CN100486630C - Medicine composition for treating eye disease, and its use - Google Patents
Medicine composition for treating eye disease, and its use Download PDFInfo
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- CN100486630C CN100486630C CNB2005100209855A CN200510020985A CN100486630C CN 100486630 C CN100486630 C CN 100486630C CN B2005100209855 A CNB2005100209855 A CN B2005100209855A CN 200510020985 A CN200510020985 A CN 200510020985A CN 100486630 C CN100486630 C CN 100486630C
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Abstract
A composite Chinese medicine for treating cataract, visual fatigue and optic atrophy is prepared from ginseng and ophiopogon root. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of ocular disease, specifically, is Chinese medicine Radix Ginseng, Radix Ophiopogonis to be pharmaceutical composition and the purposes that feedstock production forms, and belongs to the field of Chinese medicines.
Background technology
Cataract is that crystalline lens takes place muddyly to become opaquely by transparent in the eyes, hinders light and enters ophthalmic, thereby influenced vision.The initial stage muddiness is little to eyesight influence, then gradually increases the weight of, and obviously affects one's power of vision even blind.Cataract is the primary cause of disease of blinding, and nearly in the world now 2,000 ten thousand people are owing to cataract and blinding, and other has 100,000,000 cataract patients to need the surgery recovery vision, and in most Africa and Asian countries, cataract accounts for half of blind person at least.According to the result of China's investigation, cataract also is that China causes blind topmost oculopathy.Cataract has a lot of causes of disease: some is congenital cataract (being more common in the child), and ocular injury also can cause cataract, and some internal disease also can cause cataract.As diabetes, nephritis etc., also have complicated cataract, but most case and patient are with old relevant.The sickness rate of 50～60 years old senile cataract is that the old people who reaches more than 80%, 80 years old more than 60～70%, 70 years old almost reaches 100%.Along with the prolongation of world's average life span, cataract patient will be on the increase.At present, the effective method of cataract therapy is operation.
Asthenopia is the common a kind of disease of ophthalmology, and patient's symptom is varied, and the common near work that has can not be lasting, go out to lose face and eye socket around pain, blurred vision, eyes dry and astringent, shed tears etc., the severe patient headache, feel sick, dizzy.It is not a disease independently, but because one group of fatigue syndrome that a variety of causes causes.Along with the aggravation of human civilization advance and social competition, people have reached unprecedented high level to intensity and the density that eyes use.A large amount of information receives with eye, and many finenesses, the high job demand of accuracy requirement are finished, thereby the sickness rate of primary disease is improved year by year, are worth causing our attention.Asthenopia is also very high at crowd's sickness rate of 40-55 year age bracket.They have just entered presenium, conscious vision still can, but just progressively hardening and presbyopia occurs of crystal.Used adjusting power often reaches self limit during close eye.Therefore asthenopia takes place especially easily.Eyes produce ocular disease such as the myopia of suffering from other after the asthenopia easily, glaucoma, and perhaps cataract etc., therefore treating asthenopic medicine needs can prevent to produce serious consequence more by preventative application, brings misery to the patient.Its occurrence cause also is diversified, the reason of common having (1) eyes itself, and it is improper etc. to wear glasses as ametropia such as myopia, hypermetropia, astigmatism, adjusting factor, eye muscle factor, conjunctivitis, keratitis, institute; (2) systemic factor is as neurasthenia, health overwork, hysteria or involutional women; (3) environmental factors, not enough or strong excessively as illumination, distribution of light sources is inhomogeneous or glimpse, too small, the meticulous or instability of the target of watching attentively etc.Comprise four aspects for asthenopic prevention method, the one, the defective of rectification each side, the 2nd, elimination causes asthenopic various factors, the 3rd, health invigorating is avoided overwork.As correction of refractive errors, wear suitable glasses, treatment causes and changes bad reading habit by asthenopic various diseases, improves working environment and lighting condition, avoid for a long time, closely, too meticulous work.The 4th, take or drip the medicine that some can alleviating asthenopia in right amount, also can play the effect of prevention and treatment to asthenopic eyes.
The theory of the traditional Chinese medical science is thought liver opening at eye, but the cause of disease does not singly belong to liver, and through saying: " the special essence of husband's heart person the five internal organs also, its key of order person also." in the asthenopic pathogeny, injured this of the mind is very important, the traditional Chinese medical science is thought that watching for a long time is worked with one's mind and is overtaxed one's nerves consumption impairment of QI blood.
At present, with Radix Ginseng, be that raw material treatment cataract does not still have relevant report Radix Ophiopogonis, with Radix Ginseng, be the SHENMAI ZHUSHEYE treatment infantile pneumonia (Lin Ling of feedstock production Radix Ophiopogonis, Yu Zhongping, SHENMAI ZHUSHEYE treatment infantile pneumonia 86 routine observation of curative effect, the Zhejiang College Of Traditional Chinese Medicine journal, 1994 the 18th the 2nd phases of volume), the treatment viral myocarditis, infantile pneumonia, unstable angina pectoris, disease such as coronary heart disease and cardiac insufficiency and improve patients with lung cancer immunity (Song Wenguang as chemical-therapy synergistic agent, Xu Yaying, the clinical practice of SHENMAI ZHUSHEYE, China's Pharmaceutical 2001,10 (4), treat old acute cerebral infarction (Yu Yanqiu, SHENMAI ZHUSHEYE is treated old acute cerebral infarction efficacy analysis, Nanjing Railway College of Medicine's journal 1999; 18 (3): 201-204), at the treatment ocular disease, as Sun Liping, horsepower, Dong Yu, the clinical efficacy research of therapy of combining Chinese and Western medicine optic atrophy, Yunnan Chinese medicine magazine, has been reported ginseng aconite injection agent combined treatment optic atrophy at 2002 the 23rd the 5th phases of volume; Wang Xun gives birth to, " adding the flavor Rhizoma Zingiberis Recens looses " treatment asthenopia 40 examples, and the Jiangsu traditional Chinese medical science 001,22 (1): 29, reported that containing Radix Codonopsis, Radix Ophiopogonis is the formulation preparation asthenopia that feedstock production forms.Application number: 00131513.7 denomination of invention: " Chinese patent medicine of treatment myopia, amblyopia ", reported and contained totally 22 flavor treatments by Chinese herbs myopia amblyopias such as Radix Ginseng, Radix Ophiopogonis.Because Chinese medicine uses complicated, medicament selection, consumption difference all directly influence the effect of medicine and the difference of drug effect, still do not have Radix Ginseng, Radix Ophiopogonis raw material and usage, the consumption of significance bit proportioning thereof at present, the relevant report of treatment ocular disease.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition for the treatment of ocular disease, and another technical scheme of the present invention has provided the purposes of this pharmaceutical composition.
The invention provides a kind of by containing the purposes of pharmaceutical composition in the medicine of preparation treatment ocular disease that the following weight proportion raw material is prepared from:
1～100 part of Radix Ginseng, 0.1～10 part of Radix Ophiopogonis.
Radix Ginseng can be selected dissimilar processed products.
Further, it is the preparation that is prepared from by the following weight proportion raw material:
1～80 part of Radix Ginseng, 0.1～8 part of Radix Ophiopogonis.
The present invention also provides a kind of: 1～100 part of Radix Ginseng, Radix Ophiopogonis the treatment ocular disease that 0.1～10 part feedstock production forms pharmaceutical composition.
It is to be active component by Radix Ginseng extract ginsenoside, Radix Ophiopogonis extract ophiopogonin, adds the preparation that acceptable accessories or adjuvant composition are prepared from.
Wherein, the weight proportion of described ginsenoside, ophiopogonin is:
1～100 part of ginsenoside, 0.1～10 part of ophiopogonin.
Further, the weight proportion of described ginsenoside, ophiopogonin is:
1～80 part of ginsenoside, 0.1～8 part of ophiopogonin.
Wherein, described preparation is: oral formulations, injection, topical ophthalmic.
Described topical ophthalmic is: eye drop, gel for eye use, Eye ointments, ocular inserts, transdermal patch.
The present invention also provides the purposes of this pharmaceutical composition in the cataractous medicine of preparation treatment.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment asthenopia, neurotic atrophy.
Medicine of the present invention is a pure Chinese medicinal preparation, and toxic and side effects is little; Medicine material of the present invention is with Radix Ginseng, Radix Ophiopogonis compatibility, or effective site ginsenoside, ophiopogonin compatibility, the performance synergism, and the gas that nourishes heart, reinforcing the heart the moon, tranquilizing mind improves the microcirculatory effect of eye, and obviously patients in remission alleviates the patient suffering; Production technology advanced person; Dosage form is easy to use.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
The extraction of embodiment 1 medicine material medicine of the present invention
One, medical material pre-treatment
The Radix Ginseng that is up to the standards (Radix Ginseng Rubra), Radix Ophiopogonis medical material selected respectively, clean, dry, be ground into lamellar or graininess.
Two, extract
1, Radix Ginseng extracts
Take by weighing and be incubated 3 hours at 80-90 ℃ after Radix Ginseng Rubra adds 15-30 water boil doubly, filter; Medicinal residues are incubated 2 hours at 85-95 ℃ after adding 15-30 water boil doubly, filter; Medicinal residues are incubated 1.5 hours at 85-95 ℃ after adding 15-30 water boil doubly again, filter, and merging filtrate, centrifugal disgorging gets ginseng aqueous extract.
2, extract Radix Ophiopogonis
Be incubated 3 hours at 80-90 ℃ after taking by weighing the water boil that adds 15-30 times a certain amount of Radix Ophiopogonis, filter; Medicinal residues are incubated 2 hours at 85-95 ℃ after adding 15-30 water boil doubly, filter; Medicinal residues are incubated 1.5 hours at 85-95 ℃ after adding 15-30 water boil doubly again, filter, and merging filtrate, high speed centrifugation disgorging get water extract Radix Ophiopogonis.
Adopt the said extracted mode or suitably change, all can reach effect of the present invention according to above-mentioned parameter.Need not be further purified, under the purified condition, the said extracted thing can reach the requirement of preparation.
Three, purification
1, the purification of ginseng aqueous extract
Ginseng aqueous extract is regulated pH7.0-9.0 with the finite concentration sodium hydroxide, at the uniform velocity by the macroporous adsorption resin chromatography post, after absorption finishes, it is colourless to chromatographic solution to wash chromatographic column with 0.1～2% sodium hydroxide solution, when being washed till chromatographic solution pH neutrality with distilled water then, with 75%～85% ethanol liquid eluting, to there being the Saponin reaction, ethanol liquid behind the eluting is at the uniform velocity crossed the resin chromatographic column, collect effluent, left standstill 12-24 hour, filter, the decompression thin film concentration is to there not being ethanol, filter, obtain transparent light yellow Radix Ginseng extractive solution, lyophilization under the aseptic condition, get Radix Ginseng effective site dry extract, Radix Ginseng total saponins content 〉=85%.
2, Radix Ophiopogonis the water extract purification
Radix Ophiopogonis, the water extract was regulated pH7.0-9.0 with the finite concentration sodium hydroxide, at the uniform velocity by the adsorbent resin chromatographic column, after absorption finishes, it is colourless to chromatographic solution to wash chromatographic column with the 0.1-2% sodium hydroxide solution, when being washed till chromatographic solution pH neutrality with distilled water then, with 75%-85% ethanol liquid eluting, to there being the Saponin reaction, ethanol liquid behind the eluting is at the uniform velocity crossed exquisite resin chromatographic column, collect effluent, left standstill 12-36 hour, filter, the decompression thin film concentration is to there not being ethanol, filter, obtain transparent light yellow Radix Ophiopogonis extract, lyophilization under the aseptic condition, get effective site dry extract Radix Ophiopogonis, ophiopogonin content 〉=85%.
The preparation of embodiment 2 lyophilized injectable powders
1, prescription
The Radix Ginseng effective part extract 6g of embodiment 1 preparation
Effective part extract 0.6g Radix Ophiopogonis of embodiment 1 preparation
Adjuvant 100g
Water for injection adds to 500ml
2, method for making
Precision takes by weighing above-mentioned Radix Ginseng effective part extract, Radix Ophiopogonis extract, under aseptic condition, adds water and makes dissolving, and is standby.Other takes by weighing the good adjuvant of calculating (selection of adjuvant is an injectable powder adjuvant commonly used) and puts in the sterile chamber, adds water and makes dissolving.Two kinds of solution abundant mixing under stirring gently adds water again and supplies 500-1000ml.After the filtering with microporous membrane degerming, be sub-packed in the sterilized lyophilizing cillin bottle, 2-20ml/ props up, lyophilization, tamponade, gland, promptly.
The preparation of embodiment 3 lyophilized injectable powders
3, prescription
The Radix Ginseng effective part extract 24g of embodiment 1 preparation
Effective part extract 0.6g Radix Ophiopogonis of embodiment 1 preparation
Adjuvant 150g
Water for injection adds to 1000ml
Press the method preparation of embodiment 2.
The preparation of embodiment 4 lyophilized injectable powders
Prescription
The Radix Ginseng effective part extract 18g of embodiment 1 preparation
Effective part extract 1.8g Radix Ophiopogonis of embodiment 1 preparation
Adjuvant 120g
Water for injection adds to 800ml
Press the method preparation of embodiment 2.
The preparation of embodiment 5 injection
Make SHENMAI ZHUSHEYE by the process that the proportioning of embodiment 2 takes by weighing the Radix Ginseng effective part extract and prepares injection Radix Ophiopogonis behind the effective part extract routinely.
The preparation of embodiment 6 infusion solutionses
Make the Rhizoma Zingiberis Recens infusion solutions by the process that the proportioning of embodiment 3 takes by weighing the Radix Ginseng effective part extract and prepares infusion solutions Radix Ophiopogonis behind the effective part extract routinely.
The preparation of embodiment 7 medicine capsules of the present invention
1, prescription
The Radix Ginseng effective part extract 24g of embodiment 1 preparation
Effective part extract 2.4g Radix Ophiopogonis of embodiment 1 preparation
Starch 150g
Make 1000 altogether
2, method for making
By recipe quantity take by weighing starch, Radix Ginseng effective part extract and Radix Ophiopogonis effective part extract, with the equivalent abundant mix homogeneously of method that progressively increases, inspect by ready samples qualified after, divide the capsule of packing into, defective capsules such as stain is arranged are rejected in polishing, polishing send quality inspection portion to carry out packing after the product inspection.
Embodiment 8
Make the Rhizoma Zingiberis Recens tablet by the process that the proportioning of embodiment 2 takes by weighing the Radix Ginseng effective part extract and prepares tablet Radix Ophiopogonis behind the effective part extract routinely.
The preparation of embodiment 9 Rhizoma Zingiberis Recens topical ophthalmics:
1, prescription
The Radix Ginseng effective part extract 2.00g of embodiment 1 preparation
Effective part extract 0.20g Radix Ophiopogonis of embodiment 1 preparation
Sodium chloride is an amount of
Water for injection adds to 100ml
2, method for making
Get 1.00-2.00g Radix Ginseng Rubra effective part extract and 0.100.20g effective part extract Radix Ophiopogonis adds water under aseptic condition, stir gently and make dissolving fully, add the sodium chloride that has calculated weight again, all after the dissolving, add water to full dose, 100 ℃ of 30 minutes flowing steam sterilizations, aseptic subpackaged, promptly.
The preparation of embodiment 10 Rhizoma Zingiberis Recens topical ophthalmics:
Prescription
The Radix Ginseng effective part extract 15.00g of embodiment 1 preparation
Effective part extract 0.8g Radix Ophiopogonis of embodiment 1 preparation
Sodium chloride is an amount of
Water for injection adds to 1000ml
Press the method preparation of embodiment 9.
The preparation of embodiment 11 Rhizoma Zingiberis Recens topical ophthalmics:
Prescription
The Radix Ginseng effective part extract 1.20g of embodiment 1 preparation
Effective part extract 0.15g Radix Ophiopogonis of embodiment 1 preparation
Sodium chloride is an amount of
Water for injection adds to 100ml
Press the method preparation of embodiment 9.
The preparation of embodiment 12 medicine gel for eye of the present invention
Make the Rhizoma Zingiberis Recens gel for eye use by the process that the proportioning of embodiment 11 takes by weighing the Radix Ginseng effective part extract and prepares gel for eye use Radix Ophiopogonis behind the effective part extract routinely.
The substrate that gel for eye use is generally commonly used has carbomer, sodium alginate, and cellulose derivative, tragacanth, gelatin, starch, carbopol etc. add water, glycerol or propylene glycol to be made, and the raw material of drug gel of the present invention and the weight proportion of substrate and preparation method are as follows:
1, prescription
Radix Ginseng effective part extract 1.20g
Radix Ophiopogonis effective part extract 0.15g
Carbomer 934 P 10g
Glycerol 1.0ml
Tween-80 is an amount of
Water for injection adds to 1000ml
2, method for making
Under aseptic technique, take by weighing carbomer 934 P10g, add glycerol, moistening is ground evenly, adds proper amount of water for injection then and makes its swelling, and is fully after the swelling, standby as substrate.Take by weighing the Radix Ginseng effective part extract and Radix Ophiopogonis effective part extract be dissolved in the hot water for injection, add in the substrate of front, stir evenly, add Tween-80 at last, add pure water to 1000ml, promptly.
The consumption of above-mentioned raw materials, adjuvant can reasonably be replaced, and can reach the effect of gel for eye use of the present invention equally.
Embodiment 13: pharmaceutical ocular unguentum of the present invention
Take by weighing the process for preparing Radix Ginseng effective part extract and Radix Ophiopogonis Eye ointments behind the effective part extract routinely and make the Rhizoma Zingiberis Recens Eye ointments.The substrate of Eye ointments can be selected the mixture of Yellow Vaselin, liquid paraffin, lanoline for use, or other substrate, and consumption generally adopts 8:1:1, can suitably increase and decrease the consumption of liquid paraffin according to temperature.Because lanoline has stronger water absorption and adhesiveness, make eye ointment be easy to tear and mix, invest easily on the eye mask, the substrate Chinese medicine is penetrated easily.
Prescription:
Radix Ginseng effective part extract 1.8g
Radix Ophiopogonis effective part extract 0.8g
Eye pasting substrate adds to 100g
Method for making:
Porphyrize under aseptic environments fully mixes with Radix Ginseng effective part extract and effective part extract Radix Ophiopogonis, adds
A small amount of substrate is ground, and gradation is progressively increased eye pasting substrate to full dose, grinds well, and is promptly aseptic subpackaged.
Embodiment 14 medicine ocular inserts of the present invention
1, prescription
Radix Ginseng effective part extract 1.2g
Radix Ophiopogonis effective part extract 0.1g
Polyvinyl alcohol (05-88) 1.2-2.8g
Glycerol 1.0ml
Water for injection adds to 50ml
2, method for making
Get polyvinyl alcohol, glycerol, water for injection, after stirring was expanded, heating made dissolving in 90 ℃ of water-baths, crossed 80 mesh sieves while hot, got colourless clear liquid; The Radix Ginseng effective part extract that takes by weighing and Radix Ophiopogonis effective part extract be dissolved in the hot water for injection, add in the colourless clear liquid of front, stir evenly, 100 ℃ of 30min sterilizations of flowing steam are put and are chilled to about 60 ℃.Under the aseptic technique, make film scribbling on the plate glass of an amount of liquid Paraffin, dry up on the superclean bench table top, each 10-15 of ultraviolet radiation positive and negative minute, behind the assay, cutting was into about 9 * 5mm
2Small pieces, the packing promptly.
Embodiment 15: drug transdermal patch of the present invention
1, prescription
Radix Ginseng effective part extract 2.00g
Radix Ophiopogonis effective part extract 0.20g
No. 1 4g of polyacrylic resin
Dehydrated alcohol 12ml
Stearyl alcohol 12g
Lanoline 24g
Sodium laurylsulfate 2g
Water for injection adds to 1000ml
2, method for making
Patch substrate preparation: get No. 1 4g of polyacrylic resin, add dehydrated alcohol 12ml, airtight immersion; Get stearyl alcohol 12g, lanoline 24g puts water-bath fusion in another container, and in the above-mentioned resin that fully soaks of cold slightly back impouring, fully mixing is made substrate.Taking by weighing the process for preparing Radix Ginseng effective part extract and Radix Ophiopogonis transdermal patch behind the effective part extract routinely makes.
Above embodiment is only for the present invention is described further, and scope of the present invention is not subjected to the limitation of illustrated embodiment.
Below prove beneficial effect of the present invention by pharmacodynamics test.
The cataractous experiment of experimental example 1 Drug therapy of the present invention
1, material and method
1.1 material Wistar rat (available from Chengdu University of Traditional Chinese Medicine's animal center), galactose (available from Shanghai biochemical reagents two factories), medicine ophthalmic preparation of the present invention, embodiment 9 preparations.
1.2 method
1.2.1 medicament preparation 555mmolL
-1Galactose, 4.44molL
-1Galactose and 150gL
-1Injection Rhizoma Zingiberis Recens saponin is all with sterile distilled water preparation, autoclaving sterilization.
66 22d Wistar in age rat male and female half and half are divided into 5 groups at random 1.2.2 divide into groups: (7 of normal control groups, 14), cataract group (15,30) and the test injection group (14,28), test oral group (14,28), the test eye drip group (14,28).
1.2.3 preparing 22d Wistar in age rat, animal model weans lumbar injection 4.44molL in advance
-1Galactose solution (20mLkg
-1, every day 1 time), no longer increase when injected dose reaches 1mL and change drinking water into 555mmolL
-1Galactose solution.Get aqueous humor and crystalline lens with the slit lamp observation crystalline lens and at d8, d14 every day, measures Ca in crystalline lens and the aqueous humor
2+Content and crystalline lens Ca
2+-atpase activity.
1.2.4 test group administering mode
1.2.4.1 test injection group begins lumbar injection 150gL at the d4 that brings out galactose cataract
-1 injection Rhizoma Zingiberis Recens soap (0.1mL, every day 1 time) is got aqueous humor and crystalline lens in d8, d14, measures Ca in crystalline lens and the aqueous humor
2+Content and crystalline lens Ca
2+-atpase activity.
Begin oral administration gavage 150gL 1.2.4.2 test oral group at the d4 that brings out galactose cataract
-1Injection Rhizoma Zingiberis Recens soap (0.1mL, every day 1 time) is got aqueous humor and crystalline lens in d8, d14, measures Ca in crystalline lens and the aqueous humor
2+Content and crystalline lens Ca2
+-atpase activity.
1.2.4.3 test eye drip group begins eye drip 150gL at the d4 that brings out galactose cataract
-1Injection Rhizoma Zingiberis Recens soap (0.1mL, every day 1 time) is got aqueous humor and crystalline lens in d8, d14, measures Ca in crystalline lens and the aqueous humor
2+Content and crystalline lens Ca
2+-atpase activity.
1.2.5 matched group processing mode 22d Wistar in age rat is weaned in advance, intraperitoneal injection of saline (20mLkg, every day 1 time), dosage no longer increase after reaching 1mL.
1.2.6 sample determination Ca
2+Content is measured with atomic absorption spectrophotometry luminosity (flame) method; Ca
2+-atpase activity is measured then earlier with crystalline lens sample cell pulverizer 1500rmin
-1Pulverize 5min, high speed centrifugation 3000rmin
-110min gets crystalline peplos fragment Phos method
[1]Measure.
1.2.7 statistical procedures adopts t check and variance analysis.
2 results
2.1 finding cataract group cavity occurs also gradually to the central part expansion in d4 crystalline lens periphery cortex under the slit lamp, the inhomogeneous muddiness of d7 cortex, and the d14 crystalline lens is all muddy; Test oral group, test eye drip group and also cavity occurs in d4 crystalline lens periphery cortex, d7 lenticular opacity degree obviously is lighter than the cataract group, and d14 is almost completely transparent, but does not have significant difference between two test group.Test injection group less cavity occurs in d4 crystalline lens periphery cortex, and d7 lenticular opacity degree obviously is lighter than test oral group, eye drip group, and d11 is almost completely transparent,
2.2 5 groups of rat aqueous humor Ca
2+Content relatively records Ca in the rats in normal control group aqueous humor
2+Content is 61.34 ± 6.32mgL
-1Aqueous humor.D8 cataract group aqueous humor Ca
2+The normal matched group of content obviously raises, and statistical procedures has highly significant difference (P＜0.01), experimental group aqueous humor Ca
2+Content is than the obvious reduction of model group (P＜0.01).D14 cataract group ratio is d8 aqueous humor Ca on the same group
2+Content higher (P＜0.05), d14 experimental group ratio is d8 aqueous humor Ca on the same group
2+Content raises.See Table 1.
Table 1 cataract group and experimental group rat aqueous humor Ca
2+Content relatively
Annotate: # represents relatively P＜0.05 of d8 and d14;
*Expression is compared P＜0.01 with model group;
*Expression is compared P＜0.005 with model group
2.3 5 groups of rat lens Ca
2+Content relatively records rats in normal control group crystalline lens Ca
2+Content is 1.61 ± 0.07mgg
-1Albumen.D8 cataract group crystalline lens Ca
2+The normal matched group of content obviously raises, and statistical procedures has significant differences (P＜0.05); Experimental group is than model group crystalline lens Ca
2+Content reduces (P＜0.05).D14 cataract group is compared no significant change (P〉0.05) with d8 on the same group; Experimental group d14 compares crystalline lens Ca with d8 on the same group
2+Content slightly raises, and compare there was no significant difference with normal control group d14 (P〉0.05), see Table 2.
Table 2 cataract group and experimental group rat lens Ca
2+Content relatively
Annotate: # represents relatively P＜0.05 of d8 and d14;
*Expression is compared P＜0.01 with model group;
*Expression is compared P＜0.005 with model group
2.4 5 groups of rat lens cyst membrane Ca
2+-atpase activity relatively records normal control group crystalline peplos Ca
2+-atpase activity is 2.70 ± 0.11 μ mol Pi/mg albumen/h.D8 cataract group crystalline lens Ca
2+-atpase activity is starkly lower than the normal control group, and statistical procedures has highly significant difference (P＜0.005); Experimental group is also compared with the normal control group and is descended (P＜0.05), but apparently higher than the cataract group same period (P＜0.05).Cataract group d14 compares crystalline peplos Ca with d8
2+-atpase activity continues to descend (P＜0.001), and experimental group d14 compares obvious rising (P＜0.001) with d8.
Table 3 cataract group and experimental group rat lens cyst membrane
Ca
2+-atpase activity relatively
| Group | d8 | d14 |
| The normal control group | 2.70±0.11 ** | 2.68±0.26 ** |
| Model group | 1.34±0.08 | 1.15±0.06 |
| Test injection group | 2.66±0.15 ** | 2.72±0.24 ** |
| Test oral group | 2.01±0.17 * | 2.64±0.29 * |
| Test eye drip group | 1.94±0.08 * | 2.63±0.10 * |
Annotate: # represents relatively P＜0.05 of d8 and d14;
*Expression is compared P＜0.01 with model group;
*Expression is compared P＜0.005 with model group
3 conclusions
Injection Rhizoma Zingiberis Recens saponin can obviously reduce galactose and cause Ca in Wistar rat aqueous humor, the crystalline lens
2+Content improves crystalline lens Ca
2+-atpase activity, prompting injection Rhizoma Zingiberis Recens saponin can prevent or treat the cataract disease, and be about 14 days the course of treatment.From each administering mode relatively, intravenous injection injection Rhizoma Zingiberis Recens saponin can in time be treated cataract, and can shorten treatment time; External eye drip and oral injection Rhizoma Zingiberis Recens saponin all effectively prevent or the treatment cataract, but both no significant differences.Illustrate, Radix Ginseng, Radix Ophiopogonis being that different dosage form that feedstock production forms all can reach the cataractous effect of treatment.
Test example 2 medicines of the present invention are to asthenopia patient's pharmacodynamics test
Carried out clinical trial in 3 tame hospitals, the capsule and the eye drop that adopt ginsenoside and ophiopogonin to make experimentize to the asthenopia patient.
1, clinical data
Physical data: 120 examples are clinic case, male 53 examples, women 67 examples; The oldest 60 years old, minimum 15 years old, the elder of the course of disease 1 year was the shortest 10 days.Wherein test eye drip group 30 examples, test oral group 30 example, contrast eye drip group 30 examples contrast oral group 30 example.
Clinical manifestation: closely study or work, the time is of a specified duration slightly, discomfort due to dryness in the eye, distending pain of the eyeball, eyelid heavily weighs down, and eye is scorching hot. the vexed pain of neck, in addition dizzy, vexed, nausea and vomiting. blurred vision, diplopia, image is closed up.
Diagnostic criteria: the long-term oculopathy history that continues, uses is in a large number arranged.The dry and astringent distending pain of eyes is arranged, do not desire to open eyes, even the symptom of showing effect repeatedly such as headache, vexed nausea.And get rid of organic illness such as glaucoma, superficial punctate keratitis, conjunctival xerosis.Because symptomatic asthenopia can appear in these pathological changes.
2 Therapeutic Method
2.1 test oral group of ophthalmic preparation that adopts embodiment 9 preparations, every day, eye drip was 2 times, each 3-5 drips.Test eye drip group is taken medicine capsule of the present invention 2 times every day, and each 2, the 60mg/ grain.
2.2 contrast oral group of QIJU DIHUANG WAN, every day 3 times, obey 6g. at every turn
Contrast eye drip group ZHENZHU MINGMUYE, every day, sooner or later respectively once each 3-5 dripped.
Two groups was 1 course of treatment with 15 days all.Simultaneously all patients are carried out the eye hygiene propaganda, the ametrope joins mirror and corrects.
3 observation of curative effect
3.1 the criterion of therapeutical effect recovery from illness: clinical symptoms all disappears, and ophthalmologic examination is no abnormal, and near work or learning time do not have discomfort than long time.Produce effects: clinical symptoms disappears substantially, and near work or learning time, eye had discomfort than long time, alleviated through having a rest.Effectively: clinical symptoms obviously alleviates, and recurs after the drug withdrawal, can not alleviation person through having a rest.Invalid: as to use after a course of treatment not alleviator of clinical symptoms.
The result treats effect such as table 3 after 2 courses of treatment:
| Group | Cure | Produce effects | Effectively | Invalid | Cure rate (%) | Total effective rate (%) |
| Test oral group | 12 | 11 | 5 | 2 | 40 | 93.3 |
| Contrast oral group | 6 | 10 | 6 | 8 | 23.3 | 76.7 |
| Test eye drip group | 11 | 10 | 6 | 3 | 36.7 | 90 |
| Contrast eye drip group | 5 | 4 | 8 | 10 | 16.7 | 66.7 |
Through x
2Check, P＜0.05 is tested oral group and is compared with oral group of contrast and contrast eye drip group respectively, and there were significant differences for total effective rate.Through x
2Check, P＜0.05, test eye drip group compares with oral group of contrast and contrast eye drip group respectively, and there were significant differences for total effective rate.There is not notable difference between testing the eye drip group and testing oral group.
The treatment group is after treating for 1 course of treatment, and total effective rate illustrates that apparently higher than matched group medicine of the present invention has rapid-action characteristics.After treating for 2 courses of treatment, the cure rate of treatment group and total effective rate all are higher than matched group, illustrate that medicine different way of administration treatment asthenopia of the present invention is all effective in cure.
List of references
1 Zhang Yuan is prosperous, Fu Yunfeng, and Dou Shujun, etc. rat heart muscle mitochondrion Ca
2+-ATP enzyme. biochemistry and biophysics make progress 1989; 16:317.
2?Huxtable?RRJ.Physiological?action?of?taurine.J?Physiol?Res?1992；72(1)：8.
3?Delamele?NA，Paferson?CA，Borchman?D，et?al.Calcuim?transport，Ca
2+-ATPase，and?lipid?order?in?rabbit?ocular?lens?membranes.Am?J?Physoil?1991；260：731.
4?Hightower?KR，McCready?JP.Effect?of?thiol?regents?on?Ca
2+-ATP?ase?in?rabbitlens?epithelium.Gurr?Eye?Res?1991；10：299.
5?Borchman?D，Delamele?NA，Paterson?CA.Ca
2+-ATPase?activityin?the?rabbit?andbovine?lens.Invest?Ophthalmol?Vis?Sci?1988；29：982.
Claims (10)
1, a kind of medicine by the following weight proportioning is the purposes of pharmaceutical composition in preparation treatment cataract, asthenopic medicine that active component is prepared from:
1～100 part of Radix Ginseng, 0.1～10 part of Radix Ophiopogonis.
2, the purposes of pharmaceutical composition according to claim 1 in preparation treatment cataract, asthenopic medicine is characterized in that: described pharmaceutical composition is that the medicine by the following weight proportioning is the preparation that active component is prepared from:
1～80 part of Radix Ginseng, 0.1～8 part of Radix Ophiopogonis.
3, the purposes of pharmaceutical composition according to claim 1 in preparation treatment cataract, asthenopic medicine is characterized in that: described Radix Ginseng is made Radix Ginseng extract ginsenoside, described Radix Ophiopogonis and is made the Radix Ophiopogonis extract ophiopogonin.
4, the purposes of pharmaceutical composition according to claim 3 in preparation treatment cataract, asthenopic medicine, it is characterized in that: the weight proportion of described ginsenoside, ophiopogonin is: 1～100 part of ginsenoside, 0.1～10 part of ophiopogonin.
5, the purposes of pharmaceutical composition according to claim 3 in preparation treatment cataract, asthenopic medicine, it is characterized in that: the weight proportion of described ginsenoside, ophiopogonin is: 1～80 part of ginsenoside, 0.1～8 part of ophiopogonin.
6, the purposes in preparation treatment cataract, asthenopic medicine according to claim 4 or 5 described pharmaceutical compositions, it is characterized in that: the dosage form of described pharmaceutical composition is: oral formulations, injection or topical ophthalmic.
7, the purposes of pharmaceutical composition according to claim 6 in preparation treatment cataract, asthenopic medicine, it is characterized in that: described topical ophthalmic is: eye drop, gel for eye use, Eye ointments, ocular inserts or transdermal patch.
8, a kind of treatment cataract, asthenopic topical ophthalmic is characterized in that: described topical ophthalmic is that the medicine by the following weight proportioning is that active component is prepared from:
1～100 part of ginsenoside, 0.1～10 part of ophiopogonin.
9, treatment cataract according to claim 8, asthenopic topical ophthalmic is characterized in that: described topical ophthalmic is that the medicine by the following weight proportioning is that active component is prepared from:
1～80 part of ginsenoside, 0.1～8 part of ophiopogonin.
10, according to Claim 8 or 9 described treatment cataract, asthenopic topical ophthalmic, it is characterized in that: described topical ophthalmic is: eye drop, gel for eye use, Eye ointments, ocular inserts or transdermal patch.
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| CN105267619B (en) * | 2014-06-07 | 2018-05-01 | 兰州大学 | The anti-tumor Chinese medicine compound extract that a kind of suppression ras proto-oncogenes are overexpressed |
| CN108524675A (en) * | 2017-03-01 | 2018-09-14 | 广州创媒电子商务有限公司 | A kind of Chinese medicine eye paste and preparation method thereof |
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| 中药成方制剂 第十八册. 170. 1998 |
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