CN1073863A - The manufacture method of tablets for reducing enayme and replenishing liver - Google Patents

The manufacture method of tablets for reducing enayme and replenishing liver Download PDF

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CN1073863A
CN1073863A CN91111999A CN91111999A CN1073863A CN 1073863 A CN1073863 A CN 1073863A CN 91111999 A CN91111999 A CN 91111999A CN 91111999 A CN91111999 A CN 91111999A CN 1073863 A CN1073863 A CN 1073863A
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enayme
tablets
manufacture method
radix
reducing
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邓忠元
杨万英
邓金荣
邓金萍
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邓忠元
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    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
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    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract

Tablets for reducing enayme and replenishing liver is based on Treatise on Febrile Diseases " Herba Artemisiae Scopariae Decoction ", and the modern clinical Chinese herbal medicine that hepatitis is had certain curative effect of screening totally 12 flavors, the half extractum coated tablet of making, clinical proof is to hepatitis A, and hepatitis B and Glutamate pyruvate transaminase rises etc. has significant curative effect.Its manufacture method is that the pulverizing of part spice is powder, part spice decocting in water is carried twice, merging leach cooking liquid borrows effect of centrifugal force to remove macromole impurity by seperator, centrifugal liquid is condensed into clear paste and powder mixes and stirs, oven drying at low temperature is pulverized in accordance with the law and is granulated, add adjuvant and volatile oil tabletting upper garment, dispatch from the factory after the assay was approved.

Description

The manufacture method of tablets for reducing enayme and replenishing liver
The present invention relates to a kind of manufacture method by the 12 treating hepatitis medicine tablets for reducing enayme and replenishing liver made of flavor Chinese medicines (clinically get peaceful sheet, use this instead) for anti-and the peaceful practolol of market WEIDE etc. are mixed mutually with a name liver.According to data, the whole world in 1985 have 2.15 hundred million hepatitis B HBV carriers at least, wherein I mouthful promptly reach about 100,000,000, China is that hepatitis A district occurred frequently and popular district, hepatitis A virus infection rate are 70-80%, hepatitis b virus infection ratio be more than 60%, 30 years old the normal population infection rate near 100%; In the child of the BJ Children's Hospital hepatitis, hepatitis A accounts for 85.5%, and hepatitis B accounts for 4%, and non-A non-B hepatitis accounts for 6.5%; Hepatitis A accounts for 30% among the Japan hepatitis crowd, and hepatitis B accounts for 30%, and non-A non-B hepatitis accounts for 40%, and the hepatitis D that classification is in recent years come out does not have statistics.
The human liver contains a large amount of glutamate pyruvate transaminase, every gram hepatic tissue has 44000 units, and in the blood every milliliter contain 16 units, human infection after the hepatitis virus, swelling of liver cell, the inflammation necrosis, permeability of cell membrane changes, and glutamate pyruvate transaminase (G, P, T) is discharged in the blood, serum glutamic pyruvic transminase (S, G, P, T) content is raise, and clinical data proof SGPT rising person about 70% is relevant with viral hepatitis.
The present invention is the Chinese herbal medicine that screening has certain curative effect to hepatitis and reduction glutamate pyruvate transaminase on Treatise on Febrile Diseases " Herba Artemisiae Scopariae Decoction " basis; utilize modern pharmaceutical technology to make coated tablet; purpose is to provide a kind of have excellent protection hepatocyte hepatocyte recovery liver function, the treating hepatitis medicine of antiinflammatory effect of reducing enzyme levels for the clinical and numerous hepatitis of hepatitis.
The effect that this medicine of clinical proof has liver heat removing to induce sweat to dredge stasis of blood jaundice eliminating, to hepatitis A, hepatitis B and Glutamate pyruvate transaminase rises have significant curative effect.
With tablets for reducing enayme and replenishing liver treatment first type acute icterohepatitisshock except that pain in the hepatic region is inferior slightly, all the other symptom body sheets such as heating, loss of appetite, vomit, detest that oil, abdominal distention are weak, icteric index, all of serum glutamic pyruvic transminase recover normal required day number average and be shorter than the half congealed slurry of Herba Abri, inosine liquid drug combination.
All obviously be better than Sini San with tablets for reducing enayme and replenishing liver treatment chronic active and chronic persistent hepatitis, cure rate total effective rate and TTT, ZnTT, four laboratory indexes normalization rates of TR, GPT, improvement rate, the Radix Bupleuri soothing liver-QI looses, Fuganning and manyzoned polypore gantai.
In first type acute icterohepatitisshock SGPT rising person 94 examples, chemical examination meansigma methods 1139.1 units (normal value 40 units are following) peak 2870 minimums 108 average medications recovered normal person's 49 examples (52.13%) in 24 days and reduce to 41-70 person's 26 examples (27.65%) and reduce to 71-247 person's 19 routine total effective rates 100%.Chronic active and chronic persistent hepatitis Glutamate pyruvate transaminase rises 36 examples, medication 1-2 month recovery normal 25 examples (69.4%) total effective rate 86.16%.Cloudy 9 examples (27.3%) titre, 16 examples (48.5%) total effective rate 75.8% that descends that changes after the hepatitis B 33 routine medications.Any toxic and side effects is not found in white mice toxicity test and clinical verification.
Tablets for reducing enayme and replenishing liver formula proportion involved in the present invention is as follows: in Kg, Radix Curcumae 180, Radix Isatidis 170, Herba Artemisiae Scopariae 170, Herba Andrographis 130, the Radix Rehmanniae 115, Fructus Gardeniae 115, stir-baked RHIZOMA CORYDALIS with vinegar 75, Radix Bupleuri 55, Fructus Forsythiae 55, Radix Et Rhizoma Rhei 45, Herba Chelidonii 20 Oleum menthae amounts of calculation.More than system is 1,000,000.
According in 90 editions mouthfuls of pharmacopeia and 77 editions Chinese medicine voluminous dictionaries records:
Radix Curcumae: regulating qi to disperse stagnation promoting the function of the gallbladder to alleviate jaundice clinical report controls infectious hepatitis and SGPT raises respond well; Radix Isatidis: heat-clearing and toxic substances removing has antivirus action clinical report treatment infectious hepatitis and recovers the liver function effect better; Herba Artemisiae Scopariae: clearing away damp-heat jaundice eliminating subcutaneous ulcer cure mainly infectious jaundice type hepatitis clinical report bring down a fever jaundice eliminating, to dwindle the hepatomegaly effect obvious; Herba Andrographis: heat-clearing and toxic substances removing removing pathogenic heat from blood and toxic substance from the body, anticancer, clinical report treatment acute icterohepatitis, more satisfactory aspect doing well,improving and recovery liver function; The Radix Rehmanniae: clearing away heat and cooling blood, clinical report, remarkable to infectious hepatitis and SGPT rising effect; Fructus Gardeniae: the clearing away heat and promoting diuresis removing pathogenic heat from blood and toxic substance from the body, anticancer, cure mainly the jaundice clinical report, medication after 20 minutes gallbladder promptly obviously shrink.One cholestasis hepatitis patient receives remarkable result with tablets for reducing enayme and replenishing liver when all medicines are invalid; Stir-baked RHIZOMA CORYDALIS with vinegar: promoting the circulation of QI pain relieving, promoting blood circulation to remove blood stasis; Fructus Forsythiae: heat-clearing and toxic substances removing, detumescence are loose, and the knot clinical report has tangible town to tell effect.Radix Bupleuri: soothing liver-QI is brought down a fever and is cured mainly sternal rib pain, and clinical report is effective aspect third commentaries on classics oxygenase rising of inhibition paddy and recovery liver function; Radix Et Rhizoma Rhei: the anticancer jaundice due to damp-heat of controlling of the logical intestinal detoxifcation removing blood stasis of heat clearing away; Herba Chelidonii: the analgesia diuresis detoxicating and fighting cancer subcutaneous ulcer of harnessing the Yellow River, cirrhotic ascites; Oleum menthae: the wind dispelling effect is arranged, control flatulence.
The manufacture method of tablets for reducing enayme and replenishing liver involved in the present invention is as follows:
1, the prescription that feeds intake: pulverize part: Radix Curcumae 180 Herba Andrographis 100 Radix Et Rhizoma Rhei 45;
Boil and put forward part: Radix Isatidis 170 Herba Artemisiae Scopariaes 170 Radix Rehmanniae 115 Fructus Gardeniaes 115 stir-baked RHIZOMA CORYDALIS with vinegar 75 Radix Bupleuri 55 Fructus Forsythiaes 55 Herba Andrographis 30 Herba Chelidoniis 20.
Spice is handled: pulverize part, the removal of impurity, boil and put forward part: Rhizoma Corydalis is concocted to mix thoroughly in pot with vinegar 25kg by Rhizoma Corydalis 100kg and is added water with slow fire or circulate interlayer steam boil to juice equal with powder of liquid exhausted, slightly dried section 333k ± 5 oven dry or Rhizoma Corydalis 100kg mix vexed intense fire stir-fry thoroughly with vinegar 20kg and do, it is standby to pulverize the Semen Glycines size, and all the other each flavors are not all concocted.
2, pulverize the chopping of part Herba Andrographis herb, Radix Et Rhizoma Rhei smashes, and merges Radix Curcumae 328k-333k oven dry and pulverizes 80-100 mesh sieve standby (more than the deserved powder 260kg).
3, boil and put forward part and add water (in drug weight) first and boil for 10 times, keeps little boiling, boiling range 3 hours (receiving oil), leach cooking liquid device preservation in addition.Recrement adds water and keeps little boiling for 6 times, boiling range 1 hour, and leach cooking liquid merges.
4, leach cooking liquid is removed macromole impurity by DHC type disc separator (work water pressure 0.029-0.03MPa rotating speed 4450r/min).
5, liquid (centrifugal liquid) concentrating under reduced pressure after the separation becomes clear paste, more than 358K ± 5sp=1.30.
6, oven dry of clear paste and powder mix 323K-333K normal pressure or decompression-460mmHg oven dry are pulverized by the 80-100 mesh sieve.
7, the wet grain of appropriate ethanol (about 80%) system, the 323K-333K oven dry adds 1% Pulvis Talci, 0.5% magnesium stearate, sprays into and goes up the machine tabletting when collected volatile oil and Oleum menthae (dry powder 60Kg Peppermint Oil 50 0ml) shatter value is fit to.
8, go up sugar-coat, coloring agent ferrum oxide Fe 2O 3Fe 2O 3G=dry granular Kg value * 3.41.
9, test package warehouse-in.
It is as follows that the quality standard of enzyme sheet falls in proheparin involved in the present invention:
1, sensory test: this product outward appearance is the brownish red or the brown flat convex coated tablet of trembling.
2, color reaction (Radix Et Rhizoma Rhei qualitative reaction).
Get 20 of tablets for reducing enayme and replenishing liver and smash two-layer gauze wrapping, left standstill in adding distil water 60ml, water-bath 373K40 minute, divide and get supernatant, standby.
(1), getting supernatant 1ml adds NaoH test solution (90 editions Chinese Pharmacopoeia appendix 95 pages) 1ml and becomes red or the orange red 6%Hcl1ml of adding jolting becomes yellow or light yellow (the circuitous alkali of Radix Et Rhizoma Rhei anthraquinone reddens and is reversible reaction) immediately.
(2) get supernatant 1ml add NaoH test solution 1ml become red or orange red, add hydrogen peroxide 1ml heating in water bath 4 minutes or tool plug and leave standstill after 8 hours still and to be light red or shallow orange red (it is the redness that the shown redness of the circuitous alkali of oxidable other compositions is taken off, only stayed anthraquinone and alkali reaction and generated in the tablet that the oxidation of the not oxidized thing of anthraquinone institute, color shoal).
(3) surplus supernatant adds Hcl 2Drip with ether 15ml extraction dissociated anthraquinone and discard, aqueous solution adds Hcl5ml to be flung to residual ether, continues heating and put colod-application ether 30ml extracting twice water 15ml in 30 minutes and wash once.
(4) get ether extraction liquid 5ml and add NAOH test solution iml, close plug jolting, water layer shows distinct redness and adds the red disappearance of 6%Hcl1ml jolting.
(5) get ether extraction liquid 5ml and add the close plug jolting of the NAOH test solution lm(water layer ether layer that reddens add hydrogen peroxide lml in aqueous solution, still 6%HCLlml is red to disappear heating in water bath for redness adds in 4 minutes.
3, thin layer chromatography
(1) genuine rhubarb is identified: get 3 of this product, grind to coarse powder adds methanol 4ml, jolting was extracted 5 minutes repeatedly, added a cover to leave standstill that to draw supernatant in 30 minutes be need testing solution; Other gets 10% non-genuine rhubarb (standard substance of identifying through authorities) methanol solution (or 10% stilbene glucoside alcoholic solution) and is reference substance solution.Drawing above-mentioned two kinds of solution puts respectively in same silica gel G-CMC lamellae (the 1.25g silica gel G adds more than the 0.25%CMC solution 4ml378K activation 1h), with ethyl acetate: 95% ethanol: water (50: 6: 5) is developing solvent, ascending development, exhibition is taken out airing and is put observation fluorescence under the 254nm uviol lamp apart from 10-15cm.Reference substance has been located a bright blue purple fluorescence speckle in RF value about 0.5, and test sample must not have bright blue purple fluorescence speckle on the reference substance relevant position.
(2) Herba Andrographis identify (main component of Herba Andrographis is andrographolide, at Ye Zhonggao
Reach more than 1.5%, this detects and is the andrographolide qualitative reaction)
Get 100 of tablets for reducing enayme and replenishing liver and smash and add ethanol 80ml358K ± 5 water-baths in the 250ml flask and refluxed 1 hour, backflow adds 15 minutes Shanghai paper of active carbon 1.6g 343K water bath heat preservation decolouring and crosses Shanghai, and Shanghai liquid is need testing solution.Other get andrographolide standard substance 20mg add methanol 8ml make solution or get punching Nelumbo nucifera Gaertn. Powder 1.6g add methanol 10ml jolting leave standstill supernatant product solution in contrast.
Get above-mentioned test sample and reference substance solution an amount of last with chloroform in acidic alumina (200 order) lamellae (6.8 * 12 or 7 * 15) respectively: ethanol (19: 1) is that developing solvent launched 4 minutes, spray Kedde reagent (1%3,5-dinitrobenzoic acid methanol solution, 7% potassium hydroxide methanol solution mixed in equal amounts), at Rf value 0.67 place an aubergine speckle is arranged respectively, distinct degree: standard substance>powder>sheet (andrographolide (+)).
The tablets for reducing enayme and replenishing liver Figure of description is described as follows: decocting in water is carried spice and is added decocting in water and carry, boiling range 3h first, boiling range 1h for the second time, merge leach cooking liquid, remove the big impurity that divides with seperator, the centrifugal liquid concentrating under reduced pressure, clear paste with the powder mix of pulverizing part, dry, add the wet grain of appropriate ethanol system, oven dry back adds adjuvant, Oleum menthae, volatile oil, tabletting when shatter value is fit to, and is finished product after upper garment, the packing that is up to the standards.

Claims (10)

1, the present invention relates to a kind ofly have the manufacture method of the treating hepatitis medicine tablets for reducing enayme and replenishing liver of significant curative effect it is characterized in that to hepatitis A, hepatitis B and Glutamate pyruvate transaminase rises etc., part spice decocting in water is carried (receive oil) → centrifugal decontamination → concentrating under reduced pressure → mix and is pulverized the grain → oven dry of wetting of part powder → oven dry → pulverizing → system and add auxiliary material, Oleum menthae and collection wave oil → tabletting → upper garment → check → packing → finished product.
2, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that, formula proportion is (in kg, together following), Radix Curcumae 180 Radix Isatidiss 170 Artemisia anethoicles Mattf 170 Herba Andrographis 130 Radix Rehmanniae 115 Fructus Gardeniaes 115 stir-baked RHIZOMA CORYDALIS with vinegar 75 Radix Bupleuri 55 Fructus Forsythiaes 55 Radix Et Rhizoma Rhei 45 Herba Chelidoniis 20 Oleum menthae amounts of calculation, more than system is 1,000,000.
3, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 it is characterized in that decocting in water carry the part be, Radix Isatidis 170 Herba Artemisiae Scopariaes 170 Radix Rehmanniae 115 Fructus Gardeniaes 115 stir-baked RHIZOMA CORYDALIS with vinegar 75 Radix Bupleuri 55 Fructus Forsythiaes 55 Herba Andrographis 30 Herba Chelidoniis 20, pulverizing part is Radix Curcumae 180, Herba Andrographis 100 Radix Et Rhizoma Rhei 45.
4, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1, it is characterized in that decocting in water is put forward part, and to add water first be 10 times of drug weight, keeps little boiling, boiling range 3 hours, collect volatile oil, add 6 times in water for the second time, keep little and boil, boiling range 3 hours, collect volatile oil, for the second time add 6 times in water, keeps little and boil, boiling range 1 hour, twice leach cooking liquid merging.
5, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that, leach cooking liquid discards macromole impurity by the DHC disc separator.
6, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that the medicinal liquid concentrating under reduced pressure after centrifugal becomes clear paste, 358K ± 5, more than the SP=1.30.(promptly 85 ℃ ± 5 proportions are more than 1.30).
7, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that, behind clear paste and the powder mix, the 80-100 mesh sieve 400mmHg) is dried, pulverized to 323K-333K oven dry or decompression (.
8, the manufacture method of peaceful liver enzyme sheet according to claim 1, it is characterized in that, powder is with the wet grain of the ethanol system of 80% left and right sides concentration, the 323-333K oven dry, add 1% heavy Pulvis Talci of dry granular, 0.5% magnesium stearate sprays into and goes up the machine tabletting when collected volatile oil and Oleum menthae (60Kg calculates with 5000ml by dry granular) shatter value is fit to.
9, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that, goes up the used coloring agent of sugar-coat to be ferrum oxide (Fe 2O 3) Fe 2O 3G=dry granular Kg value * 3.41.
10, the manufacture method of tablets for reducing enayme and replenishing liver according to claim 1 is characterized in that, this product substrate breen after testing is very bitter, and outward appearance is that the brownish red or the smooth flavor of brown coated tablet of trembling are sweet.Radix Et Rhizoma Rhei anthraquinone reaction and andrographolide reaction all are positive, Radix Et Rhizoma Rhei should be genuine rhubarb.
CN91111999A 1991-12-30 1991-12-30 The manufacture method of tablets for reducing enayme and replenishing liver Pending CN1073863A (en)

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CN91111999A CN1073863A (en) 1991-12-30 1991-12-30 The manufacture method of tablets for reducing enayme and replenishing liver

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1049136C (en) * 1994-10-20 2000-02-09 谭世平 "Weigan" capsule for protecting liver and preparing method thereof
CN1049135C (en) * 1994-10-20 2000-02-09 谭世平 "Weigan" instant granules for protecting liver and preparing method thereof
CN1054043C (en) * 1994-03-12 2000-07-05 林育方 Pharmaceutical composition for treating typhoid fever

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1054043C (en) * 1994-03-12 2000-07-05 林育方 Pharmaceutical composition for treating typhoid fever
CN1049136C (en) * 1994-10-20 2000-02-09 谭世平 "Weigan" capsule for protecting liver and preparing method thereof
CN1049135C (en) * 1994-10-20 2000-02-09 谭世平 "Weigan" instant granules for protecting liver and preparing method thereof

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