CN104474231A

CN104474231A - Traditional Chinese medicine preparation for treating cute red eyes, sore pain and difficultly-opened eyes with bitter tears and preparation method of traditional Chinese medicine preparation

Info

Publication number: CN104474231A
Application number: CN201410754524.XA
Authority: CN
Inventors: 邓凤桂
Original assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Current assignee: GUANGDONG JUZHICHENG TECHNOLOGY Co Ltd
Priority date: 2014-12-11
Filing date: 2014-12-11
Publication date: 2015-04-01

Abstract

The invention discloses a traditional Chinese medicine preparation for treating cute red eyes, sore pain and difficultly-opened eyes with bitter tears and a preparation method of the traditional Chinese medicine preparation. The traditional Chinese medicine preparation comprises the following main raw materials: fructus viticis, flos eriocauli, radix stephaniae tetrandrae, rhizoma anemarrhenae, radix scutellariae, raw radix rehmanniae, radix bupleuri, angelica sinensis, semen celosiae, radix saposhnikoviae, semen cuscutae, silkworm shit, rhizoma cimicifugae, radix platycodonis, radix paeoniae alba, fructus arctii, semen cassiae, rhizoma alismatis and liquorice, wherein the medicinal materials can be prepared into a clinically required finished product preparation by virtue of the preparation process. The traditional Chinese medicine preparation can be used for treating eye diseases such as the cute red eyes, the sore pain and the difficultly-opened eyes with bitter tears and has treatment advantages that the treatment effect is good, both symptoms and root causes are treated, and the relapse is nearly avoided; furthermore, the traditional Chinese medicine preparation has the technical advantages that the preparation process is simple, convenient and feasible, individual difference is small, the pesticide effect is stable and definite, and the traditional Chinese medicine preparation is easy to popularize and apply.

Description

Chinese medicine preparation that treatment eyes cruelly redly swells and ache, puckery tear difficulty is opened and preparation method thereof

Technical field

The present invention discloses and a kind ofly treats Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened and preparation method thereof, belongs to the field of Chinese medicines.

Background technology

The traditional Chinese medical science is thought, husband's eye person irritability lead to, negative and positive noted, if ailment said due to cold or exposure poisonous gas, are internal organs, and day of accumulating in the course of time can not dissipate; Biography is noted in liver, and liver is by ailment said due to cold or exposure, and the part of the body cavity above the diaphragm housing the heart and lungs is stopped up stagnant, is attack in eye also, and its shape eyelid is red swollen, itches unbearably vexed, hidden puckery photophobia, and tear gum is shown in that wind more so under handing over, and be all spleen lung wind-engagings, Liver Channel is unfavorable; If rule for the treatment of ailment said due to cold or exposure is not flourishing, passes and be heat, cause that to connect eyelid red rotten more, should the speed washing stasis of blood rotten clean eyelid skin, the medicine of Er Yichufeng town liver of holding concurrently.

It is first red that this waits white of the eye, and pain of then itching, has tear windward, close puckery difficulty and open, or time impunity, send out again soon, year is dark, and eyeball becomes green color; Meet the eye on every side as lipoid is bare, horizontal red as silk, this malicious aeolian accumulation heat; Cloud again, this disease or first red for many years rotten, Liver Channel is rushed by wind heat and is formed; Or use masterpiece labor, there is impairing the liver gas and obtain; Or itch or pain, go out from two, unsteadiness of heart-QI, worry endlessly, is climb eyeball then; Or go out fascia; Cloud again, eye born of the same parents skin and flesh, has like gelling, and swollen high as peaches and plums person, going out hot tears constantly, is that pathogenic wind toxic noted.

So, rule for the treatment of wind-removing and heat-dispelling, improving acuity of vision and removing nebula, nourishing liver and kidney, lung qi dispersing are eliminated the phlegm, and just can reach the object for the treatment of both the principal and secondary aspects of a disease, thus can avoid western medicine this sick time recurrent exerbation, the shortcoming such as can not to effect a radical cure.

Summary of the invention

To be that exploitation is a kind of treat the Chinese medicine that eyes cruelly redly swells and ache, puckery tear difficulty has better effects to the technical problem to be solved in the present invention, and this Chinese medicine want to overcome Chinese medicine individual variation greatly, the not portable shortcoming such as to take.

The technical scheme that inventor solves the problems of the technologies described above is, according to self tcm clinical practice experience for many years and proved recipe handed down from one's ancestors, repeatedly adjustment is verified by clinical practice, inventor is prescription again, and develop a set of preparation technology, make this prescription can make the multiple finished dosage forms of clinical needs after utilizing its preparation technology, single eyes cruelly redly to be swollen and ache, puckery tear difficulty has very significant therapeutic effect, and stable curative effect, individual variation is little, preparation technology is simple and easy to do, be applicable to batch production, be easy to apply.This Chinese prescription is (with parts by weight):

Fructus Viticis 7-23 part, Flos Eriocauli 15-29 part, Radix Stephaniae Tetrandrae 7-19 part, Rhizoma Anemarrhenae 8-20 part, Radix Scutellariae 7-19 part, Radix Rehmanniae 11-25 part, Radix Bupleuri 8-16 part, Radix Angelicae Sinensis 10-22 part, Semen Celosiae 17-33 part, Radix Saposhnikoviae 9-21 part, Semen Cuscutae 8-20 part, Bombyx mori L. 11-27 part, Rhizoma Cimicifugae 9-23 part, Radix Platycodonis 7-15 part, Radix Paeoniae Alba 8-18 part, Fructus Arctii 6-14 part, Semen Cassiae 15-27 part, Rhizoma Alismatis 7-17 part, Radix Glycyrrhizae 8-16 part.

In practice process, preferably 3 proportionings are out:

Proportioning 1: Fructus Viticis 17 parts, Flos Eriocauli 24 parts, Radix Stephaniae Tetrandrae 13 parts, the Rhizoma Anemarrhenae 12 parts, Radix Scutellariae 12 parts, Radix Rehmanniae 19 parts, Radix Bupleuri 13 parts, Radix Angelicae Sinensis 17 parts, Semen Celosiae 27 parts, Radix Saposhnikoviae 16 parts, Semen Cuscutae 15 parts, Bombyx mori L. 18 parts, Rhizoma Cimicifugae 15 parts, Radix Platycodonis 10 parts, the Radix Paeoniae Alba 12 parts, Fructus Arctii 9 parts, Semen Cassiae 20 parts, Rhizoma Alismatis 13 parts, 12 parts, Radix Glycyrrhizae.

Proportioning 2: Fructus Viticis 15 parts, Flos Eriocauli 22 parts, Radix Stephaniae Tetrandrae 12 parts, the Rhizoma Anemarrhenae 14 parts, Radix Scutellariae 13 parts, Radix Rehmanniae 18 parts, Radix Bupleuri 12 parts, Radix Angelicae Sinensis 16 parts, Semen Celosiae 25 parts, Radix Saposhnikoviae 15 parts, Semen Cuscutae 14 parts, Bombyx mori L. 19 parts, Rhizoma Cimicifugae 16 parts, Radix Platycodonis 11 parts, the Radix Paeoniae Alba 13 parts, Fructus Arctii 10 parts, Semen Cassiae 21 parts, Rhizoma Alismatis 12 parts, 12 parts, Radix Glycyrrhizae.

Proportioning 3: Fructus Viticis 16 parts, Flos Eriocauli 23 parts, Radix Stephaniae Tetrandrae 13 parts, the Rhizoma Anemarrhenae 13 parts, Radix Scutellariae 14 parts, Radix Rehmanniae 17 parts, Radix Bupleuri 13 parts, Radix Angelicae Sinensis 15 parts, Semen Celosiae 26 parts, Radix Saposhnikoviae 14 parts, Semen Cuscutae 16 parts, Bombyx mori L. 17 parts, Rhizoma Cimicifugae 17 parts, Radix Platycodonis 12 parts, the Radix Paeoniae Alba 12 parts, Fructus Arctii 11 parts, Semen Cassiae 22 parts, Rhizoma Alismatis 13 parts, 11 parts, Radix Glycyrrhizae.

The preparation technology of this Chinese medicine is following steps:

(1), the ingredientss such as Fructus Viticis, Flos Eriocauli, Radix Stephaniae Tetrandrae, the Rhizoma Anemarrhenae, Radix Scutellariae, Radix Rehmanniae, Radix Bupleuri, Radix Angelicae Sinensis, Semen Celosiae, Radix Saposhnikoviae, Semen Cuscutae, Bombyx mori L., Rhizoma Cimicifugae, Radix Platycodonis, the Radix Paeoniae Alba, Fructus Arctii, Semen Cassiae, Rhizoma Alismatis, Radix Glycyrrhizae are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2), all medical materials are added the purified water of initial medical material 7-11 times weight, soak 12-24 hour, backflow decocts 1-4 hour, filter, add the purified water of initial weight 4-8 times weight again, backflow decocts 1-3 hour, filters and retains filtering residue, merging filtrate, being concentrated into 60 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;

(3), the filtering residue of step (2) is added the ethanol of the concentration 60-75% of 5-8 times of weight, reflux, extract, 2 times, each 2-6 hour, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(4), by the concentrated solution of step (2) and (3) gained merge, continuing to be concentrated into 60 DEG C of relative densities is the Chinese medical concrete of 1.30-1.35, for subsequent use;

(5), by the Chinese medical concrete of step (4) add adjuvant, utilize modern general Chinese medicine preparation technology to make the finished dosage forms of clinical needs, such as granule, tablet, pill, oral liquid, capsule, powder or syrup etc.

The character feature of the present invention's Chinese crude drug used:

Fructus Viticis: this product is the dry mature fruit of Verbenaceae Vitex rotundifolia or wild pepper.Acrid in the mouth, hardship, cold nature; Return bladder, liver, stomach warp; Dispelling wind and heat pathogens, the clear sharp head.

Flos Eriocauli: this product is the head inflorescence of the dry zone scape of Eriocaulaceae plant Flos Eriocauli.Acrid in the mouth, sweet, property is put down; Return liver, lung meridian; Dispelling wind and heat pathogens, improving eyesight, nebula removing.

Radix Stephaniae Tetrandrae: this product is the dry root of menispermaceous plants Radix stephaniae tetrandrae.Bitter in the mouth, cold in nature; Return bladder, lung meridian; Inducing diuresis to remove edema, wind-expelling pain-stopping.

The Rhizoma Anemarrhenae: this product is the dry rhizome of the liliaceous plant Rhizoma Anemarrhenae.Bitter in the mouth, sweet, cold in nature; Return lung, stomach, kidney channel; Clearing away heat-fire, promotes the production of body fluid and moisturizes.

Radix Scutellariae: this product is the dry root of labiate Radix Scutellariae.Bitter in the mouth, cold in nature; Return lung, gallbladder, spleen, large intestine, small intestine meridian; Heat clearing and damp drying, eliminating fire and detoxication, hemostasis, antiabortive.

Radix Rehmanniae: this product is the fresh of scrophulariaceae rehmannia glutinosa plant or dried root.Sweet in the mouth, cold in nature; GUIXIN, liver, kidney channel; Clearing away heat and cooling blood, yin nourishing, promotes the production of body fluid.

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.

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.

Semen Celosiae: this product is the dry mature seed of amaranthaceous plant Herba Celosiae argenteae.Bitter in the mouth, cold nature; Return Liver Channel; Liver heat removing, improving eyesight, nebula removing.

Radix Saposhnikoviae: this product is the dry root of umbelliferae Saposhnikovia divaricata.Acrid in the mouth, sweet, warm in nature; Return bladder, liver, spleen channel; Inducing diaphoresis to dispel wind, victory is wet, relieving convulsion.

Semen Cuscutae: this product is the dry mature seed of convolvulus cuscuta plant.Sweet in the mouth, warm in nature; Return liver,kidney,spleen warp; Nourishing the liver and kidney, controlling nocturnal emission with astringent drugs reducing urination, antiabortive, improving eyesight, antidiarrheal.

Bombyx mori L.: be the dry feces of Bombycidae animal bombyx mori larva.Sweet in the mouth; Pungent; Warm in nature; Liver; Spleen; Stomach warp; Expelling wind and removing dampness; Regulating the function of the stomach to resolve the turbidity; Promoting blood circulation to restore menstrual flow.

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 Platycodonis: this product is the dry root of Campanulaceae Radix Platycodonis.Bitter in the mouth, pungent, property is put down; Return lung meridian; Lung qi dispersing, sore-throat relieving, eliminates the phlegm, evacuation of pus.

The Radix Paeoniae Alba: this product is the dry root of ranunculaceae plant Radix Paeoniae.Bitter in the mouth, acid, cold nature; Return liver, spleen channel; Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.

Fructus Arctii: this product is the dry mature fruit of feverfew Fructus Arctii.Acrid in the mouth, hardship, cold in nature; Attach to the lung and stomach meridians; Dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat.

Semen Cassiae: this product is the dry mature seed of leguminous plant Semen Cassiae or little Semen Cassiae.Sweet in the mouth, hardship, salty, cold nature; Return liver, large intestine channel; Clearing away heat to improve acuity of vision, loosening bowel to relieve constipation.

Rhizoma Alismatis: this product is the dry tuber of Notes On Alism At Aceae Rhizoma Alismatis.Sweet in the mouth, cold in nature; Return kidney, urinary bladder channel; Diuresis, clearing away damp-heat.

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 prescription analysis of Chinese medicine preparation of the present invention:

This prescription is with Flos Eriocauli, Semen Celosiae, Semen Cassiae, Radix Rehmanniae, Fructus Viticis for monarch drug, wind-dispelling heat-dissipating, improving acuity of vision and removing nebula, expelling wind and removing dampness, clearing away heat and cooling blood; With Radix Saposhnikoviae, the Rhizoma Anemarrhenae, Rhizoma Cimicifugae, Bombyx mori L., Semen Cuscutae for ministerial drug, inducing diaphoresis to dispel wind, clearing away heat-fire, nourishing liver and kidney, elevate a turnable ladder yang-energy; With Radix Stephaniae Tetrandrae, Radix Scutellariae, the Radix Paeoniae Alba, when being classified as adjuvant drug, wind-expelling pain-stopping, eliminating fire and detoxication, suppressing the hyperactive liver nourish blood; With Radix Bupleuri, Radix Platycodonis, Fructus Arctii, Rhizoma Alismatis for making medicine, and in table solution, lung qi dispersing eliminates the phlegm, rash is detoxified; With Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, make the collaborative distillation of all property of medicine, complement each other, thus reach wind-dispelling heat-dissipating, improving acuity of vision and removing nebula, nourishing liver and kidney, suppressing the hyperactive liver nourishes blood, lung qi dispersing eliminates the phlegm effect, eyes is cruelly redly swollen and ache, treatment that puckery tear difficulty is opened has very significant effect.

Compared with prior art, Chinese medicine preparation of the present invention not only has the treatment advantage such as good effect, treating both the principal and secondary aspects of a disease, not easily recurrence, and has that preparation technology is simple and easy to do, individual variation is little, efficacy stability is definite, be easy to technical advantages such as applying.

Detailed description of the invention

Embodiment 1-3 is and any range production preparation maximum, minimum by Chinese prescription of the present invention; Embodiment 4-6 is for producing preparation by three optimum ratios; Embodiment 7 is animal toxicity experiment, carries out toxicity test to six preparations produced; Embodiment 8 is clinical effectiveness test, to three produce by optimal proportion carry out clinical trial, observation actual therapeutic effect.

Embodiment 1

(1), the ingredientss such as Fructus Viticis 23kg, Flos Eriocauli 29kg, Radix Stephaniae Tetrandrae 19kg, Rhizoma Anemarrhenae 20kg, Radix Scutellariae 19kg, Radix Rehmanniae 25kg, Radix Bupleuri 16kg, Radix Angelicae Sinensis 22kg, Semen Celosiae 33kg, Radix Saposhnikoviae 21kg, Semen Cuscutae 20kg, Bombyx mori L. 27kg, Rhizoma Cimicifugae 23kg, Radix Platycodonis 15kg, Radix Paeoniae Alba 18kg, Fructus Arctii 14kg, Semen Cassiae 27kg, Rhizoma Alismatis 17kg, Radix Glycyrrhizae 16kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

(2), all medical materials are added the purified water of initial medical material 9 times of weight, soak 18 hours, backflow decoction 3 hours, filter, add the purified water of initial weight 6 times of weight again, backflow decoction 2 hours, filters and retains filtering residue, merging filtrate, being concentrated into 60 DEG C of relative densities is that the concentrated solution of 1.20-1.25 is for subsequent use;

(3), the filtering residue of step (2) is added the ethanol of the concentration 65% of 7 times of weight, reflux, extract, 2 times, each 4 hours, filter, merging filtrate, distilling under reduced pressure removing ethanol, and to be concentrated into 60 DEG C of relative densities be that the concentrated solution of 1.20-1.25 is for subsequent use;

(5), by the Chinese medical concrete of step (4) add adjuvant, utilize modern general Chinese medicine preparation technology to make capsule, amount to crude drug amount and be about 0.72g/ capsules.

Embodiment 2

(1), the ingredientss such as Fructus Viticis 7kg, Flos Eriocauli 15kg, Radix Stephaniae Tetrandrae 7kg, Rhizoma Anemarrhenae 8kg, Radix Scutellariae 7kg, Radix Rehmanniae 11kg, Radix Bupleuri 8kg, Radix Angelicae Sinensis 10kg, Semen Celosiae 17kg, Radix Saposhnikoviae 9kg, Semen Cuscutae 8kg, Bombyx mori L. 11kg, Rhizoma Cimicifugae 9kg, Radix Platycodonis 7kg, Radix Paeoniae Alba 8kg, Fructus Arctii 6kg, Semen Cassiae 15kg, Rhizoma Alismatis 7kg, Radix Glycyrrhizae 8kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 3

(1), the ingredientss such as Fructus Viticis 7kg, Flos Eriocauli 29kg, Radix Stephaniae Tetrandrae 7kg, Rhizoma Anemarrhenae 20kg, Radix Scutellariae 7kg, Radix Rehmanniae 25kg, Radix Bupleuri 16kg, Radix Angelicae Sinensis 10kg, Semen Celosiae 17kg, Radix Saposhnikoviae 21kg, Semen Cuscutae 8kg, Bombyx mori L. 27kg, Rhizoma Cimicifugae 23kg, Radix Platycodonis 7kg, Radix Paeoniae Alba 8kg, Fructus Arctii 6kg, Semen Cassiae 27kg, Rhizoma Alismatis 17kg, Radix Glycyrrhizae 8kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 4

(1), the ingredientss such as Fructus Viticis 17kg, Flos Eriocauli 24kg, Radix Stephaniae Tetrandrae 13kg, Rhizoma Anemarrhenae 12kg, Radix Scutellariae 12kg, Radix Rehmanniae 19kg, Radix Bupleuri 13kg, Radix Angelicae Sinensis 17kg, Semen Celosiae 27kg, Radix Saposhnikoviae 16kg, Semen Cuscutae 15kg, Bombyx mori L. 18kg, Rhizoma Cimicifugae 15kg, Radix Platycodonis 10kg, Radix Paeoniae Alba 12kg, Fructus Arctii 9kg, Semen Cassiae 20kg, Rhizoma Alismatis 13kg, Radix Glycyrrhizae 12kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 5

(1), the ingredientss such as Fructus Viticis 15kg, Flos Eriocauli 22kg, Radix Stephaniae Tetrandrae 12kg, Rhizoma Anemarrhenae 14kg, Radix Scutellariae 13kg, Radix Rehmanniae 18kg, Radix Bupleuri 12kg, Radix Angelicae Sinensis 16kg, Semen Celosiae 25kg, Radix Saposhnikoviae 15kg, Semen Cuscutae 14kg, Bombyx mori L. 19kg, Rhizoma Cimicifugae 16kg, Radix Platycodonis 11kg, Radix Paeoniae Alba 13kg, Fructus Arctii 10kg, Semen Cassiae 21kg, Rhizoma Alismatis 12kg, Radix Glycyrrhizae 12kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 6

(1), the ingredientss such as Fructus Viticis 16kg, Flos Eriocauli 23kg, Radix Stephaniae Tetrandrae 13kg, Rhizoma Anemarrhenae 13kg, Radix Scutellariae 14kg, Radix Rehmanniae 17kg, Radix Bupleuri 13kg, Radix Angelicae Sinensis 15kg, Semen Celosiae 26kg, Radix Saposhnikoviae 14kg, Semen Cuscutae 16kg, Bombyx mori L. 17kg, Rhizoma Cimicifugae 17kg, Radix Platycodonis 12kg, Radix Paeoniae Alba 12kg, Fructus Arctii 11kg, Semen Cassiae 22kg, Rhizoma Alismatis 13kg, Radix Glycyrrhizae 11kg are taken respectively by Chinese prescription, pulverize respectively, for subsequent use;

Embodiment 7

The acute and chronic toxicity test of animal

(1), acute toxicity test

1, tested medicine: embodiment of the present invention 1-6 gained capsule, abolishes capsule shells, adds purified water by 1:4, make magma.

2, experimental animal: regular grade NIH mice, body weight 22g ± 3g, male and female half and half, female mice is all without pregnant.

3, the magma of mouse stomach Chinese medicine capsules modulation, when given low reaches 718.1g crude drug/kg dosage, after administration, mice occurs that light activity reduces, 1 hours recovers 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 mouse stomach embodiment 1-6 gained capsule is 718.1g crude drug/kg/d(LD ₅₀> 718.1g crude drug/kg).The clinical application every day total amount of Chinese medicine of the present invention is 0.12g crude drug/kg/d to the maximum; By weighing machine, the dosis tolerata of mouse stomach embodiment 1-6 gained capsule is 5984.2 times of clinical patient.Point out this medicine acute toxicity extremely low, clinical drug safety.

(2), long term toxicity test

1, test objective: the toxic reaction of viewing test animal after edible Chinese medicine preparation of the present invention, assesses the basic security of Chinese medicine preparation of the present invention.

2, test material:

(1), animal: select adult healthy SD rat 210, original body mass 215 ± 11g, male and female half and half, female rats is all without pregnant.

(2), medicine: embodiment of the present invention 1-6 gained Chinese medicine capsules, abolish capsule shells, add purified water by 1:4, make magma, per weight dosage is by 20 times of calculating (clinical application amount foundation Pharmacopoeia of the People's Republic of China version in 2010) of clinical application amount.

3, test method

(1), by 210 SD rats be divided into 7 groups, often organize 30, male and female half and half.Experimental animal male and female sub-cage rearing, 5, every cage, quantitative feeding (every cage 1200-1500g/ week), normal feedstuff is experimental mouse full-valence pellet feed, freely drinks water.Experimental temperature (21 ± 2) DEG C, humidity 60%-80%.The natural lighting light and shade cycle.After SD rat is bought, under this laboratory rearing condition, adapt to 2 weeks, observe general behavior performance.Test pre-test animal ingestion amount, selects qualified rat.

(2), medication

With 6 kinds of made magmas of capsule obtained by embodiment, to wherein 6 groups of SD rat oral gavages administration, every day 2 times, each volume is 0.2ml/10g body weight, successive administration 26 weeks.Remaining one group is matched group, by the normal saline of same method gavage equivalent.Experimental animal is weighed weekly 1 time, according to body weight change adjustment dosage.24h after administration in the 13rd week, often organize execution 10, male and female half and half, observe and detect indices; Remaining continuation administration was observed to 26 weeks, and 24h after last 1 administration, often organizes and put to death 10 again, male and female half and half, observe and detect indices; Remaining 10 are carried out 8 week convalescent period and observe.

(3), test item and the time

General inspection: the general status observing animal every day, as the mental status, dynamic response, behavioral activity, the change of dietary amount, defecation situation, eyes and duct secretions, hair color, cleannes etc.Body weight change situation and food ration measure weekly 1 time.

Hematological examination: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) and detect following index respectively: packed cell volume (HCT), red blood cell count(RBC) (RBC), content of hemoglobin (HGB), numeration of leukocyte (WBC), lymphocyte comparative counting (LY), platelet count (PLT), neutrophilic granulocyte comparative counting (NE), mononuclear cell comparative counting (Mon) and clotting time (CT).

Blood parameters check: after administration the 13rd, 26 week and drug withdrawal recovery the end of term (the 34th week) detect following index respectively: alanine aminotransferase (ALT), alkali phosphatase (AST), Lomefloxacin aspartate injection (AST), total bilirubin (TB), albumin (ALB), gross protein (TP), blood glucose (GLU), blood urea nitrogen (BUN), T-CHOL (TC), creatinine (Crea), uric acid (UA), blood sodium (Na ⁺), blood potassium (K ⁺), blood calcium (Ca ⁺) and β ₂-microglobulin.

Urinate biochemical and urine routine: after administration, the 13rd, 26 week and drug withdrawal recover the end of term (the 34th week) each survey 1 time.Animal metabolism cage list cage is raised and is collected 24h urine, overnight fasting before test, detects urine bilirubin (BIL), glucose (GLU), ketoboidies (KET), protein, pH value, urobilinogen (URO), urine is occulted blood (BLO), nitrite (NIT), proportion and leukocyte (WBC); Quantitative determination of radioimmunoassay urine β ₂-MG(renal tubular function obstacle sensitive indicator).

System postmortem and histopathologic examination: macroscopy is carried out to each internal organs, the organs such as heart, liver, lungs, kidney, spleen, brain, adrenal gland, thymus, thyroid, pancreas, uterus, ovary, testis, prostate are taken out and weighs, calculate organ coefficient (organ weights/body weight).With light microscopic, histological examination is carried out to above-mentioned internal organs and spinal cord, thymus, bladder, bone marrow (breastbone), duodenum, stomach, ileum, pancreas, hypophysis cerebri, optic nerve, lymph node, coton and rectal etc.

4, result of the test

The all rats of overview all do not show any abnormal conditions; Hematological examination, blood parameters inspection, urinate biochemical, urine routine, system postmortem and histopathologic examination, indices, compared with control animals, does not all have obvious difference.Therefore, Chinese medicine capsules of the present invention to SD rat without any toxic action, in view of 20 times of ratios of its behaviour dose, so can infer that to take be safe to this oral liquid for patient.

Embodiment 8,

Clinical effectiveness is tested

1, basic document is tested

Certain city's ophthalmologic hospital provides experimenter for this test, this institute has accepted from year February in August, 2011 to 2014 eye disease patient that 821 eyes cruelly redly swell and ache, puckery tear difficulty is opened for medical treatment altogether, therefrom select 240 to be applicable to and the patient being ready to participate in clinical trial, wherein man 120, age 21-68 year, female 120, age 23-67 year.Experimenter is divided into 4 groups, often organizes 60 people, men and women half and half, and these 4 groups are numbered respectively: matched group, try 1 group, try 2 groups, try 3 groups.

2, trial drug

Contrast medicine: Chloramphenicol Eye Drop, the accurate word H20063685 of traditional Chinese medicines, Yongguang Pharmaceutical Co., Ltd..

Investigational agent: the capsule (amount to crude drug amount and be about 0.72g/ capsules) manufactured by embodiment of the present invention 4-6.

3, test method

Matched group Chloramphenicol Eye Drop instills in eyelid, each 2, every day 4 times; The capsule of test group respectively manufactured by oral embodiment of the present invention 4-6, each 5 (amounting to crude drug 3.6g), every day 2 times.Within one week, be a course for the treatment of, treat 3 courses for the treatment of continuously, healing person can stop administration at any time.The situation such as patient sign change, untoward reaction in record therapeutic process.Healing person is paid a return visit after 6 months in drug withdrawal, record recidivist.

4, judgment criteria

Cure: the symptom that eyes is cruelly red to swell and ache, puckery tear difficulty is opened disappears completely, and make a definite diagnosis through doctor and fully recover;

Effective: the symptom partial disappearance that eyes is cruelly red to swell and ache, puckery tear difficulty is opened or make moderate progress, need continual cure;

Invalid: the symptom that eyes is cruelly red to swell and ache, puckery tear difficulty is opened does not obtain any improvement, even becomes more serious;

Untoward reaction: by normal usage, the prevention of consumption drug application, diagnosis or disease therapy process, there occurs the adverse reaction irrelevant with therapeutic purposes;

Recurrence: cure patient and again suffer from original disease in drug withdrawal in 6 months.

5, logging and analysis

(1), situation is characterized: matched group has 6 patients to occur the untoward reaction such as Ocular irritation in various degree, allergy; None routine untoward reaction of test group.The patient of test group is in medication after 4 days, and generally feel that health fire of moxibustion diminishes, head eye becomes salubrious, and mood agitation disappears, and middle gas is sufficient, and matched group does not then have this type of to feel.

(2), result of the test statistical analysis

After test all terminates, test data statistical analysis form is presented, in table 1.

Table 1 test data statistical analysis table

Group	Case load	Cure (rate)	Effective	Invalid	Total effective rate	Recurrence (rate)
							Matched group	60	29（48.3%）	24	7	88.3%	9（31.0%）
Try 1 group	60	43（71.7%）	13	4	93.3%	0
							Try 2 groups	60	46（76.7%）	14	0	100%	1（2.2%）
Try 3 groups	60	42（70.0%）	16	2	96.7%	0

6, conclusion

For sign situation, result of the test shows: test group does not have untoward reaction, and matched group has 6 routine untoward reaction; And test group has the regulatory function of health, and test group does not have, therefore, the treatment sign successful of test group is better than matched group.For test data statistical analysis, result shows: the average cure rate of test group is 72.8%, is 1.5 times of matched group; The average total effective rate of test group is 96.7%, higher than matched group 8.4 percentage points; The average relapse rate of test group is 0.73%, is only 1/42 of matched group, and therefore, the therapeutic effect of test group is significantly better than matched group.To sum up, compared with prior art, there is very significant technical advantage in the ophthalmics such as Chinese medicine preparation of the present invention cruelly redly to swell and ache at treatment eyes, puckery tear difficulty is opened, achieve unexpected technique effect.

Claims

1. treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened, it is characterized in that, described Chinese medicine preparation is made up of the Chinese crude drug of following weight portion:

Fructus Viticis 7-23 part Flos Eriocauli 15-29 part Radix Stephaniae Tetrandrae 7-19 part Rhizoma Anemarrhenae 8-20 part

Radix Scutellariae 7-19 part Radix Rehmanniae 11-25 part Radix Bupleuri 8-16 part Radix Angelicae Sinensis 10-22 part

Semen Celosiae 17-33 part Radix Saposhnikoviae 9-21 part Semen Cuscutae 8-20 part Bombyx mori L. 11-27 part

Rhizoma Cimicifugae 9-23 part Radix Platycodonis 7-15 part Radix Paeoniae Alba 8-18 part Fructus Arctii 6-14 part

Semen Cassiae 15-27 part Rhizoma Alismatis 7-17 part Radix Glycyrrhizae 8-16 part.

2. according to claim 1ly a kind ofly treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened, it is characterized in that, described Chinese medicine preparation can also be made up of the Chinese crude drug of following weight portion:

Fructus Viticis 17 parts of Flos Eriocaulis 24 parts of Radixs Stephaniae Tetrandrae 13 parts of Rhizoma Anemarrhenaes 12 parts

Radix Scutellariae 12 parts of Radix Rehmanniae 19 parts of Radix Bupleuri 13 parts of Radix Angelicae Sinensis 17 parts

Semen Celosiae 27 parts of Radix Saposhnikoviaes 16 parts of Semen Cuscutae 15 parts of Bombyx mori L.s 18 parts

Rhizoma Cimicifugae 15 parts of Radix Platycodoniss 10 portions of Radix Paeoniae Albas 12 parts of Fructus Arctiis 9 parts

12 parts, Semen Cassiae 20 portions of Rhizoma Alismatis 13 portions of Radix Glycyrrhizaes.

3. according to claim 1ly a kind ofly treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened, it is characterized in that, described Chinese medicine preparation can also be made up of the Chinese crude drug of following weight portion:

Fructus Viticis 15 parts of Flos Eriocaulis 22 parts of Radixs Stephaniae Tetrandrae 12 parts of Rhizoma Anemarrhenaes 14 parts

Radix Scutellariae 13 parts of Radix Rehmanniae 18 parts of Radix Bupleuri 12 parts of Radix Angelicae Sinensis 16 parts

Semen Celosiae 25 parts of Radix Saposhnikoviaes 15 parts of Semen Cuscutae 14 parts of Bombyx mori L.s 19 parts

Rhizoma Cimicifugae 16 parts of Radix Platycodoniss 11 portions of Radix Paeoniae Albas 13 parts of Fructus Arctiis 10 parts

12 parts, Semen Cassiae 21 portions of Rhizoma Alismatis 12 portions of Radix Glycyrrhizaes.

4. according to claim 1ly a kind ofly treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened, it is characterized in that, described Chinese medicine preparation can also be made up of the Chinese crude drug of following weight portion:

Fructus Viticis 16 parts of Flos Eriocaulis 23 parts of Radixs Stephaniae Tetrandrae 13 parts of Rhizoma Anemarrhenaes 13 parts

Radix Scutellariae 14 parts of Radix Rehmanniae 17 parts of Radix Bupleuri 13 parts of Radix Angelicae Sinensis 15 parts

Semen Celosiae 26 parts of Radix Saposhnikoviaes 14 parts of Semen Cuscutae 16 parts of Bombyx mori L.s 17 parts

Rhizoma Cimicifugae 17 parts of Radix Platycodoniss 12 portions of Radix Paeoniae Albas 12 parts of Fructus Arctiis 11 parts

11 parts, Semen Cassiae 22 portions of Rhizoma Alismatis 13 portions of Radix Glycyrrhizaes.

5. described a kind ofly treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened according to claim 1-4 is arbitrary, it is characterized in that, the preparation technology of described Chinese medicine preparation is following steps:

(5), by the Chinese medical concrete of step (4) add adjuvant, utilize modern general Chinese medicine preparation technology to make the finished dosage forms of clinical needs.

6. described a kind ofly treat the Chinese medicine preparation that eyes cruelly redly swells and ache, puckery tear difficulty is opened according to claim 1-4 is arbitrary, it is characterized in that, described Chinese medicine preparation can be made into granule, tablet, pill, oral liquid, capsule, powder or syrup.