CN102475760A - 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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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,, belong to field of medicaments particularly about a kind of kidney rehabilitation square preparation of treating chronic renal failure and preparation method thereof.
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, does not have concrete proportion relation.Though in patent document embodiment, also disclose the case of prescription; But Radix Astragali input amount is big; Because of 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 influences 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 objective of the invention is: a kind of kidney rehabilitation square preparation that improves prescription is provided, and it is on the proportioning of original flavour of a drug, to have done accurate adjustment, thereby the active constituent content that has guaranteed medicine is higher, and deposition 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 processed by following proportion raw material medicine: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The method for preparing of kidney rehabilitation square preparation is: with 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 → supernatant liquid filtering after, subsequent use; Again with the Radix Astragali, Flos Carthami by behind above-mentioned formula proportion amount extraction → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → get supernatant liquid filtering, subsequent use; Merge above two groups of filtratings, remove pyrogen, fine straining, sterilization.
The method for preparing of kidney rehabilitation square preparation is: after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami are selected, take by weighing Radix Et Rhizoma Rhei 1500g, the Radix Salviae Miltiorrhizae 1500g medical material of dosage, and the water flushing, water dashes and drenches decocte with water three times again; Each 7-12 times of water yield soaked 30min first, boils 30min at every turn, filters, and merging filtrate is concentrated into 3000mL; 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir the airtight 24h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.20～1.25, and it is an amount of to add 4% gelatin solution, and fully agitating solution is to there not being the tannin positive reaction; Slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, is filtered to clear and bright; Slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, and in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.Through assay, up to specification, subsequent use; Take by weighing dosage Radix Astragali 4500g, Flos Carthami 1500g, the water flushing, water dashes and drenches decocte with water three times, each 7 times of water yields again; Soak 30min first, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, and 60 ℃ of relative densities are 1.20～1.23; Put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, is filtered to clear and bright; Slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, and in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Through assay, up to specification, subsequent use.Above-mentioned filtrating is merged, add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, put cold; In 2-5 ℃ of cold preservation 24h, filter adds injection and is diluted with water to about 30% concentration to clear and bright, and the NaOH with 30% is adjusted to pH7.5; Add the injection water to 30000mL, successively through 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in the 20mL ampoule again; In 100 ℃ of flowing steam sterilization 1h, after lamp inspection was qualified, packing promptly got.
The method for preparing of kidney rehabilitation square preparation is: after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami are selected, take by weighing Radix Et Rhizoma Rhei 1500g, the Radix Salviae Miltiorrhizae 1500g medical material of dosage, and the water flushing, water dashes and drenches decocte with water three times again; Each 7-12 times of water yield soaked 30min first, boils 30min at every turn, filters, and merging filtrate is concentrated into 3000mL; 60 ℃ of relative densities are 1.18～1.22, put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir; The airtight 24-60h that leaves standstill draws supernatant liquid filtering to clear and bright, and reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, and it is an amount of to add 4% gelatin solution; Fully agitating solution is not to becoming the tannin positive reaction, slowly adds 95% ethanol and makes and contain the alcohol amount and reach 70%, stirs the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24-60h; Be filtered to clear and brightly, slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h; Filter is to clear and bright, up to specification through assay, subsequent use; Take by weighing dosage Radix Astragali 4500g, Flos Carthami 1500g, the water flushing, water dashes and drenches again, decocte with water three times, each 7-12 times of water yield; Soak 30min first, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, and 60 ℃ of relative densities are 1.18～1.23; Put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to relative density is 1.18～1.22 (60 ℃), adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h; Be filtered to clear and brightly, slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir the airtight 24h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to relative density is 1.18～1.22 (60 ℃), adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h; Filter is to clear and bright, up to specification through assay, subsequent use.Above-mentioned filtrating is merged, add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, put cold; In 2-5 ℃ of cold preservation 24h, filter adds the injection dilute with water, ultrafiltration to clear and bright; Regulate pH to 6.5-7.8, add the injection water, successively through 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in the 20mL ampoule again to 30000mL; In 100 ℃ of flowing steam sterilization 1h, after lamp inspection was qualified, packing promptly got.
The method for preparing of described kidney rehabilitation square preparation: described all time of repose are 24-60h.
The method for preparing of described kidney rehabilitation square preparation: Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali combination also add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min; After perhaps adding 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min respectively, filter, remerge; After perhaps adding 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min respectively, filter, sterilization remerges.
The method for preparing of described kidney rehabilitation square preparation: add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, put coldly, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Or add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, and filtered while hot, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright.
The method for preparing of described kidney rehabilitation square preparation: 100 ℃ of flowing steam sterilization 1h of described sterilising temp; Can also be 105 ℃, time 1h; 110 ℃, time 1h; 115 ℃, time 35-45min; 121 ℃, time 8-30min.
The method for preparing of described kidney rehabilitation square preparation: Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution merge, and after filtration or the ultrafiltration, can be prepared into kidney health freeze-dried powder, glucose infusion solutions, sodium chloride injection through ingredients.
The method for preparing of described kidney rehabilitation square preparation: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged; After filtering perhaps ultrafiltration, can process soft extract, oral liquid, mixture, syrup, aerosol, drop pill, soft capsule etc. through concentrating., concentrate drying processes capsule, granule, powder, slow release ball, tablet, dispersible tablet, controlled release tablet, slow releasing tablet, effervescent tablet, coated tablet etc. after pulverizing.
The method for preparing of described kidney rehabilitation square preparation: above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged; After filtering perhaps ultrafiltration; Can process external preparation through concentrating, like 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 on the basis of original patent 96117626.1,03141399.4, ZL03108156.8, ZL200410039420.7, ZL200410004359.2, ZL200410039418.X, being done; Because what protect in the former patent is scope; Do not have precise proportioning, and the precise proportioning of Chinese medicine directly influences the curative effect of medicine.For the medical material in the 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 influences in the compatibility of preparation, and the accurate and side effect of particularly intravenous injection liquid hold-up is vital for a short time.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 prescription effect of the present invention is better.
The prescription of five kinds of injection is following:
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, and are subsequent use.
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 each prescription group treatment groups, show that prescription one (kidney rehabilitation side) 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 contrast of the method for preparing of described kidney rehabilitation square preparation and patent 96117626.1 method for preparinies as follows
1, under agitation in condensed cream, slowly add 95% ethanol among the preparation technology of the present invention, containing alcohol amount to medicinal liquid is 70%, stir, and the airtight 24h that leaves standstill, it is good that this time precipitate with ethanol effect leaves standstill 12h than patent 96117626.1, but the overlong time production cost is higher.
2, reclaim ethanol to nothing alcohol flavor, not concrete detection index, the bad control of production process among patent 96117626.1 preparation technologies; The present invention detects index with 1.20～1.22 conducts of 60 ℃ of relative densities at this moment, so that central quality is produced in control.
3, among patent 96117626.1 preparation technologies, decoct three times, filter, merging filtrate is concentrated into 167mL; The present invention is concentrated into 100mL.Known filtrating is concentrated into 167mL, and medicinal liquid is rare, and amount of alcohol added is bigger, and sedimentation effect is undesirable, and the recovery ethanol time is long, and effective ingredient loses easily, and the invalid components difficulty is removed, and it contrasts as follows.
Three groups of medical material gained filtratings of table 6 are concentrated into different volumes and mainly contain effective component content
Can find out obviously that from last table when being concentrated to 100mL, the medicine active constituent content is higher, less to the validity of products influence.
The filtrating concentrated effect relatively
Can find out obviously that from last table when filtrating was concentrated into 1.20～1.23, the effective content of product was high, minimum to the product quality influence.
4, the main purpose of active carbon in preparation technology is decolouring and depyrogenation, and the size of addition directly has influence on medicinal liquid relevant content's index and depyrogenation effect.Addition is bigger than normal, and then loss of effective components is big, causes the finished product active constituent content defective; Addition is less than normal, is difficult to again guarantee whether depyrogenation is qualified.Active carbon addition in the 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, filter the back embedding, can reach the filtration sterilization effect through test; But medicinal liquid of the present invention is handled successively through 0.45 μ m, 0.22 μ m microporous filter membrane in-line filter, filters the back embedding, confirms to guarantee bacteria-eliminating efficacy through test.
Three, the method for preparing of described kidney rehabilitation square preparation and patent 03141399 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 is a scope, and prescription of 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 the patent 03141399,100mL * 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, each 7 times of water yields have operability.
3. in the patent 03141399, 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. among 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, and (mL: g), operability is not strong, and process is uncontrollable; The present invention is concentrated into 60 ℃ of relative densities 1.20～1.23, and is workable, can control complete process.
5. among patent 03141399 preparation technology, 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, effectively controls the product quality in the drug production process.
Four, the method for preparing of described kidney rehabilitation square 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 prescription of the present invention is not in its scope.
2.ZL 03108156.8 preparation technology's 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.ZL03108156.8 among the preparation technology, 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 among 03108156.8 preparation technology, the precipitate with ethanol time, the precipitate with ethanol temperature is all not clear and definite, does not possess operability.
5.ZL03108156.8 among the preparation technology, 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 rehabilitation square preparation and ZL200410039420.7 contrast 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 among the preparation technology, 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 less relatively.
3.ZL200410039420.7 behind the precipitate with ethanol, reclaim ethanol among the preparation technology to there not being the alcohol flavor, fuzzyyer; The present invention is concentrated into relative density 1.20-1.25, and is workable.
Six, the method for preparing of described kidney rehabilitation square preparation and ZL200410004359.2 contrast is as follows:
1, there is not the medical material immersion process among the ZL200410004359.2 preparation technology, 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 among the ZL200410004359.2 preparation technology, 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 once through 0.2 μ m microporous filter membrane among the ZL200410004359.2 preparation technology; The present invention can better remove impurities and bacteria through 0.45 μ m, 0.22 μ m filtering with microporous membrane.
Seven, the method for preparing of described kidney rehabilitation square preparation and ZL200410039418.X contrast is 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 among the preparation technology, 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 among the preparation technology, 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 among the preparation technology; The present invention is through precipitate with ethanol repeatedly, and it is more thorough to remove impurity.
The specific embodiment
Embodiment 1 kidney rehabilitation square preparation is processed injection by following proportion raw material medicine: Radix Et Rhizoma Rhei 1500g, Radix Salviae Miltiorrhizae 1500g, Radix Astragali 4500g, Flos Carthami 1500g.
The preparation of SHENKANG ZHUSHEYE: with 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 → supernatant liquid filtering after, subsequent use; Again with the Radix Astragali, Flos Carthami by behind above-mentioned formula proportion amount extraction → precipitate with ethanol → water precipitating → precipitate with ethanol → water precipitating → get supernatant liquid filtering, subsequent use; Merge above two groups of filtratings, remove pyrogen, fine straining, sterilization.
The method for preparing of embodiment 2 SHENKANG ZHUSHEYE is: after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami are selected, take by weighing Radix Et Rhizoma Rhei 1500g, the Radix Salviae Miltiorrhizae 1500g medical material of dosage, and the water flushing, water dashes and drenches again; Decocte with water three times, each 7 times of water yields are soaked 30min first, boil 30min at every turn; Filter, merging filtrate is concentrated into 3000mL, and 60 ℃ of relative densities are 1.20～1.23, put to room temperature; Slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Reclaiming ethanol to 60 ℃ relative density is 1.20～1.25, and it is an amount of to add 4% gelatin solution, and fully agitating solution is not to there being the tannin positive reaction, slowly adds 95% ethanol and makes and contain the alcohol amount and reach 70%; Stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright, and filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25; Add water for injection to 1500mL,, be filtered to clear and brightly, slowly add 95% ethanol and make and contain the alcohol amount and reach 80% in 2-5 ℃ of cold preservation 24h; Stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright, and 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, subsequent use; Take by weighing dosage Radix Astragali 4500g, Flos Carthami 1500g, the water flushing, water dashes and drenches decocte with water three times, each 7 times of water yields again; Soak 30min first, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, and 60 ℃ of relative densities are 1.20～1.23; Put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h, is filtered to clear and bright; Slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir, the airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright; Filtrate recycling ethanol to 60 ℃ relative density is 1.20～1.25, adds water for injection to 1500mL, and in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Through assay, up to specification, subsequent use.Above-mentioned filtrating is merged, add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, put cold; In 2-5 ℃ of cold preservation 24h, filter adds injection and is diluted with water to about 30% concentration to clear and bright, and the NaOH with 30% is adjusted to pH7.5; Add the injection water to 30000mL, successively through 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in the 20mL ampoule again; In 100 ℃ of flowing steam sterilization 1h, after lamp inspection was qualified, packing promptly got.
The method for preparing of embodiment 3 SHENKANG ZHUSHEYE is: after crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami are selected, take by weighing Radix Et Rhizoma Rhei 1500g, the Radix Salviae Miltiorrhizae 1500g medical material of dosage, and the water flushing, water dashes and drenches decocte with water three times again; Each 7-12 times of water yield soaked 30min first, boils 30min at every turn, filters, and merging filtrate is concentrated into 3000mL; 60 ℃ of relative densities are 1.20～1.23, put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir; The airtight 24-60h that leaves standstill draws supernatant liquid filtering to clear and bright, and reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, and it is an amount of to add 4% gelatin solution; Fully agitating solution is not to becoming the tannin positive reaction, slowly adds 95% ethanol and makes and contain the alcohol amount and reach 70%, stirs the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24-60h; Be filtered to clear and brightly, slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h; Filter is to clear and bright, up to specification through assay, subsequent use; Take by weighing dosage Radix Astragali 4500g, Flos Carthami 1500g, the water flushing, water dashes and drenches again, decocte with water three times, each 7-12 times of water yield; Soak 30min first, boil 45min at every turn, filter, merging filtrate is concentrated into 3000mL, and 60 ℃ of relative densities are 1.18～1.23; Put to room temperature, slowly add 95% ethanol and make and contain alcohol amount and reach 70%, stir the airtight 24-60h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 24h; Be filtered to clear and brightly, slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir the airtight 24h that leaves standstill; Draw supernatant liquid filtering to clear and bright, reclaiming ethanol to 60 ℃ relative density is 1.18～1.22, adds water for injection to 1500mL, in 2-5 ℃ of cold preservation 12-24h; Filter is to clear and bright, up to specification through assay, subsequent use.Above-mentioned filtrating is merged, add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, put cold; In 2-5 ℃ of cold preservation 24h, filter adds the injection dilute with water, ultrafiltration to clear and bright; Regulate pH to 6.5-7.8, add the injection water, successively through 0.45 μ m, 0.22 μ m filtering with microporous membrane, be sub-packed in the 20mL ampoule again to 30000mL; In 100 ℃ of flowing steam sterilization 1h, after lamp inspection was qualified, packing promptly got.
Embodiment 4 and embodiment 2,3 are basic identical, and different is said Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, Radix Astragali combination and adds 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min; After perhaps adding 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min respectively, filter, remerge; After perhaps adding 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min respectively, filter, sterilization remerges.
Embodiment 5 and embodiment 2,3 are basic identical, and that different is 0.5%, 100 ℃ of flowing steam heat treatment of said adding active carbon 30min; Put coldly, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Or add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min, 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; That different is 100 ℃ of flowing steam sterilization 1h of described sterilising temp; Can also be 105 ℃ of sterilization 1h, 110 ℃ of sterilization 1h, 115 ℃ of sterilization 35-45min, 121 ℃ of sterilization 8-30min; All can guarantee the aseptic requirement of product, and through testing product quality no significant difference.
Embodiment 7 and embodiment 2,3 are basic identical; Different is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged; After filtering perhaps ultrafiltration, also can be prepared into kidney health freeze-dried powder, glucose infusion solutions, sodium chloride injection through ingredients.
Embodiment 8 is basic identical with embodiment 2 and embodiment 3; Different is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged; After filtering perhaps ultrafiltration, also can process soft extract, oral liquid, mixture, syrup, aerosol, drop pill, soft capsule etc. through concentrating., concentrate drying also can process capsule, granule, powder, slow release ball, tablet, dispersible tablet, controlled release tablet, slow releasing tablet, effervescent tablet, coated tablet etc. after pulverizing.
Embodiment 9 is basic identical with embodiment 2 and embodiment 3; Different is that above-mentioned Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae group and Flos Carthami, two groups of water precipitating liquid of Radix Astragali group extracting solution are merged; After filtering perhaps ultrafiltration; Also can process external preparation through concentrating, like suppository, lotion, liniment, unguentum, patch and preparation capable of permeating skin etc.
Claims (6)
1. kidney rehabilitation square preparation of treating chronic renal failure, 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 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, oral liquid, mixture, syrup, aerosol, drop pill, soft capsule, granule, powder, slow release ball, dispersible tablet, controlled release tablet, slow releasing tablet, effervescent tablet or coated tablet.
4. the arbitrary described method for preparing of claim 1-3 is characterized in that may further comprise the steps: with 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 supernatant liquid filtering after, subsequent use; Again with the Radix Astragali, Flos Carthami by the extraction of above-mentioned formula proportion amount, precipitate with ethanol, water precipitating, precipitate with ethanol, water precipitating, get supernatant liquid filtering after, subsequent use; Merge above two groups of filtratings, remove pyrogen, fine straining, sterilization.
5. according to the arbitrary described method for preparing of claim 1-3, it is characterized in that may further comprise the steps: with crude drug Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae decocte with water three times, each 7-12 times of water yield filters; Merging filtrate, be concentrated into 3000mL, when relative density is 60 ℃ 1.20～1.23, put to room temperature, slow 95% ethanol that adds makes and contains the alcohol amount and reach 70%; Stir, the airtight 24-60h that leaves standstill draws supernatant liquid filtering to clear and bright, when reclaiming ethanol to relative density and being 60 ℃ 1.20～1.25; It is an amount of to add 4% gelatin solution, and fully agitating solution is not to there being the tannin positive reaction, slowly adds 95% ethanol and makes and contain the alcohol amount and reach 70%, stirs; The airtight 24-60h that leaves standstill draws supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, adds water for injection to 1500mL; In 2-5 ℃ of cold preservation 24-60h, be filtered to clear and brightly, slowly add 95% ethanol and make and contain alcohol amount and reach 80%, stir; The airtight 24h that leaves standstill draws supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, adds water for injection to 1500mL; In 2-5 ℃ of cold preservation 12-24h, filter is to clear and bright, subsequent use; With the Radix Astragali, Flos Carthami decocte with water three times, each 7-12 times of water yield filters, and merging filtrate is concentrated into 3000mL; When relative density is 60 ℃ 1.20～1.23, put, slowly add 95% ethanol and make and contain the alcohol amount and reach 70%, stir to room temperature; The airtight 24-60h that leaves standstill draws supernatant liquid filtering to clear and bright, when filtrate recycling ethanol to relative density is 60 ℃ 1.20～1.25, adds water for injection and is diluted to 1500mL; At 2-5 ℃ of following cold preservation 24h, filter to clear and bright, slowly add 95% ethanol and make and contain the alcohol amount and reach 80%, stir; The airtight 24h that leaves standstill draws 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; Above-mentioned filtrating is merged, add 0.5%, 100 ℃ of flowing steam heat treatment of active carbon 30min; Put coldly, in 2-5 ℃ of cold preservation 24h, filter is to clear and bright; Add injection and be diluted with water to about 30% concentration, the NaOH with 30% regulates pH to 7.5, adds injection and is diluted with water to 30000mL; Successively through 0.45 μ m, 0.22 μ m filtering with microporous membrane, sterilize again.
6. method for preparing 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, perhaps 115 ℃ of flowing steam sterilization temperature, time 35-45min, or 121 ℃ of flowing steam sterilization temperature, time 8-30min.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102475756A (en) * | 2010-11-30 | 2012-05-30 | 西安世纪盛康药业有限公司 | Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation |
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| CN102475756B (en) * | 2010-11-30 | 2014-03-19 | 西安世纪盛康药业有限公司 | Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation |
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