CN101361892B - Traditional Chinese medicine formulation for treating cataract and preparation method thereof - Google Patents
Traditional Chinese medicine formulation for treating cataract and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicine for curing cataract and a preparation method thereof. The medicine is prepared by processing the mixture of active pharmaceutical ingredients obtained from processing aloe, operculina turpethum (Chinese tinospora stem), rose flowers, medicine terminalia fruit, mastic, saffron, Secmonia, and lutein, and a carrier acceptable by the drug according to a certain proportion. The drug carrier is simple syrup and starch. Compared with the prior art, the Chinese medicine provided by the invention is used for curing cataract induced by the degeneration of yellow spots and the abnormalsavda and bile, and after-cataract, with a noticeable efficacy.
Description
Technical field
The present invention relates to a kind of cataractous Chinese medicine preparation and preparation method thereof that is used for the treatment of, belong to technical field of traditional Chinese medicine pharmacy.
Technical background
Cataract is an ophthalmology common disease, frequently-occurring disease.The initial stage that mainly shows as is looked little dusk of thing; Or look dusk in the open, the dark place is looked clearly; Or look clearly in the open, dusk is looked in the dark place, and dim day of dusk is near, does not debate the personage, only sees manually, even only deposits light sensation.The main vision that influences the old people, thereby the quality of life of having reduced elderly population.The latter is mainly seen in mental work and, and along with the formation gradually of aging society, its sickness rate is more and more higher, is having a strong impact on old people's quality of life.So the cataractous active drug of development treatment seems very important and urgent.
At present, the western medical treatment cataract is based on operative treatment, and curative effect still can.But there is relative contraindication person not implement, do not develop into to a certain degree and can not implement; And cataract operation removed most anterior capsule, whole cortex and nuclear, makes crystalline lens lose the protective effect of phylloxanthin, increased various impairment factors simultaneously, and the sickness rate of after cataract is still very high.It is a lot of to treat cataractous Chinese medicine, but all is some blood circulation promoting and blood stasis dispelling mostly, and the medicine of liver heat removing and eyesight improving because the particularity of eyes, and the multiformity of cataract pathogenic factor, often makes medicine very poor in treatment cataract curative effect, have in addition do not have an effect.
At the existing defective of present state of the art, by excavating the abundant natural resources of Chinese medicinal materials of motherland, in conjunction with a large amount of traditional Chinese medical science prescription theories and clinical pharmacodynamic experiment, we have invented a kind of prescription and have constituted clear and definite, technology is simple, for cataract, degeneration of macula and after cataract Chinese medicine preparation evident in efficacy.
Summary of the invention
The purpose of this invention is to provide the cataractous Chinese medicine preparation of a kind of treatment evident in efficacy.
Another purpose of the present invention provides the cataractous Chinese medicinal preparation method of a kind of treatment.
The present invention is achieved in that
Component is calculated by weight, and pharmaceutical composition of the present invention is to be prepared from by following materials of weight proportions:
41.6 parts of 116.6 portions of Flos Rosae Rugosaes of 167 parts of Radix Operculine trupethis of Aloe (box fruit rattan)
8.3 parts of 41.6 parts of Stigma Crocis of 83.3 parts of Olibanums of terminalia flesh
4 parts of 58.3 parts of phylloxanthins of Scammonia resin
The preparation method of preparation of the present invention: get Aloe, Radix Operculine trupethi (box fruit rattan), Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, and is standby; With gained fine drug powder and the abundant mixing of phylloxanthin, add starch or dextrin mixing, to granulate, drying gets preparation of the present invention.
The preparation scheme of medicine of the present invention is that the designer obtains by concentrated summary development to the determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs thought of cataract disease and on modern medicine pharmaceutical test basis according to motherland's traditional medicine.Cataract often betides the old people, is ophthalmology common disease, frequently-occurring disease.Its main etiology and pathogenesis is worn with age, both liver and kidney deficiency, and asthenia of essence and blood, or insufficiency of the spleen mistake fortune, vital essence can not sending nutrient upward to eye and cause, thereby causes the change of eye inner tissue.The stagnated heat of liver channel and the deficiency of YIN are held under the arm and are attacked on damp and hot, also can cause primary disease.In motherland's medical science ancient books and records, the successive dynasties document all has cataractous associated description.Cataract is called as " garden nebula cataract " " vitreous opacity " in Gu doctor nationality.The traditional Chinese medical science is thought cataractous pathogenesis or for the hepatic and renal YIN deficiency, or be deficiency of the spleen causing weakness of QI, or is to disturb on the liver-heat, or has held deficiency-heat under the arm for the deficiency of YIN.According to understanding to above-mentioned etiology and pathogenesis, designer of the present invention chooses some drug effects and concentrates raw material of Chinese medicine prescription evident in efficacy to form, Chinese medicine in the side by Aloe, Radix Operculine trupethi (box fruit rattan), Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin, phylloxanthin totally eight herbal medicines forms, full side has the degeneration of macula of treatment, after cataract; Remove unusual black gallbladder matter and bile matter, the block removing function of improving eyesight.Aspect cataractous treatment, particularly aspect the treatment of this disease convalescent period and sequela, have fabulous effect, can make cataract reach the effect for the treatment of both the principal and secondary aspects of a disease, thereby significantly reducing or eliminate of the threat of this disease health of people.
We use Aloe clearing away liver-fire, relieving restlessness nebula removing; Radix Operculine trupethi (box fruit rattan) heat-clearing and toxic substances removing, collateral dredging makes eye bright; The Flos Rosae Rugosae promoting QI circulation for relieving depression, promoting blood circulation to remove blood stasis promotes the bile secretion effect again; Scammonia resin has the effect of removing unusual black bile and bile juice; Terminalia flesh has the antibiotic and antifungic action of height; The Olibanum blood activating and promoting tissue regeneration, reducing swelling and alleviating pain has the effect that increases plasmin activity; The Flos Carthami promoting blood circulation and stopping pain, detumescence and promoting granulation has blood vessel dilating, strengthens the effect of vascular permeability; Phylloxanthin is to the increment of lens epithelial cells and divide a word with a hyphen at the end of a line and have significant inhibitory effect, and is splendid to after cataract and degeneration of macula curative effect; Full side share, to degeneration of macula and unusual black gallbladder matter and the caused cataract of bile juice; After cataract; Evident in efficacy.
For confirming that product of the present invention has effective therapeutic effect, we have carried out a series of pharmacodynamic studies;
Now, its main pharmacodynamics is described with capsule contrast CHUZHANGZEHAIPU PIAN of the present invention:
The experiment medicine:
Capsule of the present invention is the medicine of the embodiment of the invention 1 method preparation.
CHUZHANGZEHAIPU PIAN is to buy on the market.
One, to the microcirculatory influence of tame lagophthalmos conjunctiva
30 of rabbit, male and female half and half, body weight 1.8～2.2kg divides 5 groups at random, and 6 every group, matched group is irritated the normal saline of stomach with volume; CHUZHANGZEHAIPU PIAN group gastric infusion 0.3g medical material/kg; Capsules group of the present invention is gastric infusion 0.1,0.2,0.3g medical material/kg respectively, successive administration 3d, and once a day, 1h after the last administration, rabbit ear vein inject 10% fluorescein sodium normal saline solution 100mg/kg, write down the time that fluorescence appears in tame lagophthalmos conjunctiva.See Table 1
Table 1 pair family exempts from the microcirculatory influence of a conjunctiva
Matched group is compared: * * P＜0.01; With the CHUZHANGZEHAIPU PIAN group than △ P＜0.05, #P＞0.05.
The result: Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group have acceleration to the rabbit conjunctival microcirculation, compare with matched group to have significant difference.The microcirculation that Capsules group of the present invention is improved the eye conjunctiva than CHUZHANGZEHAIPU PIAN group is strong.
Two, to the influence of rat galactose cataract model
SD is a rat, at first makes eye examination, selects 50 of the normal persons of eyes, male and female half and half, and body weight 60～80g divides 5 groups at random, 10 every group.Model control group is irritated the normal saline of stomach with volume; CHUZHANGZEHAIPU PIAN group gastric infusion 0.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.2,0.4,0.6g medical material/kg respectively, successive administration 3d, once a day, each group all (is mixed in the feedstuff to the D-galactose behind the 3d, feedstuff and galactose each half), continue gastric infusion and normal saline simultaneously, every 3d checks that with eye examination with slitlamp microscope cataract forming process preceding eyes drip mydriatic.Model control group cataract maturing rate reaches more than 80%, stops administration and galactose, and muddy with core is index with forming the cataractous time, carries out the effect that statistical procedures is checked medicine.See Table 2
Table 2 pair rat galactose is from the influence of cataract model
Compare * * P＜0.01 with model control group; With the CHUZHANGZEHAIPU PIAN group than △ P＜0.05, #P＞0.05
The result: Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group have the effect that slows down core muddiness and cataract formation time to rat galactose cataract model, have significant difference with the model control group ratio.Capsules group of the present invention is stronger to the cataractous formation inhibitory action of rat galactose than CHUZHANGZEHAIPU PIAN group.
Three, to the influence of protein content and enzymatic activity in the galactose cataract rat model crystal
SD is a rat, at first makes eye examination, selects 50 of the normal persons of eyes, male and female half and half, and body weight 60～80g divides 5 groups at random, 10 every group.Each treated animal lumbar injection every day 50%D-galactose solution 15g/kg, injection at twice, 4h injects 14d continuously at interval, the administration of promptly dividing into groups on the same day of injection of d-galactose solution, model control group is irritated the normal saline of stomach with volume; CHUZHANGZEHAIPU PIAN group gastric infusion 0.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.2,0.4,0.6g medical material/kg respectively, 3 weeks of successive administration, once a day, behind last administration 16h, put to death each treated animal, take out crystal, weigh, the phosphate buffer 0.7ml that adds pH8.3 makes homogenate, 2500rpm centrifugal (4 ℃) 15min, protein content, the superoxide dismutase (SOD) in the taking-up supernatant homogenate mensuration crystal is active, the content of malonaldehyde (MDA).See Table 3.
The influence of protein content and enzymatic activity in the table 3 pair galactose cataract rat model crystal
Compare * * P＜0.01 with model control group; With the CHUZHANGZEHAIPU PIAN group than △ P＜0.05, #P＞0.05
The result: Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group all have rising to protein content and SOD activity in the galactose cataract rat model crystal, have significantly reduced the content of MDA, have significant difference with the model control group ratio.Capsules group of the present invention is stronger to protein content and enzymatic activity effect in the galactose cataract rat model crystal than CHUZHANGZEHAIPU PIAN group.
Four, sodium selenite is brought out the influence of rat cataract
Taking out the SD that gives birth to 10～I1 age in days is rat, body weight 15 ± 5g, male and female half and half, divide 5 groups at random, every group 10, the next day in cervical region subcutaneous injection 2mmol/L sodium selenite solution 5ml/kg (0.05ml/ only), inject altogether five times, in the administration of promptly dividing into groups on the same day of injection sodium selenite solution, model control group is irritated the normal saline of stomach with volume; CHUZHANGZEHAIPU PIAN group gastric infusion 0.6g medical material/kg; Capsules group of the present invention is gastric infusion 0.2,0.4,0.6g medical material/kg respectively, 2 weeks of successive administration, once a day, behind last administration 16h, put to death each treated animal, take out crystal, weigh, the phosphate buffer 0.7ml that adds pH8.3 makes homogenate, 2500rpm centrifugal (4 ℃) 15min, protein content, the superoxide dismutase (SOD) in the taking-up supernatant homogenate mensuration crystal is active, the content of malonaldehyde (MDA).See Table 4
Table 4 pair sodium selenite brings out the influence of rat cataract
Compare * * P＜0.01 with model control group; With the CHUZHANGZEHAIPU PIAN group than △ P＜0.05, #P＞0.05
The result: Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group bring out to sodium selenite that protein content and SOD activity all have rising in the crystal of rat cataract, have significantly reduced the content of MDA, have significant difference with the model control group ratio.Capsules group of the present invention is brought out in the crystal of rat cataract protein content and enzymatic activity effect to sodium selenite than CHUZHANGZEHAIPU PIAN group strong.
Five, to the outgrowth influence of human lens epithelial cell (LECs) of In vitro culture
The take the logarithm human lens epithelial cell of trophophase with carrying out cell counting behind trypsinization 2～3min of 0.25%, is adjusted cell density to 4 * 10/mL, and with cell suspension inoculation in 96 well culture plates, every hole 200 μ L, at 37 ℃, 5%CO
2Hatch in the incubator, abandon supernatant behind the 24h, matched group adds the high sugared DMEM culture fluid that contains 10% hyclone, and drug component does not add: the CHUZHANGZEHAIPU PIAN group is prepared into the solution that concentration is 0.3g/L; Capsules group of the present invention is prepared into that concentration is 0.1,0.2, the solution of 0.3g/L.Establish 8 multiple holes for every group, take out behind effect 24,48, the 72h, abandon supernatant, add the culture fluid that tetramethyl azo azoles salt (MTT) that 20 μ L mass concentrations are 5mg/mL and 180 μ L do not contain serum, take out after cultivating 4h, abandon supernatant, every hole adds dimethyl sulfoxide (DMSO) 200 μ L, behind vibration 10min on the micro oscillator, carries out colorimetric with full-automatic microplate reader, wavelength is 490nm, surveys every hole absorbance A value.See Table 5
The outgrowth influence of human lens epithelial cell (LECs) of table 5 pair In vitro culture
Compare * * P＜0.01 with matched group; With the CHUZHANGZEHAIPU PIAN group than △ P＜0.05, #P＞0.05
The result: after cataract is that lens epithelial cells (LECs) residual behind the crystalline lens ECCE changes into fibrocyte and causes.Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group can obviously suppress the propagation of people LECs, and along with the prolongation of time, absorbance reduces gradually, compare with matched group to have significant difference.Capsules group of the present invention is stronger than the inhibited proliferation of CHUZHANGZEHAIPU PIAN group residual people LECs after to lens extraction, can prevent after cataract.
Capsule of the present invention is through acute toxicity testing, the result shows: will be except that capsule Cmax of the present invention, maximum volume gastric infusion, and successive administration is 4 times in 24h, each 3h at interval, accumulation medicine total amount reaches 32g crude drug/kg, is equivalent to 622 times of clinical plan consumption.Observed 7, mice diet, activity, body weight, feces, fur, glossiness are all normal, and non-toxic reaction does not have dead.Put to death all no abnormal variation of the anatomic observation heart, lung, liver, kidney, non-toxic reaction.Show that this capsule does not have acute toxic reaction.
Capsule of the present invention is through long term toxicity test, the result shows: the basic, normal, high dosage of capsule of the present invention is respectively 1,3,6g/kg/d, be equivalent to 19.4,58.3,116.7 times of clinical plan consumption, gastric infusion is after 3 months continuously, compare with matched group, rat general features, outward appearance, diet, feces and activity, routine blood test, liver, renal function, main organs coefficient, all no abnormal change of inspection of the pathological section of the heart, liver, spleen, lung, kidney, adrenal gland, thymus, thyroid, brain, uterus, ovary, testis (epididymis).Do not find the reaction of toxic reaction and delayed toxicity in 2 weeks of drug withdrawal yet.As seen, capsule non-toxic reaction of the present invention, long-term prescription is safe and reliable.
Conclusion: Capsules group of the present invention and CHUZHANGZEHAIPU PIAN group have the effect of acceleration to the rabbit conjunctival microcirculation; Galactose cataract rat model there is the effect that slows down core muddiness and cataract formation time; Galactose and sodium selenite are brought out protein content and SOD activity all have rising in the crystal of rat cataract, significantly reduced the content of MDA; The propagation that can obviously suppress people LECs.Experiment shows that it is more obvious than the microcirculation of CHUZHANGZEHAIPU PIAN improvement eye conjunctiva to remove capsule of the present invention; Inhibited proliferation to people LECs residual behind the lens extraction is strong; The formation inhibitory action of galactose and sodium selenite being brought out rat cataract is strong.As seen, strong except that capsule of the present invention to preventing after cataract and block removing function of improving eyesight.
Clinical trial:
Clinical observation patient 227 examples of the present invention are used for the treatment of cataract, outpatient's 167 examples wherein, inpatient's 60 examples.Clinical observation shows: this product is oral; one time 5; 3 times on the one; after cataract and after cataract patient use this product, the muddy long-pendingization material of eye is come out by cyclic metabolism, increase lenticular permeability; and make optical fundus, retina, optic nerve and regulate crystalline lens; capsulociliary function obtains repairing and protection, and returning to form appears in vision.The present invention is 91.3% for treatment cataract and after cataract total effective rate.Exact efficacy in the clinical observation process does not find that the patient has untoward reaction and anaphylaxis, illustrates that this product is safe and effective.
The specific embodiment of the invention:
The embodiment of the invention 1:
The prescription proportioning:
41.6 parts of 116.6 portions of Flos Rosae Rugosaes of 167 parts of Radix Operculine trupethis of Aloe (box fruit rattan)
8.3 parts of 41.6 parts of Stigma Crocis of 83.3 parts of Olibanums of terminalia flesh
4 parts of 58.3 parts of phylloxanthins of Scammonia resin
The preparation method of capsule of the present invention: get Aloe, Radix Operculine trupethi (box fruit rattan), Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, and is standby.With gained fine drug powder and the abundant mixing of phylloxanthin, add the appropriate amount of starch mixing, to granulate, drying incapsulates, and promptly gets Chinese medicinal capsule agent of the present invention.
The embodiment of the invention 2:
The prescription proportioning:
41.6 parts of 116.6 portions of Flos Rosae Rugosaes of 167 parts of Radix Operculine trupethis of Aloe (box fruit rattan)
8.3 parts of 41.6 parts of Stigma Crocis of 83.3 parts of Olibanums of terminalia flesh
4 parts of 58.3 parts of phylloxanthins of Scammonia resin
The preparation method of granule of the present invention: get Aloe, Radix Operculine trupethi (box fruit rattan), Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, and is standby.With gained fine drug powder and the abundant mixing of phylloxanthin, add an amount of dextrin mixing, granulate, drying, pack promptly gets Chinese medicine granules of the present invention.
The embodiment of the invention 3:
The prescription proportioning:
41.6 parts of 116.6 portions of Flos Rosae Rugosaes of 167 parts of Radix Operculine trupethis of Aloe (box fruit rattan)
8.3 parts of 41.6 parts of Stigma Crocis of 83.3 parts of Olibanums of terminalia flesh
4 parts of 58.3 parts of phylloxanthins of Scammonia resin
The preparation method of tablet of the present invention: get Aloe, Radix Operculine trupethi (box fruit rattan), Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin is ground into fine powder, crosses 100 mesh sieves, and is standby.With gained fine drug powder and the abundant mixing of phylloxanthin, add the appropriate amount of starch mixing, to granulate, drying adds an amount of magnesium stearate mixing, and tabletting promptly gets Chinese medicinal tablet of the present invention.
Claims (6)
1. one kind is used for the treatment of cataractous Chinese medicine preparation, it is characterized in that it is to be prepared from by the following weight proportion raw material:
Aloe 100-200 part Radix Operculine trupethi 100-150 part Flos Rosae Rugosae 20-70 part
Terminalia flesh 50-100 part Olibanum 20-70 part Stigma Croci 5-10 part
Scammonia resin 40-80 part phylloxanthin 1-10 part.
2. according to the described Chinese medicine preparation of claim 1, it is characterized in that each raw material optimum weight proportioning is:
41.6 parts of 116.6 portions of Flos Rosae Rugosaes of 167 parts of Radix Operculine trupethis of Aloe
8.3 parts of 41.6 parts of Stigma Crocis of 83.3 parts of Olibanums of terminalia flesh
4 parts of 58.3 parts of phylloxanthins of Scammonia resin.
3. according to claim 1 or 2 described Chinese medicine preparation, it is characterized in that: described Chinese medicine preparation dosage form is granule, capsule, tablet.
4. the preparation method of Chinese medicine preparation according to claim 3 is characterized in that: gets Aloe, Radix Operculine trupethi, Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin and is ground into fine powder, cross 100 mesh sieves, and standby; With gained fine drug powder and the abundant mixing of phylloxanthin, add starch or dextrin mixing, to granulate, drying gets Chinese medicine preparation.
5. according to claim 1 or 2 described Chinese medicine preparation, it is characterized in that described preparation formulation is a capsule.
6. the preparation method of Chinese medicinal capsule agent according to claim 5 is characterized in that: gets Aloe, Radix Operculine trupethi, Flos Rosae Rugosae, terminalia flesh, Olibanum, Stigma Croci, Scammonia resin and is ground into fine powder, cross 100 mesh sieves, and standby; With gained fine drug powder and the abundant mixing of phylloxanthin, add the appropriate amount of starch mixing, to granulate with simple syrup, drying incapsulates, and promptly gets the Chinese medicinal capsule agent.
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| GB201014340D0 (en) | 2010-08-27 | 2010-10-13 | Piraee Mahmood | Nutritional supplement formulation comprising saffron and resveratrol |
| WO2012025229A1 (en) * | 2010-08-27 | 2012-03-01 | Persavita Ltd. | Composition and method of manufacture |
| CN103405611B (en) * | 2013-06-28 | 2015-09-02 | 阿不都热衣木·尼牙孜 | A kind of cephalocathartic pain relieving pills for improving acuity of sight |
| CN109954051A (en) * | 2019-04-14 | 2019-07-02 | 唐海飞 | A kind of Chinese materia medica preparation for treating cataract |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1879766A (en) * | 2006-03-07 | 2006-12-20 | 新疆维吾尔药业有限责任公司 | Medicine for treating rheumatism and preparation method thereof |
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| CN1879766A (en) * | 2006-03-07 | 2006-12-20 | 新疆维吾尔药业有限责任公司 | Medicine for treating rheumatism and preparation method thereof |
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| Title |
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| 付克，等.除障则海甫胶囊质量标准研究.《中医药信息》.2006,第23卷(第2期),第48-49页. * |
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