CN102475760B - Kidney-health compound preparation for treating chronic renal failure and preparation method thereof - Google Patents
Kidney-health compound preparation for treating chronic renal failure and preparation method thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a kidney-health compound preparation for treating chronic renal failure, which is prepared by extracting the following raw material herbs: 1500 g of rheum officinale, 1500 g of salvia, 4500 g of radix astragali, 1500 g of safflower. The preparation method of the kidney-health compound preparation comprises the following steps: performing water extraction, alcohol precipitation, tannin removal, alcohol precipitation, water precipitation, alcohol precipitation, water precipitation, supernatant filtration of the salvia according to the formula ratio for later use; performing extraction, alcohol precipitation, water precipitation, alcohol precipitation, water precipitation, and supernatant filtration of the radix astragali and safflower according to the formula ratios for later use; combining the two filtrates, removing pyrogen, performing fine filtration, separate loading, disinfection, quality inspection, and packaging. The kidney-health compound preparation of the invention has better curative effect, less side effect, and higher bioavailability; the preparation process is improved, has increased efficiency and stronger maneuverability.
Description
Technical field
The invention belongs to Chinese medicine preparation, particularly about a kind of kidney rehabilitation square preparation for the treatment of chronic renal failure and preparation method thereof, belong to field of medicaments.
Background technology
Former patent 96117626.1 discloses a kind of SHENKANG ZHUSHEYE and preparation technology thereof, and what this invention was protected is the Chinese medicine scope of application, there is no concrete proportion relation.Although also disclose the case of prescription in patent document embodiment, but Radix Astragali input amount is large, because the Radix Astragali and Radix Et Rhizoma Rhei have precipitation, the Radix Astragali and Radix Salviae Miltiorrhizae also respond, and the Radix Astragali is measured few drug effect that also affects in the compatibility of preparation, accurate and the little side effect of particularly intravenous injection liquid hold-up is vital, so the present invention has carried out perfect to prescription and preparation technology.
Summary of the invention
The object of the invention is: a kind of kidney rehabilitation square preparation that improves formula is provided, and it is to have done accurate adjustment in the proportioning of original flavour of a drug, thereby has guaranteed that the active constituent content of medicine is higher, precipitation is few, and side effect is little, and bioavailability is high.
Technical scheme
The invention provides a kind of kidney rehabilitation square preparation, 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.
The preparation method of kidney rehabilitation square preparation is: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae by above-mentioned carry → precipitate with ethanol → tannin-removing → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → supernatant liquid filtering of formula proportion water gaging after, standby; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extraction → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → get after supernatant liquid filtering, standby; Merge above two groups of filtrates, remove pyrogen, fine straining, sterilizing.
The preparation method of kidney rehabilitation square preparation is: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, after Flos Carthami is selected, take the Radix Et Rhizoma Rhei 1500g of dosage, Radix Salviae Miltiorrhizae 1500g medical material, water rinses, water shower again, decoct with water three times, each 7-12 times of water yield, soak first 30min, boil 30min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.20～1.25, add 4% gelatin solution appropriate, fully agitating solution is extremely without tannin positive reaction, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.Through assay, up to specification, standby, take dosage Radix Astragali 4500g, Flos Carthami 1500g, water rinses, water shower again, decoct with water three times, each 7 times of water yields, soak first 30min, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, through assay, up to specification, standby.Above-mentioned filtrate is merged, add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, let cool, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, inject and be diluted with water to approximately 30% concentration, with 30% NaOH, be adjusted to pH7.5, inject water to 30000mL, more successively by 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in 20mL ampoule, in 100 ℃ of flowing steam sterilization 1h, after lamp inspection is qualified, packs and get final product.
The preparation method of kidney rehabilitation square preparation is: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, after Flos Carthami is selected, take the Radix Et Rhizoma Rhei 1500g of dosage, Radix Salviae Miltiorrhizae 1500g medical material, water rinses, water shower again, decoct with water three times, each 7-12 times of water yield, soak first 30min, boil 30min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.18～1.22, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add 4% gelatin solution appropriate, fully agitating solution is to not becoming tannin positive reaction, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24-60h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, through assay, up to specification, standby, take dosage Radix Astragali 4500g, Flos Carthami 1500g, water rinses, water shower again, decoct with water three times, each 7-12 times of water yield, soak first 30min, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.18～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to relative density is 1.18～1.22 (60 ℃), add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to relative density is 1.18～1.22 (60 ℃), add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, through assay, up to specification, standby.Above-mentioned filtrate is merged, add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, let cool, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, inject dilute with water, ultrafiltration, regulates pH to 6.5-7.8, inject water to 30000mL, successively by 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in 20mL ampoule, in 100 ℃ of flowing steam sterilization 1h again, after lamp inspection is qualified, packs and get final product.
The preparation method of described kidney rehabilitation square preparation: described all time of repose are 24-60h.
The preparation method of described kidney rehabilitation square preparation: Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, the Radix Astragali combines and add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon; Or add respectively after 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, filter, remerge; Or add respectively after 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, filter, sterilizing, remerges.
The preparation method of described kidney rehabilitation square preparation: institute adds 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, lets cool, and in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Or add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, and filtered while hot, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.
The preparation method of described kidney rehabilitation square preparation: described 100 ℃ of flowing steam sterilization 1h of sterilising temp; Can also be 105 ℃, time 1h; 110 ℃, time 1h; 115 ℃, time 35-45min; 121 ℃, time 8-30min.
The preparation method of described kidney rehabilitation square preparation: Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution merge, and after filtration or ultrafiltration, can be prepared into kidney health freeze-dried powder, glucose infusion solutions, sodium chloride injection through ingredients.
The preparation method of described kidney rehabilitation square preparation: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated, can make soft extract, oral liquid, mixture, syrup, aerosol, drop pill, soft capsule etc.After pulverizing, concentrate drying makes capsule, granule, powder, slow release ball, tablet, dispersible tablet, controlled release tablet, slow releasing tablet, effervescent tablet, coated tablet etc.
The preparation method of described kidney rehabilitation square preparation: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated, can make external preparation, as suppository, lotion, liniment, unguentum, patch and preparation capable of permeating skin etc.
The invention has the advantages that:
One, its prescription proportioning is the improvement of doing on the basis of original patent 96117626.1,03141399.4, ZL03108156.8, ZL200410039420.7, ZL200410004359.2, ZL200410039418.X; because what protect in former patent is scope; there is no accurate proportioning, and the accurate proportioning of Chinese medicine directly affects the curative effect of medicine.For the medical material in prescription, the Radix Astragali and Radix Et Rhizoma Rhei have precipitation, and the Radix Astragali and Radix Salviae Miltiorrhizae also respond, and the Radix Astragali is measured few drug effect that also affects in the compatibility of preparation, particularly intravenous injection liquid hold-up accurately and side effect little be vital.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 prescription effect of the present invention is better.
The prescription of five kinds of injection is as follows:
Prescription one: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.(kidney rehabilitation square preparation 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.
Five kinds of prescriptions are prepared into the injection of 0.3g crude drug/mL by above-mentioned preparation technology, standby.
Five kinds of prescriptions of table 1 affect comparison (mmol/L, X ± SD) to CRF rat blood serum blood urea nitrogen due to adenine
Compare * P < 0.05, * * P < 0.01 with model group
Due to five kinds of prescription Dui Xianpiao ridges of table 2, CRF rat blood serum creatinine affects comparison (μ mol/L, X ± SD)
With model group comparison: * P < 0.05, * * P < 0.01
Experimental result shows: rats gavaged adenine is after two weeks, and blood BUN, Cr raise, and is significantly higher than normal rat (p < 0.01), shows that CRF forms, and grouping is treated.During treatment, continue to rats gavaged adenine, its blood BUN, Cr continues to rise, to treating after 5 weeks, model group rat BUN, Cr rise to respectively 6.5 times of normal rat with 4.3 times, show that this model presents the azotemia that carrying out property increases the weight of, the injection tail vein injection treatment rat made from five kinds of prescriptions respectively, its blood BUN, Cr is along with the blood BUN of model group rat, the rising of Cr also raises gradually, the blood BUN for the treatment of group rat, the Cr rate of climb and amplitude will be lower than model group, treat 3 weeks with after 5 weeks, the blood BUN for the treatment of group, Cr level is starkly lower than model group (p < 0.05 or p < 0.01), and the blood BUN of prescription one treatment group rat, the Cr rate of climb and amplitude are still lower than all the other each prescription group treatment groups, show that prescription one (kidney rehabilitation side) 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, the preparation method of described kidney rehabilitation square preparation and patent 96117626.1 preparation method contrasts are as follows
1, in preparation technology of the present invention, under agitation in condensed cream, slowly add 95% ethanol, to medicinal liquid, containing alcohol amount is 70%, stir, and airtight standing 24h, this time precipitate with ethanol effect is better than the standing 12h of patent 96117626.1, but overlong time production cost is higher.
2, in patent 96117626.1 preparation technologies, reclaim ethanol to without alcohol taste, specifically do not detect index, the bad control of production process; The present invention now detects index with 1.20～1.22 conducts of 60 ℃ of relative densities, so that the quality in the middle of production control.
3, in patent 96117626.1 preparation technologies, decoct three times, filter, merging filtrate, is concentrated into 167mL; The present invention is concentrated into 100mL.Known filtrate is concentrated into 167mL, and medicinal liquid is rare, and amount of alcohol added is larger, and sedimentation effect is undesirable, and the recovery ethanol time is long, and effective ingredient easily loses, and invalid components difficulty is removed, and its contrast is as follows.
Three groups of medical material gained filtrates of table 6 are concentrated into different volumes and mainly contain effective component content
From upper table, can obviously find out, when being concentrated to 100mL, medicine active constituent content is higher, less on validity of products impact.
The comparison of filtrate concentrated effect
From upper table, can obviously find out, when filtrate is concentrated into 1.20～1.23, the effective content of product is high, minimum on product quality impact.
4, the main purpose of active carbon in preparation technology is decolouring and depyrogenation, and the size of addition, directly has influence on content's index and depyrogenation effect that medicinal liquid is relevant.Addition is bigger than normal, and loss of effective components is large, causes finished product active constituent content defective; Addition is less than normal, is difficult to again guarantee that whether depyrogenation is qualified.Active carbon addition in known technology is difficult to guarantee qualified quality of liquid medicine.
5, patent 96117626.1 medicinal liquids are equipped with 0.45 μ m nuclepore membrane filter through 1, and embedding after filtering, can reach filtration sterilization effect through test; But medicinal liquid of the present invention is processed successively through 0.45 μ m, 0.22 μ m microporous filter membrane in-line filter, embedding after filtering, confirms to guarantee bacteria-eliminating efficacy through test.
Three, the preparation method of described kidney rehabilitation square preparation and patent 03141399 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.The prescription of patent 03141399 is a scope, and prescription of 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 03141399,100mL * 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, each 7 times of water yields, have operability.
3. in patent 03141399, 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 preparation technology, 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, and process is uncontrollable; The present invention is concentrated into 60 ℃ of relative densities 1.20～1.23, workable, can control complete process.
5. in patent 03141399 preparation technology, 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, effectively controls the product quality in drug production process.
Four, the preparation method of described kidney rehabilitation square preparation and ZL 03108156.8 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.The prescription of ZL 03108156.8 is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: Flos Carthami: the Radix Astragali 1.5: 1: 1: 1.5, and prescription of the present invention is not within the scope of it.
2.ZL 03108156.8 preparation technology's 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.ZL03108156.8 preparation technology, 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 technology, the precipitate with ethanol time, precipitate with ethanol temperature is all not clear and definite, does not possess operability.
In 5.ZL03108156.8 preparation technology, 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, the preparation method of described kidney rehabilitation square preparation and ZL200410039420.7 contrast are as follows
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g; In ZL200410039420.7, be ratio, not concrete formula, and proportioning in embodiment is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: the Radix Astragali: Flos Carthami is 15: 15: 55: 15, different with formula proportion of the present invention.
In 2.ZL200410039420.7 preparation technology, 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 the impurity level of extraction is also relatively less.
3.ZL200410039420.7 in preparation technology, after precipitate with ethanol, reclaim ethanol to without alcohol taste, fuzzyyer; The present invention is concentrated into relative density 1.20-1.25, workable.
Six, the preparation method of described kidney rehabilitation square preparation and ZL200410004359.2 contrast are as follows:
1, in ZL200410004359.2 preparation technology, 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 technology, 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 technology, through 0.2 μ m microporous filter membrane, filter once; The present invention, through 0.45 μ m, 0.22 μ m filtering with microporous membrane, can better remove impurities and bacteria.
Seven, the preparation method of described kidney rehabilitation square preparation and ZL200410039418.X contrast are as follows:
1. prescription proportioning is different, and prescription of the present invention is Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.In ZL200410039418.X, be ratio, not concrete formula, and proportioning in embodiment is Radix Et Rhizoma Rhei: Radix Salviae Miltiorrhizae: the Radix Astragali: Flos Carthami is 10: 10: 70: 10 and 15: 15: 55: 15,20: 20: 40: 40, different with formula proportion of the present invention.
2.ZL200410039418.X be concentrated into 80 ℃ of-90 ℃ of relative density 1.20-1.23 in preparation technology, 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 technology, Impurity removal is incomplete.
In 4.ZL200410039418.X preparation technology, Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae and the Radix Astragali, Flos Carthami all only carry out one time precipitate with ethanol; The present invention, through precipitate with ethanol repeatedly, removes impurity more thorough.
The specific embodiment
Embodiment 1 kidney rehabilitation square preparation is made injection by the crude drug of following proportioning: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The preparation of SHENKANG ZHUSHEYE: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae by above-mentioned carry → precipitate with ethanol → tannin-removing → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → supernatant liquid filtering of formula proportion water gaging after, standby; Again by the Radix Astragali, Flos Carthami by above-mentioned formula proportion amount extraction → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → get after supernatant liquid filtering, standby; Merge above two groups of filtrates, remove pyrogen, fine straining, sterilizing.
The preparation method of embodiment 2 SHENKANG ZHUSHEYE is: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, after Flos Carthami is selected, take the Radix Et Rhizoma Rhei 1500g of dosage, Radix Salviae Miltiorrhizae 1500g medical material, water rinses, water shower again, decoct with water three times, each 7 times of water yields, soak first 30min, boil 30min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.20～1.25, add 4% gelatin solution appropriate, fully agitating solution is extremely without tannin positive reaction, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.Through assay, up to specification, standby, take dosage Radix Astragali 4500g, Flos Carthami 1500g, water rinses, water shower again, decoct with water three times, each 7 times of water yields, soak first 30min, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, through assay, up to specification, standby.Above-mentioned filtrate is merged, add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, let cool, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, inject and be diluted with water to approximately 30% concentration, with 30% NaOH, be adjusted to pH7.5, inject water to 30000mL, more successively by 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in 20mL ampoule, in 100 ℃ of flowing steam sterilization 1h, after lamp inspection is qualified, packs and get final product.
The preparation method of embodiment 3 SHENKANG ZHUSHEYE is: by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, after Flos Carthami is selected, take the Radix Et Rhizoma Rhei 1500g of dosage, Radix Salviae Miltiorrhizae 1500g medical material, water rinses, water shower again, decoct with water three times, each 7-12 times of water yield, soak first 30min, boil 30min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add 4% gelatin solution appropriate, fully agitating solution is to not becoming tannin positive reaction, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24-60h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, through assay, up to specification, standby, take dosage Radix Astragali 4500g, Flos Carthami 1500g, water rinses, water shower again, decoct with water three times, each 7-12 times of water yield, soak first 30min, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, 60 ℃ of relative densities are 1.18～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, through assay, up to specification, standby.Above-mentioned filtrate is merged, add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, let cool, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, inject dilute with water, ultrafiltration, regulates pH to 6.5-7.8, inject water to 30000mL, successively by 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in 20mL ampoule, in 100 ℃ of flowing steam sterilization 1h again, after lamp inspection is qualified, packs and get final product.
Embodiment 4 and embodiment 2,3 are basic identical, and difference is described Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, the Radix Astragali combines and add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon; Or add respectively after 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, filter, remerge; Or add respectively after 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, filter, sterilizing, remerges.
Embodiment 5 and embodiment 2,3 are basic identical, difference adds active carbon 0.5% described in being, 100 ℃ of flowing steam heat treatment 30min, let cool, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright, or add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, filtered while hot, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.
Embodiment 6 and embodiment 2,3 are basic identical, difference is described 100 ℃ of flowing steam sterilization 1h of sterilising temp, can also be 105 ℃ of sterilizing 1h, 110 ℃ of sterilizing 1h, 115 ℃ of sterilizing 35-45min, 121 ℃ of sterilizing 8-30min, all can guarantee the aseptic requirement of product, and product quality no significant difference after testing.
Embodiment 7 and embodiment 2,3 are basic identical, difference is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through ingredients, also can be prepared into kidney health freeze-dried powder, glucose infusion solutions, sodium chloride injection.
Embodiment 8 is basic identical with embodiment 2 and embodiment 3, difference is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated, also can make soft extract, oral liquid, mixture, syrup, aerosol, drop pill, soft capsule etc.After pulverizing, concentrate drying also can make capsule, granule, powder, slow release ball, tablet, dispersible tablet, controlled release tablet, slow releasing tablet, effervescent tablet, coated tablet etc.
Embodiment 9 is basic identical with embodiment 2 and embodiment 3, difference is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated, also can make external preparation, as suppository, lotion, liniment, unguentum, patch and preparation capable of permeating skin etc.
Claims (6)
1. treat a kidney rehabilitation square preparation for chronic renal failure, it is characterized in that 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.
2. kidney rehabilitation square preparation according to claim 1, is characterized in that: it is freeze-dried powder, glucose infusion solutions or sodium chloride injection.
3. kidney rehabilitation square preparation according to claim 1, is characterized in that: it is soft extract, mixture, syrup, granule, powder, slow release ball or coated tablet.
4. the preparation method of the arbitrary described kidney rehabilitation square preparation of claim 1-3, is characterized in that freeze-dried powder, glucose infusion solutions, sodium chloride injection, soft extract, mixture, syrup, granule, powder, slow release ball or coated tablet prepared according to the following steps:
(1) by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae by above-mentioned formula proportion water gaging carry, precipitate with ethanol, tannin-removing, precipitate with ethanol, water precipitating, precipitate with ethanol, water precipitating, get after supernatant liquid filtering, standby;
(2) again the Radix Astragali, Flos Carthami are pressed to the extraction of above-mentioned formula proportion water gaging, precipitate with ethanol, water precipitating, precipitate with ethanol, water precipitating, get after supernatant liquid filtering, standby;
(3) merge above two groups of filtrates, remove pyrogen, fine straining, sterilizing, makes freeze-dried powder, glucose infusion solutions or sodium chloride injection; Or above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated soft extract, mixture, the syrup made; Or above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, granulation agent after concentrated pulverizing, powder, slow release ball or coated tablet.
5. according to the arbitrary described preparation method of claim 1-3, it is characterized in that freeze-dried powder, glucose infusion solutions or sodium chloride injection prepared according to the following steps:
(1) by crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae decocts with water three times, each 7-12 times of water yield, filter, merging filtrate, be concentrated into 3000mL, when relative density is 60 ℃ 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, when reclaiming ethanol to relative density and being 60 ℃ 1.20～1.25, add 4% gelatin solution appropriate, fully agitating solution is extremely without tannin positive reaction, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 24-60h, be filtered to clear and bright, slowly add 95% ethanol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, standby,
(2) take the Radix Astragali, Flos Carthami, decoct with water three times, each 7-12 times of water yield, filter, merging filtrate is concentrated into 3000mL, relative density is 60 (2: 1.20～1.23, put to room temperature, slowly add 95% ethanol to make to reach 70% containing alcohol amount, stir, airtight standing 24-60h, draw supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, add water for injection to be diluted to 1500mL, cold preservation 24h at 2-5 ℃, filter to clear and bright, slowly add 95%7 alcohol to make to reach 80% containing alcohol amount, stir, airtight standing 24h, draw supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, add water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, standby,
(3) above-mentioned filtrate is merged, add 0.5%, 100 ℃ of flowing steam heat treatment 30min of active carbon, let cool, in 2-5 ℃ of cold preservation 24h, filter, to clear and bright, inject and is diluted with water to approximately 30% concentration, and the NaOH with 30% regulates pH to 7.5, inject and be diluted with water to 30000mL, successively by 0.45 μ m, 0.22 μ m filtering with microporous membrane, sterilizing, makes freeze-dried powder, glucose infusion solutions or sodium chloride injection again; Or above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, through concentrated soft extract, mixture, the syrup made; Or above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged, after filtration or ultrafiltration, granulation agent after concentrated pulverizing, powder, slow release ball or coated tablet.
6. preparation method according to claim 5, it is characterized in that: described sterilising temp and time are 100 ℃ of flowing steam sterilization 1h, or 105 ℃ of flowing steam sterilization 1h, or 110 ℃ of flowing steam sterilization 1h, or 115 ℃ of flowing steam sterilization temperature, time 35-45min, or 121 ℃ of flowing steam sterilization temperature, time 8-30min.
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