPA group yet.The positive control medicine trihexyphenidyl that this experiment is used is to be used for clinically the m receptor blocker of disturbances in patients with Parkinson disease, finds in this experiment, and trihexyphenidyl has significant protective effect to trembling due to 1-(2-oxo-1-pyrrolidinyl)-4-(1-pyrrolidinyl)-2-butyne., proves that this experimental result is reliable.
Claims (2)
1. the application of compound Chinese medicinal preparation in the Parkinsonian medicine of preparation treatment, described compound Chinese medicinal preparation is made by the crude drug of following weight portion: Rhizoma Corydalis 65-85, Flos Daturae 10-26, Radix Salviae Miltiorrhizae 100-135, Cortex Cinnamomi 10-26, Radix Aconiti Lateralis Preparata 10-26, Lignum Aquilariae Resinatum 22-42, Radix Aucklandiae 32-52, Rhizoma Zingiberis 10-26, Fructus Amomi Rotundus 10-26, Radix Ginseng 10-26, Margarita powder 70-110, Semen Persicae 65-85, Flos Carthami 65-85, Radix Angelicae Sinensis 65-85, Rhizoma Chuanxiong 30-50.
2. application as claimed in claim 1, is characterized in that, the Parkinsonian medicine of described treatment comprise be used to improve Parkinson disease progress and late period motor complication medicine and the medicine that is used for alleviating the symptom of using the Parkinsonian that L-3,4 dihydroxyphenylalanine treats.
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| CN201110332563.7A CN103083623B (en) | 2011-10-28 | The application in Parkinsonian medicine is treated in preparation of a kind of compound Chinese medicinal preparation |
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| CN105596817A (en) * | 2015-12-24 | 2016-05-25 | 王兴铧 | Traditional Chinese medicine composition for relieving Parkinson's disease symptoms and preparation method |
| CN106309637A (en) * | 2015-06-17 | 2017-01-11 | 上海张江中药现代制剂技术工程研究中心 | Traditional Chinese medicine composition for treating Parkinson disease and preparation method thereof |
| CN106421683A (en) * | 2016-08-26 | 2017-02-22 | 广西派尼科技有限公司 | Withdrawal Chinese herbal medicine and drink and preparation method thereof |
| CN108704057A (en) * | 2018-07-25 | 2018-10-26 | 何金蔚 | A kind of Chinese herbal medicine for treating Parkinson's disease |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106309637A (en) * | 2015-06-17 | 2017-01-11 | 上海张江中药现代制剂技术工程研究中心 | Traditional Chinese medicine composition for treating Parkinson disease and preparation method thereof |
| CN105596817A (en) * | 2015-12-24 | 2016-05-25 | 王兴铧 | Traditional Chinese medicine composition for relieving Parkinson's disease symptoms and preparation method |
| CN106421683A (en) * | 2016-08-26 | 2017-02-22 | 广西派尼科技有限公司 | Withdrawal Chinese herbal medicine and drink and preparation method thereof |
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