CN1857531A - Recipe, preparing process and application of Chinese medicine preparation for treating diabetic retinopathy - Google Patents
Recipe, preparing process and application of Chinese medicine preparation for treating diabetic retinopathy Download PDFInfo
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Abstract
The present invention relates to recipe, preparation process and application of Chinese medicine preparation for treating diabetic retinopathy, and the preparation process can prepare modernized Chinese medicine preparation with high curative effect in low production cost. The Chinese medicine preparation for treating diabetic retinopathy has the functions of benefiting Qi, promoting the production of body fluid, nourishing liver and kidney, dredging meridian and improving eyesight. It is used in treating diabetic retinopathy caused by Qi-Yin deficiency, liver and kidney deficiency, and blood stasis to block channel.
Description
Technical field
The invention belongs to field of pharmaceutical technology, be specifically related to a kind of supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging and make eye bright, Chinese medicine preparation and prescription, preparation method and application that treatment of diabetic retinopathy becomes.
Background technology
Diabetes claim to quench one's thirst in the ancient medical literature of China.Be meant with polydipsia, polyuria, polyphagia and become thin, tired, urine sweet be the comprehensive disease of principal character.The major lesions position is at lung, stomach, kidney, and basic pathogenesis is cloudy body fluid deficiency consumption, scorching inclined to one side Sheng.Diabetes with the passing of time, the state of an illness is out of control, deficiency of YIN affecting YANG then, the bright blood stasis due to loss of body fluid of heat, and cause impairment of both QI and YIN, deficiency in both YIN and YANG, the resistance of the channels stasis of blood, passages through which vital energy circulates lose to be supported, and QI and blood is disorderly contrary, and the internal organs organ is impaired and furuncle, carbuncle, dizzy, the thoracic obstruction, deafness, blindness, painful, the accompanied symptoms such as lower limb are gangrenous, renal failure edema, apoplectic coma of limbs fiber crops occur.
Diabetes are a kind of endocrine metabolism diseases, can influence each organ of whole body.But more close with the relation of eyes, can cause cataract, retinopathy, temporary ametropia, ballet's disease etc., wherein retinopathy is the most common.Because The eye is the body opening of the liver, the refreshing water wheels of pupil belong to kidney, after pathological changes is involved Liver and kidney, and how concurrent eye disorders.Hepatic and renal YIN deficiency, eyes losing nutrition, interior-heat caused by deficiency of YIN in addition, the cloudy consumption of gas is hindered, the handsome blood of the deficiency of vital energy is unable, deficiency of YIN blood is capable unsmooth, all can cause a network stasis of blood resistance, the network blood trouble is overflow, modern study shows, occur these diseases pathological changes and doctor trained in Western medicine diabetic renal papillary necrosis (DR) quite.DR is according to domestic and foreign literature, and average prevalence is up to 50%.
Diabetic retinopathy is the most common and serious ocular complications of diabetes, and the infringement of its retinal microvascular aspect can cause the eyes irreversibility blind, does not still have effectively control medicine at present.Through having consulted a large amount of documents and materials, still there is not certainly the effectively medicine of treatment DR so far.It is reported that chemical medicine Doxium, Chinese patent medicine SHIHUYEGUANG WAN, Radix Rehmanniae Pilulae for Improving Eyesight, QIJU DIHUANG WAN, YUNNAN BAIYAO, Radix Salviae Miltiorrhizae Injection treatment DR have certain curative effect.But its above-mentioned prescription cost is higher, and interactional mechanism is difficult to sake of clarity, to the process of DR, does not still have sure curative effect.
Summary of the invention
At the deficiencies in the prior art, the problem to be solved in the present invention provides a kind of requirement that had both met the modern preparation of Chinese medicine, reduced production cost again and treatment supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging evident in efficacy makes eye bright, be used for the treatment of diabetic renal papillary necrosis, belong to deficiency of qi and yin, deficiency of the liver and kindey, obstruction of collaterals by blood stasis person, card is seen the Chinese medicine preparation of blurring of vision, dryness with foreign body sensation in the eyes, spiritlessness and weakness, soreness of the waist and knees, dysphoria with feverish sensation in the chest palms and soles, night sweat, thirst and liking drink, dizziness and tinnitus, constipation.
By a large amount of clinical and experimentatioies, observing the change of DR optical fundus blood vessel, the capable stasis of blood, retinal hemorrhage, vitreous hemorrhage and hemorheology changes, particularly whole blood viscosity increases etc., has proposed the DR mechanism of folder blood stasis of holding concurrently, and this meets the viewpoint of the traditional Chinese medical science " prolonged illness must the stasis of blood ".This prescription just this understanding basis on based on supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, be aided with the product that collateral dredging makes eye bright, treating both the principal and secondary aspects of a disease reaches DR is improved symptom, increases to look the purpose that makes eye bright.
Be monarch drug with the Radix Astragali, Radix Puerariae in this prescription.Radix Astragali invigorating the spleen and replenishing QI is the key medicine for the treatment of diabetes at all times.Radix Puerariae clearing away heat and promoting production of body fluid, relieving restlessness are quenched the thirst, and cure mainly dysphoria with smothery sensation disease such as quench one's thirst, but elevate a turnable ladder yang-energy also promote to reach on the body fluid and make eye bright, be highly suitable for treating diabetes and diabetic oculopathy.The Radix Astragali, Radix Puerariae phase 5, supplementing QI for promoting the production of body fluid yin nourishing, the pathogenesis of the diabetes that link closely deficiency of both QI and YIN.Fructus Lycii, Radix Rehmanniae are minister.Fructus Lycii replenishing YIN and blood, replenishing vital essence to improve eyesight, the moon of auxiliary Radix Puerariae nourishing the liver and kidney; The Radix Rehmanniae nourishing YIN and benefiting blood is successive dynasties treatments deficiency of YIN heat in blood and key medicine hemorrhage, that quench one's thirst etc.Semen Cassiae, Fructus Leonuri, Pollen Tyjphae, Hirudo are assistant.The Semen Cassiae liver heat removing and eyesight improving, the Zuo Gegen tonifying YIN purges heat, the energy nourishing the liver and kidney of holding concurrently; Quenching the thirst by the Zuo Gegen the lung moistening and production of body fluid promoting in the Fructus Leonuri beneficial Tianjin that makes eye bright, helps Radix Astragali invigorating the spleen and replenishing QI.Pollen Typhae removing heat from blood and promoting blood circulation, removing stasis to stop bleeding.Because of it has the dual regulation of promoting blood circulation and hemostasis, so be widely used in various blood stasis and hemorrhage disease.The eye disease that this side cures mainly is that the diabetes disease is gone into network for a long time, and blood stagnancy due to deficiency of QI, the stasis of blood hinder due to the eye network, and stasis of blood resistance can make a network hemorrhage, and the hemorrhage stasis of blood that increases the weight of hinders.Because Pollen Typhae can promoting blood circulation and hemostasis, thus the eye network stasis of blood hinder or hemorrhage in all be suitable available.Hirudo cures mainly the disease of all blood stasis.Be used for getting the effect that its collateral dredging makes eye bright outside a network stasis of blood resistance or the blood oozing from the body openings or subcuta neous tissue network.Medicine reasonable recipe of the present invention, function cures mainly clearly, and process route is complete, and is quality controllable, and pharmacodynamics and toxicological test show that this prescription curative effect is clear and definite, safety non-toxic.Clinical trial shows that also this compound effect is definite, has broad application prospects.
The Chinese medicine that the present invention becomes for treatment of diabetic retinopathy.It is characterized in that forming with Chinese medicines such as the Radix Astragali, Radix Puerariae, Radix Rehmanniae, Fructus Lycii, Semen Cassiae, Fructus Leonuri, Pollen Typhae, Hirudos.Wherein the Radix Astragali, Radix Puerariae are monarch drug, and Fructus Lycii, Radix Rehmanniae are ministerial drug, and Semen Cassiae, Fructus Leonuri, Pollen Tyjphae, Hirudo are adjuvant drug.
The Chinese medicine that treatment of diabetic retinopathy becomes, the part by weight of the Chinese medicine that it is characterized in that respectively distinguishing the flavor of is:
15～19 parts of 15～19 parts of Fructus Lycii of 16～20 portions of Radix Rehmanniae of 16～20 parts of Radix Puerariaes of the Radix Astragali
1～3 part of 9～13 portions of Hirudo of 4～8 parts of Pollen Typhaes of 9～13 parts of Fructus Leonuris of Semen Cassiae
Chinese medicinal preparation method of the present invention is, with 8 flavor Chinese medicines (Semen Cassiae fragmentation, Pollen Typhae is decocted a drug wrapped) of described weight proportion, measured 65% alcohol refluxs 1～5 hour with 6～10 times, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.20 (60 ℃), standby.Medicinal residues decoct 1～4 time with 4～12 times of water gagings respectively, and each 1～5 hour, collecting decoction, supernatant is got in remove impurity, is evaporated to the extractum of relative density 1.10～1.20 (60 ℃), mixes with alcohol-extracted extract.Must mix extractum.
Wherein, be preferably 2～4 hours with 65% alcohol reflux time.
Wherein, the extractum water after the alcohol extraction decocts number of times and is preferably 2～3 times, and decoct the preferred time is 2～4 hours at every turn.
The preparation method of Chinese medicine composition of the present invention can also be: with 8 flavor Chinese medicine (Semen Cassiae fragmentations of described weight proportion, Pollen Typhae is decocted a drug wrapped), decoct 1～4 time with 4～12 times of water gagings, each 1～5 hour, collecting decoction, supernatant is got in remove impurity, be evaporated to the extractum of relative density 1.10～1.20 (60 ℃), standby.Medicinal residues are with 6～10 times of amount 65% alcohol refluxs 1～5 hour, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.20 (60 ℃), mix with the water extracted immersing paste.Must mix extractum.
Wherein, the dosage form of described medicine is a said dosage form on any pharmaceutics.
Dosage form of the present invention is the various dosage forms that the extraction extractum of Chinese medicine composition by invention is prepared from.
Wherein, preferred dosage form is granule, capsule, tablet, powder, concentrated pill, oral liquid, suspensoid, slow releasing preparation.
Wherein, described dosage form most preferably is granule, capsule, tablet.
The present invention is made up of the Radix Astragali, Radix Puerariae, Radix Rehmanniae, Hirudo etc., has the effect that supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging make eye bright, and is used for the treatment of the eye disease that deficiency of qi and yin, deficiency of the liver and kindey, the order network stasis of blood of holding concurrently stagnate.Be applicable to that mainly diabetic renal papillary necrosis belongs to deficiency of qi and yin, deficiency of the liver and kindey, the stagnant person of the order network stasis of blood of holding concurrently.
Preparation (the bright granule of called after stilbene) main pharmacodynamics, toxicology test that Chinese medicine of the present invention is formed show no obvious toxic-side effects, normal taking dose safety.II, III clinical trial phase also show safety of the present invention, effective.
With streptozotocin (Strephozotocin, STZ) set up the animal model of diabetic retinopathy (DR) for derivant, with the Doxium is matched group, has studied the bright granule of stilbene brings out diabetes rat hemorheology, retinal microvascular form, polyhydric alcohol path and visual function to STZ influence.
1, STZ is brought out the influence of hemorheology alone n diabetic rats
With STZ is that derivant has successfully duplicated diabetes rat model, and the characteristic that 3 months animal patterns possess diabetic renal papillary necrosis after the modeling changes.Begin to use respectively the high, medium and low dosage continuous irrigation of the bright granule of stilbene stomach 3 months in 4th month, and establish the Doxium matched group.Observe general state, body weight, blood glucose, the HbA of rat
1C and hemorheological variation.The result shows: this product can be improved the survival condition of STZ diabetes rat and hemorheological property etc.
2, STZ is brought out the microvascular influence of diabetic retinal tissue in rat
With STZ is that derivant has duplicated diabetes rat model, and 4th month begins to use respectively the high, medium and low dosage continuous irrigation of the bright granule of stilbene stomach 3 months behind model copy, establishes the Doxium matched group.Observe retinal capillary form, base film thickness, vascular endothelial cell (E) and pericyte's number (P) by rat retina tissue pathological slice and retinal vessel digestion shop sheet.The result shows: the bright granule height of stilbene, middle dosage group base film thickness are significantly less than negative control group (P＜0.05), and E/P ratio is lower than negative control group (P＜0.05), and this product is suitable to the effect and the Doxium of basement membrane and pericyte.
3, STZ is brought out the influence of diabetes rat polyhydric alcohol path
Cause diabetes rat model with STZ; began to gavage the bright granule of stilbene in 4th month; continuous 3 months; detect glucose, sorbitol, fructose content in the rat retina tissue through high performance liquid chromatogram instrument (HPLC); the result shows: the high, medium and low dosage group of the bright granule of stilbene all can reduce glucose in the retinal tissue of rats with diabetic mellitus, sorbitol, fructose content; prompting this product has the effect that suppresses polyhydric alcohol path Showed Very Brisk, can prevent the infringement of retinal microvascular.
4, STZ is brought out the influence of diabetic retinal tissue in rat function
Cause diabetes rat model with STZ, the 4th month begins to gavage the bright granule of stilbene, and continuous 3 months, adopt the visual electrophysiology instrument to detect rat flash electroretinogram (ERG), retina oscillatory potential (Ops), observe the influence of this product to the diabetes rat visual function.The result shows: the diabetes rat visual function through the bright granule therapy of stilbene obviously improves, and shows as the recovery of a, b wave-amplitude, and each wavelet amplitude of OPs, net amplitude raise, and peak latency shortens.
Toxicology test of the present invention shows:
1, acute toxicity test
The mice maximum tolerated dose (MTD) of the bright granule suspension of stilbene is 166.4g crude drug/kg after measured, promptly is equivalent to 222 times of clinical every day of dosage, and with the bright granule suspension of 2.08g crude drug/ml stilbene, the 0.4g/10g body weight is irritated stomach twice on the one.Do not see in seven days after the administration that mice has tangible toxic reaction.
2, long term toxicity test
To rat continuous irrigation stomach stilbene bright granule 48g crude drug/kg and 24g crude drug/kg (be equivalent to 64 times of clinical 60kg people amount on probation on the one with 32 times) 6 months, compare with matched group, rat behavior is movable normal, and the organ coefficient that hematology, blood biochemical are learned index and main organs does not have significant change.13 kinds of main organs such as the pathologic finding rat heart, liver, spleen, lung, kidney relatively do not have obvious histopathology infringement with matched group.4 weeks of drug withdrawal are not found the slowness toxic reaction.Show the bright granule of stilbene to the long-term gastric infusion safe dose of rat more than 48g crude drug/kg.
Clinical trial of the present invention shows:
II phase clinical studies show:
1. treatment of diabetic retinopathy becomes curative effect of disease relatively
After treatment of diabetic retinopathy becomes 3 months, test group curative effect of disease produce effects 43 examples, obvious effective rate 40.2%, effective 44 examples, effective percentage 41.1%, invalid 20 examples, inefficiency 18.7% worsens 0 example, deterioration rate 0.0%, total effective rate 81.3%; Matched group curative effect of disease produce effects 31 examples, obvious effective rate 29.5%, effective 44 examples, effective percentage 41.9%, invalid 30 examples, inefficiency 28.6% worsens 0 example, deterioration rate 0.0%, total effective rate 71.4%.Two groups of efficacy results show that test group obvious effective rate and total effective rate are better than matched group, but two groups of curative effect comparative test groups and matched group therapeutic equivalence, the difference not statistically significant.
2. Syndrome in TCM marquis curative effect relatively
Treat after 3 months test group produce effects 25 examples, obvious effective rate 23.4%, effective 53 examples, effective percentage 49.5%, invalid 29 examples, inefficiency 27.1%, total effective rate 72.7%; Matched group produce effects 15 examples, obvious effective rate 14.3%, effective 48 examples, effective percentage 45.7%, invalid 42 examples, invalid 40.0 rate %, total effective rate 60.0%.Treatment two groups of tcm syndrome curative effects in March compare, and the test group curative effect is better than matched group, and difference has statistical significance, and treatment two groups of tcm syndrome total effective rates in March compare, and the test group curative effect is better than matched group, and difference has statistical significance.
Tcm symptom treatment back test group is all than obviously improving before the treatment, and wherein the curative effect of tcm symptoms such as test group dryness with foreign body sensation in the eyes, spiritlessness and weakness, thirst and liking drink, spontaneous sweating, soreness of the waist and knees, dysphoria with feverish sensation in the chest palms and soles is better than matched group, and difference has statistical significance.
3. the ophthalmology curative effect relatively
Treat after 3 months, test group vision, optical fundus be hemangioma quantity, optical fundus rigid ooze out with softly ooze out, all than obviously improving before the treatment, difference has statistical significance to retinal hemorrhage; The test group eyesight improving is better than matched group, and difference has statistical significance; Test group microangioma number improves, improvements rigidly oozed out in the optical fundus, softly ooze out that improvements, retinal hemorrhage improve, the curative effect and the matched group of blurring of vision improvement, dryness with foreign body sensation in the eyes improvement are suitable, the difference not statistically significant.
4. other curative effects relatively
The tcm syndrome integration is relatively: tcm syndrome integration and all obviously improving before the treatment behind two groups of patient treatments, and treating front and back difference all has statistical significance; Integration and comparison before and after the treatment between two groups, treatment group treatment curative effect is better than matched group, and difference has statistical significance.
Change of blood sugar compares: glycolated hemoglobin is than preceding obvious reduction of treatment after 3 months in the test group treatment, and difference has statistical significance; Zero difference before and after two groups of fasting glucose, the blood glucose treatment in 2 hours after the meal.
Safety results:
Two groups adverse events 11 examples take place altogether, and test group 2 examples wherein are respectively left eye and look thing and fly thing shadow 1 example, and blood glucose fluctuation 1 example is all irrelevant certainly with medicine; Matched group 9 examples are respectively nauseating, dizzy 1 example (relevant certainly with medicine), stomach discomfort 5 examples (relevant with the medicine possibility), blood glucose fluctuation 2 examples, puffiness of face, diarrhoea 1 example.In this clinical research, do not find the untoward reaction relevant with the test group medicine, adverse events is all judged with trial drug irrelevant, does not observe trial drug the heart, liver, renal function, blood system are had a significant effect.Matched group judges that through observing the doctor untoward reaction relevant with the matched group medicine has stomach discomfort, nauseating, dizzy, and is similar to the untoward reaction of this medicine report, adverse reaction rate 5.61%.
III phase clinical studies show:
1. treatment of diabetic retinopathy becomes curative effect of disease relatively
Treatment of diabetic retinopathy becomes 3 months, test group curative effect of disease produce effects 64 examples, obvious effective rate 18.1%, effective 173 examples, invalid 19 examples, inefficiency 49.0%, effective percentage 49.0%, invalid 115 examples, inefficiency 32.6% worsens 1 example, deterioration rate 0.3%, total effective rate 67.1%; Matched group curative effect of disease produce effects 25 examples, obvious effective rate 14.2%, effective 67 examples, effective percentage 38.1%, invalid 83 examples, inefficiency 47.2% worsens 1 example, deterioration rate 0.6%, total effective rate 52.3%.Treatment two groups of curative effect of disease in March compare, and the test group curative effect is better than matched group, and difference has statistical significance; Treatment two groups of disease total effective rates in March compare, and the test group curative effect is better than matched group, and difference has statistical significance.
Treatment of diabetic retinopathy becomes 6 months, test group curative effect of disease produce effects 39 examples, and obvious effective rate 35.8%, effective 51 examples, effective percentage 46.8%, invalid 19 examples, inefficiency 17.4% worsens 0 example, total effective rate 82.6%; Matched group curative effect of disease produce effects 12 examples, obvious effective rate 20.0%, effective 33 examples, effective percentage 55.0%, invalid 15 examples, inefficiency 25.0% worsens 0 example, total effective rate 75.0%.Treatment two groups of curative effect of disease in June compare, and the test group curative effect is better than matched group, and difference has statistical significance; Treatment two groups of disease total effective rates in June compare, and test group curative effect and matched group are suitable, the difference not statistically significant.
Test group treatment 3 months and 6 months curative effect of disease compare, and obvious effective rate and total effective rate treatment ratio treatment in 6 months increased in 3 months.
2. Syndrome in TCM marquis curative effect relatively
Treat after 3 months test group produce effects 72 examples, obvious effective rate 20.4%, effective 190 examples, effective percentage 53.8%, invalid 67 examples, inefficiency 25.8%, total effective rate 74.2%; Matched group produce effects 14 examples, obvious effective rate 8.0%, effective 94 examples, effective percentage 53.4%, invalid 68 examples, invalid 38.6 rate %, total effective rate 61.4%.After treatment March two groups relatively, test group Syndrome in TCM marquis curative effect is better than matched group, difference has statistical significance; Test group tcm syndrome total effective rate is better than matched group, and difference has statistical significance.
Treat after 6 months test group produce effects 44 examples, obvious effective rate 38.3%, effective 59 examples, effective percentage 51.3%, invalid 12 examples, inefficiency 10.4%, total effective rate 89.6%; Matched group produce effects 15 examples, obvious effective rate 24.2%, effective 36 examples, effective percentage 58.1%, invalid 11 examples, inefficiency 17.7%, total effective rate 82.3%.After treatment June two groups relatively, test group Syndrome in TCM marquis curative effect is better than matched group, difference has statistical significance; Test group tcm syndrome total effective rate and matched group are suitable, the difference not statistically significant.
Test group is demonstrate,proved Hou Jifen and is lower than matched group when treating 3 months, and difference has statistical significance, and the disappearance rate of constipation, dryness with foreign body sensation in the eyes is higher than matched group, and difference has statistical significance.
3. the ophthalmology curative effect relatively
Treat after 3 months, test group vision, optical fundus be hemangioma quantity, optical fundus rigid ooze out with softly ooze out, all than obviously improving before the treatment, difference has statistical significance to retinal hemorrhage; Test group eyesight improving, dryness with foreign body sensation in the eyes improvement are better than matched group, and difference has statistical significance; Test group microangioma number improves, improvements rigidly oozed out in the optical fundus, soft curative effect and the matched group that oozes out improvements, retinal hemorrhage improvement, blurring of vision improvement is suitable, the difference not statistically significant.
Treat after 6 months, test group vision, optical fundus be hemangioma quantity, optical fundus rigid ooze out with softly ooze out, retinal hemorrhage, blurring of vision, all than obviously improving before the treatment, difference has statistical significance to dryness with foreign body sensation in the eyes; The curative effect and the matched group of test group are suitable, the difference not statistically significant
4. other curative effects relatively
The tcm symptom disappearance rate compares: the disappearance rate for the treatment of test group dryness with foreign body sensation in the eyes, constipation after 3 months is higher than matched group, difference has statistical significance, the disappearance rate and the matched group of blurring of vision, spiritlessness and weakness, thirst and liking drink, spontaneous sweating, soreness of the waist and knees, dizziness, tinnitus are suitable, the difference not statistically significant; The disappearance rate and the matched group for the treatment of after 6 months two groups of blurring of vision, dryness with foreign body sensation in the eyes, spiritlessness and weakness, thirst and liking drink, spontaneous sweating, soreness of the waist and knees, constipation, dizziness, tinnitus are suitable, the difference not statistically significant.
The tcm syndrome integration is relatively: tcm syndrome integration and all obviously improving before the treatment behind two groups of patient treatments, and treating front and back difference all has statistical significance; Integration and comparison before and after the treatment between two groups, 3 months curative effects of treatment group treatment are better than matched group, and difference has statistical significance, and 6 months are suitable with matched group, the difference not statistically significant; Between two groups before and after the treatment integration and difference relatively, treatment group curative effect is better than matched group, difference has statistical significance.
Change of blood sugar compares: zero differences before and after two groups of fasting glucose treatments; Two groups of patient treatments of 2 hours after the meal blood glucose after 3 months and 6 months post-prandial glycemia all decline arranged than treatment, difference all has statistical significance before and after the treatment; Glycolated hemoglobin is than preceding obvious reduction of treatment after 6 months in two groups of treatments, and difference has statistical significance; Treatment of control group is the preceding obviously reduction of treatment of glycolated hemoglobin after 3 months, and difference has statistical significance.
Blood Lipid compares: treated 3 months and the preceding obviously reduction of treatment of test group triglyceride in 6 months, difference has statistical significance; Zero difference before and after two groups of cholesterol, high density lipoprotein and low density lipoprotein, LDL treatments.
Hemorheology changes relatively: the equal zero difference of difference before and after two groups of whole blood viscosity, plasma viscosity and Fibrinogen treatments.
Safety results:
This clinical research is by the inspection before, during and after ordinary circumstance, hematuria routine, liver function, renal function and electrocardiogram are treated, not observing trial drug has a significant effect to the heart, liver, renal function, blood system, 17 routine adverse events reports appear altogether, test group 7 examples wherein, relevant 1 example that is defined as untoward reaction with trial drug, show as: stomach discomfort, adverse reaction rate 0.28%; Matched group 10 examples, relevant 7 examples that are defined as untoward reaction with control drug, performance: dizziness, skin rash, stomach discomfort, nauseating, inappetence, part patient ALT raises, and obtains alleviation, adverse reaction rate 3.93% after treatment.
The specific embodiment
Embodiment 1: oral granular formulation
1, takes by weighing raw material by weight ratio: 18 parts of the Radixs Astragali, 18 parts of Radix Puerariaes, 17 parts of Radix Rehmanniae, 17 parts of Fructus Lycii, 11 parts of Semen Cassiaes, 6 parts of Fructus Leonuris, 11 parts of Pollen Typhaes, 2 parts of Hirudos.The Semen Cassiae fragmentation, Pollen Typhae is decocted a drug wrapped.Fully soak into 6 times of amount 65% ethanol.
2, extract: measured 65% alcohol refluxs 2 hours with 6 times, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.12 (60 ℃), standby.Medicinal residues decoct 2 times with 8 times of water gagings respectively, and each 2 hours, collecting decoction filtered, and gets filtrate, is evaporated to the extractum of relative density 1.10～1.12 (60 ℃), mixes with the alcohol extraction clear paste.
3, preparation: with extract dry, the granulation that makes, packing, promptly.
Embodiment 2: oral capsule
1, takes by weighing raw material by weight ratio: 18 parts of the Radixs Astragali, 18 parts of Radix Puerariaes, 16 parts of Radix Rehmanniae, 16 parts of Fructus Lycii, 12 parts of Semen Cassiaes, 6 parts of Fructus Leonuris, 12 parts of Pollen Typhaes, 2 parts of Hirudos.The Semen Cassiae fragmentation, Pollen Typhae is decocted a drug wrapped.Fully soak into 8 times of amount 65% ethanol.
2, extract: measured 65% alcohol refluxs 2 hours with 8 times, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.12 (60 ℃), standby.Medicinal residues decoct 2 times with 12 times of water gagings respectively, and each 2 hours, collecting decoction, centrifugal, extracting centrifugal liquid is evaporated to the extractum of relative density 1.10～1.12 (60 ℃), mixes with the alcohol extraction clear paste.
3, preparation: the extractum that makes as binding agent, is added an amount of starch and dextrin with conventional method, spray granulation, drying, the granulate that sieves, the softgel shell of packing into promptly gets capsule.
Embodiment 3: oral tablet
1, takes by weighing raw material by weight ratio: 18 parts of the Radixs Astragali, 18 parts of Radix Puerariaes, 17 parts of Radix Rehmanniae, 17 parts of Fructus Lycii, 11 parts of Semen Cassiaes, 6 parts of Fructus Leonuris, 11 parts of Pollen Typhaes, 2 parts of Hirudos.The Semen Cassiae fragmentation, Pollen Typhae is decocted a drug wrapped.Fully soak into 6 times of amount 65% ethanol.
2, extract: measured 65% alcohol refluxs 2 hours with 6 times, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.12 (60 ℃), standby.Medicinal residues decoct 2 times with 4 times of water gagings respectively, and each 2 hours, collecting decoction, centrifugal, extracting centrifugal liquid is evaporated to the extractum of relative density 1.20 (60 ℃), mixes with the alcohol extraction clear paste.
3, preparation: the extractum that makes is spray-dried, granulate, will do the Pulvis Talci of particle weight adding 3%, with sieve (14 an order) granulate, mixing, tabletting.
Claims (8)
1, a kind of Chinese medicine of treatment of diabetic retinopathy change is characterized in that it is that following raw material of Chinese medicine is made:
15～19 parts of 15～19 parts of Fructus Lycii of 16～20 portions of Radix Rehmanniae of 16～20 parts of Radix Puerariaes of the Radix Astragali
1～3 part of 9～13 portions of Hirudo of 4～8 parts of Pollen Typhaes of 9～13 parts of Fructus Leonuris of Semen Cassiae
More than each raw material add up to 100 parts.
2, the preparation method of the described Chinese medicine composition of claim 1, it is characterized in that: with 8 flavor Chinese medicine (Semen Cassiae fragmentations of described weight proportion, Pollen Typhae is decocted a drug wrapped), measured 65% alcohol refluxs 1～5 hour with 6～10 times, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.20 (60 ℃), standby.Medicinal residues decoct 1～4 time with 4～12 times of water gagings respectively, and each 1～5 hour, collecting decoction, supernatant is got in remove impurity, is evaporated to the extractum of relative density 1.10～1.20 (60 ℃), mixes with alcohol-extracted extract.Must mix extractum.
3, the preparation method of Chinese medicine composition according to claim 2 is characterized in that, with 65% alcohol reflux 2～4 hours.
4, the preparation method of Chinese medicine composition according to claim 2 is characterized in that, the extractum water after the alcohol extraction decocts 2～3 times, each 2～4 hours.
5, the preparation method of the described Chinese medicine composition of claim 1, it is characterized in that: with 8 flavor Chinese medicine (Semen Cassiae fragmentations of described weight proportion, Pollen Typhae is decocted a drug wrapped), decoct 1～4 time with 4～12 times of water gagings, each 1～5 hour, collecting decoction, remove impurity, get supernatant, be evaporated to the extractum of relative density 1.10～1.20 (60 ℃), standby.Medicinal residues are with 6～10 times of amount 65% alcohol refluxs 1～5 hour, filtrate recycling ethanol, and be concentrated into the extractum of relative density 1.10～1.20 (60 ℃), mix with the water extracted immersing paste.Must mix extractum.
6, the application of the described Chinese medicine composition of claim 1 in the medicine that supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging that the preparation treatment of diabetic retinopathy becomes make eye bright.
7, the application of Chinese medicine composition according to claim 6 in the medicine that supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging that the preparation treatment of diabetic retinopathy becomes make eye bright is characterized in that the dosage form of described medicine is a said dosage form on any pharmaceutics.
8, the application of Chinese medicine composition according to claim 7 in the medicine that supplementing QI for promoting the production of body fluid, nourishing the liver and kidney, collateral dredging that the preparation treatment of diabetic retinopathy becomes make eye bright, it is characterized in that the dosage form of described medicine is granule, capsule, tablet, powder, concentrated pill, oral liquid, suspensoid, slow releasing preparation.
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| CN 200610071264 CN1857531A (en) | 2006-03-21 | 2006-03-21 | Recipe, preparing process and application of Chinese medicine preparation for treating diabetic retinopathy |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103768282A (en) * | 2014-02-11 | 2014-05-07 | 西安市第四医院 | Oral medicine for treating diabetic retinopathy |
| CN105031546A (en) * | 2015-08-28 | 2015-11-11 | 河北君临药业有限公司 | Traditional Chinese medicine for preventing and treating diabetic retinopathy and preparation method of traditional Chinese medicine |
| CN106539083A (en) * | 2016-10-28 | 2017-03-29 | 河南省科高植物天然产物开发工程技术有限公司 | It is a kind of to be used to prevent and treat diabetic retinopathy, alleviate asthenopic compositionss |
-
2006
- 2006-03-21 CN CN 200610071264 patent/CN1857531A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103768282A (en) * | 2014-02-11 | 2014-05-07 | 西安市第四医院 | Oral medicine for treating diabetic retinopathy |
| CN103768282B (en) * | 2014-02-11 | 2016-08-17 | 西安市第四医院 | The oral drugs for the treatment of diabetic retinopathy |
| CN105031546A (en) * | 2015-08-28 | 2015-11-11 | 河北君临药业有限公司 | Traditional Chinese medicine for preventing and treating diabetic retinopathy and preparation method of traditional Chinese medicine |
| CN105031546B (en) * | 2015-08-28 | 2018-11-06 | 河北君临药业有限公司 | A kind of Chinese medicine and preparation method thereof of prevention and treatment diabetic retinopathy |
| CN106539083A (en) * | 2016-10-28 | 2017-03-29 | 河南省科高植物天然产物开发工程技术有限公司 | It is a kind of to be used to prevent and treat diabetic retinopathy, alleviate asthenopic compositionss |
| CN106539083B (en) * | 2016-10-28 | 2020-01-17 | 河南省科高植物天然产物开发工程技术有限公司 | A composition for preventing and treating diabetic retinopathy and relieving asthenopia |
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