CN102475753B - Kidney-health patch for treating chronic renal failure and preparation method thereof - Google Patents
Kidney-health patch for treating chronic renal failure and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a kidney-health patch for treating chronic renal failure and a preparation method thereof, and the kidney-health patch is prepared by the following raw material herbs: 1500 g of rheum officinale, 1500 g of salvia, 4500 g of radix astragali, 1500 g of safflower. The preparation method comprises the following steps: extracting raw material herbs of rheum officinale and salvia according to the formula ratios, performing first alcohol precipitation, tannin removal, second alcohol precipitation, water precipitation, third alcohol precipitation, and second water precipitation; extracting radix astragali and safflower according to the formula ratios, performing first alcohol precipitation, water precipitation, second alcohol precipitation, water precipitation, concentration, and drying to prepare the patch. The advantages of the invention are that accurate adjustment is performed based on the original ratios; the patch has less side effect, is safe for application, has lasting effect and high bioavailability.
Description
Technical field
The invention belongs to Chinese medicine preparation, particularly about a kind of kidney health patch for the treatment of chronic kidney hypofunction and preparation method thereof.
Background technology
Former patent 200410039418.X discloses a kind of medicine for treating chronic kidney failure and preparation method thereof; what its prescription was protected is the Chinese medicine scope of application; there is no concrete proportion relation; although also disclose the case of prescription in patent document embodiment; but Radix Astragali use amount is high; because the Radix Astragali and Radix Et Rhizoma Rhei have precipitation; the Radix Astragali and Radix Salviae Miltiorrhizae also can react; if Radix Astragali input amount in the compatibility of preparation is few; can affect drug effect again; the proportioning of Chinese medicine directly affects the curative effect of preparation, and accurate and side effect is little is vital.
Summary of the invention
The object of the invention is: a kind of kidney health patch for the treatment of chronic kidney hypofunction and preparation method thereof is provided, and it is to have done accurate adjustment in original proportioning, and side effect is little, use safety, effect is lasting, and bioavailability is high.
Technical scheme of the present invention is: a kind of kidney health patch for the treatment of chronic kidney hypofunction is provided, it is characterized in that it is to be made by the crude drug of following proportioning: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The preparation method of described kidney health patch, after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are extracted by above-mentioned formula proportion amount, first precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly after time precipitate with ethanol, secondary water precipitating; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, precipitate with ethanol, water precipitating, secondary precipitate with ethanol, water precipitating more again, ultrafiltration, concentrate drying is made patch.
The preparation method of kidney health patch of the present invention is: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the 7-12 that amount of water is crude drug for the first time doubly measures, soak after 30min, boil 30min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 30min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add 5% gelatin solution, tannin-removing, add 95% ethanol, to containing alcohol amount, be 75%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, it is clear and bright and when being concentrated into relative density and being 60 ℃ 1.18～1.25 that cold preservation 38～55h gets supernatant liquid filtering, adding 95% ethanol is 80% to containing alcohol amount, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, standby, dosage Flos Carthami, Milkvetch Root, the 7-12 that amount of water is crude drug for the first time doubly measures, soak 30min, boil 45min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 45min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 38-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, by above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution merges, stir, ultrafiltration, filtrate is concentrated into relative density in the time of 60 ℃ 1.18～1.25, 60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
The preparation method of kidney health patch of the present invention is: after Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g medical material are selected, and cleaning, infiltration, cutting, oven dry, take the Radix Et Rhizoma Rhei 1500g of dosage, Radix Salviae Miltiorrhizae 1500g medical material, 10 times of amounts that amount of water is crude drug for the first time, soak after 30min, boil 30min, filter, 8 times of amounts that amount of water is crude drug for the second time, boil 30min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add 5% gelatin solution, tannin-removing, add 95% ethanol, to containing alcohol amount, be 75%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 4 times of amounts of medicinal liquid, cold preservation 42～55h gets that supernatant liquid filtering is clear and bright and to be concentrated into relative density be 60 ℃ 1.20～1.22, adding 95% ethanol is 80% to containing alcohol amount, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, standby, dosage Flos Carthami, Milkvetch Root, 10 times of amounts that amount of water is crude drug for the first time, soak 30min, boil 45min, filter, 8 times of amounts that amount of water is crude drug for the second time, boil 45min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 4 times of amounts of medicinal liquid, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 that cold preservation 42-55h gets supernatant liquid filtering, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 48-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 48～55h, get supernatant liquid filtering clear and bright after, standby, by above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution, mixing and stirring, ultrafiltration, filtrate be concentrated into relative density in the time of 60 ℃ 1.20～1.22,60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
The described appropriate amount of auxiliary materials that adds is made patch: its component is that drug storehouse layer is polyisobutylene MML-10030 part, polyisobutylene-LM-MS37 part, 59 parts, mineral oil, 16 parts of medicines, 860 parts of chloroforms; Adhesion layer is polyisobutylene MML-10032 part, 40 parts of polyisobutylene-LM-MS, 65 parts, mineral oil, 5 parts of medicines, 360 parts of chloroforms; By drug storehouse layer and adhesion layer recipe quantity, take each composition, after dissolving, make respectively drug storehouse layer and adhesion layer substrate, drug storehouse layer substrate is layered on the aluminum plastic film that 65ml is thick, dry or natural drying, form the thick drug storehouse layer of approximately 50 μ m; Adhesion layer substrate is layered on the silicon paper that 200 μ m are thick, makes the thick adhesion layer of approximately 50 μ m, drug storehouse layer is compound to adhesion layer, using non-woven fabrics as back lining materials, it is qualified to detect, packing.
The described appropriate amount of auxiliary materials that adds is made patch, and patch is electronic patch, is about to above-mentioned patch and answers with backing at drug storehouse layer, and installation's power source and chip on backing, with the percutaneous dosing method administration of safety, convenience, controlled release.
The described appropriate amount of auxiliary materials that adds is made patch, and patch is micropin patch, and both it mixed micropin drug-supplying system by the drug storehouse layer of above-mentioned patch, the array structure pin that is needle-like with silicon, polymer, metal etc., arrival does not have blood vessel, almost there is no the active epidermal area of nervous tissue, improves drug osmotic amount.
The described appropriate amount of auxiliary materials that adds is made patch, and patch is cataplasma, and both it was by above-mentioned concentrated solution, gelatin 270g, arabic gum 360g, PEG-4000 450g, sodium polyacrylate 360g, glycerol 360g, zinc oxide 18g; Get gelatin, arabic gum adds suitable quantity of water swelling, heating makes to dissolve, in 50 ℃ of water-baths, constantly stir, add successively zinc oxide, PEG400 and sodium polyacrylate, glycerol, mix homogeneously, getting Chinese medicine extraction extractum and substrate heats at 50 ℃ of constant temperature water baths, stir 20～40min mix homogeneously, be applied on non-woven fabrics, lid lining, prune molding, pack and get final product.
The invention has the advantages that:
One, its prescription proportioning is the improvement of doing on original patent 96117626.1,03141399.4, ZL03108156.8, ZL200410039420.7, ZL200410004359.2, ZL200410039418 basis, because Radix Astragali input amount is high in former patent, because the Radix Astragali and Radix Et Rhizoma Rhei have precipitation, the Radix Astragali and Radix Salviae Miltiorrhizae also can react, if Radix Astragali input amount in the compatibility of preparation is few, can affect drug effect again.The proportioning of ZL200410039420.7, ZL200410039418.X embodiment is 1.0: 1.0: 7.0: 1.0 and 1.5: 1.5: 5.5: 1.5, ZL03108156.8,03141399.4 prescription proportioning is in an embodiment 1.5: 1.0: 1.0: 1.5, and several patent taste of Chinese medicine proportion relations are completely different.The present invention, through a large amount of experiment contrasts, proves that proportioning effect of the present invention is better, and its experiment Data Comparison is as follows:
Prescription one consumption is: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g, appropriate amount of auxiliary materials.
Prescription two consumptions are: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 5500g, Flos Carthami 1500g, appropriate amount of auxiliary materials.
Prescription three consumptions are: Radix Et Rhizoma Rhei 1667g, Radix Salviae Miltiorrhizae 1667g, Radix Astragali 5000g, Flos Carthami 1666g, appropriate amount of auxiliary materials.
Prescription four-function amount is: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 1500g, Flos Carthami 1000g, appropriate amount of auxiliary materials.
Prescription five consumptions are: Radix Et Rhizoma Rhei 1000g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 7000g, Flos Carthami 1000g, appropriate amount of auxiliary materials.
Animal experiment study shows: five kinds of prescriptions all can reduce blood urea nitrogen (BUN), creatinine (Cr) level of chronic renal failure (CRF) rat, alleviate the azotemia that carrying out property increases the weight of, rising hemoglobin (Hb), improve anemia, to adenine CRF rat, still can improve albumin (ALB) level, renal hypertrophy is alleviated, and kidney coefficient obviously reduces.And prescription one effect is more obvious, is better than other and respectively organizes prescription.Experimental result refers to following table 1-5.
Five kinds of prescriptions of table 1 affect comparison (mmol/L, X ± SD) to CRF rat blood serum blood urea nitrogen due to adenine
Compare * P < 0.05, * * P < 0.01 with model group
Due to five kinds of prescription Dui Xianpiao ridges of table 2, CRF rat blood serum creatinine affects comparison (μ mol/L, X ± SD)
With model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: rats gavaged adenine is after two weeks, and blood BUN, Cr raise, and is significantly higher than normal rat (p < 0.01), shows that CRF forms, and grouping is treated.During treatment, continue to rats gavaged adenine, its blood BUN, Cr continues to rise, to treating after 5 weeks, model group rat BUN, Cr rise to respectively 6.5 times of normal rat with 4.3 times, show that this model presents the azotemia that carrying out property increases the weight of, the injection tail vein injection treatment rat made from five kinds of prescriptions respectively, its blood BUN, Cr is along with the blood BUN of model group rat, the rising of Cr also raises gradually, the blood BUN for the treatment of group rat, the Cr rate of climb and amplitude will be lower than model group, treat 3 weeks with after 5 weeks, the blood BUN for the treatment of group, Cr level is starkly lower than model group (p < 0.05 or p < 0.01), and the blood BUN of prescription one treatment group rat, the Cr rate of climb and amplitude are still lower than all the other each prescription groups, show that prescription one reduces the blood BUN of adenine CRF rat, Cr, improve the effect of azotemia, be better than prescription two and prescription three, prescription four, prescription five.
Five kinds of prescriptions of table 3 affect comparison (g/L, X ± SD) to CRF rat hemoglobin due to adenine
With model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: rats gavaged adenine is after two weeks, the existing institute of Hb level declines, and along with giving the increase of adenine number of days, Hb also decreases, after treatment 5 weeks, model group rat Hb level is significantly lower than normal rat (P < 0.01).Although injection for treating group rat Hb is also reducing gradually, decrease speed is slower, and in treatment, in the time of 5 weeks, its Hb level is significantly higher than the model group same period (P < 0.05), and the successful of prescription one is better than all the other each prescription groups.Show that prescription one can alleviate the Anemia of adenine CRF rat, effect is better than prescription two and prescription three, prescription four, prescription five.
Five kinds of prescriptions of table 4 affect comparison (g/L, X ± SD) to CRF rat serum albumin due to adenine
With model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: model group rat is after treatment 5 weeks, serum albumin obviously reduces (comparing P < 0.05 with normal rat), hypoalbuminemia when treatment group can be improved rat CRF, while treating 5 weeks, serum albumin levels is significantly higher than model group (p < 0.05).Prescription one effect is significantly better than all the other four groups.
Five kinds of prescriptions of table 5 affect comparison (mg/100g body weight, X ± SD) to CRF kidney of rats coefficient due to adenine
With model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: the rat of oral adenine retains right renal hypertrophy, and weight obviously increases, normal 4.4 times of the kidney coefficient average out to of model group.The kidney coefficient of injection for treating group rat is all less than model group, there were significant differences for kidney coefficient (p < 0.01 and p < 0.05), and prescription one (p < 0.01) kidney coefficient is less than all the other four groups (p < 0.05).
Two, the invention has the advantages that: external preparation, easy to use, bioavailability is high, short treating period, good effect, has QI invigorating and consolidates, and the effect of dissipating stasis and purging turbidity, is applicable to chronic renal failure, and especially to renal function moderate, above infringement has better effects.
Animal experiment study shows: kidney health patch can obviously reduce chronic renal failure (CRF) rat and blood urea nitrogen (BUN), creatinine (Cr) level, alleviate the azotemia that carrying out property increases the weight of, renal hypertrophy is alleviated, and kidney coefficient reduces, and experimental result refers to following table 1-3.
The impact (mmol/L, X ± SD) of table 1 kidney health patch on 5/6 nephrectomy CRF rat blood serum blood urea nitrogen
Note: with model group comparison: * P < 0.05, * * P < 0.01
The impact (μ mol/L, X ± SD) of table 2 kidney health patch on 5/6 nephrectomy CRF rat blood serum creatinine
Note: with model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: after modeling, rat BUN, Cr obviously raise, and drug treatment is after 5 weeks, and different patches has certain reducing effect to BUN, Cr.
The impact (mg/100g body weight, X ± SD) of table 3 kidney health patch on 5/6 nephrectomy CRF kidney of rats coefficient
Note: with model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: treat and put to death rat after 5 weeks and cut open and get kidney, visible residual kidney obviously increases (1.6 times that the average kidney coefficient of model group is normal group) while performing the operation.The kidney coefficient of kidney health patch treatment group rat is less than model group.Show that kidney health patch can alleviate glomerule hypertrophy, suppress mesangial cell and matrix secreted, obviously reduce the hardening ratio of glomerule, alleviate renal tubules overdistension and epithelial damage, alleviate interstitial fibrosis, promote reparation and the mitochondrial hyperplasia of renal cells.
Three, the preparation method of described kidney health patch and the contrast of 96117626.1 preparation methoies are as follows:
1, in patent 96117626.1 preparation methoies, medicinal material extract water consumption is 7 times of medical material amount, and existing process water consumption is 7-12 times; 7 times of water consumptions of former technique, when medical material soaks after 30min, most of water that extracts is absorbed by medical material, and extraction efficiency reduces, and causes part medical material active substance not to be fully extracted, and be increased to after 10 times, most of working substance mass-energy extracts completely, but surpasses 14 times, and impurity extracted amount also increases, effective ingredient content back has decline phenomenon, and has greatly increased energy consumption.Amount of water is 10 times for the first time, and 8 times for the second time, 7 times of effects are best for the third time.
2, the present invention adds 95% ethanol, and to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, and this time precipitate with ethanol effect is better than the 12h of patent 96117626.1, and active constituent content is high after testing, precipitate fully and completely, but overlong time production cost is higher.
3, in patent 96117626.1 preparation methoies, reclaim ethanol to without alcohol taste, specifically do not control index, the bad control of production process, the present invention is now concentrated into relative density 1.20～1.25 as detecting, so that production control procedure quality with 60 ℃.
4, in patent 96117626.1 preparation methoies, under agitation in condensed cream, slowly add 4% gelatin solution, and the present invention adds 5% gelatin solution tannin-removing; Add 95% ethanol, patent 96117626.1 is to add 250ml to calculate containing alcohol amount to be approximately 60%, to be difficult to remove tannin, and that the present invention adds to containing alcohol amount 75% its tannin-removing effect is better, and the quality of production is easily controlled.
As by the gelatin of variable concentrations to Radix Et Rhizoma Rhei, the tannin-removing effect comparison of medicinal liquid after Radix Salviae Miltiorrhizae extracts, best with gelatin 5%, 4% gelatin is because concentration is rarer, in tannin-removing process, gelatin solution use amount is excessive, increased the volume of medicinal liquid, reduced the concentration of medicinal liquid, not only tannin-removing effect is poor, also strengthened man-hour simultaneously, improved energy consumption, 6% gelatin solution, because gelatin solution concentration is excessive, effective ingredient is easily wrapped and loses, cause active constituent content to reduce, therefore through test of many times, 5% gelatin solution tannin-removing effect is better and medicinal liquid extraction component content is higher, after tannin-removing, alcohol precipitation concentration confirms through overtesting, when alcohol precipitation concentration is 60%, gelatin in medicinal liquid is difficult to eliminate, and 75% alcohol precipitation concentration can remove the unnecessary gelatin after tannin-removing completely, form gradient with one, two, three precipitate with ethanol again, be conducive to the extraction of effective ingredient and the removal of invalid components, and the high consumption of ethanol content is relatively few, not only capable of reducing energy consumption but also can reduce work hours.
5, in patent 96117626.1 preparation methoies, secondary precipitate with ethanol extracting solution is with distilled water diluting 14 to 84ml, and the feasibility of operation is not strong, and scope is crossed large-scale production process difficult quality and controlled.So adopting, the present invention adds 4 times of water gagings so that control quality and operation in production process.
Four, the preparation method of described kidney health patch and patent 03141399.4 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.The prescription of patent 03141399.4 is a scope, and the present invention is not within the scope of it, and the proportioning in embodiment is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 1500g, Flos Carthami 1000g.
2. in patent 03141399.4 preparation method, 100mL * 50mL, not clearly stating is what, does not also know what the content of statement is, does not possess operability.And the present invention clear and definite the water yield of extracting, decoct with water three times, there is operability.
3. in patent 03141399.4 preparation method, there is no the process of water soaking, medicinal liquid extracts not exclusively; The clear and definite soak time 30min of the present invention, extraction time 30min is more complete to the extraction of effective ingredient.Contrast as follows.
4. in patent 03141399.4 preparation method, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae extract are concentrated into 1: 1.5 (mL: g); Flos Carthami, Radix Astragali extractive solution are concentrated into 1: 2.2 (mL: g), operability is not strong, the very difficult control of process; The present invention is concentrated into relative density 1.20～1.23 (60 ℃), workable, can control concentration process.
5. in patent 03141399.4 preparation method, reclaim ethanol to without alcohol taste, specifically do not detect index, the bad control of production process; When the present invention is concentrated into 60 ℃ of relative densities, 1.20～1.22 as detecting indexs, can effectively control the product quality in drug production process.
Five, the preparation method of described kidney health patch and ZL 03108156.8 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The prescription of ZL 03108156.8 is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: Flos Carthami: the Radix Astragali 1.5: 1: 1: 1.5, and this ratio does not comprise prescription of the present invention.
2.ZL 03108156.8 preparation method Chinese medicine is prescription in proportion, not concrete formula, and the not concrete mode of operation of extracting, does not possess operability yet.
In 3.ZL 03108156.8 preparation method, there is no the process of water soaking, medicinal liquid extracts not exclusively, the clear and definite soak time 30min of the present invention, extraction time 30min is more complete to the extraction of effective ingredient.Contrast as follows
In 4.ZL 03108156.8 preparation method, the precipitate with ethanol time, precipitate with ethanol temperature is all not clear and definite, does not possess operability.
In 5.ZL 03108156.8 preparation method, filtrate is concentrated into 5 grams of dry/mL filtrates, after 80% precipitate with ethanol, adds again water to be diluted to 5 grams of dry/mL solution, cannot operate.
Six, the preparation method of described kidney health patch and ZL200410039420.7 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g; In ZL200410039420.7, be ratio, not concrete formula, and proportioning in embodiment is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: the Radix Astragali: Flos Carthami is 15: 15: 55: 15, different with formula proportion of the present invention.
In 2.ZL200410039420.7 preparation method, decocting time is 1-2h, overlong time, and energy consumption is excessive, and the impurity level of extraction also increases relatively; Decocting time of the present invention is 30min, and energy consumption is suitable, and in good effective component extracting, the impurity level of extraction is also relatively less.
In 3.ZL200410039420.7 preparation method, after precipitate with ethanol, reclaim ethanol extremely without alcohol taste, fuzzyyer, the present invention is concentrated into regulation relative density, workable.
Seven, the preparation method of described kidney health patch and ZL200410004359.2 contrast are as follows:
1, in ZL200410004359.2 preparation method, there is no medical material immersion process, and decocting time 1-2h, the time is longer, and extraction efficiency is lower; And the present invention soaks 30min, decoct 30min more reasonable.
2, in ZL200410004359.2 preparation method, after collecting decoction, be concentrated into relative density 1.00-1.15, alcohol adding amount is larger, and expends man-hour; The present invention is concentrated into relative density 1.20-1.23, can enhance productivity preferably.
Eight, the preparation method of described kidney health patch and ZL200410039418.X contrast are as follows:
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.In ZL200410039418.X, be ratio, not concrete formula, and proportioning in embodiment is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: the Radix Astragali: Flos Carthami is 10: 10: 70: 10 and 15: 15: 55: 15,20: 20: 40: 40, different with formula proportion of the present invention.
2.ZL200410039418.X be concentrated into 80 ℃ of-90 ℃ of relative density 1.20-1.23 in preparation method, operability is poor; It is 1.20～1.23 that the present invention is concentrated into 60 ℃ of relative densities, more easy to operate and control quality.
3.ZL200410039418.X there is no tannin-removing technique in preparation method, Impurity removal is incomplete.
In 4.ZL200410039418.X preparation method, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae and the Radix Astragali, Flos Carthami all only carry out one time precipitate with ethanol; The present invention, through precipitate with ethanol repeatedly, removes impurity more thorough.
The specific embodiment
Embodiment 1
It is to be made by the crude drug of following proportioning for kidney health patch: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The preparation method of kidney health patch, after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are extracted by above-mentioned formula proportion amount, first precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly after time precipitate with ethanol, secondary water precipitating; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, precipitate with ethanol, water precipitating, secondary precipitate with ethanol, water precipitating more again, ultrafiltration, after concentrate drying, makes patch.
Embodiment 2
The preparation method of kidney health patch is: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the 7-12 that amount of water is crude drug for the first time doubly measures, soak after 30min, boil 30min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 30min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add 5% gelatin solution, tannin-removing, add 95% ethanol, to containing alcohol amount, be 75%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, cold preservation 38～55h gets that supernatant liquid filtering is clear and bright and to be concentrated into relative density be 60 ℃ 1.18～1.25, adding 95% ethanol is 80% to containing alcohol amount, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, standby, dosage Flos Carthami, Milkvetch Root, the 7-12 that amount of water is crude drug for the first time doubly measures, soak 30min, boil 45min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 45min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 38-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, by above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution merges, stir, ultrafiltration, filtrate is concentrated into relative density in the time of 60 ℃ 1.18～1.25, 60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
Embodiment 3
The preparation method of kidney health patch is: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, 10 times of amounts that amount of water is crude drug for the first time, soak after 30min, boil 30min, filter, 8 times of amounts that amount of water is crude drug for the second time, boil 30min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add 5% gelatin solution, tannin-removing, add 95% ethanol, to containing alcohol amount, be 75%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 4 times of amounts of medicinal liquid, cold preservation 42～55h gets that supernatant liquid filtering is clear and bright and to be concentrated into relative density be 60 ℃ 1.20～1.22, adding 95% ethanol is 80% to containing alcohol amount, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, standby, dosage Flos Carthami, Milkvetch Root, 10 times of amounts that amount of water is crude drug for the first time, soak 30min, boil 45min, filter, 8 times of amounts that amount of water is crude drug for the second time, boil 45min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water for injection to 4 times of amounts of medicinal liquid, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 that cold preservation 42-55h gets supernatant liquid filtering, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 48-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 48～55h, get supernatant liquid filtering clear and bright after, standby, by above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution, mixing and stirring, ultrafiltration, filtrate be concentrated into relative density in the time of 60 ℃ 1.20～1.22,60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
The appropriate amount of auxiliary materials that adds described in embodiment is made patch: its component is that drug storehouse layer is polyisobutylene MML-10030 part, 37 parts of polyisobutylene-LM-MS, 59 parts, mineral oil, 16 parts of medicines, 860 parts of chloroforms; Adhesion layer is polyisobutylene MML-10032 part, 40 parts of polyisobutylene-LM-MS, 65 parts, mineral oil, 5 parts of medicines, 360 parts of chloroforms; By drug storehouse layer and adhesion layer recipe quantity, take each composition, after dissolving, make respectively drug storehouse layer and adhesion layer substrate, drug storehouse layer substrate is layered on the aluminum plastic film that 65ml is thick, dry or natural drying, form the thick drug storehouse layer of approximately 50 μ m; Adhesion layer substrate is layered on the silicon paper that 200 μ m are thick, makes the thick adhesion layer of approximately 50 μ m, drug storehouse layer is compound to adhesion layer, using non-woven fabrics as back lining materials, it is qualified to detect, packing.
To make patch be the electronic patch of kidney health to the appropriate amount of auxiliary materials that adds described in embodiment, and it is multiple with backing at drug storehouse layer by above-mentioned patch, and installation's power source and chip on backing, with the percutaneous dosing method administration of safety, convenient, controlled release.
To make patch be kidney health micropin patch to the appropriate amount of auxiliary materials that adds described in embodiment, it mixes micropin drug-supplying system by the drug storehouse layer of above-mentioned patch, the array structure pin that is needle-like with silicon, polymer, metal etc., arrival does not have blood vessel, the active epidermal area that almost there is no nervous tissue, improves drug osmotic amount.
To make patch be kidney health cataplasma to the appropriate amount of auxiliary materials that adds described in embodiment, and it is by above-mentioned concentrated solution, gelatin 270g, arabic gum 360g, PEG-4000 450g, sodium polyacrylate 360g, glycerol 360g, zinc oxide 18g; Get gelatin, arabic gum adds suitable quantity of water swelling, heating makes to dissolve, and in 50 ℃ of water-baths, constantly stirs, and adds successively zinc oxide, PEG400 and sodium polyacrylate, glycerol, mix homogeneously.Get Chinese medicine extraction extractum and substrate and heat at 50 ℃ of constant temperature water baths, stir 20～40min mix homogeneously, be applied on non-woven fabrics, lid lining, prunes molding, be up to the standards, and packing.
Claims (5)
1. a kidney health patch for the treatment of chronic kidney hypofunction, is characterized in that being made by the crude drug of following proportioning: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
2. the preparation method of kidney health patch described in claim 1, it is characterized in that: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae by above-mentioned formula proportion amount with after water extraction, first precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly after time precipitate with ethanol, secondary water precipitating, get supernatant liquid filtering, standby; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion water extraction for amount, precipitate with ethanol, water precipitating, secondary precipitate with ethanol, water precipitating more again, get supernatant liquid filtering, standby; Above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution are merged, and ultrafiltration, after concentrate drying, makes patch.
3. the preparation method of kidney health patch described in claim 1, is characterized in that:
(1) get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the 7-12 that amount of water is crude drug for the first time doubly measures, soak after 30min, boil 30min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 30min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add 5% gelatin solution, tannin-removing, add 95% ethanol, to containing alcohol amount, be 75%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, it is clear and bright and when being concentrated into relative density and being 60 ℃ 1.18～1.25 that cold preservation 38～55h gets supernatant liquid filtering, adding 95% ethanol is 80% to containing alcohol amount, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, standby,
(2) dosage Flos Carthami, Milkvetch Root, the 7-12 that amount of water is crude drug for the first time doubly measures, soak 30min, boil 45min, filter, the 7-12 that amount of water is crude drug for the second time doubly measures, boil 45min, filter, the 7-12 that amount of water is crude drug for the third time doubly measures, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 38-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 4 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 38-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.18～1.25, add water to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, standby,
(3) above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution are merged, stir, ultrafiltration, filtrate be concentrated into relative density in the time of 60 ℃ 1.18～1.25,60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
4. the preparation method of kidney health patch described in claim 1, is characterized in that:
(1) get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, 10 times of amounts that amount of water is crude drug for the first time, soak after 30min, boil 30min, filter, 8 times of amounts that amount of water is crude drug for the second time, boil 30min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 30min, filter, merge three times water extraction liquid, while being concentrated into 60 ℃ of relative densities 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add 5% gelatin solution, tannin-removing, add 95%2 alcohol, to containing alcohol amount, be 75%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 4 times of amounts of medicinal liquid, it is clear and bright and when being concentrated into relative density and being 60 ℃ 1.20～1.22 that cold preservation 42～55h gets supernatant liquid filtering, adding 95%2 alcohol is 80% to containing alcohol amount, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, standby,
(2) dosage Flos Carthami, Milkvetch Root, 10 times of amounts that amount of water is crude drug for the first time, soak 30min, boiling 45min filters, 8 times of amounts that amount of water is crude drug for the second time, boil 45min, filter, 7 times of amounts that amount of water is crude drug for the third time, boil 45min, filter, merge three times water extraction liquid, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, standing 48-60h, get supernatant liquid filtering clear and bright, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 4 times of amounts of medicinal liquid, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 that cold preservation 42-55h gets supernatant liquid filtering, add 95% ethanol, to medicinal liquid, containing alcohol amount is 80%, it is clear and bright that standing 48-60h gets supernatant liquid filtering, reclaim ethanol to relative density 60 ℃ time 1.20～1.22, add water to 2 times of amounts of medicinal liquid, cold preservation 48～55h, get supernatant liquid filtering clear and bright after, standby,
(3) by above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group solution, mixing and stirring, ultrafiltration, filtrate be concentrated into relative density in the time of 60 ℃ 1.20～1.22,60 ℃ dry after, pulverize, add appropriate amount of auxiliary materials and make patch.
5. according to the preparation method of kidney health patch described in claim 3 or 4, it is characterized in that: it is drug storehouse layer and adhesion layer that described patch forms, and drug storehouse layer is polyisobutylene MML-10030 part, polyisobutylene-LM-MS37 part, 59 parts, mineral oil, 16 parts of medicines, 860 parts of chloroforms; Adhesion layer is polyisobutylene MML-10032 part, polyisobutylene-LM-MS40 part, and 65 parts, mineral oil, 5 parts of medicines, 360 parts of chloroforms, are compound to adhesion layer by drug storehouse layer, using non-woven fabrics as back lining materials.
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