CN102488806A - Renal failure treating Chinese medicinal preparation and preparation method thereof - Google Patents
Renal failure treating Chinese medicinal preparation and preparation method thereof Download PDFInfo
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- CN102488806A CN102488806A CN2011104379403A CN201110437940A CN102488806A CN 102488806 A CN102488806 A CN 102488806A CN 2011104379403 A CN2011104379403 A CN 2011104379403A CN 201110437940 A CN201110437940 A CN 201110437940A CN 102488806 A CN102488806 A CN 102488806A
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Abstract
The invention discloses a renal failure treating Chinese medicinal preparation, which consists of heterophylly falsestarwort root, coptis root, rhizoma pinellinae praeparata, dried orange peel, indian buead, rhubarb, red-rooted salvia root, twotooth achyranthes root and the like. A preparation to a mobile phase is inspected with a high performance liquid chromatography method: the ratio of methanol to water is 45:55; a detection wavelength is 254 nanometers; the theoretical number of plates is more than or equal to 5000; and not less than 3.2mg of total alkaloids is contained in every 0.35g of berberine hydrochloride. A preparation method of the preparation comprises the following steps of: preparing materials, and preparing raw rhubarb powder from a part of the rhubarb; preparing rhubarb thick paste from a part of the rhubarb; preparing a medicament thick paste: preparing mixed thick paste; uniformly mixing the mixed thick paste with the raw rhubarb powder; preparing renal failure treating medicinal powder; preparing into a capsule, a tablet, an instant herbal medicine, powder and an oral liquid; and inspecting. A renal failure treating medicament provided by the invention has the advantages of higher chemical stability, stable product quality, higher content uniformity, very low content deviation, great increase in active ingredients, quick release of contents after the preparation is taken, high in-vivo utilization ratio and high absorbing rate.
Description
Technical field
The present invention relates to a kind of method for preparing of Chinese medicine preparation, specifically is a kind of SHENSHUAINING Chinese medicine preparation and preparation method thereof.
Background technology
Chronic renal failure is that the renal function that multiple chronic renal disease causes goes down.Because RE and regulatory function are not normal; Cause water, electrolyte and acid-base balance extremely disorderly; And nitrogen matter metabolite is in vivo due to the retention, and CRF is very harmful to people ' s health, belongs to severe crisis; And classified as one of the world's seven big difficult and complicated illness, be that one of key project problem that solves is badly in need of in the world of medicine.The present CRF of treatment both at home and abroad mainly takes hemodialysis, peritoneal dialysis and renal transplantation method, expensive, and reaching individual to society, family is white elephant per capita.And Chinese medicine is to progress, the patients in remission that delays CRF and the crucial effect of having improved the quality of living.Chinese medicine preparation SHENSHUAINING film-coat preparation can fast, effectively reduce blood urea nitrogen, serum creatinine level aspect the treatment CRF; Improve uremia's clinical symptoms, improve immune function of human body, the depleted progress of delaying chronic kidney; Improve renal anemia, postpone the beginning dialysis time, reduce the dialysis number of times." SHENSHUAINING film-coat preparation " clinical verification total effective rate is up to 83.2%.Mostly existing SHENSHUAINING film-coat preparation, capsule, electuary are crude drug is pulverized aftershaping.The various crude drug that Chinese medicine preparation adopted are because of reasons such as the place of production, weather, seasons, and wherein contained active ingredient is not quite similar.The crude drug and identical preparation technology of equal number often appear adopting in the production, in the product of producing active ingredient inequality, make that the active ingredient in the Chinese medicine preparation is difficult to accurate control.Crude drug is pulverized the back straight forming, makes that the effective ingredient in the products material is low, and drug chemistry performance and quality are unstable, and absorbance is lower, and dosage is bigger, and small product size is bigger, and medicine all need take bigger space at transportation, storage.
Summary of the invention
The objective of the invention is to overcome the deficiency that exists on the existing SHENSHUAINING preparation technique; Provide a kind of to Chinese medicine SHENSHUAINING preparation. the technical scheme of a kind of SHENSHUAINING Chinese medicine preparation of upgrading and preparation method thereof; The SHENSHUAINING preparation chemical stability of producing by this scheme strengthens; Constant product quality, the content homogeneity is better, and effective ingredient and absorbance improve.
Technical scheme of the present invention is: a kind of SHENSHUAINING Chinese medicine preparation is the medicament of processing by following mass parts crude drug: Radix Pseudostellariae 200-300, Rhizoma Coptidis 80-120, Rhizoma Pinelliae Preparatum 200-300, Pericarpium Citri Reticulatae 80-120, Poria 150-250, Radix Et Rhizoma Rhei 500-700, Radix Salviae Miltiorrhizae 600-800, Radix Achyranthis Bidentatae 150-250, Flos Carthami 80-120, Radix Glycyrrhizae 80-120; It is characterized in that, check preparation: mobile phase: methanol with HPLC
:Water=45:55, detection wavelength: 254nm, number of theoretical plate>=5000 contain total alkaloids in berberine hydrochloride, and every 0.35g is greater than 3.2mg.
Described medicament is the described capsule of pharmaceutics, tablet, electuary, powder, oral liquid.
A kind of method for preparing of SHENSHUAINING Chinese medicine preparation is characterized in that, concrete steps are following:
(1) is equipped with crude drug, crude drug remove impurity, dust removal by claim 1;
(2) getting mass parts is that the Radix Et Rhizoma Rhei of 40-60% prepares the Radix Et Rhizoma Rhei fecula;
(3) getting mass parts is that the Radix Et Rhizoma Rhei of 40-60% prepares the Radix Et Rhizoma Rhei thick paste;
(4) preparation Rhizoma Coptidis, Poria, Radix Pseudostellariae, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Pinelliae Preparatum, Pericarpium Citri Reticulatae, Radix Achyranthis Bidentatae, Radix Glycyrrhizae medicine thick paste:
(5) the Radix Et Rhizoma Rhei thick paste mixes dense thick paste with medicine thick paste mixing simmer down to;
(6) mix dense thick paste and step (2) Radix Et Rhizoma Rhei fecula mix homogeneously;
(7) spray drying is crushed to the 100-120 order, is SHENSHUAINING medicated powder;
(8) be prepared as capsule, tablet, electuary, powder, oral liquid with SHENSHUAINING medicated powder by common process;
(9) check: check medicament with HPLC: mobile phase: methanol-water (45:55), detection wavelength: 254nm, number of theoretical plate >=5000, contain total alkaloids in berberine hydrochloride, every 0.35g is greater than 3.2mg.
The concrete steps of the said Radix et Rhizoma Rhei (processed) fecula of step (2) are: get Radix Et Rhizoma Rhei 50%, be crushed to the 100-120 order, 60 ℃ of-75 ℃ of sterilizations are the Radix Et Rhizoma Rhei fecula.
The concrete steps of the said Radix et Rhizoma Rhei (processed) thick paste of step (3) are: get Radix Et Rhizoma Rhei 50%, be crushed to the 30-50 order, drop in the percolation jar, use concentration to be solvent as 60-70%EOH, percolation was collected percolate after 24 hours, and being concentrated into density is 1.20-1.35 g/cm
3, being the Radix Et Rhizoma Rhei thick paste, described EOH solvent is 95% dehydrated alcohol, described simmer down to vacuum concentration.
The concrete steps of the said Rhizoma Coptidis of step (4), Poria, Radix Pseudostellariae, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Pinelliae Preparatum, Pericarpium Citri Reticulatae, Radix Achyranthis Bidentatae, Radix Glycyrrhizae medicine thick paste are: raw medicinal material drops into water and carries jar; Divide three water to carry; With three extracting liquid filterings, being concentrated into density is 1.40-1.65g/cm
3, be extractum; Extractum is chilled to 30 ± 5 ℃, uses concentration to regulate as 95%EOH, and making the EOH content in the extractum is 60% o'clock, and the precipitate with ethanol that stirs left standstill precipitate with ethanol 72 hours, gets clear liquid medicine through filtering, be concentrated into to density be 1.40-1.65g/cm
3, being the medicine thick paste, described EOH solvent is 95% dehydrated alcohol, described simmer down to vacuum concentration or heating concentrate.
The dense thick paste of the described mixing of step (5) be medicine thick paste that Radix Et Rhizoma Rhei thick paste that step (3) is made and step (4) make put into same container stir, heat be concentrated into to density be 1.50-1.66g/cm
3The dense thick paste of mixing.
The said spray drying of step (7) drying time is 2-2.5 hours, and the dry materials temperature is lower than 95 ℃.
The present invention adopts modern pharmaceutical technology to prepare the SHENSHUAINING Chinese medicine preparation.Modern pharmaceutical technology is normally with the mode of crude drug through extracting, the active ingredient of extracting crude drug.Radix Et Rhizoma Rhei is the Main Ingredients and Appearance in the SHENSHUAINING Chinese medicine preparation, if the mode through extracting, the character of crude drug will change, and possibly change preparation curative effect and orientation treatment, if all directly adopt crude drug, occurs untoward reaction easily, and preparation is difficulty also.For guaranteeing the unique curative effect of SHENSHUAINING preparation in the treatment chronic renal failure; The present invention is made as fecula with 50% of Radix Et Rhizoma Rhei; Other 50% is prepared as the Radix Et Rhizoma Rhei thick paste after extracting; Remaining crude drug is prepared as the medicine thick paste through extraction, and again the Radix Et Rhizoma Rhei fecula being mixed the back spray drying with Radix Et Rhizoma Rhei thick paste and medicine thick paste is SHENSHUAINING medicated powder, and SHENSHUAINING medicated powder is prepared form of Chinese drug such as capsule, tablet, electuary, powder, oral liquid by conventional method.Quality control of the present invention is to check preparation with HPLC, controls indexs such as mobile phase, wavelength, number of theoretical plate especially, the most important thing is to control total alkaloid contents.Advanced technology of the present invention, technology are reasonable, and the present invention can prepare form of Chinese drug such as capsule, tablet, electuary, powder, oral liquid easily by conventional method.The chemical stability of SHENSHUAINING Chinese medicine preparation of the present invention strengthens, constant product quality, and the content homogeneity is better, and content deviation is very low, and effective ingredient significantly improves, and after preparation was absorbed, content can discharge rapidly, utilization rate, absorbance height in the body.
Pharmacology, the test of pesticide effectiveness of the SHENSHUAINING Chinese medicine preparation of the present invention's preparation are following:
1, toxicological test, experimental animal toxic reaction useless when the result shows normal use.The concrete test as follows:
A, acute toxicity test: its mouse oral is irritated the maximum dose 34.0g/80ml/kg of stomach body weight, amounts to crude drug in whole 233.14g/kg body weight, is 323.8 times of adult's clinical application amount.
B, institute for drug control, Yunnan Province " SHENSHUAINING preparation long-term toxicity test for animals " show; " rat oral gavage is given SHENSHUAINING preparation 2.1g/kg/ day and 7.0g/kg/ day; be equivalent to the day for human beings 15 times and 50 times with product dosage; calculate with body weight, successive administration did not see that animal appearance was unusual in 100 days, and body weight gain is normal; And, hematology detection biochemical through blood, main organs coefficient determination and histopathologic examination, the result shows that SHENSHUAINING preparation gastric infusion was not found overt toxicity in 100 days ".
C, long term toxicity test: the result shows its mouse oral filling stomach SHENSHUAINING capsule medicated powder 2.00,3.30, three dose groups of 4.50g/kg.bw; Amount to crude drug 1.37,2.26,3.09g/kg.bw, 19.00,31.43,42.85 times of the clinical application amount that is equivalent to be grown up.Successive administration 12 all results are: do not cause obvious toxic reaction; Experimental animal hematology, serum biochemistry, electrolyte and urine detection index are not seen obviously unusual; Histopathologic examination does not observe the animal viscera organ Histological change relevant with the animal subject medicine; The result shows SHENSHUAINING medicated powder 2.00 g/kg.bw, amounts to crude drug 1.37 g/kg.bw, is the safe dose term of reference below 19.00 times with respect to adult's clinical application amount.
D, the unify result of the test that influences of respiratory system of cardiovascular system is shown: anaesthetized dog blood pressure, respiratory frequency, respiratory depth and electrocardiogram are not all had obviously influence through the SHENSHUAINING Chinese medicine preparation.The neural result of influence to mice shows: mouse mainline SHENSHUAINING Chinese medicine preparation, dosage are that 10,20,30,40 mg/kg. all do not have obvious influence to These parameters.
2, pharmacodynamics test shows that the present invention goes down to have widely to the renal function that is caused by multiple chronic renal disease and uses, concrete test as follows:
A, institute for drug control, Yunnan Province pharmacological room show that to " pharmacological action of SHENSHUAINING preparation and effect " research said preparation can " effectively reduce blood urea nitrogen, creatinine level fast; Improve uremia's clinical symptoms, improve immune function of human body; The postponing chronic kidney function failure process is improved renal anemia, postpones the beginning dialysis time, reduces the dialysis number of times ".
" the SHENSHUAINING preparation is to the influence of immunologic hypofunction mice carbon clearance speed " of B, institute for drug control, Yunnan Province pharmacological room show, " cortisone 100mg/kg organizes continuous three days subcutaneous injections and can obviously suppress mice carbon and clean up speed, with the blank group relatively; through check, difference has the significance meaning, P 0.01; animal presents immunologic function and reduces, and uses SHENSHUAINING preparation 0.07g/kg simultaneously, and 2.10g/kg or levamisole obviously the antagonism cortisone to the inhibitory action of immunologic function; combination group K value and cortisone group are relatively; positive t checks or t checks through examining, difference and highly significant property meaning is arranged or utmost point significance meaning, P < 0.01 or P < 0.001.This shows that the SHENSHUAINING preparation has the effect that improves the MNP function of regulating ".
The conclusion of C, " influence that the SHENSHUAINING preparation forms immunologic hypofunction mice lgM " is " cyclophosphamide 7.5mg, kg, ip group successive administration 10 days, mice HC
50 value obviously reduces, and compares with the blank group, and difference has significance meaning p<0.05, show the animal model that causes humoral immune function low.As share SHENSHUAINING preparation 2.10gkg, quite Coming-of-Age Day is with 15 times of dosage, according to the weight or revolve imidazoles 100mg/kg, but the humoral immunization inhibitory action of antagonism cyclophosphamide then, the adjusting humoral immune function.Make it to keep normal level.But SHENSHUAINING preparation 0.70g/kg does not then have this effect ".
D, " the SHENSHUAINING preparation is to LT influence " conclusion are; " SHENSHUAINING preparation 0.15mg/ml and 0.3mg/ml can significantly strengthen the T lymphocyte transformation that PHA stimulates; with the blank group relatively; difference has highly significant property meaning, P 0.01 with significance meaning P 0.001, this shows that the SHENSHUAINING preparation can improve cellular immune function ".
The conclusion of E, " the SHENSHUAINING preparation is to the influence of mice reserpine type syndrome of spleen-deficiency " is, " /> body temperature obviously descends for reserpine 0.1mg/kg, SC group successive administration 7 days; mice body weight, with blank relatively; difference has utmost point significance meaning, P 0.001, show and cause the animals with spleen deficiency model.Giving reserpine 8-14 days give SHENSHUAINING preparation 2.10g/kg or decoction of four noble drugs 20 g/kg simultaneously, can make the mice with spleen deficiency body weight, the body temperature rebound significantly, with the reserpine group relatively, difference has utmost point significance meaning P < 0.001.SHENSHUAINING preparation 0.70 gkg can make mice with spleen deficiency body weight rise P < 0.01, and body temperature is not had obvious influence.Show that than the result SHENSHUAINING preparation has obvious improvement effect to insufficiency of the spleen symptom ".
The conclusion of F, " the SHENSHUAINING preparation is to the influence of the mouse immune organ of suffering from a deficiency of the kidney " is, " a hydrocortisone 0.5mg/ intramuscular injection once can make mouse thymus; the adrenal gland; splenatrophy, organ index and normal control group relatively, difference has significance meaning or highly significant property meaning; P 0.01 or P 0.001, show and cause the animal model of suffering from a deficiency of the kidney.Give pieces of Jin ' gui shenqi 4.5g/kg or SHENSHUAINING preparation 2.10 g/kg can make the mouse thymus of suffering from a deficiency of the kidney; The adrenal gland; Spleen weight returns to normally, and its organ index and model control group compare, and difference has highly significant property meaning or utmost point significance meaning; P 0.05 or P 0.01, show and cause the animal model of suffering from a deficiency of the kidney.Give JINGUI SHENQI WAN 4.5g/kg; SHENSHUAINING preparation 2.10 g/kg can make the mouse thymus of suffering from a deficiency of the kidney, and spleen weight returns to normally, and its organ index and model control group are relatively; Difference has significance meaning or highly significant property meaning; P 0.05 or P 0.01, though the adrenal gland has recovery trend statistical procedures significant difference property meaning, P>0.05 ".
The conclusion of G, " the SHENSHUAINING preparation is to the influence of charcoal end efflux time " is; " SHENSHUAINING preparation 0.70g/kg and 2.10 g/kg and Radix Et Rhizoma Rhei 20 g/kg can obviously shorten the charcoal end and find time; compare with blank; difference all has utmost point significance meaning, p 0.1, this shows that the SHENSHUAINING preparation has significant discharge function ".
The conclusion of H, " the SHENSHUAINING preparation is to the influence of syndrome of blood stasis rat blood rheological characteristic " is, " swimming 14 days continuously of blank group rat, the height of blood viscosity; low shear rate increases, reflection " glue ", packed cell volume is set up reflection " dense "; plasma viscosity and fibronectin increase reflection and " gather " />; to be that blood denaturation is sticking, dense, with fixed attention, gather change, show and cause the syndrome of blood stasis animal model.Irritate stomach and give the SHENSHUAINING preparation 2.10 g/kg, be equivalent to the day for human beings 15 times with dosage, or BUYANG HUANWU TANG 20 g/kg; Can make the height of WBV, low shear rate, whole blood reduced viscosity, erythrocyte viscosity, packed cell volume, plasma viscosity, fibrin it's too late erythrocyte sedimentation rate shows and reduces, with the blank group relatively; Difference has the significance meaning, highly significant property meaning and utmost point significance meaning, and P < 0.05; P 0.10 or P 0.001, irritate stomach and give SHENSHUAINING preparation 70gkg, be equivalent to the day for human beings 5 times with dosage; Packed cell volume is significantly reduced, compare with the blank group, difference has the significance meaning; P 0.05, the rarely seen reduction trend of other index and statistics does not have the significance meaning.This result show the SHENSHUAINING preparation can obviously improve syndrome of blood stasis rat blood rheological characteristic sticking, dense, coagulate, gather to change have function of promoting blood circulation to disperse blood clots ".
The conclusion of I, " the SHENSHUAINING preparation is to the influence of chronic renal failure rat " is, " /> rat gave adenine continuous 20 days by irritating stomach 400mg/kg day, creatinine in the blood; blood urea nitrogen, medium molecular substance total amount, serium inorganic phosphorus; blood sodium, and the blood osmotic pressure, urine amount and albumen significantly raise; Creatinine clearance rate, blood calcium, bicarbonate, erythrocyte, packed cell volume, hemoglobin, urine amount and albumen significantly reduce.With the normal control group relatively, difference has highly significant property meaning and extremely remarkable meaning, P 0.01 or P < 0.001, histological examination also representes that renal tissue accomplishes on time, and this shows and causes rat chronic renal failure model.The SHENSHUAINING preparation is pressed 2.10g/>kg/ day, is equivalent to 15 times of consumption per day, calculates with body weight, irritates stomach and gives the renal failure rat, continuous 30 days; Can make creatinine in the blood, blood urea nitrogen, medium molecular substance total amount, serium inorganic phosphorus, blood sodium; The blood osmotic pressure, urine amount and urine protein significantly reduce, and make creatinine clearance rate, blood calcium, bicarbonate; Erythrocyte, packed cell volume, hemoglobin, urine amount and albumen significantly raise.With the blank group relatively, difference has significance meaning, highly significant property meaning or utmost point significance meaning, < 0.05, P < 0.01 or P < 0.001 for P.Also can make 0.70 g/>kg/ day of SHENSHUAINING preparation middle creatinine blood urea nitrogen, medium molecular substance total amount, serium inorganic phosphorus, blood osmotic pressure, urine protein, the urine amount significantly reduces, and makes creatinine fall rate clearly, and creatinine significantly raises in bicarbonate, packed cell volume, hemoglobin and the urine.With the blank group relatively, difference has the significance meaning, highly significant property meaning or utmost point significance meaning, < 0.05, P < 0.01 or P < 0.001 for P.Renal tissue learn check result show SHENSHUAINING preparation 0.70 gkg, 2.10 g/kg or Radix Et Rhizoma Rhei to renal tissue infringement does not all have obviously improvement.The result shows: the SHENSHUAINING preparation all improves significantly to changes such as the hypofunction of chronic renal failure kidney of rats, metabolite retention, water, electrolyte and acid base imbalance and kidney concentrating function obstacles ".
Adopt traditional method that crude drug is pulverized the back straight forming and prepare in SHENSHUAINING Film coated tablets and the SHENSHUAINING capsule that adopts method preparation of the present invention the active constituent content contrast and see table 1, each effective ingredient obviously improves.
Table 1 adopts active constituent content synopsis in traditional method preparation for preparing and the preparation that adopts method preparation of the present invention
Clinical use contrast:
Make a definite diagnosis renal insufficiency I phase patient 30 examples through hospital, Scr:133-177 μ mol/L, renal insufficiency II phase patient 30 examples, Scr:177-442 μ mol/L; Renal insufficiency III phase patient 30 routine Scr:442-707 μ mol/L; Take the treatment of SHENSHUAINING film-coat preparation, 1 month is a course of treatment, concrete method of administration:
1, renal insufficiency I phase patient: each 4,3 times on the one.
2, renal insufficiency II phase patient: respectively obey 5 at 8,13,18 o'clock every day, 22 o'clock or be taken at bed time 6.
3, renal insufficiency III phase patient: 8,13,18,22 o'clock every days or be taken at bed time 6.
Make a definite diagnosis renal insufficiency I phase patient 30 examples through hospital, Scr:133-177 μ mol/L, renal insufficiency II phase patient 30 examples, Scr:177-442 μ mol/L; Renal insufficiency III phase patient 30 routine Scr:442-707 μ mol/L; Take SHENSHUAINING capsule for treating of the present invention, one month is a course of treatment, concrete method of administration:
1, renal insufficiency I phase patient: Scr:133-177 μ mol/L; Each 1,3 times on the one.
2, renal insufficiency II phase patient: Scr:177-442 μ mol/L; Respectively obey 1 at 8,13,18 o'clock every day, 22 o'clock or be taken at bed time 1.
3, renal insufficiency III phase patient: Scr:442-707 μ mol/L; Respectively obey 1 or be taken at bed time 1 at 8,13,18,22 o'clock every day.
The curative effect of taking medicine after 1 course of treatment is taken 3-6 the course of treatment with to take the SHENSHUAINING film-coat preparation identical, does not all see gastrointestinal upset or toxic and side effects.
The specific embodiment
1, SHENSHUAINING capsule
Concrete steps are following:
(1) is equipped with crude drug such as table 2, crude drug remove impurity, dust removal;
(2) get Radix Et Rhizoma Rhei 50%, be crushed to the 100-120 order, 60 ℃ of-75 ℃ of sterilizations are the Radix Et Rhizoma Rhei fecula;
(3) get Radix Et Rhizoma Rhei 50% preparation Radix Et Rhizoma Rhei thick paste; The concrete steps of Radix et Rhizoma Rhei (processed) thick paste are: get Radix Et Rhizoma Rhei 50%, be crushed to the 30-50 order, drop in the percolation jar; Use concentration to be solvent as 60-70%EOH, percolation was collected percolate after 24 hours; Collect percolate to color light till, use pump to squeeze into vacuum concentration pot and be concentrated into density and be 1.20-1.35 g/cm
3, be the Radix Et Rhizoma Rhei thick paste, realize precipitation when concentrating, described EOH solvent is 95% dehydrated alcohol;
(4) preparation Rhizoma Coptidis, Poria, Radix Pseudostellariae, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Pinelliae Preparatum, Pericarpium Citri Reticulatae, Radix Achyranthis Bidentatae, Radix Glycyrrhizae medicine thick paste; Concrete steps are: raw medicinal material drops into water and carries jar; Divide three water to carry, with three extracting solution conventional filtrations, being concentrated into density is 1.40-1.65g/cm
3, be extractum; Extractum is chilled to 30 ± 5 ℃, uses concentration to regulate as 95%EOH, and making the EOH content in the extractum is 60% o'clock, and the precipitate with ethanol that stirs left standstill precipitate with ethanol 72 hours, got clear liquid medicine and filtered through routine, be concentrated into to density be 1.40-1.65g/cm
3, being the medicine thick paste, described EOH solvent is 95% dehydrated alcohol.Adopt film-rising evaporator in this embodiment, realize precipitation when concentrating, the film-rising evaporator I of preheating is about concentrated solution inlet temperature 85 degree, about concentrated solution outlet temperature 95 degree; The film-rising evaporator II: about concentrated solution outlet temperature 100 degree, concentration is 28%-45%; Indirect steam pressure is 0.30-0.50Mpa; The film-rising evaporator III: about concentrated solution outlet temperature 120 degree, concentration is 60%-75%; Indirect steam pressure is 0.40-0.60Mpa; The concentrated solution heater: the concentrated solution outlet temperature is about 95 degree; More than concentrated solution outlet temperature 100 degree, concentration is more than 35%; Volatile matter is no more than 0.50% in the leaching product; Indirect steam pressure is 0.40Mpa, and superheated steam pressure is 0.04-0.06Mpa;
(5) the Radix Et Rhizoma Rhei thick paste mixes dense thick paste with medicine thick paste mixing simmer down to, the dense thick paste of described mixing be medicine thick paste that Radix Et Rhizoma Rhei thick paste that step (3) is made and step (4) make put into same uncovered concentration pan internal heating concentrate stir simultaneously, heat be concentrated into to density be 1.50-1.66g/cm
3The dense thick paste of mixing.
(6) mix dense thick paste and step (2) Radix Et Rhizoma Rhei fecula mix homogeneously;
(7) spray drying, be 2-2.5 hours drying time, and it is 2-2.5 hours that the dry materials temperature is lower than 95 ℃ of said spray drying drying times, and the dry materials temperature is lower than 95 ℃ and is crushed to the 100-120 order, is SHENSHUAINING medicated powder;
(8) be prepared as the capsule medicament with SHENSHUAINING medicated powder by common process, concrete steps are: crushing screening: pulverized the 100-120 mesh sieve; Total mixing: in SHENSHUAINING medicated powder, add the adjuvant Pulvis Talci of SHENSHUAINING medicated powder gross weight 3%, mix homogeneously, start mixed 1 hour; Filling: disintegrate limit≤22 minute; Loading amount: 0.35g ± 8%; Bubble-cap: go up temperature of heating plate: 138 ℃--145 ℃; Following temperature of heating plate: 135 ℃--142 ℃; Typewriting imprint temperature: 140 ℃--170 ℃; Heat-sealing temperature: 205 ℃--218 ℃.
(9) check: contain total alkaloids in berberine hydrochloride, every 0.35g is no less than 3.2mg; Detection method is: HPLC: mobile phase: methanol: water=45:55, detection wavelength: 254nm, number of theoretical plate>=5000, and moisture :≤5.0%, disintegration :≤22 minutes, content uniformity: 0.35g ± 8% (0.322-0.378).
2, SHENSHUAINING tablet
Step (1)-(7) and step (9) are identical with the preparation capsule, and step (8) is to be prepared as tablet with SHENSHUAINING medicated powder by common process.
3, SHENSHUAINING electuary, powder
Step (1)-(7) and step (9) are identical with the preparation capsule, and step (8) is to be prepared as electuary or powder with SHENSHUAINING medicated powder by common process.
Check: contain total alkaloids in berberine hydrochloride, every 0.35g must not be less than 2.0mg; Detection method is: HPLC: mobile phase: methanol: water=45:55, detection wavelength: 254nm, number of theoretical plate>=5000, moisture :≤5.0%.
4, SHENSHUAINING oral liquid
Step (1)-(7) and step (9) are identical with the preparation capsule, and step (8) is to prepare oral liquid with SHENSHUAINING medicated powder by common process.
Table 2
Claims (8)
1. a SHENSHUAINING Chinese medicine preparation is the medicament of processing by following mass parts crude drug: Radix Pseudostellariae 200-300, Rhizoma Coptidis 80-120, Rhizoma Pinelliae Preparatum 200-300, Pericarpium Citri Reticulatae 80-120, Poria 150-250, Radix Et Rhizoma Rhei 500-700, Radix Salviae Miltiorrhizae 600-800, Radix Achyranthis Bidentatae 150-250, Flos Carthami 80-120, Radix Glycyrrhizae 80-120; It is characterized in that, check preparation: mobile phase: methanol with HPLC
:Water=45:55, detection wavelength: 254nm, number of theoretical plate>=5000 contain total alkaloids in berberine hydrochloride, and every 0.35g is greater than 3.2mg.
2. a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 1 is characterized in that, described medicament is the described capsule of pharmaceutics, tablet, electuary, powder, oral liquid.
3. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 1 is characterized in that, concrete steps are following:
Be equipped with crude drug, crude drug remove impurity, dust removal by claim 1;
The Radix Et Rhizoma Rhei of getting mass parts and be 40-60% prepares the Radix Et Rhizoma Rhei fecula;
The Radix Et Rhizoma Rhei of getting mass parts and be 40-60% prepares the Radix Et Rhizoma Rhei thick paste;
Preparation Rhizoma Coptidis, Poria, Radix Pseudostellariae, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Pinelliae Preparatum, Pericarpium Citri Reticulatae, Radix Achyranthis Bidentatae, Radix Glycyrrhizae medicine thick paste:
The Radix Et Rhizoma Rhei thick paste mixes dense thick paste with medicine thick paste mixing simmer down to;
Mix dense thick paste and step (2) Radix Et Rhizoma Rhei fecula mix homogeneously;
Spray drying is crushed to the 100-120 order, is SHENSHUAINING medicated powder;
Be prepared as capsule, tablet, electuary, powder, oral liquid with SHENSHUAINING medicated powder by common process;
Check: check medicament with HPLC: mobile phase: methanol-water (45:55), detection wavelength: 254nm, number of theoretical plate >=5000, contain total alkaloids in berberine hydrochloride, every 0.35g is greater than 3.2mg.
4. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 3 is characterized in that, the concrete steps of the said Radix et Rhizoma Rhei (processed) fecula of step (2) are: get Radix Et Rhizoma Rhei 50%, be crushed to the 100-120 order, 60 ℃ of-75 ℃ of sterilizations are the Radix Et Rhizoma Rhei fecula.
5. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 3 is characterized in that, the concrete steps of the said Radix et Rhizoma Rhei (processed) thick paste of step (3) are: get Radix Et Rhizoma Rhei 50%; Be crushed to the 30-50 order; Drop in the percolation jar, use concentration to be solvent as 60-70%EOH, percolation is after 24 hours; Collect percolate, being concentrated into density is 1.20-1.35 g/cm
3, being the Radix Et Rhizoma Rhei thick paste, described EOH solvent is 95% dehydrated alcohol, described simmer down to vacuum concentration.
6. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 3; It is characterized in that; The concrete steps of the said Rhizoma Coptidis of step (4), Poria, Radix Pseudostellariae, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Pinelliae Preparatum, Pericarpium Citri Reticulatae, Radix Achyranthis Bidentatae, Radix Glycyrrhizae medicine thick paste are: raw medicinal material drops into water and carries jar; Divide three water to carry, with three extracting liquid filterings, being concentrated into density is 1.40-1.65g/cm
3, be extractum; Extractum is chilled to 30 ± 5 ℃, uses concentration to regulate as 95%EOH, and making the EOH content in the extractum is 60% o'clock, and the precipitate with ethanol that stirs left standstill precipitate with ethanol 72 hours, got the supernatant medical filtration, be concentrated into to density be 1.40-1.65g/cm
3, being the medicine thick paste, described EOH solvent is 95% dehydrated alcohol, described simmer down to vacuum concentration or heating concentrate.
7. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 3; It is characterized in that, the dense thick paste of the described mixing of step (5) be medicine thick paste that Radix Et Rhizoma Rhei thick paste that step (3) is made and step (4) make put into same container stir, heat be concentrated into to density be 1.50-1.66g/cm
3The dense thick paste of mixing.
8. the method for preparing of a kind of SHENSHUAINING Chinese medicine preparation as claimed in claim 3 is characterized in that, the said spray drying of step (7) drying time is 2-2.5 hours, and the dry materials temperature is lower than 95 ℃.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103071006A (en) * | 2013-02-07 | 2013-05-01 | 云南理想药业有限公司 | Preparation method and quality inspection method of traditional Chinese medicine for treating kidney failure |
| CN103830466A (en) * | 2012-11-27 | 2014-06-04 | 包桂荣 | Medicine for treating early kidney failure |
| CN104758515A (en) * | 2015-04-08 | 2015-07-08 | 云南理想药业有限公司 | Traditional Chinese medicinal composition for treating nephropathy as well as preparation method and detection method thereof |
| CN104857213A (en) * | 2015-05-13 | 2015-08-26 | 云南理想药业有限公司 | Preparation method for traditional Chinese medicine composition for treating nephropathy |
| CN105250283A (en) * | 2015-10-27 | 2016-01-20 | 淄博齐鼎立专利信息咨询有限公司 | Application of Chaetoconvosins B in preparation of drug for treating renal insufficiency |
| CN105628851A (en) * | 2014-10-31 | 2016-06-01 | 九芝堂股份有限公司 | Detection method of traditional Chinese medicine preparations |
| CN112972566A (en) * | 2019-12-13 | 2021-06-18 | 云南雷允上理想药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for reducing deposition of uric acid or urate |
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| CN1562195A (en) * | 2004-03-24 | 2005-01-12 | 云南理想药业有限公司 | Mediciation for curing chronic kidney function failure and its prepn. method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1562195A (en) * | 2004-03-24 | 2005-01-12 | 云南理想药业有限公司 | Mediciation for curing chronic kidney function failure and its prepn. method |
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| CN103830466A (en) * | 2012-11-27 | 2014-06-04 | 包桂荣 | Medicine for treating early kidney failure |
| CN103071006A (en) * | 2013-02-07 | 2013-05-01 | 云南理想药业有限公司 | Preparation method and quality inspection method of traditional Chinese medicine for treating kidney failure |
| CN103071006B (en) * | 2013-02-07 | 2014-10-22 | 云南理想药业有限公司 | Preparation method and quality inspection method of traditional Chinese medicine for treating kidney failure |
| CN105628851A (en) * | 2014-10-31 | 2016-06-01 | 九芝堂股份有限公司 | Detection method of traditional Chinese medicine preparations |
| CN105628851B (en) * | 2014-10-31 | 2017-10-31 | 九芝堂股份有限公司 | A kind of detection method of Chinese medicine preparation |
| CN104758515A (en) * | 2015-04-08 | 2015-07-08 | 云南理想药业有限公司 | Traditional Chinese medicinal composition for treating nephropathy as well as preparation method and detection method thereof |
| CN104857213A (en) * | 2015-05-13 | 2015-08-26 | 云南理想药业有限公司 | Preparation method for traditional Chinese medicine composition for treating nephropathy |
| CN104857213B (en) * | 2015-05-13 | 2020-10-27 | 云南雷允上理想药业有限公司 | Preparation method of traditional Chinese medicine composition for treating nephropathy |
| CN105250283A (en) * | 2015-10-27 | 2016-01-20 | 淄博齐鼎立专利信息咨询有限公司 | Application of Chaetoconvosins B in preparation of drug for treating renal insufficiency |
| CN112972566A (en) * | 2019-12-13 | 2021-06-18 | 云南雷允上理想药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for reducing deposition of uric acid or urate |
| CN112972566B (en) * | 2019-12-13 | 2022-05-31 | 云南雷允上理想药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for reducing deposition of uric acid or urate |
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Application publication date: 20120613 |