CN102475756B - Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation - Google Patents
Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation Download PDFInfo
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Abstract
The invention belongs to a traditional Chinese medicine preparation, in particular relates to a Shenkang injection compound preparation for treating chronic renal failure. The Shenkang injection compound preparation for treating chronic renal failure is prepared from the following bulk pharmaceutical chemicals: 1500g of rheum officinale, 1500g of roots of the red-rooted salvia, 4500g of Astragalus mongholicus and 1500g of red flower. The preparation method comprises the following steps of: after the bulk pharmaceutical chemicals of the rheum officinale and the roots of red-rooted salvia are extracted in the ratio in the formula, carrying out primary ethanol precipitation, removing tan, carrying out secondary ethanol precipitation and water precipitation, carrying out third ethanol precipitation, and carrying out secondary water precipitation to remove pyrogen and sterilize; then, extracting the red flower and the Astragalus mongholicus in the ratio in the formula, carrying out primary ethanol precipitation and water precipitation, and carrying out secondary ethanol precipitation and water precipitation to remove pyrogen and sterilize; and finally, combining the two groups of liquid medicine, diluting, carrying out ultrafiltration and fine filtering, and sterilizing to obtain the Shenkang injection compound preparation. The Shenkang injection compound preparation has the advantages of precision in regulating the original ratio, high effectiveness, smaller side effect, high acting speed and high bioavailability. In addition, the product quality and the production efficiency are further improved, and energy consumption is reduced.
Description
Technical field
The invention belongs to Chinese medicine injection, particularly about a kind of kidney health injection compound preparation for the treatment of chronic renal failure and preparation method thereof.Specifically belong to field of medicaments.
Background technology
Former patent 96117626.1 discloses a kind of SHENKANG ZHUSHEYE and preparation method thereof, and 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, 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.Because the accurate and little side effect of intravenous fluid active constituent content is vital.So we have carried out inquiring into research to the prescription of kidney health injection compound preparation and preparation method again, to find better Radix Astragali input amount and preparation method, guarantee safety of medicine, effective, cost-saving.
Summary of the invention
One of object of the present invention is: a kind of kidney health injection compound preparation is provided, and it is to have done accurate adjustment on original prescription, and effective percentage is higher, and side effect is less, and rapidly, bioavailability is high in effect.
Two of object of the present invention is: a kind of preparation method of kidney health injection compound preparation is provided, and it can further improve product quality and production efficiency.
Technical scheme of the present invention is: a kind of kidney health injection compound preparation is provided, and it is made by the crude drug of following proportioning: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
Kidney health injection compound preparation preparation method is: 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 inferior precipitate with ethanol, secondary water precipitating, depyrogenation, sterilizing; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, again precipitate with ethanol, water precipitating, again after secondary precipitate with ethanol, water precipitating, depyrogenation, sterilizing; Finally merge above two groups of medicinal liquids, dilution, forms through ultrafiltration, fine straining → subpackage → sterilizing → quality inspection → packing.
Described kidney health injection compound preparation preparation method 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, be concentrated into relative density 1.18～1.25 in the time of 60 ℃, 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 for injection 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH, to 6.5-7.8, is put a sterilizing in sealing bucket, 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 for injection 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 6.5-7.8, put sterilizing in sealing bucket, standby, the intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group is sequentially added into, then adds water for injection to be diluted to full dose, stir, ultrafiltration, adjust pH to 6.5～7.8, medicinal liquid is embedding after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed successively, sterilizing.
Described kidney health injection compound preparation preparation method 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, 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 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 for injection 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, puts in sealing bucket 105 ℃, or 110 ℃, sterilizing 1h is 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, cold preservation 42～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22, 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, put interior 105 ℃ of sealing bucket, or 110 ℃, sterilizing 1h, standby, the intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group is sequentially added into, then adds water for injection dilution, stir, ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed successively, sterilizing.
Described kidney health injection compound preparation preparation method is: three extracting in waters before a precipitate with ethanol, amount of water is respectively: extract for the first time water and be 12 times of amounts of crude drug, be for the second time 10 times of amounts, be 8 times of amounts for the third time, filter respectively, merge concentrated after, precipitate with ethanol, water precipitating time of repose are 48h.
Described kidney health injection compound preparation preparation method: sterilising temp is at 100 ℃-110 ℃, time 1h; Or 115 ℃, time 35-45min; Or 121 ℃, time 8-30min.
Described kidney health injection compound preparation preparation method: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group extracting solution are merged, after ultrafiltration, through ingredients, be prepared into kidney health injection, kidney health freeze-dried powder or kidney health glucose infusion solutions or kidney health sodium chloride injection.
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.Accurate and little side effect for intravenous fluid active constituent content is vital.The invention has the advantages that medicine is directly by intravenous injection, rapidly, bioavailability is high in effect, short treating period, and 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.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:
Five kinds of prescriptions of kidney health injection compound preparation are as follows:
Prescription one: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.(prescription of the present invention)
Prescription two: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 5500g, Flos Carthami 1500g.
Prescription three: Radix Et Rhizoma Rhei 1667g, Radix Salviae Miltiorrhizae 1667g, Radix Astragali 5000g, Flos Carthami 1666g.
Prescription four: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 1500g, Flos Carthami 1000g.
Prescription five: Radix Et Rhizoma Rhei 1000g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 7000g, Flos Carthami 1000g.
Animal experiment study shows: five kinds of prescriptions all can reduce serum 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, adenine is caused to CRF rat, still can improve albumin (ALB) level, renal hypertrophy is alleviated, kidney coefficient obviously reduces.Experiment confirms that prescription one effect is comparatively obvious, is better than other each prescriptions.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 prescription group treatment groups, show that kidney health injection compound preparation 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, and there were significant differences for kidney coefficient (p < 0.01 and p < 0.05), and prescription one kidney coefficient is less than all the other four groups.
Two, preparation method and the contrast of 96117626.1 preparation methoies of described kidney health injection compound preparation 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 now, with being concentrated into 60 ℃ of relative densities 1.20～1.25 as detecting, facilitates production control procedure quality.
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 be removed completely, after tannin-removing, 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 the present invention adopts 4 times of amounts to add water for injection so that control quality and operation in production process.
6, in technique of the present invention, increased medicinal liquid is evenly sub-packed in special stainless steel storage vat, airtight, at 105 ℃ of flowing steam sterilization 60min, after sterilizing, medicinal liquid is by the intermediate quality standard subsequent processing of being allowed for access after the assay was approved.The present invention has increased the sterilization process of intermediate in technique, has reduced the bacteria containing amount of pharmaceutical intermediate, guarantees the aseptic requirement of product.
7, active carbon is decolouring and removes the pyrogen in medicinal liquid in the object of this application, and addition directly has influence on content's index and the depyrogenation effect of medicinal liquid.Addition is excessive, and loss of effective components is large, causes finished product content defective; Addition is few, is difficult to guarantee that decolouring and medicinal liquid pyrogen are qualified.In known technology, active carbon addition is generally 0.1-2.0%, and scope is larger, operating difficulties; Addition of the present invention is 0.5%, compares with 0.63% of patent 96117626.1, has both retained more effective ingredient, and pyrogen test again can be qualified.
8, in production technology of the present invention, adopt the de-charcoal of grouping, it is compared with de-charcoal after merging filtrate: merge de-charcoal larger to chrysophanol in extracting solution, emodin, general anthraquinone composition influence, effective ingredient obviously reduces, if active constituent content is too low, two groups of materials, all by calcellation, have increased production cost and risk; The de-charcoal of grouping can effectively be controlled its content, has reduced production cost and risk.
9, in preparation method of the present invention, adopt ultrafiltration to filter, can guarantee decolorizing effect, can remove again macromolecular substances and anaphylactogen in medicine, improve the quality of products, guarantee safe medication.
10, medicinal liquid of the present invention is successively after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed, during embedding, can effectively guarantee the aseptic level of medicinal liquid, and the embedding after 1 filter filtration that 0.45 μ m microporous filter membrane is housed of patent 96117626.1 medicinal liquids confirms not reach good filtration sterilization effect through challenge test.
11, sterilising conditions temperature comparison:
Experiment shows, 100 ℃ of sterilising conditions, and 1h, 110 ℃, 1h, 115 ℃, 35min, 121 ℃, 8min all can guarantee the aseptic level of medicine, and product detection no significant difference, therefore sterilising temp can be decided to be 100-110 ℃, time 1h.115 ℃ of temperature, 35～45min; 121 ℃ of temperature, 8～30min also can guarantee the aseptic requirement of product.
Three, preparation method and patent 03141399.4 contrast of described kidney health injection compound preparation 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 60 ℃ of relative densities 1.20～1.23, 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; The present invention is concentrated into 60 ℃ of relative densities 1.20～1.22 as detecting index, can effectively control the product quality in drug production process.
Four, preparation method and ZL 03108156.8 contrast of described kidney health injection compound preparation 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.
Five, preparation method and the ZL200410039420.7 contrast of described kidney health injection compound preparation 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.
4.ZL200410039420.7 merge two groups of filtrates in preparation method, after activated carbon adsorption is filtered, inject and be diluted with water to 50% concentration; The present invention's grouping adds active carbon can better remove pigment and pyrogen, improves the quality of products and safety.
Six, preparation method and the ZL200410004359.2 contrast of described kidney health injection compound preparation 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.
3, in ZL200410004359.2 preparation method, through 0.2 μ m microporous filter membrane, filter 1 time; The present invention, through 0.22 μ m filtering with microporous membrane 2 times, can better remove impurities and bacteria.
Seven, preparation method and the ZL200410039418.X contrast of described kidney health injection compound preparation 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
It is made embodiment 1 kidney health injection compound preparation by the crude drug of following proportioning: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
After crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae being extracted by above-mentioned formula proportion amount during preparation, first precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly after time precipitate with ethanol, secondary water precipitating, depyrogenation, sterilizing; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, again precipitate with ethanol, water precipitating, again after secondary precipitate with ethanol, water precipitating, depyrogenation, sterilizing; Finally merge above two groups of medicinal liquids, dilution, through ultrafiltration, fine straining, sterilizing.
Embodiment 2 kidney health injection compound preparation preparation methoies are: get Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, 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, 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 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 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 ℃ 1.18～1.25 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH to 6.5～7.8, put a sterilizing in sealing bucket, 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 for injection 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 38～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH to 6.5～7.8, put sterilizing in sealing bucket, standby, the intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group is sequentially added into, then adds water for injection dilution, stir, ultrafiltration, adjust pH to 6.5～7.8, medicinal liquid is embedding after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed successively, after sterilizing, lamp inspection are qualified, packing.
Embodiment 3 kidney health injection compound preparation preparation methoies are: get Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, 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, 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 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 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, 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, puts in sealing bucket 105 ℃, or 110 ℃, sterilizing 1h is 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, cold preservation 42～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22, 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, put interior 105 ℃ of sealing bucket, or 110 ℃, sterilizing 1h, standby, the intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group is sequentially added into, then adds water for injection dilution, stir, ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed successively, after sterilizing, lamp inspection are qualified, packing.
Embodiment 4 kidney health injection compound preparation preparation methoies are substantially the same manner as Example 3, difference is three extracting in waters before a precipitate with ethanol, to be respectively that to extract for the first time water be 12 times of amounts of crude drug, extract water be for the second time 10 times of amounts of crude drug, extract 8 times of amounts that water is crude drug for the third time amount of water, filter respectively, merge concentrated after, precipitate with ethanol, water precipitating time of repose are 48h.
Embodiment 5 is substantially the same manner as Example 3, and difference is that sterilising temp is controlled at 100 ℃-110 ℃, time 1h; Or 115 ℃, time 35-45min; 121 ℃, time 8-30min, they all can guarantee the aseptic level of medicine, and product detects no significant difference.The equipment at concrete selective basis scene, working condition and requirement and determine.
In above-described embodiment, above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group extracting solution are merged, after ultrafiltration, through ingredients, be prepared into SHENKANG ZHUSHEYE, kidney health freeze-dried powder or kidney health glucose infusion solutions or kidney health sodium chloride injection.
In a word, proportioning raw materials of the present invention and production technology are not limited only to the protection of injection, also comprise other dosage form.The process of not describing in detail in the present invention is consistent with known technology, publication and industry standard with unit consumption.
Claims (2)
1. a kidney health injection compound preparation, is characterized in that: the crude drug by following proportioning is made according to following steps: crude drug is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g, take the Radix Et Rhizoma Rhei of dosage, 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, 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 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 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, 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, puts in sealing bucket 105 ℃, or 110 ℃, sterilizing 1h is 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, cold preservation 42～55h, get supernatant liquid filtering clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22, 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 for injection to 2 times of amounts of medicinal liquid, cold preservation 42～55h, get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, adjust pH is to 7.5-7.8, put interior 105 ℃ of sealing bucket, or 110 ℃, sterilizing 1h, standby, the intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, Radix Astragali group is sequentially added into, then adds water for injection dilution, stir, ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filter filtrations that 0.22 μ m microporous filter membrane is housed successively, sterilizing.
2. kidney health according to claim 1 injection compound preparation, is characterized in that: described 105 ℃, or 110 ℃, sterilizing 1h replaces with 115 ℃, sterilization time 35-45min, or 121 ℃, sterilization time 8-30min.
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