CN104758599A - Traditional Chinese medicine preparation for treating hypotension and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating hypotension and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating hypotension and a preparation method thereof, which belongs to the technical field of traditional Chinese medicine. The traditional Chinese medicine preparation comprises the following bulk drug: Codonopsis pilosula, Radix Astragali, prepared rehmannia root, eucommia, Chinese angelica, cibotium rhizome, radix bupleuri, spatholobus stem, uncaria, phellodendron, cassia twig, Polygonatum sibiricum, large jujube, achyranthes root, Dipsacus asper wall, rhizoma cimicifugae and licorice. The traditional Chinese medicine preparation prepared by the preparation method has obvious treatment effect on hypotension, in addition, the preparation has the advantages of simple preparation technology process, stable drug effect of the preparation, little individual difference, and easy popularization and application.
Description
Technical field
The present invention relates to technical field of Chinese medicines, be specifically related to one and treat hypotensive Chinese medicine preparation.
Background technology
Hypotension refers to the subnormal state of systemic arterial pressure power.Because hypertension usually causes the infringement of the important organs such as the heart, brain, kidney and attention clinically, also there is clear stipulaties in World Health Organization (WHO) to hypertensive diagnostic criteria, but hypotensive diagnosis there is no unified standard.
Medically measure brachial arterial pressure lower than 90/60mmHg continuous for adult 3 times, claim hypotension.Clinically, having a dizzy spell often appears in Symptomatic hypotension, fatigue and weak, soreness of the waist and knees, insomnia agitation, inappetence, shallow complexion, the symptoms such as orthostatic black Mongolian at the moment very then topples over, the traditional Chinese medical science treats by the category such as " dizzy ", " asthenia ", has unique advantage.Chinese medical discrimination hypotension, is often divided into following two typings by hypotension:
(1) sinking of QI of middle-JIAO type
Disease opinion is had a dizzy spell, meet dynamic meet labor what for, very then eye Before-daybreak falls forward, and Mental fatigue is breathed hard, anorexia and loose stool, light red tongue, white and thin fur, thready and weak pulse.Control suitable invigorating the spleen and replenishing QI, ascending up spleen-Qi and Yang.
(2) type of deficiency of both QI and YIN
Disease opinion is had a dizzy spell, meet dynamic meet labor what for, very then eye Before-daybreak falls forward, lethargy, dry mouth and throat, shallow complexion, palpitation and insomnia, poor appetite, the few tongue of red tongue, thready and weak pulse.Control suitable benefiting qi and nourishing blood, nourshing Yin and drynsessmoistening prescription.
(3) deficiency of kidney yin type
Disease opinion is had a dizzy spell, soreness of the waist and knees, spiritlessness and weakness, palpitation and amnesia, dysphoria with feverish sensation in the chest palms and soles, and difference of sleeping night sweat, red tongue tongue is few, thready and stringy pulse.Controlling should kidney tonifying nourishing YIN.
(4) deficiency of heart-YANG and kidney-YANG type
Disease is seen dizzy, and feel oppressed in cardiopalmus or ambition, spontaneous perspiration, refreshing tired drowsiness, aching pain in waist and back, coldness of the body with chills, pale complexion, loose stool, or has impotence and seminal emission, light red tongue or lightly fatly have indentation or purple dark, and tongue is white, thready and weak pulse or late heavy.Control suitable temperature compensation heart kidney, rouse oneself yang-energy.
(5) dampness blocking in middle-JIAO type
Disease sees that a Mongolian is unclear, uncomfortable in chest indigestion and loss of appetite, inappetence, and xerostomia mouth sticks, and stool is smooth or with stench, light red tongue, thick and greasy fur or Huang, relaxed and soft pulse.Control and should wet by Wen Huashui, during stomach function regulating is smooth.
Summary of the invention
The technical problem to be solved in the present invention is that exploitation one treats the good Chinese medicine of hypotension effect, and the finished product preparation that modern clinic needs made by this Chinese medicine by the shortcoming utilizing Modern preparations technology to overcome Chinese medicine.
For solving the problems of the technologies described above, the technical scheme of inventor is, first according to the checking of adjustment repeatedly of self tcm clinical practice experience for many years and clinical practice, has invented a brand-new Chinese prescription; Secondly, invented a set of preparation technology this Chinese prescription being made finished product preparation in conjunction with modern pharmaceutical and preparation technique, the Chinese medicine preparation obtained therefrom has very significant therapeutic effect to hypotension.
Chinese prescription of the present invention is: Radix Codonopsis 13-23 part, Radix Astragali 14-28 part, Radix Rehmanniae Preparata 15-29 part, Cortex Eucommiae 8-18 part, Radix Angelicae Sinensis 14-26 part, Rhizoma Cibotii 7-17 part, Radix Bupleuri 10-20 part, Caulis Spatholobi 12-24 part, Ramulus Uncariae Cum Uncis 8-16 part, Cortex Phellodendri 7-15 part, Ramulus Cinnamomi 9-17 part, Rhizoma Polygonati 15-27 part, Fructus Jujubae 11-23 part, Radix Achyranthis Bidentatae 8-16 part, Radix Dipsaci 7-15 part, Rhizoma Cimicifugae 7-13 part, Radix Glycyrrhizae 8-14 part.
The preferred Chinese prescription of the present invention is following three excellent proportionings:
Proportioning 1: Radix Codonopsis 18 parts, the Radix Astragali 21 parts, Radix Rehmanniae Preparata 22 parts, the Cortex Eucommiae 13 parts, Radix Angelicae Sinensis 20 parts, Rhizoma Cibotii 12 parts, Radix Bupleuri 15 parts, Caulis Spatholobi 18 parts, Ramulus Uncariae Cum Uncis 12 parts, Cortex Phellodendri 11 parts, Ramulus Cinnamomi 13 parts, Rhizoma Polygonati 21 parts, 17 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 12 parts, Radix Dipsaci 11 parts, Rhizoma Cimicifugae 10 parts, 11 parts, Radix Glycyrrhizae.
Proportioning 2: Radix Codonopsis 19 parts, the Radix Astragali 23 parts, Radix Rehmanniae Preparata 23 parts, the Cortex Eucommiae 14 parts, Radix Angelicae Sinensis 21 parts, Rhizoma Cibotii 11 parts, Radix Bupleuri 14 parts, Caulis Spatholobi 16 parts, Ramulus Uncariae Cum Uncis 11 parts, Cortex Phellodendri 10 parts, Ramulus Cinnamomi 12 parts, Rhizoma Polygonati 22 parts, 16 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 11 parts, Radix Dipsaci 12 parts, Rhizoma Cimicifugae 11 parts, 12 parts, Radix Glycyrrhizae.
Proportioning 3: Radix Codonopsis 17 parts, the Radix Astragali 20 parts, Radix Rehmanniae Preparata 21 parts, the Cortex Eucommiae 12 parts, Radix Angelicae Sinensis 23 parts, Rhizoma Cibotii 13 parts, Radix Bupleuri 16 parts, Caulis Spatholobi 19 parts, Ramulus Uncariae Cum Uncis 13 parts, Cortex Phellodendri 12 parts, Ramulus Cinnamomi 14 parts, Rhizoma Polygonati 23 parts, 18 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 13 parts, Radix Dipsaci 13 parts, Rhizoma Cimicifugae 11 parts, 13 parts, Radix Glycyrrhizae.
The preparation technology above-mentioned Chinese prescription being made preparation is following steps:
(1) each taste Chinese crude drug is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 6-12 times of weight after mixing is 60-80% ethanol, soaks 6-12 hour, backflow decocts, extract 2 times, each 2-5 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 7-12 times of weight, backflow decoction three times, each 1-4 hour, filters, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made the Chinese medicine finished product preparation (as dosage forms such as capsule, granule, tablet, powder, pill, syrups) of clinical needs.
The character Characteristic of Chinese medicine preparation of the present invention Chinese crude drug used:
Radix Codonopsis: the dry root that this product is Campanulaceae Radix Codonopsis, element spends Radix Codonopsis (RADIX CODONOPSIS PILOSULAE from Northwest of China) or radix codonpsis tangshen.Sweet in the mouth, property is put down; Return spleen, lung meridian; Invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali or Radix Astragali.Sweet in the mouth, warm in nature; Return lung, spleen channel; Invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
Radix Rehmanniae Preparata: this product is the Preparation process product of Radix Rehmanniae.Sweet in the mouth, slightly warm in nature; Return liver, kidney channel; Nourishing YIN and supplementing blood, beneficial essence fills out marrow.
The Cortex Eucommiae: this product is the dry bark of the Eucommiaceae plant Cortex Eucommiae.Sweet in the mouth, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, antiabortive.
Radix Angelicae Sinensis: this product is the dry root of umbelliferae angelica.Sweet in the mouth, pungent, warm in nature; Return liver, the heart, spleen channel; Enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.
Rhizoma Cibotii: this product is the dry rhizome of Dicksoniaceae plant Rhizoma Cibotii.Bitter in the mouth, sweet, warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, strong spinal column, wind-damp dispelling.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii..Bitter in the mouth, cold nature; Return liver, gallbladder meridian; Reconciling superficies and interior, soothing the liver, yang invigorating.
Caulis Spatholobi: this product is the dry rattan of leguminous plant spatholobus suberectus (Caulis Sargentodoxae, Radix seu Caulis Verntilaginis Leiocarpae, SANYE Caulis Spatholobi, nine layers of wind).Bitter in the mouth, sweet, warm in nature; Return liver, kidney channel; Enrich blood, invigorate blood circulation, dredging collateral.
Ramulus Uncariae Cum Uncis: this product is the dry stem and branch with belt hook of Maguireothamnus speciosus Ramulus Uncariae Cum Uncis, Ramulus Uncariae macrophyllae, Ramulus Uncariae Cum Uncis, Uncaria sinensis (Oliv.) Havil. or stockless fruit Ramulus Uncariae Cum Uncis.Sweet in the mouth, cool in nature; Return liver, pericardium channel; Heat clearing away suppressing the hyperactive liver, dispelling wind and relieving convulsion.
Cortex Phellodendri: this product is the dry bark of rutaceae wampee or Cortex Phellodendri.Bitter in the mouth, cold in nature; Return kidney, urinary bladder channel; Heat clearing and damp drying, pathogenic fire purging removes steams, detoxification sore treatment.
Ramulus Cinnamomi: this product is the dry twig of canella Cortex Cinnamomi.Acrid in the mouth, sweet, warm in nature; GUIXIN, lung, urinary bladder channel; Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.
Rhizoma Polygonati: this product is the dry rhizome of liliaceous plant P. kingianum, Rhizoma Polygonati or Polygonatum cyrtonema Hua.Sweet in the mouth, property is put down; Return spleen, lung, kidney channel; Boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney tonifying.
Fructus Jujubae: this product is the dry mature fruit of Rhamnaceae jujube Fructus Jujubae.Sweet in the mouth, warm in nature; Return spleen, stomach warp; Invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.
Radix Achyranthis Bidentatae: this product is the dry root of amaranthaceous plant Radix Achyranthis Bidentatae.Bitter in the mouth, acid, property is put down; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, eliminating blood stasis and inducing menstruation, conducting blood to flow downwards.
Radix Dipsaci: this product is the dry root of Dipsacaceae plant Radix Dipsaci.Bitter in the mouth, pungent, slightly warm in nature; Return liver, kidney channel; Invigorating the liver and kidney, bone and muscle strengthening, continuous injured, only metrorrhagia.
Rhizoma Cimicifugae: this product is the dry rhizome of ranunculaceae plant C.heracleifolia, Cimicifuga Dahurica or Rhizoma Cimicifugae.Acrid in the mouth, micro-sweet, cold nature; Return lung, spleen, stomach, large intestine channel; Deliver rash, heat-clearing and toxic substances removing, elevate a turnable ladder yang-energy.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down; GUIXIN, lung, spleen, stomach warp; Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The side of the Chinese prescription of Chinese medicine preparation of the present invention separates:
Chinese prescription of the present invention is with Radix Rehmanniae Preparata, the Radix Astragali, Radix Angelicae Sinensis, Radix Codonopsis, Rhizoma Polygonati for monarch drug, nourishing YIN and supplementing blood, invigorating QI to consolidate the body surface resistance, enrich blood invigorate blood circulation, spleen invigorating lung benefiting, boosting qi and nourishing yin; With Caulis Spatholobi, Fructus Jujubae, Radix Bupleuri, Radix Achyranthis Bidentatae for ministerial drug, dredging collateral of enriching blood, nourishing blood to tranquillize the mind, soothing the liver yang invigorating, eliminating blood stasis and inducing menstruation; With the Cortex Eucommiae, Rhizoma Cibotii, Radix Dipsaci, Ramulus Cinnamomi for adjuvant drug, the kidney invigorating bone strengthening, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI; With Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Cimicifugae for making medicine, heat clearing away suppressing the hyperactive liver, heat clearing and damp drying, deliver rash; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, make all medicine negative and positive harmonious, complement each other, jointly reach the effects such as nourishing YIN and supplementing blood, invigorating QI to consolidate the body surface resistance, spleen invigorating lung benefiting, nourishing blood to tranquillize the mind, the kidney invigorating bone strengthening, soothing the liver yang invigorating, heat clearing and damp drying, have very significant therapeutic effect to hypotension.
Compared with prior art, the treatment advantage such as Chinese medicine preparation of the present invention has that therapeutic effect is good, instant effect, medical treatment combine, have no side effect, also has that preparation process is simple and easy to do, preparation efficacy stability individual variation is little, be easy to technical advantages such as applying.
Detailed description of the invention
Embodiment 1
Capsule is produced in the ratio of Chinese prescription minimum zone of the present invention and the optimal parameter of production technology of the present invention:
(1) Radix Codonopsis 13kg, Radix Astragali 14kg, Radix Rehmanniae Preparata 15kg, Cortex Eucommiae 8kg, Radix Angelicae Sinensis 14kg, Rhizoma Cibotii 7kg, Radix Bupleuri 10kg, Caulis Spatholobi 12kg, Ramulus Uncariae Cum Uncis 8kg, Cortex Phellodendri 7kg, Ramulus Cinnamomi 9kg, Rhizoma Polygonati 15kg, Fructus Jujubae 11kg, Radix Achyranthis Bidentatae 8kg, Radix Dipsaci 7kg, Rhizoma Cimicifugae 7kg, Radix Glycyrrhizae 8kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
Embodiment 2
Capsule is produced in the ratio of Chinese prescription maximum magnitude of the present invention and the optimal parameter of production technology of the present invention:
(1) Radix Codonopsis 23kg, Radix Astragali 28kg, Radix Rehmanniae Preparata 29kg, Cortex Eucommiae 18kg, Radix Angelicae Sinensis 26kg, Rhizoma Cibotii 17kg, Radix Bupleuri 20kg, Caulis Spatholobi 24kg, Ramulus Uncariae Cum Uncis 16kg, Cortex Phellodendri 15kg, Ramulus Cinnamomi 17kg, Rhizoma Polygonati 27kg, Fructus Jujubae 23kg, Radix Achyranthis Bidentatae 16kg, Radix Dipsaci 15kg, Rhizoma Cimicifugae 13kg, Radix Glycyrrhizae 14kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
Embodiment 3
Capsule is produced by the optimal parameter of the arbitrary proportion within the scope of Chinese prescription of the present invention and production technology of the present invention:
(1) Radix Codonopsis 23kg, Radix Astragali 14kg, Radix Rehmanniae Preparata 29kg, Cortex Eucommiae 8kg, Radix Angelicae Sinensis 26kg, Rhizoma Cibotii 7kg, Radix Bupleuri 20kg, Caulis Spatholobi 12kg, Ramulus Uncariae Cum Uncis 16kg, Cortex Phellodendri 7kg, Ramulus Cinnamomi 17kg, Rhizoma Polygonati 15kg, Fructus Jujubae 23kg, Radix Achyranthis Bidentatae 8kg, Radix Dipsaci 15kg, Rhizoma Cimicifugae 7kg, Radix Glycyrrhizae 14kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
Embodiment 4
Capsule is produced in the ratio of the proportioning 1 of Chinese prescription optimum ratio of the present invention and the optimal parameter of production technology of the present invention:
(1) Radix Codonopsis 18kg, Radix Astragali 21kg, Radix Rehmanniae Preparata 22kg, Cortex Eucommiae 13kg, Radix Angelicae Sinensis 20kg, Rhizoma Cibotii 12kg, Radix Bupleuri 15kg, Caulis Spatholobi 18kg, Ramulus Uncariae Cum Uncis 12kg, Cortex Phellodendri 11kg, Ramulus Cinnamomi 13kg, Rhizoma Polygonati 21kg, Fructus Jujubae 17kg, Radix Achyranthis Bidentatae 12kg, Radix Dipsaci 11kg, Rhizoma Cimicifugae 10kg, Radix Glycyrrhizae 11kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
Embodiment 5
Capsule is produced in the ratio of Chinese prescription optimum ratio 2 of the present invention and the optimal parameter of production technology of the present invention:
(1) Radix Codonopsis 19kg, Radix Astragali 23kg, Radix Rehmanniae Preparata 23kg, Cortex Eucommiae 14kg, Radix Angelicae Sinensis 21kg, Rhizoma Cibotii 11kg, Radix Bupleuri 14kg, Caulis Spatholobi 16kg, Ramulus Uncariae Cum Uncis 11kg, Cortex Phellodendri 10kg, Ramulus Cinnamomi 12kg, Rhizoma Polygonati 22kg, Fructus Jujubae 16kg, Radix Achyranthis Bidentatae 11kg, Radix Dipsaci 12kg, Rhizoma Cimicifugae 11kg, Radix Glycyrrhizae 12kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
Embodiment 6
Capsule is produced in the ratio of Chinese prescription optimum ratio 3 of the present invention and the optimal parameter of production technology of the present invention:
(1) Radix Codonopsis 17kg, Radix Astragali 20kg, Radix Rehmanniae Preparata 21kg, Cortex Eucommiae 12kg, Radix Angelicae Sinensis 23kg, Rhizoma Cibotii 13kg, Radix Bupleuri 16kg, Caulis Spatholobi 19kg, Ramulus Uncariae Cum Uncis 13kg, Cortex Phellodendri 12kg, Ramulus Cinnamomi 14kg, Rhizoma Polygonati 23kg, Fructus Jujubae 18kg, Radix Achyranthis Bidentatae 13kg, Radix Dipsaci 13kg, Rhizoma Cimicifugae 11kg, Radix Glycyrrhizae 13kg is taken by Chinese prescription of the present invention;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 8 times of weight after mixing is 75% ethanol, soaks 8 hours, backflow decocts, extract 2 times, each 3 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 10 times of weight, backflow decoction three times, each 2 hours, filter, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made capsule, specification: amount to crude drug 1.44g/ capsules.
The toxicity test of Chinese medicine preparation of the present invention
1, acute toxicity test
(1) test medicine: the capsule manufactured by embodiment of the present invention 1-6, abolishes capsule shells, adds purified water, be modulated into magma, for subsequent use.
(2) experimental animal: Kunming mouse, body weight 19g ± 3g, male and female half and half, female mice is all without pregnant.
(3) magma of mouse stomach Chinese medicine capsules preparation of the present invention, when given low reaches 772.5g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1.5 hours recover normal, Continuous Observation 7 days after administration, none animal dead, its overall health of patients, diet, take the photograph water, urine and body weight increase all normal.
(4) result of the test shows: the maximum dosage-feeding of the capsule manufactured by mouse stomach embodiment of the present invention 1-6 is 772.5g crude drug/kg/d(LD50 > 772.5g crude drug/kg).Chinese medicine preparation clinical application every day total amount of the present invention is 0.24g crude drug/kg/d; By weighing machine, the dosis tolerata of mouse stomach capsule of the present invention is 3218.8 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.
2, long-term toxicity test for animals
(1) test medicine: embodiment of the present invention 1-6 gained Chinese medicine capsules, abolishes capsule shells, adds purified water, be modulated into magma, for subsequent use.
(2) experimental animal: regular grade SD rat, body weight 205g ± 11g, male and female half and half, female rats is all without pregnant.
(3) method and result:
By 6 kinds of Chinese medicine capsules: be divided into high, medium and low three dosage groups, per weight dosage is respectively 180,60,20 times of patient's dose; Experimental mouse is divided into 19 groups at random, and wherein the capsule magma of 18 groups of difference gavages, 6 kinds of three dosage, remains one group of gavage normal saline (20 times of patient's dose); All 19 groups of all continuous gavages 180 days, observe animal general toxic reaction and the order of severity, check each position, and carry out hematology, the pathological examination of the main organs such as ALT, BUN and the heart, liver, spleen, lung, kidney, stomach after execution by rule of operation;
Through long-term feeding, all there is not toxic reaction in 19 groups of rats.Physically well develop.Macroscopic appearance and main organs no abnormality seen.Peripheral hemogram and Serum ALT, BUN compare with matched group and change without pathologic.The all not significant changes such as the pathological replacement heart, liver, spleen, lung, kidney, stomach, therefore, think through proved by pathology, 6 kinds of Chinese medicine capsules show without chronic toxicity animal.
By above two toxicity tests, prove that the present invention is safe by the Chinese medicine capsules that embodiment 1-6 makes, have no side effect, can be taken by patient.
The test of pesticide effectiveness of Chinese medicine preparation of the present invention:
1, test objective
Observe the impact of medicine of the present invention on rat cardiac output and blood.
2, trial drug
Matched group: normal saline;
The arbitrary made capsule of test group: embodiment of the present invention 4-6, abolishes capsule shells, adds purified water and be modulated into pasty state.
3, experimental animal, SD rat, body weight 210 ± 14g, male and female half and half, female rats, all without pregnant, is provided by laboratory animal research center, Shanghai.
4, statistical method
Result of the test with
represent, adopt t inspection to measure the significance of group difference.
5, test method and result
(1) on the kinemic impact of rat
Get rat 20, male and female half and half, fasting 24h, be divided into 2 groups at random, often organize 10.Be respectively matched group and test group, matched group oral normal saline, the oral magma modulated of test group, dosage is 4.8g crude drug/kg/d, successive administration 5 days.First use urethane (10ml/Kg) intraperitoneal injection of anesthesia, make intubate with trachea, practice artificial respiration.Lumbar injection chlorination succinum alkali (1mg/Kg) is to eliminate autonomous respiration, and adjustment respirator makes respiratory depth and respiratory frequency and autonomous respiration close.By AI-600G impedance plethysmogram plug-in unit, trace impedance cardiogram by level Four method (do electrode with filamentary silver, pass from corresponding dorsal sc), calculate every pulse blood discharge amount, numeration heart rate (HR), calculate cardiac output (CO).In order to avoid the cardiac output caused by weight differences is different, be all converted into per kilogram of body weight cardiac output [CO:L/ (minKg)] during calculating, after last administration, 2h records cardiac output, and result of the test is in table 1.
Table 1 Chinese medicine preparation of the present invention on the kinemic impact of rat (
)
Note: compared with normal saline group, * * P < 0.01.
Experimental data from table 1: compared with saline control group, Chinese medicine preparation of the present invention can obviously increase rat cardiac output, and reaches significant statistical significance; Result of study is pointed out: Chinese medicine preparation of the present invention can increase rat cardiac output, has obvious therapeutical effect to it.
(2) on the impact of rat blood pressure
Get rat 20, male and female half and half, fasting 24h, be divided into matched group, test group, often organize 10.First use urethane (10ml/Kg) intraperitoneal injection of anesthesia, back of the body position is fixed in laboratory table, makees tracheorrhaphy from, tracheal intubation, is separated side common carotid artery, insert ductus arteriosus, connect the pressure transducer in two road physiographs with stop,threeway.Side femoral artery inserts a PE50 polyethylene tube for blood-letting.Opposite side femoral arteriography for injecting 0.5mg/100g heparin in case blood clotting and for blood transfusion.Abdominal operation, finds out duodenum, inserts polyethylene tube and fix it, for administrable in intestinal tube.After tracing Normal Cervical arteriotony (11.8 ± 1.07kpa) curve, the slow blood-letting of femoral artery, make Blood pressure of carotid artery continually and steadily at 6.67kpa, 30min rear intestinal is to the modulation pastel of Chinese medicine preparation of the present invention, dosage is 4.8g crude drug/kg/d, matched group to normal saline, observe blood pressure, and record the results are shown in following table 2.
Table 2 Chinese medicine preparation of the present invention on the impact of rat blood pressure (
)
Note: compared with normal saline group, * * P < 0.01.
Experimental data from table 2: Chinese medicine preparation of the present invention can raise rat carotid artery systolic pressure, compares with normal saline group, reaches significant statistical meaning.
To sum up, Chinese medicine preparation of the present invention has to be increased test rat cardiac output and raises the effects such as rat carotid artery systolic pressure, and these effects are pharmacological basis for the treatment of hypotension, inference thus, and Chinese medicine preparation of the present invention has the hypotensive effect for the treatment of.
The clinical trial of Chinese medicine preparation of the present invention
1, basic document
200 hypotensives are collected in this clinical trial altogether, age 21-67 year, wherein man 80, female 120; All patients are divided into 4 groups, are respectively matched group, test 1, test 2, test 3 groups, make the comparability possessed in sex, age, the course of disease etc. between each group on statistical significance.
2, medication is tested
Contrast medicine: Midodrine hydrochloride, the accurate word H20060551 of traditional Chinese medicines, Sinopharm Chuankang Pharmaceutical Co., Ltd.;
The capsule that investigational agent: embodiment of the present invention 4-6 produces, specification: amount to crude drug 1.44g/ capsules.
3, test method
Matched group oral hydrochloride midodrine, every day 2 times, each 2.5mg, more than 8 hours, interval; Test 1-3 group is the capsule produced of oral embodiment 4-6 respectively, every day 2 times, each 5, more than 8 hours, interval; All subject two months, the situation such as the performance of the record patient state of an illness, untoward reaction in therapeutic process, carries out in treatment end trackings to healing person for 6 months later pays a return visit, record recurrent cases.
4, evaluation criterion
Cure: patient recovers normal, dizzy, orthostatic is dizzy, tired, dyspepsia, trick cold limbs, cardio palmus shape disappear completely;
Effective: blood pressure most time is normal, dizzy, orthostatic is dizzy, tired, dyspepsia, trick cold limbs, cardio palmus shape significantly alleviate;
Effective: blood pressure normal time increases before comparatively treating, dizzy, orthostatic is dizzy, tired, dyspepsia, trick cold limbs, cardio palmus shape make moderate progress;
Invalid: all symptoms are all without any improvement, even more serious;
5, result of the test statistics and analysis
(1) in whole therapeutic process, test group 3 groups do not have the routine untoward reaction of appearance one; The untoward reaction such as matched group has 9 patients to occur arrhythmia in various degree, shivers, erythra, untoward reaction rate is up to 18%.
(2) after treatment all terminates, by as shown in table 3 for result of the test statistical analysis:
Table 3 test data statistical analysis table
6, conclusion
Compared with matched group, test group has no adverse reaction; The average cure rate of test group is 45.3%, higher than matched group 1.7 times; The average total effective rate of test group is 98%, higher than matched group 18 percentage points; The average relapse rate of test group is 13.0%, is only about 1/4 of matched group; Therefore, test illustrates that Chinese medicine preparation of the present invention has more treatment advantage than contrast medicine, so Chinese medicine preparation of the present invention has more creativeness relative to prior art, obtains beyond thought technique effect.
Claims (6)
1. treat a hypotensive Chinese medicine preparation, it is characterized in that being made up of the raw material of following weight portion: Radix Codonopsis 13-23 part, Radix Astragali 14-28 part, Radix Rehmanniae Preparata 15-29 part, Cortex Eucommiae 8-18 part, Radix Angelicae Sinensis 14-26 part, Rhizoma Cibotii 7-17 part, Radix Bupleuri 10-20 part, Caulis Spatholobi 12-24 part, Ramulus Uncariae Cum Uncis 8-16 part, Cortex Phellodendri 7-15 part, Ramulus Cinnamomi 9-17 part, Rhizoma Polygonati 15-27 part, Fructus Jujubae 11-23 part, Radix Achyranthis Bidentatae 8-16 part, Radix Dipsaci 7-15 part, Rhizoma Cimicifugae 7-13 part, Radix Glycyrrhizae 8-14 part.
2. treat hypotensive Chinese medicine preparation according to claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Codonopsis 18 parts, the Radix Astragali 21 parts, Radix Rehmanniae Preparata 22 parts, the Cortex Eucommiae 13 parts, Radix Angelicae Sinensis 20 parts, Rhizoma Cibotii 12 parts, Radix Bupleuri 15 parts, Caulis Spatholobi 18 parts, Ramulus Uncariae Cum Uncis 12 parts, Cortex Phellodendri 11 parts, Ramulus Cinnamomi 13 parts, Rhizoma Polygonati 21 parts, 17 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 12 parts, Radix Dipsaci 11 parts, Rhizoma Cimicifugae 10 parts, 11 parts, Radix Glycyrrhizae.
3. treat hypotensive Chinese medicine preparation according to claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Codonopsis 19 parts, the Radix Astragali 23 parts, Radix Rehmanniae Preparata 23 parts, the Cortex Eucommiae 14 parts, Radix Angelicae Sinensis 21 parts, Rhizoma Cibotii 11 parts, Radix Bupleuri 14 parts, Caulis Spatholobi 16 parts, Ramulus Uncariae Cum Uncis 11 parts, Cortex Phellodendri 10 parts, Ramulus Cinnamomi 12 parts, Rhizoma Polygonati 22 parts, 16 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 11 parts, Radix Dipsaci 12 parts, Rhizoma Cimicifugae 11 parts, 12 parts, Radix Glycyrrhizae.
4. treat hypotensive Chinese medicine preparation according to claim 1, it is characterized in that being made up of the raw material of following weight portion: Radix Codonopsis 17 parts, the Radix Astragali 20 parts, Radix Rehmanniae Preparata 21 parts, the Cortex Eucommiae 12 parts, Radix Angelicae Sinensis 23 parts, Rhizoma Cibotii 13 parts, Radix Bupleuri 16 parts, Caulis Spatholobi 19 parts, Ramulus Uncariae Cum Uncis 13 parts, Cortex Phellodendri 12 parts, Ramulus Cinnamomi 14 parts, Rhizoma Polygonati 23 parts, 18 parts, Fructus Jujubae, Radix Achyranthis Bidentatae 13 parts, Radix Dipsaci 13 parts, Rhizoma Cimicifugae 11 parts, 13 parts, Radix Glycyrrhizae.
5. prepare as arbitrary in claim 1-4 as described in the method for the hypotensive Chinese medicine preparation for the treatment of, it is characterized in that comprising following processing step:
(1) each taste Chinese crude drug is taken by prescription;
(2) by Radix Rehmanniae Preparata, Rhizoma Cibotii, Caulis Spatholobi, Ramulus Uncariae Cum Uncis, Cortex Phellodendri, Rhizoma Polygonati, Radix Achyranthis Bidentatae, Radix Dipsaci, Rhizoma Cimicifugae, pulverize respectively, the concentration adding 6-12 times of weight after mixing is 60-80% ethanol, soaks 6-12 hour, backflow decocts, extract 2 times, each 2-5 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be the concentrated solution of 1.18-1.23, for subsequent use;
(3) Radix Codonopsis, the Radix Astragali, the Cortex Eucommiae, Radix Angelicae Sinensis, Radix Bupleuri, Ramulus Cinnamomi, Fructus Jujubae, Radix Glycyrrhizae are pulverized respectively, after mixing, add the purified water of 7-12 times of weight, backflow decoction three times, each 1-4 hour, filters, merging filtrate, being concentrated into 60 DEG C of relative densities is the concentrated solution of 1.18-1.23, for subsequent use;
(4) merged by concentrated solution obtained in step (2) and (3), mix homogeneously, continuing to be evaporated to 60 DEG C of relative densities is the thick paste of 1.32-1.36, is Chinese medical concrete;
(5) utilize modern general Chinese medicine preparation technology, step (4) gained Chinese medical concrete is made the Chinese medicine finished product preparation of clinical needs.
6., according to the arbitrary described hypotensive Chinese medicine preparation for the treatment of of claim 1-4, it is characterized in that: the dosage form of described Chinese medicine preparation is capsule, granule, tablet, powder, pill and syrup.
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| CN103550745A (en) * | 2013-11-07 | 2014-02-05 | 王敬侠 | Traditional Chinese medicine composition for treating hypotension and preparation method of traditional Chinese medicine composition for treating hypotension |
| CN104107263A (en) * | 2014-06-23 | 2014-10-22 | 周剑峰 | Traditional Chinese medicinal preparation for treating hypotension |
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| CN103550745A (en) * | 2013-11-07 | 2014-02-05 | 王敬侠 | Traditional Chinese medicine composition for treating hypotension and preparation method of traditional Chinese medicine composition for treating hypotension |
| CN104107263A (en) * | 2014-06-23 | 2014-10-22 | 周剑峰 | Traditional Chinese medicinal preparation for treating hypotension |
Non-Patent Citations (1)
| Title |
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| 向楠: "《中药临床药理学》", 31 January 2010, 中国医药科技出版社 * |
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