CN102258709B - Traditional Chinese medicine preparation for treating diabetic retinopathy, and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating diabetic retinopathy, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating diabetic retinopathy, and a preparation method thereof. The traditional Chinese medicine preparation is prepared from the following components in parts by weight: 180-210 parts of astragalus root, 180-210 parts of rehmannia root, 230-260 parts of red sage root, 180-210 parts of pseudo-ginseng, 230-260 parts of cassia seed, 230-260 parts of feather cockscomb seed, 180-210 parts of motherwort fruit and 140-155 parts of lophatherum. The traditional Chinese medicine preparation can effectively treat diabetic retinopathy, has exact curative effect, no toxic side effect, fewer medicinal raw materials and easy-to-control quality, and provides a new medicine option for patients with diabetic retinopathy.
Description
Technical field
The present invention relates to technical field of Chinese medicines, particularly relate to Chinese medicine preparation of a kind of treatment of diabetic retinopathy change and preparation method thereof.
Background technology
Increase even surplus along with what raising, the nutrition of living standards of the people were taken in; The sickness rate of China's diabetes (diabetes) is constantly soaring; Ten thousand people surplus the diabetics 4000 are arranged at present approximately, and diabetes and complication thereof just China's people health and life security in serious harm.Diabetic renal papillary necrosis (DR) is a diabetes common but severe complication; Find that after deliberation the DR incidence rate is along with the diabetic duration progress raises gradually, onset diabetes after 5 years the retinopathy incidence rate be about 25%; Can be after increasing to 60%, 15 year after 10 years up to 75%～80%.There is typical retinal microvascular infringement in DR; Its clinical manifestation is microangioma, hemorrhagely, rigid ooze out, cotton-wool patches (soft oozing out), intraretinal microvascular abnormality, the change of vein beading appearance, new vessels and proliferation of fibrous tissue etc., is the one of the main reasons of diabetics blinding.Therefore, human beings'health in the high incidence of DR, high blinding property serious threat, is the great brainstorm subject that current medical domain is badly in need of solution.
The traditional Chinese medical science is thought: diabetes, blurring of vission (diabetes and retinopathy) are because of deficiency of kidney-YIN, and the liver failing to be nourished, essence and blood can not sending nutrient upward to eye, and deficiency of both QI and YIN hyperamization row is not smooth, and the order network is closed in the congestion resistance, loss of nutrient of eyes, evil resistance order key and cause order and do not have finding.Primary disease is this with the deficiency of both QI and YIN, and congestion resistance network is mark, and deficiency of both qi and yin becomes silted up for main pathogenesis, through the primary disease overall process.Therefore, supplementing QI and nourishing YIN, promoting blood circulation to remove obstruction in the collateral can be used as the principle of treatment of DR.The Drug therapy of DR comprises Western medicine and treatment by Chinese herbs at present.Be used for clinical Western medicine and mainly contain calcium dobesilate, the medicine epalrestat of aldose reductase inhibitor class, tolrestat etc., but these medicines all have characteristics such as cost an arm and a leg, untoward reaction is more.Chinese medicine mainly contains sugar net capsule; Be to be prepared from Radix Panacis Quinquefolii, Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Radix Rehmanniae, Radix Rehmanniae Preparata, Fructus Lycii, Herba Dendrobii, Cortex Moutan, Radix Et Rhizoma Rhei, Rhizoma Chuanxiong and Fructus Aurantii; The used raw medicinal material kind of this capsule preparations is more, and prescription is complicated, difficult quality control.
Summary of the invention
Technical problem to be solved by this invention is the defective that overcomes prior art, Chinese medicine preparation that the treatment of diabetic retinopathy that provides a mass to be easy to control becomes and preparation method thereof, and this Chinese medicine preparation good effect is selected for the patient provides more medication.
In order to solve the problems of the technologies described above, the present invention adopts following technical scheme:
According to listed as parts by weight, the Chinese medicine preparation that treatment of diabetic retinopathy of the present invention becomes is to be prepared from for 140～155 parts 180～210 parts of the Radixs Astragali, 180～210 parts in the Radix Rehmanniae, 230～260 parts of Radix Salviae Miltiorrhizaes, 180～210 parts of Radix Notoginseng, 230～260 parts of Semen Cassiaes, 230～260 parts of Semen Celosiae, 180～210 parts of Fructus Leonuris and Herba Lophatheri.
Preferably, above-mentioned Chinese medicine preparation is to be prepared from for 145～150 parts 190～200 parts of the Radixs Astragali, 190～200 parts in the Radix Rehmanniae, 240～250 parts of Radix Salviae Miltiorrhizaes, 190～200 parts of Radix Notoginseng, 240～250 parts of Semen Cassiaes, 240～250 parts of Semen Celosiae, 190～200 parts of Fructus Leonuris and Herba Lophatheri.
Best, the Chinese medicine preparation of aforementioned therapies diabetic renal papillary necrosis is to be prepared from for 147 parts 196 parts of the Radixs Astragali, 196 parts in the Radix Rehmanniae, 245 parts of Radix Salviae Miltiorrhizaes, 195 parts of Radix Notoginseng, 245 parts of Semen Cassiaes, 245 parts of Semen Celosiae, 196 parts of Fructus Leonuris and Herba Lophatheri.
The present invention also provides the preferred for preparation method of aforementioned Chinese medicine preparation: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, soak the back and decoct three times, merge decoction liquor, filter, filtrating concentrates, and adds Radix Notoginseng powder, and mixing is processed Chinese medicine preparation.
Preferably, above-mentioned method for preparing is: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 10～15 times of weight for the first time, for the second time with the water that respectively adds 8～12 times of weight for the third time; Decoct, merge decoction liquor, filter; It is 1.21～1.25 thick extractum that filtrating is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed Chinese medicine preparation.
Best, aforementioned method for preparing is: get Radix Notoginseng and pulverize, it is subsequent use to cross 100 orders; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 12.5 times of weight for the first time, for the second time with the water that respectively adds 10 times of weight for the third time; Each decocted 1 hour, merged decoction liquor, filtered; It is 1.21～1.25 thick extractum that filtrate decompression is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed Chinese medicine preparation.
Aforementioned Chinese medicine preparation is a hard capsule, during preparation, and after adding Radix Notoginseng powder, mixing, 80 ℃ of drying under reduced pressure are pulverized, and cross 60 mesh sieves, incapsulate, and promptly get hard capsule.
It is monarch drug that Radix Astragali tonifying Qi and lifting yang in the side, benefit are defended consolidating superficial resistance; Radix Rehmanniae YIN nourishing and the production of body fluid promoting, Radix Salviae Miltiorrhizae, pseudo-ginseng blood-circulation-invigovating collateral dredging, strengthening the circulation of qi promoting effect is ministerial drug; Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri liver heat removing and eyesight improving, through aura are adjuvant; Full side share, and treating both the principal and secondary aspects of a disease is played supplementing QI and nourishing YIN altogether, improving acuity of vision and removing nebula, the effect of blood circulation and channel invigorating.
Experiment one: preparation process research
1, the selection foundation of process route
1.1 prescription drug physicochemical property and modern pharmacological research
The Radix Astragali mainly contains saponin component, and flavones ingredient and polysaccharide composition contain amino acids in addition.Saponins is its effective ingredient, mainly contains astragaloside I, II, III, IV, V, VI, VII, Isoastragaloside, II, IV and Sayasaponin etc.The pharmacological research data shows that Radix Astragali aqueous solution has the hemorheology of improvement, anti-thrombosis function; Can suppress TNF-α, protection pericyte avoids infringement, and damage has protective effect behind the rat retina ischemia-reperfusion that simultaneously diabetic renal papillary necrosis is caused.In addition, Radix Astragali Mongolici total polysaccharide has two-ways regulation blood glucose, and the protection vascular endothelial cell suppresses the effect of microangiopathies, therefore adopts the water boiling and extraction method.
The chemical constituent of Radix Salviae Miltiorrhizae is mainly fat-soluble diterpene quinones and soluble salvianolic acid constituents.Liposoluble constituent is mainly tanshinone, the TANSHINONES II
A, the TANSHINONES II
B, cryptotanshinone, Methyl tanshinoate etc.Water soluble ingredient is mainly danshensu, protocatechualdehyde, salvianolic acid A, B, C, D, E, F, G etc.Documents and materials show that tanshinone and salvianolic acid constituents all have microcirculation improvement and hemorheology effect, and the Radix Salviae Miltiorrhizae water extract is protected endotheliocyte in addition, alleviates ischemical reperfusion injury; The salvianolic acid class can suppress cataract and form, and reduces MDA content, strengthens the crystalline lens oxidation resistance, so with water boiling and extraction.
Radix Notoginseng mainly contains saponin component (like arasaponin, ginsenoside etc.) and non-saponin component (like Radix Notoginseng polysaccharide, aminoacid, flavonoid, sterols etc.).Documents and materials show, Radix Notoginseng powder treatment simple type diabetic retinopathy can obviously improve its eye microcirculation, so can retinal ischemia, anoxic conditions, total effective rate reaches 80.6%.The pharmacology data shows that also Radix Notoginseng, Radix Salviae Miltiorrhizae all can reduce ICAM-1 and the VEGF content of blood vessel hyperplasia property retinopathy mice, thus the inhibitory action certain to being formed with of retinal neovascularization.
It is main with iridoid glycoside that the Radix Rehmanniae mainly contains glycoside, is mainly catalpol, polysaccharide, aminoacid, trace element etc.The pharmacology data shows, Radix Rehmanniae decocting fluid power strengthens ED, suppresses in the blood vessel condensate and thrombosis in condensate, the platelet, thus microcirculation improvement, simultaneously to diabetic complication particularly diabetic nephropathy certain preventive and therapeutic effect is arranged.And Dihuang polysaccharide promotes outside the hemopoietic function except that raise immunity is arranged, can also blood sugar lowering.So with water boiling and extraction.
Semen Cassiae mainly contains anthraquinone components such as emodin, chrysophanol, chrysophanic acid, aloe-emodin, physcione, still contains VA, saccharide, the trace element Fe of protein and needed by human, Zn, Mn, Cu etc.The pharmacological research data shows that the Semen Cassiae decoct irritates stomach for rabbit or Canis familiaris L., and the function that stimulates LDH in the ocular tissue is arranged.After taking Semen Cassiae, can prevent and delay the generation and the development of senile cataract, so with water boiling and extraction.
It is main with stachydrine that Fructus Leonuri mainly contains alkaloid, and fatty oil, and other contains vitamin A.The clinical ophthalmics such as conjunctival congestion and swelling pain, nebula that are used to treat more.Consider that alkaloid generally is present in the Chinese medicine with the form of salt, water soluble, so combine the contained chemical constituent physicochemical property of these article and modern pharmacology, clinical research situation, these article extract with decocte with water technology.
1.2 confirming of basic technology route
We are Chinese medicine compound, according to traditional medication custom, adopt boiling water extraction method; Wherein because of Radix Notoginseng is a valuable medicinal, take the method for former powder adding, contained polysaccharide component has certain therapeutical effect to curing the disease disease in the Radix Astragali, the Radix Rehmanniae; So take water boiling and extraction, and wouldn't adopt impurity removal process.
2, medical material pre-treating technology research
The prescription Chinese crude drug Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Radix Rehmanniae, Semen Cassiae, Herba Lophatheri, Fructus Leonuri, Semen Celosiae medical material are that " 2005 editions one one of Chinese pharmacopoeia is recorded article, is identified by professor Dong Lisha of Guiyang College of Traditional Chinese Medicine.
The Radix Astragali: be the leguminous plant Radix Astagali
Astragalus membranaceus(Fisch.) Bge.
Var. mongholicus(Bge.) dry root of Hsiao.Spring, Qiu Erji excavate, and remove fibrous root and root head, dry.
Radix Salviae Miltiorrhizae: be the labiate Radix Salviae Miltiorrhizae
Salvia miltiorrhizaBge. dry root and rhizome.Spring, Qiu Erji excavate, and remove silt, drying.
Radix Notoginseng: be panax araliaceae plant
Panax notoinseng(Burk.) the dry root and rhizome of F.H.Chen.Dig before medicine is opened autumn, cleans, and separates main root, supporting root, reaches rhizome, drying.
The Radix Rehmanniae: be scrophulariaceae rehmannia glutinosa plant
Rehmannia glutinosaLibosch. dried root.Excavate autumn, removes removing LU, fibrous root and silt, Radix Rehmanniae slowly cured to eighty per cant do.
Semen Cassiae: be the leguminous plant Semen Cassiae
Cassia obtusifoliaL. dry mature seed.The mature fruit of gathering autumn is dried, and lays seed, removes impurity.
Herba Lophatheri: be the grass Herba Lophatheri
Lophatherum gracileBrongn. dry stem and leaf.Do not tap before taking out spica summer, dry.
Fructus Leonuri: be the labiate Herba Leonuri
Leonurus japonicusHoutt. dry mature fruit.Summer, autumn extract Herb when Herb blossom fall, fruit maturation, dry, and lay fruit, remove blade, impurity.
Semen Celosiae: be the feverfew Herba Celosiae argenteae
Celosia argenteaL. dry mature seed.Tap plant or win fruit ear during fruit maturation autumn, dries, and collects seed, removes impurity.
3, the screening of process conditions
3.1 Study on extraction
3.1.1 the mensuration of medical material water absorption rate
Get recipe quantity medical material (except the Radix Notoginseng) 60g, soak different time, measure water absorption rate with 8 times of water gagings.See table 1.
Table 1 medical material water absorption rate is investigated
Can be known that by table 1 the medical material water absorption rate is 241%, is handled easily, be 250% to calculate with water absorption rate, and promptly the medical material water absorption is heavy 2.5 times of medical material.
3.1.2 single factor of soak time is investigated
Under the condition that satisfies the medical material water absorption rate, investigate soak time, to the influence of prescription extractum rate, serve as to investigate index with the total solid matters yield, optimize single factor scope that prescription extractum rate is had the greatest impact.
Get recipe quantity medical material (except the Radix Notoginseng) 60g and add 10 times of water gagings, soak 0 h respectively, 1h, 3h, 5h, 8h behind the 12h, decocts 3 times, and each 1h filters, and medicinal liquid dissolves to 250ml surely, and is subsequent use.
From above-mentioned filtrating, get 10ml and dry by the fire to constant weight in 105 ℃, put into exsiccator 0.5h, weigh.The result sees table 2, and table 3 is seen in variance analysis
Total solid matters yield (%)={ the dried cream gross weight of compound recipe (g)/inventory (g) } * 100%
Table 2 soak time is investigated
Table 3 one factor analysis of variance table
One factor analysis of variance shows: P 0.05, explain that different soak times has significant difference, simultaneously, for 5h, 8h, there was no significant difference between the 12h.According to the needs of practicing thrift cost, selecting soak time for use is 5h.
3.1.3 the quadrature factor of decocting process
Under the condition that satisfies the medical material water absorption rate, soak 5h, investigate the principal element of amount of water, decocting time, three influence decoctions of decoction number of times effect, by each factor 3 level, use L
9(3
4) orthogonal table arrangement test (table 4).Boiled process adopts orthogonal test to screen (table 5), serves as to investigate index with the total solid matters yield, and extraction process is inquired into.Table 6 is seen in variance analysis.
Table 4 factor level table
Take by weighing recipe quantity medical material (except the Radix Notoginseng) 60g, make an experiment by (table 2) (soaking 5h for the first time) by orthogonal test table, medicinal liquid filters, and is settled to 250ml.Subsequent use.
From above-mentioned filtrating, get 10ml and dry by the fire to constant weight in 105 ℃, put into exsiccator internal cooling 0.5h, weigh.
Total solid matters yield (%)={ the dried cream gross weight of compound recipe (g)/inventory (g) } * 100%
Table 5 decocting process condition L
9(3
4) orthogonal test arrangement and result
Table 6 analysis of variance table
3.1.4 interpretation of result: with the total solid matters yield is index, can get from table 5, table 6 analysis, and factor A, C have the significance influence; Simultaneously, extreme difference C＞A＞B, C3＞C2＞C1; A2＞A3＞A1, B3＞B2＞B1 confirms that its optimum extraction process is A2B3C3; But B does not have significance because of factor, selects best level B2 promptly to decoct 1.0h according to practicing thrift cost and productions needs, and seven flavor medicine thing decocting in water extraction optimum process condition such as the Radix Astragali is so: A2B2C3; Be that medical material soaks 5h, 10 times of water gagings decoct (adding 2.5 times of water gagings for the first time), each 1 hour 3 times.
3.1.5 the process certification of three lot sample article experiment: get medical materials such as the Radix Astragali, Radix Salviae Miltiorrhizae; Press optimum extraction process condition A2B2C3 and extract, measure the total solid matters yield, the result shows (seeing table 7): the total solid matters yield is 20.68%; RSD=3.35% explains that process stabilizing is feasible.
Table 7 technology stability demonstration test
3.2, concentrate and drying
3.2.1 the extractum relative density is to the influence of extract dry time
60g extracts according to optimised process with recipe quantity medical material (except the Radix Notoginseng), and decocting liquid filters, and is settled to 250ml.Subsequent use.Precision is measured the equivalent extracting solution, is evaporated to different relative densities, mixes with Notoginseng Root (100 order), and in 80 ℃ of drying under reduced pressure, time length sees drying.The result sees table 8
Table 8 extractum relative density is to the influence of drying time
Result of the test shows: when extractum is concentrated into relative density and is 1.31-1.35; The used time is the shortest; But being concentrated into relative density is 1.21-1.25, during 1.26-1.30, with relative density be that 1.31-1.35 extract dry time phase difference is little; Based on the consideration of plant produced efficient, selecting extractum is concentrated into relative density is 1.21-1.25.
3.2.2 baking temperature is to the influence of extract dry time
Get said extracted liquid 100ml, being concentrated into relative density is 1.21-1.25, is dried to constant weight with different temperatures, and time and drying quality see drying.See table 9
Under table 9 different temperatures to the influence of extract dry time
Can be known that by table 9 adopt the drying under reduced pressure method, rate of drying is fast, temperature is low, and the gained dry extract is more loose, be easy to pulverize, wherein 80 ℃ of used time of drying under reduced pressure short and be easy to pulverize, therefore adopt 80 ℃ of drying under reduced pressure extractum.
4, preparations shaping technical study
Mainly studied the moulding process of hard capsule.
4.1 the mensuration of angle of repose
With the series connection of 3 funnels and be fixed in the height place of 3cm on the graph paper of horizontal positioned, extractum powder (60 order) is poured in the uppermost funnel along funnel respectively, till the bell mouth under the powder cone tip that forms touches.Measure the diameter of conical base by graph paper, calculate angle of repose (tga=H/r).See table 10.
The mensuration of table 10 intermediate angle of repose
Can know that by table 10 be 32.29o the angle of repose at dried cream powder end, explain that flowability is fine, be convenient to filled capsules.
4.2 the dry extract hygroscopicity is investigated
These article are placed with certain moisture property when relative humidity is big.Therefore, the hygroscopicity of these article is investigated, and obtained critical relative humidity.
Take by weighing some parts of these article (every part of about 0.2g) respectively, be tiled in the weighing botle of dry constant weight the about 2mm of thickness; Place the close drying device of 7 different relative humidity, open the weighing bottle cap, by table sampling at interval; In weighing behind the maintenance 72h under the room temperature; The weight change of working sample and character change, and according to the equilibrium relative humidity mapping, obtain critical relative humidity.The result sees 11.
Table 11 hygroscopicity is investigated result of the test
Show that by table 11 result of the test hygroscopicity is relevant with the relative humidity of environment, when relative humidity 58% when following, do not see obvious moisture absorption, critical relative humidity is 58% (abscissa of the curve point of intersection of tangents among Fig. 1).Therefore, should relative humidity be controlled at below 58% in process of production, the while finished product is airtight package as early as possible as far as possible.
4.3 bulk density is measured
Take by weighing the about 5g of extract powder, put in the 10ml graduated cylinder, hands is held graduated cylinder by falling within on the plank under the 5cm height, after the repeated vibrations 5 times, reads the volume number, calculates bulk density, and the result sees table 12.
Table 12 extract powder bulk density is measured table as a result
These article bulk density is 0.85 g/ml, be distributed into the capsule of 0.5 g/ grain after, the tolerant volume of every intragranular is 0.59ml, optional No. 0 Capsules (volume is 0.67ml).
Get 10 No. 0 capsules and use the extract powder trial assembly, weighing, average loading amount is the 0.5010g/ grain, RSD%=2.98.So confirm to select for use capsule No. 0.
4.4 the capsule dose is confirmed
Dose is confirmed: it is 26g that these article are taken the crude drug amount every day, and a day clothes extractum amount is about 8.38g, drafts day clothes 3 times, and dose is the 4-6 grain at every turn.
4.5 packing container
The capsule that the installs sealing of packing in the plastic bottle is preserved, investigate through preliminarily stabilised, room temperature (relative humidity is controlled at 58%) was preserved 180 days down, and capsule still keeps neatly, and no adhesion is out of shape, hardening, phenomenon such as break.Content does not have the moisture absorption, air slaking, stiff, phenomenon such as caking is spoiled.
4.6 pilot scale
Carry out 10 times of productions of three batches of amplifications by working out preparation process condition, the production technology index is carried out comprehensive assessment, medical material and finished product are carried out performance rating, investigate these article preparation technology's reasonability.By data show in table 13, the table 14, should produce 10000 finished products by feeding intake theory, the capsule net yield is not less than 85%.The explained hereafter condition meets the big production requirement of factory, and operability is stronger, and finished product, medical material, semi-manufactured goods quality are controlled, and end product quality is stable.
Table 13 pilot scale processing parameter
Table 14 pilot product quality testing data
Experiment two: clinical drug efficacy study
One, test objective
Through clinical trial the health giving quality and the safety of the sugared ' Yanming ' capsules for clearing eyes of promoting blood circulation are observed, and carried out Comparison of therapeutic research with the Doxium capsule.
Two, EXPERIMENTAL DESIGN
1. object of study is originated
The selected case of this problem is in January, 2003 to the 2003 year December Guizhou Province Kweiyang traditional Chinese medical science two and attaches the department of endocrinology inpatient of institute.
2. case choice criteria
2.1 diagnostic criteria
2.1.1 diabetes Western medicine diagnose standard (with reference to WHO expert consulting report in 1999, the new standard that October in the same year, China's diabetes association adopted)
That is: fasting glucose (FPG) >=7.0mmol/L (126mg/dl); Or back 2 hours blood glucose (2HPG) >=11.1mmol/L (200mg/dl) of clothes sugar in the carbohydrate tolerance test (OGTT); Or random blood sugar >=11.1mmol/L (200mg/dl).(above is the venous plasma measured value)
2.1.2 the diabetic renal papillary necrosis diagnosis reaches standard by stages
(1) clear and definite diabetes medical history person is arranged.
(2) the diabetics optical fundus the distinctive microangioma of retina occurs, hemorrhagely, rigid ooze out, softly ooze out, retinal neovascularization etc.
(3) stages of DR standard
According to China Chinese Society of Ophthalmology in 1987 retinopathy group standard, diabetic renal papillary necrosis is divided into simple type and proliferous type totally 6 phases.
A. simple type
The I phase: microangioma is arranged or merge little hemorrhage.
The II phase: have that yellow-white is rigid to ooze out or merge ecchymosis.
The III phase: have that yellow-white is soft to ooze out or merge ecchymosis.
B. proliferous type
The IV phase: there is new vessels on the optical fundus or merges vitreous hemorrhage.
The V phase: there are new vessels and fiber propagation in the optical fundus.
The VI phase: there are new vessels and fiber propagation in the optical fundus, and detachment of retina takes place.
2.1.3 tcm syndrome diagnostic criteria
Chinese medical discrimination is syndrome of deficiency of both qi and yin or deficiency of both qi and yin syndrome of blood stasis; " new Chinese medicine treatment of diabetic retinopathy become clinical research the guideline " (Beijing of developing and publishing with Ministry of Health of the People's Republic of China; The Chinese Medicine science and technology .2002 of publishing house 313-315) is reference standard.
Syndrome of deficiency of both qi and yin
Primary symptom: eye outward appearance end is good, blurring of vision, dryness with foreign body sensation in the eyes, fatigue and weakness, the lazy speech of breathing hard, dysphoria with feverish sensation in the chest palms and soles, dry mouth and throat.Inferior disease: thirst and liking drink, palpitation and insomnia, the red constipation of urinating, corpulent tongue is big, red tongue with a little fluid, thready and rapid pulse.
The blood clots absorbing stagnates and demonstrate,proves
Primary symptom: blurring of vision, dryness with foreign body sensation in the eyes, complexion is dark silent.Inferior disease: squamous and dry skin, numb limbs and tense tendons, purplish tongue or the petechia ecchymosis is arranged, hesitant pulse or carefully puckery.
Allly meet 3 of above-mentioned primary symptoms, or 2 of primary symptoms, 2 of inferior diseases, promptly diagnosable.
2.2 the standard of including in
2.2.1 I type that all department of endocrinology are clarified a diagnosis or type patient.
2.2.2 meet above-mentioned Chinese and western medicine diagnostic criteria.
2.2.3 age 30-90 year, diabetic duration 2 years to 20 years.
2.2.4 the patient understands the purpose of test, the main effect and the contingent reaction of medicine, and the signature Informed Consent Form.
2.2.5 being in January, 2003 to the 2003 year December Kweiyang traditional Chinese medical science two, the selected case of this problem attaches the department of endocrinology inpatient of institute.
2.3 exclusion standard (" the new Chinese medicine clinical research guideline " issued with reference to Ministry of Public Health in 2002)
(1) gestation, women breast-feeding their children.
(2) abnormal liver function.
(3) diabetic nephropathy generation renal failure (azotemia phase, uremia's phase).
(4) other serious diseases (as: malignant tumor, acute myocardial infarction, heart failure, suffering from acute stroke, cacopathia, chronic alcoholism etc.) are arranged.
(5) other oculopathy amalgamator (like glaucoma, serious cataract, non-diabetic hemorrhagic retinopathy, uveitis, detachment of retina, optic nerve disease etc.) is arranged.
(6) suffers from anaphylactic disease or to this medicine allergy sufferers.
2.4 rejecting standard
(1) do not meet the standard of including in, can't judge curative effect, or data not umbra ring curative effect judgement person's patient.
(2) patient who does not take medicine on time on request.
The patient that (3) can not follow up a case by regular visits on request.
3 observation indexs
3.1 safety observation
(1) general health check-up item inspection.
(2) blood, urine, just conventional rifle is looked into.
(3) heart, liver, kidney function test.EKG, ALT, BUN, Cr are for must do project.
The untoward reaction that (4) possibly occur comprises the clinical manifestation of untoward reaction, unusual, the order of severity that detects index, removing method and result etc., with its safety of objective evaluation.
3.2 health giving quality observation
(1) the test before and after look suffer from eye vision, the visual field, retina oscillatory potential (oscillatory potentials, OPs).
(2) optical fundus, fluorescence fundus angiography, hemorheology index.
(3) do fasting glucose, blood glucose, routine blood test, routine urinalysis, stool routine examination, hepatic and renal function and Electrocardioscopy in 2 hours after the meal respectively before the test and after testing January, February and March.
(4) also the variation of clinical symptoms, sign is observed in attention, notes untoward reaction and toxic and side effects.
(5) traditional Chinese medical science disease sign is observed: fatigue and weakness, the lazy speech of breathing hard, soreness of waist and knee, dry mouth and throat, dysphoria with feverish sensation in the chest palms and soles, dizziness headache, lumbago, numb limbs and tense tendons, constipation with dry stool, xerostomia desire drink, oliguria yellow skin, dim complexion, squamous and dry skin, tongue, arteries and veins etc.
4 research methoies
4.1 object of study is divided into groups
This problem is observed 80 routine DR patients altogether, totally 160 eyes, and all patients are the type patient.Women's 32 examples wherein, male's 48 examples, age 33-89 year, diabetic duration 2 years to 20 years.Case adopts non-at random blind comparative study method, and the experimenter is divided into treatment group and matched group at random, and the treatment group adopts Chinese patent medicine sugared ' Yanming ' capsules for clearing eyes (hard capsule of the present invention) treatment of promoting blood circulation, 120 eyes of totally 60 examples, male's 38 examples wherein, women's 22 examples; Age 33-89 year, 65.2 years old mean age; Retinopathy is by stages: I phase 58 eyes, II phase 38 eyes, III phase 24 eyes.Matched group adopts the Doxium Drug therapy, 40 eyes of totally 20 examples, male's 10 examples wherein, women's 10 examples; Age 43-70 year, 60.7 years old mean age; Retinopathy is by stages: I phase 12 eyes, II phase 22 eyes, III phase 6 eyes.Two groups of ages and state of an illness no significant difference (P is equal>0. 05), the tool comparability.The equal informed consent of all experimenters and this research of voluntary accepting.
4.2 Therapeutic Method
Test medication the last fortnight gives Primary Care with control and stable blood glucose, includes test after the glucostasis in.
The sugared ' Yanming ' capsules for clearing eyes treatment group 4.2.1 Chinese medicine is promoted blood circulation.
The sugared ' Yanming ' capsules for clearing eyes (hard capsule of the present invention) of promoting blood circulation attaches the Drug Manufacturing Room of institute by the Kweiyang traditional Chinese medical science two provides 0.50g/grain.Lot number: 020324.Oral, each 2.0g, 3 times on the 1st, 3 months was 1 course of treatment.
4.2.2 Doxium capsule for treating group.
The Doxium capsule is produced the 500mg/ grain by the big pharmaceutical factory of Austrian Yi Biwei.Lot number: X20000117.Oral, each 500mg, 3 times on the 1st, 3 months was 1 course of treatment.
5. efficacy determination
5.1 the curative effect determinate standard of diabetic renal papillary necrosis is (with reference to 2002 editions " the clinical research guidelines that the new Chinese medicine treatment of diabetic retinopathy becomes "
5.1.1 produce effects
(1) vision progress >=4 row, or vision >=1.0.
(2) optical fundus change to show the retina microangioma number by (+++) reduce to (++) or by (++) reduce to (+) or by (+) to disappearance; The retinal hemorrhage amount reduce to (+) by (+++) or by (++) to disappearing; Seepage discharge by (+++) reduce to (++) or by (++) reduce to (+) or by (+) to disappearing.Microangioma, hemorrhage, ooze out to change and have 2 above indexs to reach requirement.
(3) fluorescence fundus angiography show the retina mean circulation time (MCT) obviously shorten, the macular edema degree obviously alleviates, retinal capillary does not have perfusion area and dwindles, vascular leakage obviously alleviates.
5.1.2 effectively
(1) vision progress >=2 row.
(2) optical fundus change to show the retina microangioma number by (+++) reduce to (++) or by (++) reduce to (+) or by (+) to disappearance; The retinal hemorrhage amount reduce to (+) by (+++) or by (++) to disappearing; Seepage discharge by (+++) to (++) or by (++) reduce to (+) or by (+) to disappearing.Microangioma, hemorrhage, ooze out to change and have the above index of l item to reach requirement.
(3) fluorescence fundus angiography show the retina mean circulation time (MCT) shorten, the macular edema degree alleviates, retinal capillary does not have that perfusion area dwindles, vascular leakage obviously alleviates.
5.1.3 it is invalid
Each item index does not reach above-mentioned effective standard person.
5.1.4 worsen
(1) vision room for manoeuvre >=2 row.
(2) fundus photography shows that proliferative changes such as new vessels appear in retina.
(3) fluorescence fundus angiography demonstration retinal capillary does not have perfusion area expansion, and macular edema increases the weight of, and vascular leakage increases.
5.2 traditional Chinese medical science Zheng Hou criterion of therapeutical effect
5.2.1 judge the disease curative effect according to integration method.
(1) primary symptom reduces with time disease scalar quantization integrated value in the evaluating basis syndrome.
(2) computing formula
Effective percentage=[integration before (integration before the treatment-treatment back integration) ÷ treatment] * 100%
5.2.2 evaluation criteria
(1) primary symptom and sign all disappear in the produce effects syndrome, and effective percentage is more than 95%.
(2) the primary symptom overwhelming majority in effective syndrome disappears, and effective percentage is more than 70%.
(3) primary symptom in the invalid syndrome disappears basically, effective percentage 60%.
(4) primary symptom that worsens in the syndrome has certain improvement or does not have improvement, effective percentage＜30%.
6. statistical procedures adopts the SPSS11.0 statistical software to carry out date processing.Sample average is represented with x ± s before and after the treatment, and measurement data adopts the t check, and enumeration data is used X
2Check, ranked data are checked with Ridit.P＜0.05 expression has significant difference or dependency, P>0.05 expression there was no significant difference.
Three, result of the test
1. MAIN OUTCOME MEASURES result and analysis
1.1 two groups of preceding treatment backs that reach of treatment reach two hours after the meal blood sugar detection results on an empty stomach.See table 15
Fasting glucose and 2 hours after the meal blood sugar detection results before the treatment of two groups in table 15 and after treatment January, February, March
The result: table 15 shows, two groups of glycemic control are all stable in the test overall process, before two groups of treatments and after treatment January, February, March on an empty stomach and two hours after the meal blood sugar detection results, there was no significant difference (P is equal>0.05) relatively between group and in the group.
1.2 hemorheological variation
Hemorheology testing result before and after two groups of patient treatments.See table 16.
Determination of Blood Rheology result (
± s) before and after two groups of patient treatments of table 16
Annotate: the single group treatment of * front and back are P < 0.05 relatively
The result: table 16 shows, WBV before two groups of treatments, Fibrinogen, packed cell volume no significant difference (P>0.05); All there is significant difference two groups of treatment backs before treating, the sugared ' Yanming ' capsules for clearing eyes treatment group of promoting blood circulation after the treatment, Doxium matched group WBV, Fibrinogen descend, packed cell volume descends, no significant difference between two groups (P>0.05).
1.3 vision situation of change
Change the scoring back with vision and judge curative effect, sugar eye Mingzhi treatment of promoting blood circulation is organized in 60 examples, produce effects 6 examples (10%), and effective 39 examples (65%), invalid 15 examples (25.0%) worsen 0 example, total effective rate 75%;
In Doxium matched group 20 examples, produce effects 2 examples (10%), effective 14 examples (70%), invalid 4 examples (20%) worsen 0 example, total effective rate 80%; Curative effect there was no significant difference between two groups of sugared ' Yanming ' capsules for clearing eyes treatment groups, Doxium matched group of promoting blood circulation (P>0.05).
1.4 visual field situation of change
Change the scoring back with the treatment rearward vision and judge curative effect, sugar eye Mingzhi treatment of promoting blood circulation is organized in 60 examples, produce effects 3 examples (5%), and effective 42 examples (70%), invalid 15 examples (25.0%) worsen 0 example, total effective rate 75%; Produce effects 11 examples (55%) in Doxium matched group 20 examples, effective 6 examples (30%), invalid 3 examples (15%) worsen 0 example, total effective rate 80%.Curative effect there was no significant difference between two groups of sugar eye Mingzhi treatment groups, Doxium matched group of promoting blood circulation (P>0.05).Point out the sugared ' Yanming ' capsules for clearing eyes of promoting blood circulation to improve DR patient's defect of visual field situation.
1.5 the optical fundus situation of change is seen table 17.
Optical fundus efficacy determination result before and after two groups of patient treatments of table 17
The result: table 17 shows, curative effect there was no significant difference between two groups of sugar eye Mingzhi treatment groups of promoting blood circulation, Doxium matched group (P>0.05).
1.6 retina oscillatory potential (OPs) changes, and sees table 18.
OPs measures result (
± s) before and after two groups of patient treatments of table 18
Annotate: before and after the single group treatment of * relatively P 0.05,
The result: table 18 shows, OPs no significant difference before two groups of treatments (P>0.05).All there is significant difference two groups of treatment backs before with respect to treatment, and the sugared ' Yanming ' capsules for clearing eyes treatment group of promoting blood circulation after the treatment, Doxium matched group OPs increase no significant difference (P>0.05).
1.7 table 19 is seen in the comprehensive therapeutic effect analysis.
Comprehensive therapeutic effect evaluation result behind two groups of patient treatments of table 19
The result: table 19 shows, sugar eye Mingzhi treatment group of promoting blood circulation total effective rate 75%, Doxium matched group total effective rate 80%; Total effective rate no significant difference between two groups of comprehensive therapeutic effect results, two groups of the sugared ' Yanming ' capsules for clearing eyes treatment groups of promoting blood circulation, Doxium matched group (P>0.05).
1.8 safety analysis
All case is treated viewing duration, and obvious adverse reaction is not seen in all no abnormal change of routine blood test, routine urinalysis, liver, renal function, and clinical practice has safety.
Four, conclusion (of pressure testing)
Promote blood circulation sugared ' Yanming ' capsules for clearing eyes through MAIN OUTCOME MEASURES is compared test, result and contrast medicine (Doxium), the total effective rate no significant difference (P>0.05).
The sugared ' Yanming ' capsules for clearing eyes of promoting blood circulation can play therapeutical effect preferably to diabetic retinopathy, and no obvious toxic-side effects is clinically taken safe and reliablely, has exploitation and is worth.
Five, model case
Zhou Hong, woman, 64 years old, home address: No. 40, East Road, Guiyang city.Clinical symptoms: because of polydipsia repeatedly, surplus the polyuria 10 year, 1 year surplus being admitted to hospital of companion's visual deterioration, the eyes blurring of vision is attached most importance to left eye during prescription on individual diagnosis, and it is not congested that the patient found to have diabetes, body to look into pair external eyes before 10 years, and cornea is clear, and crystalline lens does not have muddiness.Vision, right eye 0.4, left eye 0.1 is checked through fluorescence fundus angiography; Looking nipple at the bottom of the meeting right eye has strip hemorrhage, near the retina the nipple little hemangioma is arranged, and the rigid of macular area adularescent oozes out; The central fovea luminous reflectance disappears, the left eye vitreous opacity, and the nipple face is looked on the optical fundus has big lamellar hemorrhage; On near the nipple the retina little hemangioma is arranged, the rigid of macular area adularescent oozes out, and is diagnosed as diabetic retinopathy.Chinese medical discrimination is the deficiency of both qi and yin syndrome of blood stasis, gives the insulin regular blood sugar control, and the sugared ' Yanming ' capsules for clearing eyes of promoting blood circulation is oral, each 2g (4), and 3 times on the 1st, be 1 course of treatment March.Finish back patient's vision the course of treatment and be clearly better, whole body does not have discomfort, and check each item index: the petechia absorbs on the right eye nipple; The little hemangioma in optical fundus does not exist, and macular area white is oozed out whole absorptions, and the central fovea luminous reflectance is visible; Clear before the disappearance of left eye vitreous opacity, optical fundus, the vision right eye reaches 0.8; Left eye reaches 0.6, follows up a case by regular visits to 5 years visions and keeps stable.According to the diabetic renal papillary necrosis curative effect determinate standard, be judged to be produce effects.
Compared with prior art, Chinese medicine preparation of the present invention effectively treatment of diabetic retinopathy becomes, and determined curative effect has no side effect, and raw materials used medicine is less, and quality is easy to control, selects for patients with diabetic retinopathy provides a kind of new medication.
The specific embodiment
Embodiment 1: raw material: Radix Astragali 196g, Radix Rehmanniae 196g, Radix Salviae Miltiorrhizae 245g, Radix Notoginseng 195g, Semen Cassiae 245g, Semen Celosiae 245g, Fructus Leonuri 196g, Herba Lophatheri 147g.
Method for preparing: get Radix Notoginseng and pulverize, it is subsequent use to cross 100 orders; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 12.5 times of weight for the first time, soaked 5 hours, for the second time with the water that respectively adds 10 times of weight for the third time; Each decocted 1 hour, merged decoction liquor, filtered, and it is 1.21～1.25 thick extractum that filtrate decompression is concentrated into 60 ℃ of relative densities; Cooling adds Radix Notoginseng powder, mixing, 80 ℃ of drying under reduced pressure; Pulverize, cross 60 mesh sieves, incapsulate, process 1000 of hard capsules.
Usage and dosage: oral, 3 times on the one, each 4～6.
Embodiment 2: raw material: Radix Astragali 200g, Radix Rehmanniae 190g, Radix Salviae Miltiorrhizae 240g, Radix Notoginseng 190g, Semen Cassiae 240g, Semen Celosiae 250g, Fructus Leonuri 200g, Herba Lophatheri 145g.
Method for preparing: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 15 times of weight for the first time, soaked 6 hours, for the second time with the water that respectively adds 12 times of weight for the third time; Each decocted 2 hours, merged decoction liquor, filtered, and it is 1.21～1.25 thick extractum that filtrate decompression is concentrated into 60 ℃ of relative densities; Cooling adds Radix Notoginseng powder, mixing, 80 ℃ of drying under reduced pressure; Pulverize, cross 60 mesh sieves, incapsulate, process 1000 of hard capsules.
Usage and dosage: oral, 3 times on the one, each 4～6.
Embodiment 3: raw material: Radix Astragali 190g, Radix Rehmanniae 200g, Radix Salviae Miltiorrhizae 250g, Radix Notoginseng 200g, Semen Cassiae 250g, Semen Celosiae 240g, Fructus Leonuri 190g, Herba Lophatheri 150g.
Method for preparing: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 10 times of weight for the first time, for the second time with the water that respectively adds 12 times of weight for the third time; Decoct, merge decoction liquor, filter; It is 1.21～1.25 thick extractum that filtrating is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed 1000 in tablet by common process.
Usage and dosage: oral, 3 times on the one, each 4～6.
Embodiment 4: raw material: Radix Astragali 210g, Radix Rehmanniae 210g, Radix Salviae Miltiorrhizae 260g, Radix Notoginseng 180g, Semen Cassiae 230g, Semen Celosiae 260g, Fructus Leonuri 180g, Herba Lophatheri 140g.
Method for preparing: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 12 times of weight for the first time, for the second time with the water that respectively adds 11 times of weight for the third time; Decoct, merge decoction liquor, filter; It is 1.21～1.25 thick extractum that filtrating is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed 1000 in tablet by common process.
Usage and dosage: oral, 3 times on the one, each 4～6.
Embodiment 5: raw material: Radix Astragali 180g, Radix Rehmanniae 180g, Radix Salviae Miltiorrhizae 230g, Radix Notoginseng 210g, Semen Cassiae 260g, Semen Celosiae 230g, Fructus Leonuri 210g, Herba Lophatheri 155g.
Method for preparing: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 14 times of weight for the first time, for the second time with the water that respectively adds 8 times of weight for the third time; Decoct, merge decoction liquor, filter; It is 1.21～1.25 thick extractum that filtrating is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed 1000 in tablet by common process.
Usage and dosage: oral, 3 times on the one, each 4～6.
Claims (8)
1. the Chinese medicine preparation that becomes of a treatment of diabetic retinopathy; It is characterized in that: according to listed as parts by weight, it is to be prepared from for 140～155 parts 180～210 parts of the Radixs Astragali, 180～210 parts in the Radix Rehmanniae, 230～260 parts of Radix Salviae Miltiorrhizaes, 180～210 parts of Radix Notoginseng, 230～260 parts of Semen Cassiaes, 230～260 parts of Semen Celosiae, 180～210 parts of Fructus Leonuris and Herba Lophatheri.
2. the Chinese medicine preparation that becomes according to the said treatment of diabetic retinopathy of claim 1, it is characterized in that: it is to be prepared from for 145～150 parts 190～200 parts of the Radixs Astragali, 190～200 parts in the Radix Rehmanniae, 240～250 parts of Radix Salviae Miltiorrhizaes, 190～200 parts of Radix Notoginseng, 240～250 parts of Semen Cassiaes, 240～250 parts of Semen Celosiae, 190～200 parts of Fructus Leonuris and Herba Lophatheri.
3. the Chinese medicine preparation that becomes according to the said treatment of diabetic retinopathy of claim 2, it is characterized in that: it is to be prepared from for 147 parts 196 parts of the Radixs Astragali, 196 parts in the Radix Rehmanniae, 245 parts of Radix Salviae Miltiorrhizaes, 195 parts of Radix Notoginseng, 245 parts of Semen Cassiaes, 245 parts of Semen Celosiae, 196 parts of Fructus Leonuris and Herba Lophatheri.
4. the method for preparing of the Chinese medicine preparation of each said treatment of diabetic retinopathy change of claim 1 to 3 is characterized in that: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, soak the back and decoct three times, merge decoction liquor, filter, filtrating concentrates, and adds Radix Notoginseng powder, and mixing is processed Chinese medicine preparation.
5. the method for preparing of the Chinese medicine preparation that becomes according to the said treatment of diabetic retinopathy of claim 4 is characterized in that: get Radix Notoginseng and pulverize subsequent use; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 10～15 times of weight for the first time, for the second time with the water that respectively adds 8～12 times of weight for the third time; Decoct, merge decoction liquor, filter; It is 1.21～1.25 thick extractum that filtrating is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed Chinese medicine preparation.
6. the method for preparing of the Chinese medicine preparation that becomes according to the said treatment of diabetic retinopathy of claim 5, it is characterized in that: get Radix Notoginseng and pulverize, it is subsequent use to cross 100 orders; Get the Radix Astragali, the Radix Rehmanniae, Radix Salviae Miltiorrhizae, Semen Cassiae, Semen Celosiae, Fructus Leonuri and Herba Lophatheri and mix, add the water of 12.5 times of weight for the first time, for the second time with the water that respectively adds 10 times of weight for the third time; Each decocted 1 hour, merged decoction liquor, filtered; It is 1.21～1.25 thick extractum that filtrate decompression is concentrated into 60 ℃ of relative densities, and cooling adds Radix Notoginseng powder; Mixing is processed Chinese medicine preparation.
7. the method for preparing of the Chinese medicine preparation that becomes according to each said treatment of diabetic retinopathy of claim 4 to 6, it is characterized in that: said Chinese medicine preparation is a hard capsule.
8. the method for preparing of the Chinese medicine preparation that becomes according to the said treatment of diabetic retinopathy of claim 7 is characterized in that: after adding Radix Notoginseng powder, and mixing, 80 ℃ of drying under reduced pressure are pulverized, and cross 60 mesh sieves, incapsulate, and promptly get hard capsule.
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| CN108853329A (en) * | 2018-08-14 | 2018-11-23 | 陕西惠福药业有限公司 | A kind of drug for treating the illnesss such as the eyeground pathological changes as caused by diabetes and microangiopathies |
| CN111358890A (en) * | 2020-04-29 | 2020-07-03 | 重庆三峡医药高等专科学校 | Traditional Chinese medicine composition for treating non-proliferative diabetic retinopathy and extract and preparation thereof |
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