CN104784354A - Traditional Chinese medicine acupoint injection for treating migraine and preparation method of traditional Chinese medicine acupoint injection - Google Patents

Traditional Chinese medicine acupoint injection for treating migraine and preparation method of traditional Chinese medicine acupoint injection Download PDF

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CN104784354A
CN104784354A CN201510216296.5A CN201510216296A CN104784354A CN 104784354 A CN104784354 A CN 104784354A CN 201510216296 A CN201510216296 A CN 201510216296A CN 104784354 A CN104784354 A CN 104784354A
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gained
flowers
rabdosia rubescens
chinese traditional
edgeworthia chrysantha
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CN104784354B (en
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王玉琳
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Heilongjiang University of Chinese Medicine
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Heilongjiang University of Chinese Medicine
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Abstract

The invention relates to the field of medicine, in particular to a traditional Chinese medicine acupoint injection for treating migraine and a preparation method of the traditional Chinese medicine acupoint injection. The acupoint injection is prepared from the following raw materials in parts by weight: 20-40 parts of fragrant flower, 8-15 parts of tribulusterrestris and 5-16 parts of rabdosia rubescens; the preparation process comprises the following steps: crushing dried fragrant flower, tribulusterrestris and rabdosia rubescens, and filtering through a 200-mesh sieve; adding three times of 70% ethanol in volume, extracting in a water bath at 80 DEG C for 5 hours, and mixing extract liquids; adding three times of water in volume, standing over the night, and filtering through a 0.45micron microfiltration membrane; and adding a pH modifier to adjust the pH to be 6.2-6.8, sterilizing, and sub-packaging. The traditional Chinese medicine acupoint injection is used for preparing medicines for migraine. Animal experiment and clinical experiment researches show that the traditional Chinese medicine acupoint injection provided by the invention has a good treatment effect on migraine, and has good safety.

Description

One treats migrainous Chinese Traditional Medicine into Point liquid and preparation method thereof
Technical field
The invention belongs to field of medicaments, be specifically related to one and treat migrainous Chinese Traditional Medicine into Point liquid and preparation method thereof.
Background technology
Migraine is a kind of clinical common primary headache, and a lot of disease is in child and adolescence, and the young and middle-aged phase reaches onset peak, and women's prevalence is higher than male, and prevalence is 5% ~ 10%, often has genetic background.This disease is with ictal middle severe, sample of beating headache for main clinical manifestation, and headache mostly is inclined side, and generally continue 4 ~ 72 hours, Nausea and vomiting, light, Sound stimulat or daily routines all can increase the weight of.
Migrainous pathogenesis it be unclear that, and mainly contains following theory at present to the migrainous pathogenesis of doctor trained in Western medicine:
Blood vessel theory: this theory is thought that intracranial vessel shrinks and caused migraine aura symptom, outer, the intracranial vessel expansion of cranium subsequently, tissues surrounding vascular produces vasoactive polypeptides and causes aseptic inflammation, and then causes the headache of pulsation.Carotid artery and superficial temporal artery local compression, vasoconstrictor peptide such as Ergotamine can alleviate this theory of stage of attack headache support.
Neural theory: this theory think migraine time function of nervous system change be primary, the change of blood flow is secondary.Migraine aura is suppressed to cause by autgmentability cortex.Suppressed to refer to the neuroelectricity activity inhibition zone originating from brain rear portion cortex that various destructive stimulus causes by autgmentability cortex, this inhibition zone is expanded, with autgmentability oligemia to contiguous cortex with the speed of 2 ~ 5mm/min.Autgmentability cortex suppresses explain migraine aura symptom well.In addition, 5-hydroxy tryptamine (5-hydroxy tryptamine is called for short 5-HT) participates in headache generation.The Headache attacks starting stage, 5-HT disengages from platelet, directly acts on intracranial thin vessels and makes it to shrink, and invest in blood vessel wall.During 5-HT lowering of concentration, acting on the tension contractility event resolves of large artery trunks, there is headache in blood vessel wall expansion.5-HT is neurotransmitter, is also circulatory mediator, all has impact to neural and blood vessel.Central 5-HT receptor stimulating agent triptan medicine is used for migrainous treatment, confirms that nervous dysfunction participates in migrainous outbreak.But some drugs such as the 5-HT such as gastrodine, pizotifen antagonist also can play migrainous therapeutical effect migraine.
Trigemino-vascular theory: this theory thinks that trigeminal ganglion infringement may be the neural basal that migraine produces.After trigeminal ganglion and fiber irriate thereof, Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-NH2, calcitonin-gene-related peptide and other neuropeptides can be caused to discharge to be increased.These materials act on cerebrovascular wall, cause vasodilation and occur pulsatile headache.
From above-mentioned hypothesis, to it be unclear that migrainous pathogenesis both at home and abroad at present, single pathogenesis hypothesis is difficult to make reasonable dismissal to migrainous outbreak and clinical drug therapy effect, and the result of even various hypothesis is conflicting, as.Central 5-HT receptor stimulating agent triptan medicine and the 5-HT such as gastrodine, pizotifen antagonist etc. all can play certain therapeutical effect to migraine.Study of incident mechanism delayed, defines serious restriction to the research and development of migraine treatment medicine.Medicine research and development field is difficult to predicted by the pharmacological action of a certain medicine or inferred that can it play migrainous therapeutical effect.
At present, be used for the treatment of migrainous conventional Western medicine to comprise: calcium ion antagonist, example hydrochloric acid flunarizine; Beta-3 adrenergic receptor blocker, as Propranolol, timolol; Antuepileptic, as valproic acid and topiramate; Tricyclics, as amitriptyline; 5-HT antagonist, as pizotifen etc.Said medicine all to nervous system or cardiovascular system etc. exist significant side effect (Zhao Yingzhao, Yin Guang, Zhang Na, thank to rosy clouds, Zhao Shuo, Wei Hui, Fu Lingran, Mu Qian. migrainous progress. clinical rational drug use .2014; 7 (4A): 196-197.).
Chinese medicine has more discussion for migrainous etiology and pathogenesis from ancient times to the present, the obstruction of collateral caused by windphlegm think that it is that prolonged illness causes the stasis of blood, the basis of be worried fatigue, eating and drinking without temperance, feelings will internal injury occurring, qi depression to blood stasis, excessive rising of liver-YANG, caused by visceral dysfunction.Be used for the treatment of that migrainous conventional Chinese medicine is mainly circulation of qi promoting, invigorates blood circulation, blood stasis dispelling class medicine is as Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Rhizoma Gastrodiae, Ramulus Uncariae Cum Uncis etc.Have ictal due to migraine and occur severe headache rapidly, therefore being used for the treatment of migrainous medicine and needing that there is feature easy to carry and use.The Chinese medicine of current clinical treatment primary disease still based on decoction, decoction inconvenience, be unfavorable for promote (Wu Shaojun. migraine tcm clinical therapeutic advance. the up-to-date medical information digest 2014 in the world; L4 (23): 140-142.).
The current clinical onset mechanism of migraine it be unclear that; therefore in clinical, western medicine effect bad; conventional medication only can improve the pain of patient; but cure the symptoms, not the disease; along with the increase of pain number of times; cerebral injury in patients is serious all the more; the course of disease is longer; the probability that apoplexy occurs is larger; (Cui's Min, Liu Jixia, Li Xiuying is brought greater impact to minimal invasive treatment; Wang Dongqiong, Duan Linghuan. acupuncture Combined with Chinese Herbal treats migrainous clinical curative effect analysis. contemporary Chinese medicinal application .2015; 9 (3): 226-227.).
Acupuncture is one of basic methods of China's Chinese traditional treatment, has obtained certain effect to migrainous treatment, but acupuncture and moxibustion therapy migraine class chronic disease often needs that let the acupuncture needle remain at a certain point treatment, and time of retaining needle is longer, cannot adapt to the prehuman fast pace life pattern of order.Therefore often need to coordinate Drug therapy to improve the compliance of patient, avoiding treatment to interrupt the common acupoint selection position of acupuncture and moxibustion therapy migraine is wind pond, the sun, Baihui, according to dialectical difference, can add and get other acupuncture points, as: liver-Yang sthenia type adds Shuaigu, connected valleys, Tai Chong, Zhongzhu; On expectorant is turbid, the type of disturbing adds interior pass, tsu san li, sp 6, sp 9, rich and prosperous; Obstruction of collaterals by blood stasis type adds connected valleys, ke shu, the sea of blood; Liver-kidney yin deficiency adds too punching, Taixi, shen shu.
Type Treated with Point-injection Therapy is carried out gradually throughout the country and is achieved certain curative effect in recent years.Choose injectable drug kind varied.In bibliographical information, use single drug injection to account for 28.5%, multi-medicament hybrid injection accounts for 71.5%.Total medicine 28 kinds.Wherein Chinese medicine accounts for 35.7%, Western medicine 64.3%.Herbal function is followed successively by blood circulation promoting medicine 60%, liver wind calming drug 20%, treating SHAO YANG disease by mediation and wind-expelling pain-stopping medicine each 10%.Chinese medicine is still with Chinese medicine blood circulation promoting and blood stasis dispelling, and Western medicine is based on trophic nerve and local anesthesia.Migraine Treated by points injection compares Chinese medicine and western medicine and acupuncture is used alone better efficacy, and untoward reaction is few.But; still lack the system mechanism research of Migraine Treated by points injection at present; because which limit the research and development of acupoint injection therapy medicine; especially Chinese Traditional Medicine into Point medicine research and development (Dong Shuzhong, Liu Yang. simple applying acupoint injecting method treatment migraine progress. clinical progress .2013; 15 (22): 11-12.).
Summary of the invention
For above-mentioned prior art, an object of the present invention is to provide one and treats migrainous Chinese Traditional Medicine into Point liquid.
For realizing above-mentioned object, the technical solution used in the present invention is:
One treats migrainous Chinese Traditional Medicine into Point liquid, is made up of the raw material of following weight: flowers of Edgeworthia chrysantha Lindl 20 ~ 40, in vain
Fructus Tribuli 8 ~ 15, Rabdosia rubescens 5 ~ 16.
As the preferred technical solution of the present invention, described Chinese Traditional Medicine into Point liquid is made up of the raw material of following weight: flowers of Edgeworthia chrysantha Lindl 30, Fructus Atriplicis Sibiricae 14, Rabdosia rubescens 8.
As the preferred technical solution of the present invention, described Chinese Traditional Medicine into Point liquid is made up of the raw material of following weight: flowers of Edgeworthia chrysantha Lindl 35, Fructus Atriplicis Sibiricae 9, Rabdosia rubescens 10.
As the preferred technical solution of the present invention, described Chinese Traditional Medicine into Point liquid is made up of the raw material of following weight: flowers of Edgeworthia chrysantha Lindl 25, Fructus Atriplicis Sibiricae 12, Rabdosia rubescens 15.
Another aspect provides the preparation method of above-mentioned Chinese Traditional Medicine into Point liquid, comprise the following steps:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, add pH adjusting agent and regulate pH to be 6.2 ~ 6.8;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
Described pH adjusting agent is citric acid.
This Chinese Traditional Medicine into Point liquid may be used for migraine treatment medicine.
Flowers of Edgeworthia chrysantha Lindl described in technical scheme of the present invention is the dry flower of Isolated From Thymelaeaceae Species Edgeworthia chrysantha Lindl. Edgeworthia chrysantha Lindl..
Fructus Atriplicis Sibiricae described in technical scheme of the present invention, also referred to as Fructus Tribuli, is the dry mature fruit of zygophyllaceae plant Fructus Tribuli fourth (TribulusterrestrisL.).It is originated, quality standard is all on the books in Chinese Pharmacopoeia version one in 2010.
Rabdosia rubescens described in technical scheme of the present invention, for labiate is cracked rice the dry aerial parts of fork Rabdosiarubescenss (Hemsl.) Hara.It is originated, quality standard is all on the books in Chinese Pharmacopoeia version one in 2010.
Acupoint injection therapy of the present invention selects various infusion of medicine relevant acupoints with a kind of method of disease therapy.The acupuncture point that wherein various disease is selected is not quite similar.
Acupoint injection therapy liquid injection site of the present invention is the clinical proof main acupuncture point relevant with migraine, as wind pond, the sun, Baihui etc., can single acupuncture point Unilateral injection, as only injected Ipsilateral Fengchi acupoint; Also can single acupuncture point Bilateral injections, as only injected bilateral wind temple, also can many acupoint injection therapies as carried out acupoint injection therapy in Ipsilateral wind pond, temple simultaneously.This is known in those skilled in the art.
Fructus Atriplicis Sibiricae belongs to liver wind calming drug in Chinese medicine, have and treat migrainous report for traditional Chinese compound medicine, but need other a large amount of prescriptions such as the compatibility Radix Angelicae Dahuricae, Radix Glycyrrhizae, Ramulus Uncariae Cum Uncis, Pheretima, Radix Cyathulae can play overall treatment effect, flowers of Edgeworthia chrysantha Lindl, Rabdosia rubescens all have application clinically, but there is not yet it both at home and abroad and be used for the treatment of migrainous bibliographical information.
The present inventor finds in experimentation, the compound liquid preparation of flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens composition, through acupoint injection therapy administration, to migraine, there is unexpected therapeutic effect, and compare the convenient administration approach such as oral, intravenous injection, have that dosage is low, safety advantages of higher.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is further explained.Should be understood that, following examples only for explaining the present invention, instead of limit the scope of the invention.
embodiment 1 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 300g
Fructus Atriplicis Sibiricae 140g
Rabdosia rubescens 80g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.3;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 2 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 300g
Fructus Atriplicis Sibiricae 140g
Rabdosia rubescens 80g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.5;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 3 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 300g
Fructus Atriplicis Sibiricae 140g
Rabdosia rubescens 80g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.7;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 4 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 350g
Fructus Atriplicis Sibiricae 90g
Rabdosia rubescens 100g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.6;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 5 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 350g
Fructus Atriplicis Sibiricae 90g
Rabdosia rubescens 100g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.3;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 6 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 350g
Fructus Atriplicis Sibiricae 90g
Rabdosia rubescens 100g
Preparation:
1) Fructus Tribuli, flowers of Edgeworthia chrysantha Lindl are pulverized, cross 400 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes in gained extracting solution, leave standstill cooling;
4) step 3) gained liquid coolant filtered, adding Fructus Citri Limoniae acid for adjusting pH is 6.5;
5) by the sterilizing of step 4) gained, subpackage, to obtain final product.
embodiment 7 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 250g
Fructus Atriplicis Sibiricae 120g
Rabdosia rubescens 150g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.4;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 8 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 250g
Fructus Atriplicis Sibiricae 120g
Rabdosia rubescens 150g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.6;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 9 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 250g
Fructus Atriplicis Sibiricae 120g
Rabdosia rubescens 150g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.7;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 10 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 390g
Fructus Atriplicis Sibiricae 145g
Rabdosia rubescens 150g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.7;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 11 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 210g
Fructus Atriplicis Sibiricae 90g
Rabdosia rubescens 55g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.3;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 12 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 210g
Fructus Atriplicis Sibiricae 130g
Rabdosia rubescens 140g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.5;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 13 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 210g
Fructus Atriplicis Sibiricae 85g
Rabdosia rubescens 145g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.7;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 14 treats migrainous Chinese Traditional Medicine into Point liquid and preparation thereof
Flowers of Edgeworthia chrysantha Lindl 340g
Fructus Atriplicis Sibiricae 85g
Rabdosia rubescens 120g
Preparation:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding Fructus Citri Limoniae acid for adjusting pH is 6.5;
5) by step 4) gained solution sterilization, subpackage, to obtain final product.
embodiment 15 treats the research of migrainous Chinese Traditional Medicine into Point liquid preclinical pharmacodynamics of San
1 materials and methods
1.1 instruments, material
Gilson GAD2E type high performance liquid chromatograph, Gilson 118 type uv/vis detector; LGR16-W type high speed cold
Freeze centrifuge (Beijing Medical Centrifugal Machine Factory); 5-hydroxy tryptamine (i.e. 5-HT) reference substance (Sigma company, analytical pure); Flunarizine hydrochloride injection (Henan Fusen Medicine Co., Ltd).
1.2 animal grouping and modelings
Male SD rat, body weight 240 ~ 280g, is provided by Heilongjiang University of Chinese Medicine's Experimental Animal Center, and quanrantine is 1 week, carries out adaptability raising in quanrantine.
In view of nitroglycerin type Nerve in Migraine Model modeling method is simple, be widely used, the pharmacology that after injection nitroglycerin, in body, release NO occurs stimulates the hypothesis (blood vessel theory, neural theory, trigemino-vascular theory) as (vasodilation, neuroinflamation, neurotransmitter change) multiple migraine attack mechanism of can coincideing preferably, and the animal Nerve in Migraine Model made by nitroglycerin, the performance of its behavioristics conforms to the migrainoid clinical manifestation of people with outbreak pattern.This experiment adopts nitroglycerin to set up rat Nerve in Migraine Model.Modeling method is as follows:
Rat skin lower injection nitroglycerin (Guangzhou Baiyunshan Mingxing Pharmaceutical Co., Ltd.'s production) calculates according to nitroglycerin, and dosage is 9.5mg/kg body weight.After rat injection nitroglycerin 2 h, to occur that ears are rubescent, forelimb is frequently scratched one's head, to climb the behavior forecasting models successes such as cage.
5-HT detection method of content in 1.3 serum and cerebral tissue
In serum and cerebral tissue, 5-HT detection method of content is as follows:
Sacrificed by decapitation rat, collect neck arteries blood 3 mL, frozen centrifugation, gets serum, puts-20 DEG C of refrigerators pending.Simultaneously, ice pan is separated rat hypothalamus rapidly, remove meninges and blood vessel, rearmounted liquid nitrogen container of accurately weighing is preserved, after 24 h, the tissue in liquid nitrogen container is put in homogenizer, with 5% perchloric acid homogenate, in temperature 4 DEG C, the centrifugal 20min of rotating speed 10 000 r/min, get supernatant, put-20 DEG C of Refrigerator stores.During test sample, thawed at room temperature, 0.22 μm of filtering with microporous membrane; Get above-mentioned serum 200 μ L to put in 1.5 mL EP pipes, then add isopyknic 5% perchloric acid solution, add a cover and shake up, room temperature places 20 min, and centrifugal 15 min of 10 000 r/min, get supernatant, 00.22 μm of filtering with microporous membrane.The cerebral tissue filtered respectively and blood sample 20 μ L, 5-HT content in high effective liquid chromatography for measuring sample.
The chromatographic condition of high effective liquid chromatography for measuring 5-HT content is as follows:
Chromatographic column: SinoChrom ODS-BP post (250 mm × 4.6 mm ID, 5 μm 0. 05, Dalian Yi Lite); Mobile phase: 50 mmol/LKH 2pO 3: methanol=95: 5 (phosphoric acid adjusts pH to 4. 0), determined wavelength 275 nm, flow velocity is 1. 0 ml/m in, column temperature: 40 DEG C, sample size: 20 μ L.
2.2 grouping and administrations
Get modeling success rat 90, be divided into 9 groups at random, often organize 10, each treated animal administration is following (for setting up unified standard, avoid the experimental result difference that animal acupuncture point error causes, rat Baihui acupoint is all chosen in acupoint injection therapy administration, and the nation of position reference Huaxing at rat acupuncture point, Lee takes leave Rong etc. the development of rat acupuncture point collection of illustrative plates. and laboratory animal and zoopery .1991 the 1st phase 1-5 page .):
A group: after rat injection nitroglycerin 2 h, Baihui acupoint injecting normal saline 0.2ml/, as blank group;
B group: after rat injection nitroglycerin 2 h, acupoint injection therapy liquid 2mL/ prepared by tail vein injection embodiment 1 only, as intravenous administration approach matched group;
C group: after rat injection nitroglycerin 2 h, acupoint injection therapy liquid 0.2mL/ prepared by Baihui acupoint injection embodiment 1 only;
D group: after rat injection nitroglycerin 2 h, acupoint injection therapy liquid 0.2mL/ prepared by Baihui acupoint injection embodiment 4 only;
E group: after rat injection nitroglycerin 2 h, acupoint injection therapy liquid 0.2mL/ prepared by Baihui acupoint injection embodiment 7 only;
F group: after rat injection nitroglycerin 2 h, adopt water for injection dilute hydrochloric acid flunarizine injection, Baihui acupoint drug administration by injection 0.2mL/ only, is 0.05mg/ according to flunarizine hydrochloride cubage, as positive controls.
G group: get 900g flowers of Edgeworthia chrysantha Lindl (in embodiment 1 consumption 3 times), the preparation method (do not add Fructus Atriplicis Sibiricae and Rabdosia rubescens) same according to embodiment 1 is prepared into acupoint injection therapy liquid, after rat injection nitroglycerin 2 h, Baihui acupoint only injects acupoint injection therapy liquid 0.2mL/ prepared by the method, as flowers of Edgeworthia chrysantha Lindl single medicinal material matched group;
H group: get 420g Fructus Atriplicis Sibiricae (in embodiment 1 consumption 3 times), the preparation method (do not add flowers of Edgeworthia chrysantha Lindl and Rabdosia rubescens) same according to embodiment 1 is prepared into acupoint injection therapy liquid, after rat injection nitroglycerin 2 h, Baihui acupoint only injects acupoint injection therapy liquid 0.2mL/ prepared by the method, as Fructus Atriplicis Sibiricae single medicinal material matched group;
I group: get 240g Rabdosia rubescens (in embodiment 1 consumption 3 times), the preparation method (do not add flowers of Edgeworthia chrysantha Lindl and Fructus Atriplicis Sibiricae) same according to embodiment 1 is prepared into acupoint injection therapy liquid, after rat injection nitroglycerin 2 h, Baihui acupoint only injects acupoint injection therapy liquid 0.2mL/ prepared by the method, as Rabdosia rubescens single medicinal material matched group.
2.3 observe and measurement index
After administration in 4h, observe each group of rat to scratch one's head number of times, after having observed behavioral indexes, put to death each group of rat, sacrificed by decapitation rat measures 5-HT content in rat blood serum and cerebral tissue according to this experiment 1.3 " serum and cerebral tissue in 5-HT detection method of content " the described method of part.
2 statistical dispositions
Adopt SPSS 12.0 software.Each group of data represent with mean+SD, and adopt one factor analysis of variance and Student Newman Keuls to check, P<0.05 is that difference has statistical significance, and P<0.01 is for having significant difference.
3 experimental results
After administration in 4h, observe each group of rat and to scratch one's head number of times, and experiment terminates 5-HT assay in rear each group of rat blood serum and cerebral tissue and the results are shown in following table:
n=10。A: p<0.05 compared with blank group; B is p<0.01 compared with blank group; C is p<0.05 compared with positive controls; D is p<0.01 compared with positive controls.
From upper table result, acupoint injection therapy liquid prepared by embodiment 1,4,7 significantly can reduce number of times difficult to tackle after rat administration in 4h in Migraine Rats model Baihui acupoint single position drug administration by injection, and its Be very effective is better than Flunarizine hydrochloride injection.
Acupoint injection therapy liquid tail vein injection administration prepared by embodiment 1 also significantly can reduce the number of times difficult to tackle after rat administration in 4h, but effect is lower than acupoint injection therapy administration.
Flowers of Edgeworthia chrysantha Lindl, Rabdosia rubescens single medicinal material adopt embodiment 1 method to be prepared into acupoint injection therapy liquid (3 times amount) rat after the administration of Baihui acupoint acupoint injection therapy in 4h and to scratch one's head number of times no difference of science of statistics compared with blank group.Prompting flowers of Edgeworthia chrysantha Lindl, Rabdosia rubescens are used alone migraine without therapeutic effect.
Fructus Atriplicis Sibiricae single medicinal material adopts embodiment 1 method to be prepared into acupoint injection therapy liquid (3 times amount) rat after the administration of Baihui acupoint acupoint injection therapy in 4h and scratches one's head number of times by significant difference compared with blank group, but significantly lower than acupoint injection therapy liquid prepared by embodiment 1,4,7.In the compound medicine that prompting flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens are made, Fructus Atriplicis Sibiricae may play main pharmacodynamics effect, but simple dependence Fructus Atriplicis Sibiricae cannot play the effect that compound medicine can reach, and flowers of Edgeworthia chrysantha Lindl, Rabdosia rubescens may have potentiation to the drug effect of Fructus Atriplicis Sibiricae.
In cerebral tissue and serum 5-HT content's index and corresponding treatment group 4h in number of times difficult to tackle contrast known, the acupoint injection therapy liquid that flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens are made raises the Be very effective of 5-HT content lower than positive controls, but after minimizing administration, in 4h, the scratch one's head Be very effective of number of times of rat is better than positive controls, and the acupoint injection therapy liquid that prompting flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens are made is treated migrainous mechanism of action and may be had nothing to do with rising 5-HT.
To sum up, experimental result shows, after acupoint injection therapy liquid acupoint injection therapy administration prepared by embodiment 1,4,7 can significantly reduce administration, rat is scratched one's head number of times in 4h, and Be very effective is better than single medicinal material, positive control drug, and acupoint injection therapy effect is better than intravenous administration.Its mechanism of action may not rely on the adjustment to 5-HT in cerebral tissue and serum.
embodiment 16 treats migrainous Chinese Traditional Medicine into Point liquid clinical pharrnacokinetics and safety research
1 data and method
1.1 physical data
All cases all derives from the attached second hospital's Neurology Department of Heilongjiang University of Chinese Medicine, wherein male patient 30 example, female patient 60 example, 24 ~ 60 years old age, 40.5 ± 2.3 years old mean age.The course of disease is the shortest 1 month, the longest 5 years, average 2.5 ± 1.4 years.
All patients are all in stage of attack, and get rid of the headache because cerebrovascular, intracranial infection, occupying lesion and hypertension, wound etc. cause.
1.2 diagnostic criterias adopt 1998 International Headache association (ISH) formulate migraine diagnostic criteria (Mao Junxiong, Li Chunyan,
Zhang Xiang builds. practical neurological clinical. and Shijiazhuang: Hebei science tech publishing house .1999:350-551).
1.3 Therapeutic Method
Random 9 groups of patient, often organizes 10 patients, each group patient's administration acupuncture point and the medicine given as follows:
Medication: injection operation is according to GB GB/T21709.6-2008(acupuncture technique working specification the 6th part: acupoint injection therapy) perform.After patient's medicine-feeding part routine disinfection, draw each group of corresponding acupoint injection therapy liquid 1mL with disposable syringe, thrust above-mentioned acupuncture point fast with No. 6 syringe needles subcutaneous, slightly carry slotting, when patient has acid swollen sense, suction is without after blood back, slowly injected by medicinal liquid, art finishes with aseptic cotton balls pressing pin hole for a moment.1 time every other day, be for 5 times the l course for the treatment of, treat 2 courses for the treatment of.
1.4 criterion of therapeutical effect
(1) fully recover: headache and simultaneous phenomenon disappear, follow up a case by regular visits to half a year more than after terminating the course for the treatment of without recurrence; (2) effective: headache and simultaneous phenomenon obviously alleviate, terminate occasionally have recurrence in later six months the course for the treatment of, degree is comparatively light, decreased duration; (3) effective: headache degree and simultaneous phenomenon alleviate to some extent, seizure frequency reduces, decreased duration; (4) invalid: after 2 courses for the treatment of, symptom is without improvement.
2 results
Each group the results are shown in following table
Wherein cure rate, obvious effective rate, effective percentage, inefficiency computational methods are that the patient numbers meeting corresponding criterion of therapeutical effect respectively organizes patient numbers divided by 10().Each group of total effective rate be each group of cure rate, obvious effective rate, efficient summation.
As seen from the above table, the acupoint injection therapy liquid of embodiment 1, embodiment 4, embodiment 7 preparation respectively at Baihui acupoint or Ipsilateral Fengchi acupoint or the administration of Ipsilateral temple acupoint injection therapy, each administration 1mL, 1 time every other day, be for 5 times the l course for the treatment of, treat 2 courses for the treatment of, total effective rate is all higher than 80%.9 groups of patient data joint accounts, only have 4 examples invalid, namely during 9 groups of patient's joint accounts, total effective rate can reach 95.6%.
Wherein several recovery from illness follow-up of patients has no recurrence in more than 1 year.
Follow up a case by regular visits in 3 months after each group of patient treatment terminates, have no medicine-feeding part untoward reaction and other untoward reaction relevant to Drug therapy.
Result of the test shows, the Chinese medicine compound acupoint injection therapy liquid that prompting flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens are made has good therapeutic effect to migraine, and safety is higher.

Claims (7)

1. treat a migrainous Chinese Traditional Medicine into Point liquid, it is characterized in that, be made up of the raw material of following weight: flowers of Edgeworthia chrysantha Lindl 20 ~ 40, Fructus Atriplicis Sibiricae 8 ~ 15, Rabdosia rubescens 5 ~ 16.
2. Chinese Traditional Medicine into Point liquid according to claim 1, is characterized in that, described parts by weight of raw materials proportioning is: flowers of Edgeworthia chrysantha Lindl 30, Fructus Atriplicis Sibiricae 14, Rabdosia rubescens 8.
3. Chinese Traditional Medicine into Point liquid according to claim 1 and 2, is characterized in that, described parts by weight of raw materials proportioning is: flowers of Edgeworthia chrysantha Lindl 35, Fructus Atriplicis Sibiricae 9, Rabdosia rubescens 10.
4. the Chinese Traditional Medicine into Point liquid according to any one of claims 1 to 3, is characterized in that, described parts by weight of raw materials proportioning is: flowers of Edgeworthia chrysantha Lindl 25, Fructus Atriplicis Sibiricae 12, Rabdosia rubescens 15.
5. the preparation method of the Chinese Traditional Medicine into Point liquid described in any one of Claims 1-4, is characterized in that, comprise the following steps:
1) get dry flowers of Edgeworthia chrysantha Lindl, Fructus Atriplicis Sibiricae, Rabdosia rubescens pulverizing, cross 200 mesh sieves, the First Astronautic Research Institute for Measurement and Test obtains the volume of powder;
2) adding 3 times of volumetric concentrations to step 1) gained powder is 70% ethanol, and at 80 DEG C, water-bath extracts 5 hours, and mixed by gained extracting solution, the First Astronautic Research Institute for Measurement and Test obtains the volume of extracting solution;
3) to step 2) add the water of 3 times of volumes, hold over night in gained extracting solution, 0.45 μm of microporous filter membrane filters to obtain filtrate;
4) by step 3) gained filtrate, adding pH adjusting agent Fructus Citri Limoniae acid for adjusting pH is 6.2 ~ 6.8;
5) by step 4) gained solution sterilization, subpackage, both.
6. preparation method according to claim 5, is characterized in that, described pH adjusting agent is citric acid.
7. the Chinese Traditional Medicine into Point liquid as described in any one of Claims 1 to 4, is characterized in that, this Chinese Traditional Medicine into Point liquid is preparing the application in migraine treatment medicine.
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