CN102475756A - 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 of treating 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, does not have concrete proportion relation.Though in patent document embodiment, also disclose the case of prescription, 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 influence 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 and the method for preparing of kidney health injection compound preparation again, to find better Radix Astragali input amount and method for preparing, guarantee safety of medicine, effective, practice thrift cost.
Summary of the invention
One of the object of the invention is: a kind of kidney health injection compound preparation is provided, and it is on original prescription, to have done accurate adjustment, and effective percentage is higher, and side effect is littler, and effect is rapid, and bioavailability is high.
Two of the object of the invention is: a kind of method for preparing 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 processed by following proportion raw material medicine: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
Kidney health injection compound preparation method for preparing is: after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are extracted by above-mentioned formula proportion amount, earlier precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly behind time precipitate with ethanol, the secondary water precipitating, depyrogenation, sterilization; Again with the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, again precipitate with ethanol, water precipitating, again behind secondary precipitate with ethanol, the water precipitating, depyrogenation, sterilization; Merge above two groups of medicinal liquids at last, dilution forms through ultrafiltration, fine straining → packing → sterilization → quality inspection → packing.
Described kidney health injection compound preparation method for preparing is: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, amount of water is that the 7-12 of crude drug doubly measures for the first time, soak 30min after, boil 30min, filter; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 30min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time; Boil 30min, filter, merge three times the water extract, be concentrated into relative density 1.18～1.25 in the time of 60 ℃; Add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%, leaves standstill 38-60h, gets supernatant liquid filtering to clear and bright; Reclaim ethanol to relative density in the time of 60 ℃ 1.18～1.25, add 5% gelatin solution, tannin-removing adds 95% ethanol; To the alcohol amount of containing is 75%, leave standstill 38-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25; 4 times of amounts that add water for injection to medicinal liquid, it is clear and bright and to be concentrated into relative density be 60 ℃ 1.18～1.25 that cold preservation 38～55h gets supernatant liquid filtering, and adding 95% ethanol is 80% to containing the alcohol amount, leaves standstill 38-60h; It is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 2 times of amounts of water for injection to 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 put sterilization in the sealing bucket to 6.5-7.8, and is subsequent use; Dosage Flos Carthami, Milkvetch Root, for the first time amount of water is that the 7-12 of crude drug doubly measures, and soaks 30min, boils 45min, filters; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 45min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 38-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 4 times of amounts of water for injection to medicinal liquid; Cold preservation 38～55h, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%; Leaving standstill 38-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 2 times of amounts of water for injection to 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 are put sterilization in the sealing bucket to 6.5-7.8, and is subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds water for injection again and be diluted to full dose, stir; Ultrafiltration; The back embedding is filtered through 2 filters that 0.22 μ m microporous filter membrane is housed successively in adjust pH to 6.5～7.8, medicinal liquid, sterilizes.
Described kidney health injection compound preparation method for preparing is: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, amount of water is 10 times of amounts of crude drug for the first time, behind the immersion 30min, boils 30min, filters; Amount of water is 8 times of amounts of crude drug for the second time, boils 30min, filters, and amount of water is 7 times of amounts of crude drug for the third time; Boil 30min, filter, merge three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22; Add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%, leaves standstill 48-60h, gets supernatant liquid filtering to clear and bright; Reclaim ethanol to relative density in the time of 60 ℃ 1.20～1.22, add 5% gelatin solution, tannin-removing adds 95% ethanol; To the alcohol amount of containing is 75%, leave standstill 48-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22; 4 times of amounts that add water for injection to medicinal liquid, it is clear and bright and to be concentrated into relative density be 60 ℃ 1.20～1.22 that cold preservation 42～55h gets supernatant liquid filtering, and adding 95% ethanol is 80% to containing the alcohol amount, leaves standstill 48-60h; It is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 2 times of amounts of water for injection to 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 the sealing bucket 105 ℃, perhaps 110 ℃, sterilization 1h, subsequent use; Dosage Flos Carthami, Milkvetch Root, amount of water is 10 times of amounts of crude drug for the first time, soaks 30min, boils 45min, filters; Amount of water is 8 times of amounts of crude drug for the second time, boils 45min, filters, and amount of water is 7 times of amounts of crude drug for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 48-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 4 times of amounts of water for injection to medicinal liquid, cold preservation 42～55h; It is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%, and leaving standstill 48-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22; 2 times of amounts that add water for injection to 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, perhaps 110 ℃, sterilization 1h, subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds water for injection dilution again, stir, ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filters that 0.22 μ m microporous filter membrane is housed filter successively, sterilizes.
Described kidney health injection compound preparation method for preparing is: three extracting in waters before a precipitate with ethanol; Amount of water is respectively: extract for the first time 12 times of amounts, the second time that water is a crude drug and be 10 times of amounts, be 8 times of amounts for the third time; Filter respectively, merge concentrate after, precipitate with ethanol, water precipitating time of repose are 48h.
Described kidney health injection compound preparation method for preparing: sterilising temp is at 100 ℃-110 ℃, time 1h; Or 115 ℃, time 35-45min; Or 121 ℃, time 8-30min.
Described kidney health injection compound preparation method for preparing: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group extracting solution are merged; After the ultrafiltration, be prepared into kidney health injection, kidney health freeze-dried powder or kidney health glucose infusion solutions or kidney health sodium chloride injection through ingredients.
The invention has the advantages that:
One, its prescription proportioning is the improvement of on original patent 96117626.1,03141399.4, ZL03108156.8, ZL200410039420.7, ZL200410004359.2, ZL200410039418 basis, being done; Because Radix Astragali input amount is high in the 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 influence drug effect again.Accurate and little side effect for the intravenous fluid active constituent content is vital.The invention has the advantages that medicine directly through intravenous injection, effect is rapid, and bioavailability is high, 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, especially infringement more than the renal function moderate is had 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 in an embodiment is 1.5: 1.0: 1.0: 1.5, several patent taste of Chinese medicine proportion relations are different fully.The present invention proves that through a large amount of experiment contrasts proportioning effect of the present invention is better, and its experimental data contrasts as follows:
Five kinds of prescriptions of kidney health injection compound preparation are following:
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) is improved anemia; Adenine is caused the CRF rat; Still can improve albumin (ALB) level, the kidney hypertrophy is alleviated, the kidney coefficient obviously reduces.Experiment confirm prescription one effect is comparatively obvious, is superior to other each prescriptions.Experimental result sees following table 1-5 for details.
Five kinds of prescriptions of table 1 are to the influence of CRF rat blood serum blood urea nitrogen due to the adenine relatively (mmol/L, X ± SD)
Compare * P＜0.05, * * P＜0.01 with model group
Five kinds of prescriptions of table 2 are to the influence of CRF rat blood serum creatinine due to the fast mountain range of gland relatively (μ mol/L, X ± SD)
Compare with model group: * P＜0.05, * * P＜0.01
Experimental result shows: the 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, divides into groups to treat.Continue to give the rats gavaged adenine during the treatment; Its blood BUN, Cr continue to rise, after treating for 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 of processing with five kinds of prescriptions respectively, its blood BUN, Cr are along with the blood BUN of model group rat, the rising of Cr also raise gradually, and the blood BUN of treatment group rat, the Cr rate of climb and amplitude will be lower than model group; After 3 weeks of treatment and 5 weeks; The blood BUN of treatment group, Cr level are starkly lower than model group (p＜0.05 or p＜0.01), and blood BUN, the Cr rate of climb and the amplitude of prescription one treatment group rat still are lower than all the other prescription group treatment groups, show that kidney health injection compound preparation prescription one reduces blood BUN, the Cr of adenine CRF rat; Improve the effect of azotemia, be superior to prescription two and prescription three, prescription four, prescription five.
Five kinds of prescriptions of table 3 are to the influence of CRF rat hemoglobin due to the adenine relatively (g/L, X ± SD)
Compare with model group: * P＜0.05, * * P＜0.01
Experimental result shows: the rats gavaged adenine is after two weeks, and the Hb level is existing to descend, and along with the increase that gives the adenine number of days, Hb also decreases, and after 5 weeks of treatment, model group rat Hb level significantly is lower than normal rat (P＜0.01).Though injection for treating group rat Hb is also reducing gradually, decrease speed is slower, and during 5 weeks, its Hb level is significantly higher than the model group same period (P＜0.05) in treatment, and the effect of prescription one obviously is better than all the other each prescription groups.Show that prescription one can alleviate the Anemia of adenine CRF rat, effect is superior to prescription two and prescription three, prescription four, prescription five.
Five kinds of prescriptions of table 4 are to the albuminous influence of CRF rat blood serum due to the adenine relatively (g/L, X ± SD)
Compare with model group: * P＜0.05, * * P＜0.01
Experimental result shows: the model group rat is after 5 weeks of treatment; Serum albumin obviously reduces (comparing P＜0.05 with normal rat); Hypoalbuminemia when the treatment group can be improved rat CRF, the serum albumin level is significantly higher than model group (p＜0.05) when treating for 5 weeks.Prescription one effect obviously is better than all the other four groups.
Five kinds of prescriptions of table 5 are to the influence of CRF kidney of rats coefficient due to the adenine relatively (mg/100g body weight, X ± SD)
Compare with model group: * 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 all is less than model group, and there were significant differences for the kidney coefficient (p＜0.01 and p＜0.05), and prescription one kidney coefficient is less than all the other four groups.
Two, the method for preparing of described kidney health injection compound preparation and the contrast of 96117626.1 method for preparinies are as follows
1, in patent 96117626.1 method for preparinies, the medicinal material extract water consumption is 7 times of medical material amount, and existing process water amount is 7-12 times; 7 times of water consumptions of former technology, after medical material soaked 30min, most of water that extracts was absorbed by medical material; Extraction efficiency reduces, and causes part medical material active substance not by abundant extraction, and after being increased to 10 times; Most of working substance mass-energy extracts fully, but surpasses 14 times, and the impurity extracted amount also increases; The effective ingredient content back has the decline phenomenon, and has increased energy consumption greatly.Amount of water is 10 times for the first time, and 8 times for the second time, 7 efficiency-timed fruits are best for the third time.
2, the present invention adds 95% ethanol, and containing pure amount to medicinal liquid is 70%, leaves standstill 48-60h, and this time precipitate with ethanol effect is better than the 12h of patent 96117626.1, and is high through detecting active constituent content, precipitate completely, but the overlong time production cost is higher.
3, reclaim ethanol in patent 96117626.1 method for preparinies to there not being the alcohol flavor, do not have concrete controlling index, the bad control of production process, the present invention are at this moment with being concentrated into 60 ℃ of relative densities 1.20～1.25 as detecting convenient control production process quality.
4, under agitation in condensed cream, slowly add 4% gelatin solution in patent 96117626.1 method for preparinies, and the present invention adds 5% gelatin solution tannin-removing; Add 95% ethanol, patent 96117626.1 is to add 250ml to calculate and contain the alcohol amount for about 60%, is difficult to remove tannin, and the present invention adds to that to contain alcohol amount 75% its tannin-removing effect better, and the quality of production is controlled easily.
Gelatin as with variable concentrations compares the tannin-removing effect that Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae extract the back medicinal liquid, and is best with gelatin 5%, and 4% gelatin is because concentration is rarer; The gelatin solution use amount is excessive in the tannin-removing process, has increased the volume of medicinal liquid, has reduced the concentration of medicinal liquid; Not only the tannin-removing effect is relatively poor, has also strengthened man-hour simultaneously, has improved energy consumption; 6% gelatin solution, because gelatin solution concentration is excessive, effective ingredient is prone to be wrapped and loses; Cause active constituent content to reduce, so through test of many times, 5% gelatin solution tannin-removing effect is better and medicinal liquid extraction component content is higher; Alcohol precipitation concentration confirms through overtesting behind the tannin-removing; When alcohol precipitation concentration was 60%, the gelatin in the medicinal liquid was difficult to eliminate, and 75% alcohol precipitation concentration promptly can be removed fully; Form gradient with one, two, three precipitate with ethanol again behind the tannin-removing; Help the extraction of effective ingredient and the removal of invalid components, and the high consumption of ethanol content is few relatively, not only capable of reducing energy consumption but also can reduce work hours.
5, in patent 96117626.1 method for preparinies secondary precipitate with ethanol extracting solution with distilled water diluting 14 to 84ml, the feasibility of operation is not strong, scope is crossed large-scale production process difficult quality control.So the present invention adopts 4 times of amounts to add water for injection so that control of quality and operation in the production process.
6, increased in the technology of the present invention medicinal liquid evenly is sub-packed in the special stainless steel storage vat, airtight, at 105 ℃ of flowing steam sterilization 60min, sterilization back 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 technology, reduced the bacteria containing amount of pharmaceutical intermediate, guarantees the aseptic requirement of product.
7, active carbon is decolouring and removes the pyrogen in the medicinal liquid that in this application aims addition directly has influence on the content's index and the depyrogenation effect of medicinal liquid.Addition is excessive, and loss of effective components is big, causes finished product content defective; Addition is few, is difficult to guarantee that decolouring and medicinal liquid pyrogen are qualified.The active carbon addition is generally 0.1-2.0% in the known technology, and scope is bigger, operating difficulties; Addition of the present invention is 0.5%, compares with 0.63% of patent 96117626.1, has both kept more effective ingredient, and pyrogen test again can be qualified.
8, adopt grouping to take off charcoal in the production technology of the present invention; It with merging filtrate after take off charcoal and compare: merge that to take off charcoal bigger to chrysophanol in the extracting solution, emodin, general anthraquinone composition influence; Effective ingredient obviously reduces; If active constituent content is low excessively, two groups of materials all will cancel, and increase production cost and risk; Divide into groups to take off charcoal and can effectively control its content, reduced production cost and risk.
9, adopt ultrafiltration to filter in the method for preparing of the present invention, can guarantee decolorizing effect, can remove macromolecular substances and anaphylactogen in the medicine again, improve the quality of products, guarantee safe medication.
10, medicinal liquid of the present invention is successively after 2 filters that 0.22 μ m microporous filter membrane is housed filter; Can effectively guarantee the aseptic level of medicinal liquid during embedding; And patent 96117626.1 medicinal liquids filter the back embedding through 1 filter that 0.45 μ m microporous filter membrane is housed, and confirm not reach filtration sterilization effect preferably through the challenge test.
11, the sterilising conditions temperature is relatively:
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, so 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, the method for preparing of described kidney health injection compound preparation and patent 03141399.4 contrast are as follows
1. the 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 in its scope, and the proportioning in the embodiment is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1000g, Radix Astragali 1500g, Flos Carthami 1000g.
2. in patent 03141399.4 method for preparing, 100mL * 50mL, not offering some clarification on is what, does not know that also what the content of explaining is, do not possess operability.And the present invention clear and definite the water yield of extracting, decocte with water three times has operability.
3. in patent 03141399.4 method for preparing, do not have the process of water logging bubble, 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 method for preparing, 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, and (mL: g), operability is not strong, and process is difficult to control; The present invention is concentrated into 60 ℃ of relative densities 1.20～1.23, and is workable, can control concentration process.
5. in patent 03141399.4 method for preparing, reclaim ethanol to nothing alcohol flavor, not concrete detection 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 the drug production process.
Four, the method for preparing of described kidney health injection compound preparation and ZL 03108156.8 contrast are as follows
1. the 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 a 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 method for preparing Chinese medicine is a prescription in proportion, not concrete prescription, and the yet not concrete mode of operation of extracting does not possess operability.
3.ZL in 03108156.8 method for preparing, do not have the process of water logging bubble, 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.ZL in 03108156.8 method for preparing, the precipitate with ethanol time, the precipitate with ethanol temperature is all not clear and definite, does not possess operability.
5.ZL in 03108156.8 method for preparing, filtrating is concentrated into 5 gram dries/mL filtrating, behind 80% precipitate with ethanol, adds entry again and is diluted to 5 gram dry/mL solution, can't operate.
Five, the method for preparing of described kidney health injection compound preparation and ZL200410039420.7 contrast are as follows
1. the 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; Among the ZL200410039420.7 ratio, not concrete prescription, and the proportioning among the embodiment is a Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: the Radix Astragali: Flos Carthami is 15: 15: 55: 15, and different with formula proportion of the present invention.
2.ZL200410039420.7 decocting time is 1-2h in the method for preparing, 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 effective component extracting preferably, the impurity level of extraction is also less relatively.
3.ZL200410039420.7 behind the precipitate with ethanol, reclaim ethanol to there not being the alcohol flavor in the method for preparing, fuzzyyer, the present invention is concentrated into the regulation relative density, and is workable.
4.ZL200410039420.7 merge two groups of filtratings in the method for preparing, after activated carbon adsorption is filtered, add injection and be diluted with water to 50% concentration; The present invention divides into groups to add active carbon can better remove pigment and pyrogen, improves the quality of products and safety.
Six, the method for preparing of described kidney health injection compound preparation and ZL200410004359.2 contrast are as follows
1, there is not the medical material immersion process in the ZL200410004359.2 method for preparing, and decocting time 1-2h, the time is longer, and extraction efficiency is lower; And the present invention soaks 30min, and it is more reasonable to decoct 30min.
2, be concentrated into relative density 1.00-1.15 behind the collecting decoction in the ZL200410004359.2 method for preparing, alcohol adding amount is bigger, and expends man-hour; The present invention is concentrated into relative density 1.20-1.23, can enhance productivity preferably.
3, filter 1 time through 0.2 μ m microporous filter membrane in the ZL200410004359.2 method for preparing; The present invention can better remove impurities and bacteria through 0.22 μ m filtering with microporous membrane 2 times.
Seven, the method for preparing of described kidney health injection compound preparation and ZL200410039418.X contrast are as follows:
1. the 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.Be ratio among the ZL200410039418.X, not concrete prescription, and the proportioning among the embodiment is a 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, and 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 the method for preparing, operability is relatively poor; It is 1.20～1.23 that the present invention is concentrated into 60 ℃ of relative densities, more easy to operate and control of quality.
3.ZL200410039418.X do not have tannin-removing technology in the method for preparing, Impurity removal is incomplete.
4.ZL200410039418.X Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae and the Radix Astragali, Flos Carthami all only carry out one time precipitate with ethanol in the method for preparing; The present invention is through precipitate with ethanol repeatedly, and it is more thorough to remove impurity.
The specific embodiment
It is processed embodiment 1 kidney health injection compound preparation by following proportion raw material medicine: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
After during preparation crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae being extracted by above-mentioned formula proportion amount, earlier precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly behind time precipitate with ethanol, the secondary water precipitating, depyrogenation, sterilization; Again with the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, again precipitate with ethanol, water precipitating, again behind secondary precipitate with ethanol, the water precipitating, depyrogenation, sterilization; Merge above two groups of medicinal liquids at last, dilution is through ultrafiltration, fine straining, sterilization.
Embodiment 2 kidney health injections compound preparation method for preparing is: get Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, amount of water is that the 7-12 of crude drug doubly measures for the first time, soak 30min after, boil 30min, filter; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 30min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time; Boil 30min, filter, merge three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.18～1.25; Add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%, leaves standstill 38-60h, gets supernatant liquid filtering to clear and bright; Reclaim ethanol to relative density in the time of 60 ℃ 1.18～1.25, add 5% gelatin solution, tannin-removing adds 95% ethanol; To the alcohol amount of containing is 75%, leave standstill 38-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25; 4 times of amounts that add water for injection to 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, and adding 95% ethanol is 80% to containing the alcohol amount, leaves standstill 38-60h; It is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 2 times of amounts of water for injection to medicinal liquid, cold preservation 38～55h; Get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, sterilization in the sealing bucket is put in adjust pH to 6.5～7.8, and is subsequent use; Dosage Flos Carthami, Milkvetch Root, for the first time amount of water is that the 7-12 of crude drug doubly measures, and soaks 30min, boils 45min, filters; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 45min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 38-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 4 times of amounts of water for injection to medicinal liquid; Cold preservation 38～55h, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%; Leaving standstill 38-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 2 times of amounts of water for injection to medicinal liquid, cold preservation 38～55h; Get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter; Cold preservation, sterilization in the sealing bucket is put in adjust pH to 6.5～7.8, and is subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds the water for injection dilution again, stir; Ultrafiltration, adjust pH to 6.5～7.8, medicinal liquid is embedding after 2 filters that 0.22 μ m microporous filter membrane is housed filter successively; Through the sterilization, lamp inspection qualified after, the packing.
Embodiment 3 kidney health injection compound preparation method for preparing is: get Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, amount of water is 10 times of amounts of crude drug for the first time, behind the immersion 30min, boils 30min, filters; Amount of water is 8 times of amounts of crude drug for the second time, boils 30min, filters, and amount of water is 7 times of amounts of crude drug for the third time; Boil 30min, filter, merge three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22; Add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%, leaves standstill 48-60h, gets supernatant liquid filtering to clear and bright; Reclaim ethanol to relative density in the time of 60 ℃ 1.20～1.22, add 5% gelatin solution, tannin-removing adds 95% ethanol; To the alcohol amount of containing is 75%, leave standstill 48-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22; 4 times of amounts that add water for injection to 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, and adding 95% ethanol is 80% to containing the alcohol amount, leaves standstill 48-60h; It is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 2 times of amounts of water for injection to 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 the sealing bucket 105 ℃, perhaps 110 ℃, sterilization 1h, subsequent use; Dosage Flos Carthami, Milkvetch Root, amount of water is 10 times of amounts of crude drug for the first time, soaks 30min, boils 45min, filters; Amount of water is 8 times of amounts of crude drug for the second time, boils 45min, filters, and amount of water is 7 times of amounts of crude drug for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 48-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 4 times of amounts of water for injection to medicinal liquid, cold preservation 42～55h; It is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%, and leaving standstill 48-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22; 2 times of amounts that add water for injection to 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, perhaps 110 ℃, sterilization 1h, subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds the water for injection dilution again, stir; Ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filters that 0.22 μ m microporous filter membrane is housed filter successively; Through the sterilization, lamp inspection qualified after, the packing.
Embodiment 4 kidney health injection compound preparation method for preparing and embodiment 3 are basic identical; Different is three extracting in waters before a precipitate with ethanol; Amount of water is respectively to extract for the first time to extract 12 times of amounts, the second time that water is a crude drug water and be 10 times of amounts of crude drug, extract 8 times of amounts that water is a crude drug for the third time; Filter respectively, merge concentrate after, precipitate with ethanol, water precipitating time of repose are 48h.
Embodiment 5 and embodiment 3 are basic identical, and different is that sterilising temp is controlled at 100 ℃-110 ℃, time 1h; Perhaps 115 ℃, time 35-45min; 121 ℃, time 8-30min, they all can guarantee the aseptic level of medicine, and product detects no significant difference.The concrete equipment of selecting according to the scene, working condition and requirement and decide.
In the foregoing description above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group extracting solution are merged, after the ultrafiltration, be prepared into SHENKANG ZHUSHEYE, kidney health freeze-dried powder or kidney health glucose infusion solutions or kidney health sodium chloride injection through ingredients.
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 among the present invention is consistent with known technology, publication and industry standard with the unit consumption.
Claims (7)
1. a kidney health of treating chronic renal failure is injected compound preparation, and it is characterized in that: it is processed by following proportion raw material medicine: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
2. kidney health injection compound preparation according to claim 1 is characterized in that said preparation is: injection with small volume, freeze-dried powder, glucose infusion solutions or sodium chloride injection.
3. the method for preparing of claim 1 or 2 described kidney health injection compound preparations; After it is characterized in that comprising the following steps: crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae extracted by above-mentioned formula proportion amount; Earlier precipitate with ethanol, tannin-removing, again secondary precipitate with ethanol, water precipitating, repeatedly behind time precipitate with ethanol, the secondary water precipitating; Depyrogenation, sterilization; Again with the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extract, again precipitate with ethanol, water precipitating, again behind secondary precipitate with ethanol, the water precipitating, depyrogenation, sterilization; Merge above two groups of medicinal liquids at last, dilution is through ultrafiltration, fine straining, sterilization.
4. the method for preparing of claim 1 or 2 described kidney health injection compound preparations after it is characterized in that comprising the following steps: Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae added 7-12 times of water gaging for crude drug and soak 30min, is boiled 30min, filters; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 30min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time; Boil 30min, filter, merge three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.18～1.25; Add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%, leaves standstill 38-60h, gets supernatant liquid filtering to clear and bright; Reclaim ethanol to relative density in the time of 60 ℃ 1.18～1.25, add 5% gelatin solution, tannin-removing adds 95% ethanol; To containing the alcohol amount is 75%, leaves standstill 38-60h, and it is clear and bright to get supernatant liquid filtering; Reclaim ethanol to relative density in the time of 60 ℃ 1.18～1.25, add 4 times of amounts of water for injection to 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 the alcohol amount, leaves standstill 38-60h, and it is clear and bright to get supernatant liquid filtering; Reclaim ethanol to relative density in the time of 60 ℃ 1.18～1.25, add 2 times of amounts of water for injection to medicinal liquid, cold preservation 38～55h; Get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter, cold preservation, sterilization in the sealing bucket is put in adjust pH to 6.5～7.8, and is subsequent use; Dosage Flos Carthami, Milkvetch Root, for the first time amount of water is that the 7-12 of crude drug doubly measures, and soaks 30min, boils 45min, filters; For the second time amount of water is that the 7-12 of crude drug doubly measures, and boils 45min, filters, and amount of water is that the 7-12 of crude drug doubly measures for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.18～1.25, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 38-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 4 times of amounts of water for injection to medicinal liquid; Cold preservation 38～55h, it is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.18～1.25 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%; Leaving standstill 38-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.18～1.25, adds 2 times of amounts of water for injection to medicinal liquid, cold preservation 38～55h; Get supernatant liquid filtering clear and bright after, add 0.5% active carbon, boil 30min, filter; Cold preservation, sterilization in the sealing bucket is put in adjust pH to 6.5～7.8, and is subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds water for injection dilution again, stir, ultrafiltration, adjust pH to 6.5～7.8, medicinal liquid is embedding after 2 filters that 0.22 μ m microporous filter membrane is housed filter successively, sterilizes.
5. the method for preparing of claim 1 or 2 described kidney health injection compound preparations, it is characterized in that comprising: get Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, amount of water is 10 times of amounts of crude drug for the first time, soak 30min after; Boil 30min, filter, amount of water is 8 times of amounts of crude drug for the second time, boils 30min; Filter, amount of water is 7 times of amounts of crude drug for the third time, boils 30min, filters; Merge three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, containing the alcohol amount to medicinal liquid is 70%; Leave standstill 48-60h, get supernatant liquid filtering to clear and bright, reclaim ethanol to relative density in the time of 60 ℃ 1.20～1.22, add 5% gelatin solution; Tannin-removing adds 95% ethanol, is 75% to containing the alcohol amount, leaves standstill 48-60h; It is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 4 times of amounts of water for injection to medicinal liquid, and 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 the alcohol amount, leaves standstill 48-60h, and it is clear and bright to get supernatant liquid filtering; Reclaim ethanol to relative density in the time of 60 ℃ 1.20～1.22, add 2 times of amounts of water for injection to 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 the sealing bucket 105 ℃, perhaps 110 ℃, sterilization 1h, subsequent use; Dosage Flos Carthami, Milkvetch Root, amount of water is 10 times of amounts of crude drug for the first time, soaks 30min, boils 45min, filters; Amount of water is 8 times of amounts of crude drug for the second time, boils 45min, filters, and amount of water is 7 times of amounts of crude drug for the third time, boils 45min; Filter, merges three times the water extract, be concentrated into relative density in the time of 60 ℃ 1.20～1.22, add 95% ethanol, containing to medicinal liquid that alcohol measures is 70%; Leave standstill 48-60h, it is clear and bright to get supernatant liquid filtering, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22, adds 4 times of amounts of water for injection to medicinal liquid, cold preservation 42～55h; It is clear and bright and be concentrated into relative density in the time of 60 ℃ 1.20～1.22 to get supernatant liquid filtering, adds 95% ethanol, and containing the alcohol amount to medicinal liquid is 80%, and leaving standstill 48-60h, to get supernatant liquid filtering clear and bright, reclaims ethanol to relative density in the time of 60 ℃ 1.20～1.22; 2 times of amounts that add water for injection to 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, perhaps 110 ℃, sterilization 1h, subsequent use; The intermediate of above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali group is sequentially added into, adds water for injection dilution again, stir, ultrafiltration, adjust pH to 7.5～7.6, medicinal liquid is embedding after 2 filters that 0.22 μ m microporous filter membrane is housed filter successively, sterilizes.
6. according to the method for preparing of claim 4 or 5 described kidney health injection compound preparations; It is characterized in that: described three extracting in waters before a precipitate with ethanol; Amount of water is respectively to extract for the first time to extract 12 times of amounts, the second time that water is a crude drug water and be 10 times of amounts of crude drug, extract 8 times of amounts that water is a crude drug for the third time; Filter respectively, merge concentrate after, precipitate with ethanol, water precipitating time of repose are 48h.
7. according to the method for preparing of claim 4 or 5 described kidney health injection compound preparations, it is characterized in that: described sterilising temp is at 100 ℃-110 ℃, time 1h; Or 115 ℃, time 35-45min; Or 121 ℃, time 8-30min.
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| CN102475756B (en) | 2014-03-19 |
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