The Chinese medicine preparation that the purpose of this invention is to provide a kind of treatment chronic hepatitis Bhepatic fibrosis of the effect with hard masses softening and resolving, dissolving blood stasis and detoxication, supplementing QI and nourishing YIN.
Another object of the present invention provides a kind of preparation method of Chinese medicine preparation of above-mentioned treatment chronic hepatitis Bhepatic fibrosis.
The Chinese medicine preparation of treatment chronic hepatitis Bhepatic fibrosis of the present invention is made by following materials based on weight:
Carapax Trionycis 110-130 part Radix Paeoniae Rubra 80-90 part Radix Angelicae Sinensis 40-60 part
Radix Notoginseng 40-60 part Radix Codonopsis 80-90 part Radix Astragali 80-90 part
Placenta Hominis 40-50 part Cordyceps 20-30 part Baphicacanthus cusia plate 130-150 part
Fructus Forsythiae 130-150 part Rhizoma Curcumae 20-30 part
The Chinese medicine preparation of treatment chronic hepatitis Bhepatic fibrosis of the present invention considers that blood stasis hinders in the liver network, suitable disperse blood stasis and dredge collateral is for wanting, it is unclear to take into account the surplus heresy of pyretic toxicity simultaneously, adapt to and to face the dirty void of liver spleen kidney three, so suitable heat-clearing and toxic substances removing, nourishing blood to suppress the hyperactive liver, invigorating the spleen and benefiting QI, kidney tonifying, essence replenishing, thereby reach reinforcement and elimination in combination, the purpose of giving consideration to both the incidental and fundamental.This Chinese medicine preparation cures mainly mass in the abdomen under side of body rib dull pain or the rib, and complexion is dark dim, distension and fullness in the abdomen, and the poor appetite loose stool, spiritlessness and weakness, xerostomia and hardship, red thread port wine stain, the spider sand palm, body of the tongue is dim or ecchymosis is arranged, and the tongue fur BOHUANG is greasy, stringy and thready pulse.The chronic hepatitis Bhepatic fibrosis patient sees above-mentioned obstruction of collaterals by blood stasis, and deficiency of qi and yin, pyretic toxicity are not use up patient and all can be used.
Wherein, described Carapax Trionycis is monarch in we.Its salty in the mouth is flat, goes into liver, kidney channel, but its both hard masses softening and resolving, but nourishing YIN for suppressing the hyperactive YANG again, so the card of having hindered in the cloudy blood of blood stasis congelation, Liver and kidney of primary disease appropriateness particularly." herbal classic " meaning: " hard long-pending, the cold and heat of main trusted subordinate, remove painful abdominal mass, polyp, the erosion of the vulva, hemorrhoid, evil meat "." Bencao Congxin " meaning: " controlling the disease of the cloudy blood system of fainting ".
We are minister with Radix Angelicae Sinensis, Radix Paeoniae Rubra, Radix Notoginseng three flavors, to strengthen nourshing blood and promoting blood circulation, the power of blood stasis-eliminating and stagnation-dissipating.Radix Angelicae Sinensis sweet in the mouth suffering is warm in nature, and merit is specially enriched blood and invigorated blood circulation, thus nourishing blood to suppress the hyperactive liver, blood circulation promoting and blood stasis dispelling.The Radix Paeoniae Rubra bitter in the mouth is slightly cold, and has clearing away heat and cooling blood, and the merit of disperse blood stasis and dredge collateral is specially gone into Liver Channel, " herbal classic " meaning: " main pathogen stomachache is removed the broken hard knot of arthralgia due to stagnation of blood, cold and heat, pain relieving, diuresis ".Radix Notoginseng sweet and slightly bitter taste flavor temperature is dissipating blood stasis for subsidence of swelling, the medicine of hemostasis analgesic therapy.More than three medicines help Carapax Trionycis disappear abdominal mass, go to gather, the effect of eliminating mass and relieving fullness piece, eliminating evil and just do not hinder.
Radix Codonopsis described in the we, Radix Astragali invigorating the spleen and benefiting QI; Described Cordyceps, Placenta Hominis enriching kidney essence; Described Radix Isatidis, Fructus Forsythiae heat-clearing and toxic substances removing are assisted the less important syndrome of treatment from three different aspects, are to be adjuvant drug.Radix Codonopsis is sweet flat, invigorating the spleen and replenishing QI, and " Bencao Congxin " meaning: " main invigorating the spleen and replenishing QI and taste, relieving thirst and restlessness ... a little less than the middle feeble QI are mended in order to transfer, and be very smooth and proper." the sweet tepor of the Radix Astragali, by the gas lift sun, the consolidating superficial resistance poison holding; " not Lu " meaning: " deficient by the husband, five kinds of over strain is won thin, quench the thirst, stomachache, dysentery, QI invigorating, Li Yin gas ".The same usefulness of ginseng stilbene, warming and invigorating the spleen and stomach, ascending spleen-QI is changed angry blood, i.e. the main idea of so-called " seeing the disease of liver, knowing the liver disease will be transmitted into the spleen, tonifying the spleen in the ban ".The Cordyceps sweet in the mouth is flat, is the product of nourishing lung and kidney; " detailed outline is picked up any lost article from the road " meaning: " warm in nature warm, by the lean marrow." the Placenta Hominis sweet-salty is warm in nature, QI invigorating is arranged, nourishes blood, beneficial smart effect, is the in love product of flesh and blood, so the disease of all insufficiency of vital energy and bloods, deficiency of the kidney all can be taken.The body of the cloudy damage of essence void of kidney, QI and blood is all hindered, with the passing of time reached to this two flavor for the liver spleen, all can play the kidney tonifying easing the affected liver, held up the effect of spleen by kidney.The Radix Isatidis bitter in the mouth is cold in nature, and the merit of eliminating fire and detoxication, dispersing swelling and dissipating binds is arranged, so be persons particularly liable to develop skin infection's panacea." herbal classic " meaning: " control cold and heat, scrofula, scrofula, carbuncle, malignant boil, stagnation of pathogenic heat, evil poison." product of two flavor heat-clearing and toxic substances removing, at unclear the resembling and establish of pyretic toxicity.
Rhizoma Curcumae described in the we, its property toil is warm in nature, and it is logical that the hot hardship of loosing of this product is let out temperature, specially goes into the Liver Channel blood system, though energy circulation of qi promoting blood stasis dispelling, the merit of eliminating stagnation repercussive, this survival dose is less in the right side, also plays the energy of guiding action, so be messenger drug.
In a word, the Chinese medicine preparation reinforcement and elimination in combination of treatment chronic hepatitis Bhepatic fibrosis of the present invention, giving consideration to both the incidental and fundamental, the surplus heresy of pyretic toxicity is removed, liver spleen kidney three dirty functions are recovered, now the blood stasis in the liver network is dissipated, reach the purpose of setting upright eliminating mass, have that hard masses softening and resolving, blood stasis dispelling are separated, the effect of supplementing QI and nourishing YIN.Effective percentage is 81.67%, and cure rate reaches 55.23%.
The preparation method of the Chinese medicine preparation of treatment chronic hepatitis B liver fibrosis of the present invention comprises Carapax Trionycis, Radix Notoginseng, Radix Paeoniae Rubra, Cordyceps, Placenta Hominis is ground into fine powder; With Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae distillating extracting oil, the aqueous solution after the distillation is stand-by, and medicinal residues are decocted with water 1-2 hour, filters, and filtrate and above-mentioned aqueous solution merge; Radix Codonopsis, the Radix Astragali and Radix Isatidis three flavors are decocted with water three times, each 1-2 hour, merge three times decocting liquid, filter to get filtrate; All filtrates and aqueous solution are merged, after the centrifugal roguing, being evaporated to relative density under 50 ℃ is the thick paste shape of 1.25-1.30, vacuum drying becomes dry extract, is ground into fine powder, and with the fine powder and the right amount of auxiliary materials mixing of above-mentioned Carapax Trionycis, Radix Notoginseng, Radix Paeoniae Rubra, Cordyceps, the Placenta Hominis five tastes, make granule and dry, the volatile oil that adds above-mentioned Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae three flavors again, mixing, compacting gets final product in flakes.
Wherein, described Carapax Trionycis is a Carapax Trionycis (processed), its chemical constituent contains animal glue, keratin, iodine matter and VD etc., all unsuitable long-time heating decocts, and answers powder to be used as medicine, the peculiar microstructure of the osseous tissue of its cellular scrambling hole, can be used as principal character with other medical material difference, should should check one by one to the Carapax Trionycis (processed) of buying earlier during preparation that discard in transportation, duration of storage goes mouldy, rancid person, product are put in the baking oven in 100-110 ℃ of dry for standby only; Described Radix Paeoniae Rubra is for containing the survey medical material, main 4 kinds of derivants that contain monoterpenes effective ingredient paeoniflorin, hepatocyte DNA is synthesized the effect that is significantly increased, the heart, hepatomicrosome there are remarkable inducing action and are beneficial to detoxifcation, also contain compositions such as gallic acid tannin, but it is on the low side that effective ingredient is put forward yield, the powder composition of can remaining valid that is used as medicine is beneficial to assay again, the Radix Paeoniae Rubra decoction pieces to buying during preparation, after assay meets the requirements, sieve earlier, remove the dedust bits, the rapid rinsing of reuse clear water once, remove silt, only the product drying for standby; Described Radix Notoginseng is a rare medicinal herbs, contains arasaponin R
1, panaquilon Rh
1, R
2, R
c, Rg
1The composition special acid dencichine of invigorating blood circulation, 16 seed amino acids, multiple inorganic elements and alkaloid etc., one or two kind of solvent is difficult to effective ingredient is carried to the greatest extent, be advisable so all be used as medicine with powder, during preparation the Radix Notoginseng of buying is sieved earlier, remove the dedust bits, the rinsing of reuse clear water once, remove silt, only the product dry for standby; Described Cordyceps is rare medicinal herbs, and the master contains crude protein 25.32%, carbohydrate 28.9%, and fat 8.4%, crude fibre 18.53%, other contains Vit B
120.2 μ g/100g etc., one or two kind of solvent is difficult to its effective ingredient is carried to the greatest extent, is advisable so all be used as medicine with powder, chooses quasi-fibrous attachment and impurity during preparation earlier, puts baking oven then in 75-85 ℃ of dry for standby; Described Placenta Hominis is the system Placenta Hominis, its complicated component, contain multiple antibody, interferon, β-inhibitive factor, hormone and enzyme etc., should not decoct with alcohol or water heating and extract, also be used as medicine, should check one by one the system Placenta Hominis of buying during preparation, discard rancid person with powder, clean product are put pressure cooker and are steamed 0.5h, the taking-up dry for standby in 121 ℃.The accurate weighing of five tastes medical material after above-mentioned pre-treatment, mix homogeneously is ground into fine powder, and breaking method is a mechanical crushing method, and used pulverizer is that Yantai City Zhifu pharmaceutical machine factory produces, and it pulverizes unit control station, WZS by the automatic control of ZKF-3 type
3Horizontal commentaries on classics sieve of-470 class and hF
3Three major parts such as-200 type pulverizers are formed, its work efficiency is for per hour pulverizing the 20-200kg medical material, the granularity of sieving can be adjusted arbitrarily between the 20-400 order, actual 120 mesh sieves of selecting for use are pulverized, because it belongs to the automatic circulation type grinding mode, its flour extraction can reach more than 95%, and then with fine powder cobalt-60 irradiation sterilization method, irradiation dose is 5kGy, can guarantee that this product hygiology is qualified.
The method of described distillating extracting oil is pharmacopeia first method (48 pages of appendix of Chinese Pharmacopoeia nineteen ninety version), promptly getting Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae is mixed in the flask, add water distillation 1-5 hour that 7-9 doubly measures, described ministerial drug Radix Angelicae Sinensis contains volatile oil, ligustilide, Aden's phenol, choline, ferulic acid and several amino acids; The messenger drug Rhizoma Curcumae contains volatile oil curcumenol, curdione, phenolic constituent, organic acid, resin, starch etc.; The adjuvant drug Fructus Forsythiae, contain volatile oil, forsythin 4.89%, betulic acid, ursolic acid, oleanolic acid, Fructus Forsythiae acid, phillygenol, Arctiin etc., three flavor merging add hot water (>80 ℃, because of Saponin is arranged) and use steam distillation, and average must the measuring of collecting volatile oil is 0.97ml.In the preparation addition of volatile oil be carrying of volatile oil the amount; Its adding method is: 76% dissolve with ethanol volatile oil with 7-9 doubly measures is sprayed onto on the dried particles airtight 35-45 minute after shaking up.
Described adjuvant drug Radix Codonopsis contains polysaccharide, Saponin, glucose, sucrose, 9 kinds of sterol compositions, 17 seed amino acids, 12 kinds of organic acid, 14 kinds of inorganic elementss etc., to nerve immunity, the multiple effect of digestive system; The described adjuvant drug Radix Astragali contains astragaloside, 21 seed amino acids, glucuronic acid, folic acid, 14 kinds of trace element, polysaccharide, choline etc.Astragaloside is the effective ingredient of antiviral, the infringement of anti-liver toxicity, and its polysaccharide and water solublity decoct have tangible liver protection function; Described adjuvant drug Radix Isatidis contains 7 seed amino acids such as indigo glycoside, sucrose, arginine, indigo, indirubin etc.; Three flavor medicines heating decoctings boil to be carried cream and is used as medicine more suitable.
Concentration process after described all filtrates and the aqueous solution carries out in E1-1 type vacuum concentration pot (being produced by Changshu pharmaceutical machine factory), vacuum often is controlled at 0.06-0.07Mpa so that the liquid temperature 50-70 ℃ of evaporation down, per hour can be evaporated moisture content 60-80 liter.
The pressure of the dry run of described concentrated thick paste is at 620-670mmHg, and temperature is 70-80 ℃, is ground into fine powder behind the one-tenth dry extract, and average paste volume is 10.8kg, and average paste-forming rate is 20.6%.
The preparation method of the Chinese medicine preparation of treatment chronic hepatitis Bhepatic fibrosis of the present invention can also comprise behind former powder of crude drug and the extract powder mixing, add cane sugar powder and starch, mix homogeneously is made soft material with ethanol as wetting agent, the granulation of sieving is put oven drying and is got dried particles.This particulate Quality Control parameter is:
1, moisture: 3-5% is generally 3.5%
2, granule size: 14-22 order.
3, content of paeoniflorin: every 0.5g granule contains paeoniflorin must not be less than 2.1mg.
Wherein, the addition of described cane sugar powder is a 5.5-9.5/ medicated powder gross weight; The addition of starch is 1.2/ medicated powder gross weight; Described concentration of ethanol is 67-71%; Described sieve granularity is 16 orders; Described oven temperature is 75-85 ℃, and be 1.5-2.5 hour drying time.
The preparation method of the Chinese medicine preparation of treatment chronic hepatitis Bhepatic fibrosis of the present invention can also comprise that adding magnesium stearate belongs to the lubricated adjuvant of hydrophobicity, its effect in technology be increase the flowability of medicine in the tabletting process with reduce between drug particles and the granule, frictional force and adhesion strength between granule and the mechanical part, can be after granulation, add before the tabletting, addition is 0.25-1%.
The preparation method of the Chinese medicine preparation of treatment chronic hepatitis Bhepatic fibrosis of the present invention is scientific and reasonable, has fully kept the active ingredient of the medicine of respectively distinguishing the flavor of, thereby has guaranteed the drug effect of this Chinese medicine preparation.
Further describe the present invention below in conjunction with embodiment
Embodiment
A kind of Chinese medicine preparation for the treatment of chronic hepatitis Bhepatic fibrosis, it is made by the raw material of following parts by weight:
Carapax Trionycis 120g Radix Paeoniae Rubra 85g Radix Angelicae Sinensis 50g
Radix Notoginseng 50g Radix Codonopsis 85g Radix Astragali 85g
Placenta Hominis 45g Cordyceps 25g Baphicacanthus cusia plate 140g
Fructus Forsythiae 140g Rhizoma Curcumae 25g
During preparation, earlier Carapax Trionycis, Radix Notoginseng, Radix Paeoniae Rubra, Cordyceps, Placenta Hominis are ground into fine powder; With Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae distillating extracting oil, the aqueous solution after the distillation is stand-by, and medicinal residues are decocted with water 1 hour, filters, and filtrate and above-mentioned aqueous solution merge; Radix Codonopsis, the Radix Astragali and Radix Isatidis three flavors are decocted with water three times, each 1.5 hours, merge three times decocting liquid, filter to get filtrate; All filtrates and aqueous solution are merged, after the centrifugal roguing, under 50 ℃, be evaporated to relative density and be 1.30 thick paste shape, vacuum drying becomes dry extract, is ground into fine powder, and with the fine powder and the right amount of auxiliary materials mixing of above-mentioned Carapax Trionycis, Radix Notoginseng, Radix Paeoniae Rubra, Cordyceps, the Placenta Hominis five tastes, make granule and dry, the volatile oil that adds above-mentioned Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae three flavors again, mixing, compacting gets final product in flakes.
Wherein, described Carapax Trionycis is a Carapax Trionycis (processed), should should check one by one the Carapax Trionycis (processed) of buying earlier during preparation, discards transportation, duration of storage mildew change, rancid person, and product are put in the baking oven in 100 ℃ of dry for standby only; Described Radix Paeoniae Rubra is for containing the survey medical material, and the Radix Paeoniae Rubra decoction pieces to buying during preparation after assay meets the requirements, sieves earlier, removes the dedust bits, and the rapid rinsing of reuse clear water is once removed silt, only the product drying for standby; When described Radix Notoginseng prepares, the Radix Notoginseng of buying is sieved earlier, remove the dedust bits, the rinsing of reuse clear water is once removed silt, only the product dry for standby; When described Cordyceps prepares, choose quasi-fibrous attachment and impurity earlier, put baking oven then in 80 ℃ of dry for standby; Described Placenta Hominis should be checked the system Placenta Hominis of buying during preparation one by one for the system Placenta Hominis, discards rancid person, and clean product are put pressure cooker and steamed 0.5h, the taking-up dry for standby in 121 ℃.The accurate weighing of five tastes medical material after above-mentioned pre-treatment, mix homogeneously is ground into fine powder, and breaking method is a mechanical crushing method, and used pulverizer is that Yantai City Zhifu pharmaceutical machine factory produces, and it pulverizes unit control station, WZS by the automatic control of ZKF-3 type
3Horizontal commentaries on classics sieve of-470 class and hF
3Three major parts such as-200 type pulverizers are formed, and its work efficiency is for per hour pulverizing the 20-200kg medical material, and the granularity of sieving selects for use 120 mesh sieves to pulverize, because it belongs to the automatic circulation type grinding mode, its flour extraction can reach more than 95%.And then with fine powder cobalt-60 irradiation sterilization method, irradiation dose is 5kGy, can guarantee that this product hygiology is qualified.
The method of described distillating extracting oil is pharmacopeia first method (48 pages of appendix of Chinese Pharmacopoeia nineteen ninety version), promptly gets Radix Angelicae Sinensis, Rhizoma Curcumae, Fructus Forsythiae and is mixed in the flask, adds the water distillation 3 hours of 8 times of amounts, and average must the measuring of collecting volatile oil is 0.97ml.In the preparation addition of volatile oil be carrying of volatile oil the amount; Its adding method is: 76% dissolve with ethanol volatile oil with 8 times of amounts is sprayed onto on the dried particles airtight 40 minutes after shaking up.
Concentration process after described all filtrates and the aqueous solution carries out in E1-1 type vacuum concentration pot (being produced by Changshu pharmaceutical machine factory), and vacuum often is controlled at 0.065Mpa, so that the liquid temperature per hour can be evaporated 70 liters of moisture content 60 ℃ of evaporations down.
The pressure of the dry run of described concentrated thick paste is at 640mmHg, and temperature is 75 ℃, is ground into fine powder behind the one-tenth dry extract, and average paste volume is 10.8kg, and average paste-forming rate is 20.6%.
Behind former powder and extract powder mixing with crude drug, add cane sugar powder, starch, mix homogeneously becomes soft material with ethanol as wetting agent, and the granulation of sieving is put oven drying and is got dried particles.This particulate Quality Control parameter is:
1, moisture: 3-5% is generally 3.5%.
2, granule size: 14-22 order.
3, content of paeoniflorin: every 0.5g granule contains the Chinese herbaceous peony glycoside must not be less than 2.1mg.
Wherein, the addition of described cane sugar powder is 7/ medicated powder gross weight; The addition of starch is 1.2/ medicated powder gross weight; Described concentration of ethanol is 69%; The described granularity of sieving is 16 orders; Described oven temperature is 80 ℃, and be 2.0 hours drying time.
Also add magnesium stearate after granulation, before the tabletting, addition is 0.5%.