CN103301217A - Composition and applications thereof, pharmaceutical preparation and health-care product - Google Patents
Composition and applications thereof, pharmaceutical preparation and health-care product Download PDFInfo
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- CN103301217A CN103301217A CN2013102244148A CN201310224414A CN103301217A CN 103301217 A CN103301217 A CN 103301217A CN 2013102244148 A CN2013102244148 A CN 2013102244148A CN 201310224414 A CN201310224414 A CN 201310224414A CN 103301217 A CN103301217 A CN 103301217A
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- 239000000825 pharmaceutical preparation Substances 0.000 title claims abstract description 21
- 239000000203 mixture Substances 0.000 title claims description 74
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 50
- 238000002360 preparation method Methods 0.000 claims abstract description 44
- 238000000034 method Methods 0.000 claims abstract description 42
- 102000004196 processed proteins & peptides Human genes 0.000 claims abstract description 33
- 108090000765 processed proteins & peptides Proteins 0.000 claims abstract description 33
- 210000004185 liver Anatomy 0.000 claims abstract description 31
- 229930003944 flavone Natural products 0.000 claims abstract description 30
- 235000011949 flavones Nutrition 0.000 claims abstract description 30
- 229920001184 polypeptide Polymers 0.000 claims abstract description 30
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- 150000002212 flavone derivatives Chemical class 0.000 claims abstract description 16
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 claims abstract description 16
- 238000000108 ultra-filtration Methods 0.000 claims abstract description 10
- 238000002156 mixing Methods 0.000 claims abstract description 3
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Landscapes
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the field of biomedicines and health-care products, and particularly relates to a pharmaceutical composition, a preparation and applications. According to the liver extraction technology in the pharmaceutical composition, the micromolecular polypeptides active substances can be extracted by adopting a method for combining low-temperature homogenization, tool enzyme extraction and low-molecular-weight ultrafiltration, the method is simple and convenient, safe and effective, no more chemical reagents are related, and the yield is high; in the hovenia dulcis thunb extraction technology, the general flavone of natural plant can be extracted by adopting an ethanol extraction method, so that the yield is improved, and the safety and effectiveness can be achieved; and proper starch is added in the concentrated extracting solution as an excipient to be directly frozen and dried, thus ensuring that the active ingredients of the product can not be damaged. The functions of better protecting the liver and dispelling the effects of alcohol can be achieved by mixing anthony pig liver extract and hovenia dulcis thunb flavone. The pharmaceutical composition can be developed into a pharmaceutical preparation or health-care food.
Description
Technical field
The present invention relates to biological medicine and field of health care products, particularly a kind of composition and use thereof, pharmaceutical preparation and health product.
Background technology
Liver is the body of gland organ of human body maximum, play central action in substance metabolism and energy metabolism, it not only participates in digesting and assimilating of nutrient substance, is the metabolism place of material, and participate in biotransformation and the drainage of multiple metabolite and foreign body, also participate in the process of immune regulation of body.All kinds of hepatopathys are commonly encountered diseases and frequently-occurring disease, and hepatocellular degeneration necrosis or atrophy finally cause liver failure.Hepatopathy is of a great variety, and sorting technique is different, usually hepatopathy can be divided into viral hepatitis, alcoholic liver disease, drug induced hepatic injury, fatty liver, liver cirrhosis and hepatocarcinoma etc.
Alcoholic liver disease (ALD) is as the term suggests refer to because a series of pathological changes such as liver injury of causing of absorption ethanol." alcoholic liver disease diagnostic criteria (draft) " according to hepatopathy branch of October calendar year 2001 China medical association fatty liver, ethanol hepatopathy group are formulated is divided into five types with alcoholic liver disease by pathological diagnosis standard typing: light type alcoholic hepatic disease (AML), alcoholic fatty liver (AFL), alcoholic hepatitis (AH), alcoholic cirrhosis (AC) and alcoholic fibrosis (AF).This is because long-term excessive drinking causes ethanol (ethanol) and acetaldehyde in the liver significantly to raise, and makes at last liver that a kind of alcoholic liver disease of steatosis, necrosis occurs repeatedly.
At present, alcoholic liver has become the second largest hepatopathy that is only second to viral hepatitis.Along with the raising of people's living standard, alcoholic liver also rises year by year at the sickness rate of China.According to the World Health Organization's rough Statistics: approximately there is 1,500 ten thousand-2,000 ten thousand people excessive drinking in the whole world, and 10%-20%(150 ten thousand-4,000,000 is arranged among these people) alcoholic liver disease in various degree arranged.Die among the people of liver cirrhosis at 40%-90%, it is patients with alcoholic liver diseases that 2.6 ten thousand people are approximately arranged.The alcoholic liver hazardness is huge, but want that carrying out early prevention from symptom finds to acquire a certain degree of difficulty, because alcoholic liver is in early days generally without specific symptom and sign, only the continuation along with the state of an illness develops, then the indication that some digestive system and hepatopathy occur just can be taken seriously, as do not take effective measures, the state of an illness will continue to worsen and increase the weight of, and alcoholic hepatitis, hepatic fibrosis can occur gradually and liver cirrhosis occurs.Therefore, correctly be familiar with ethanol to the infringement of liver, in time diagnosis and scientific prevention and cure alcoholic liver have great importance.
Summary of the invention
In view of this, the invention provides a kind of composition and use thereof, pharmaceutical preparation and health product.Adopt low-temperature homogenate in the liver extraction process in the said composition, toolenzyme extracts, and the method that the low-molecular-weight ultrafiltration combines is extracted micromolecule polypeptide class active substance, and method is easy, and is safe and effective, do not relate to too much chemical reagent, and yield is high; In the Semen Hoveniae (Fructus Hoveniae) extraction process, adopt ethanol extraction method, extract the natural plants total flavones, improved yield, safe and effective; Extracting solution after concentrated adds an amount of starch as excipient, and directly lyophilization has guaranteed that the product effective ingredient is not destroyed.Piglets liver extract and Semen Hoveniae (Fructus Hoveniae) flavone are mixed, have preferably hepatoprotective, antialcoholism action.
In order to realize the foregoing invention purpose, the invention provides following technical scheme:
The invention provides a kind of compositions, it is comprised of LEx and Semen Hoveniae extract (Fructus Hoveniae extract), and described LEx (in polypeptide) is 0.5～1.5:0.5～1.5 with the mass ratio of described Semen Hoveniae extract (Fructus Hoveniae extract) (take flavone);
The extracting method of LEx is: get animal livers after the first pretreatment, mix rear homogenate with normal saline and obtain homogenate, after regulating pH value to 7.0～8.0, add pancreatin, enzymolysis 1.5～3h under 36～40 ℃ condition, be incubated 15～35min after being heated to 80～95 ℃, supernatant is collected in filtration, cooling, centrifugal, regulates pH value to 6.0～7.0, obtain the liver extracting solution, after the first post processing and get final product;
The extracting method of Semen Hoveniae extract (Fructus Hoveniae extract) is: get Semen Hoveniae (Fructus Hoveniae) after the second pretreatment, and after 75～95% ethanol mixes, the 2.5～3.5h that under 55～70 ℃ condition, refluxes, sucking filtration is collected the first filtrate and the first filtering residue; After getting the first filtering residue and 75～95% ethanol mixing, the 2.5～3.5h that under 55～70 ℃ condition, refluxes, sucking filtration is collected the second filtrate and the second filtering residue; Get the second filtering residue, after 75～95% ethanol mixes, the 2.5～3.5h that under 55～70 ℃ condition, refluxes, sucking filtration is collected the 3rd filtrate, merges the first filtrate, the second filtrate, the 3rd filtrate, obtains Semen Hoveniae extracting solution, through the second post processing and get final product.
The present invention extracts the micromolecule polypeptide class active substance that purification forms from fresh piglets liver, possess following biological effect:: 1. can synthesize by the newborn hepatocellular DNA of obvious stimulation, promote liver cell mitochondria, the rough endoplasmic reticulum of damage to recover, promote liver cell regeneration.2. improve the phagocytic function of liver Kupffer Cell, prevent that toxin from intestinal to hepatocellular infringement, suppressing tumor necrosis factor (TNF) activity and Na+, K+-ATP inhibition of enzyme activity factor active promotes the reparation after the hepatic necrosis.3. the hepatocyte injury of tetrachloro-methane induction there is preferably protective effect.The be significantly improved effect of survival rate of the liver failure of 4. D-Gal being led to.
Semen Hoveniae (Fructus Hoveniae) has another name called Semen Hoveniae (Fructus Hoveniae), chicken feet pears, sweet midnight, is the Rhamnaceae plant, and medicinal part is the fruits and seeds with the meat fruit stem, and the fruit stem stalk is concave shape, and meat expands, and is bronzing when ripe, and Glabrous is fragrant and sweet good to eat.Fruit is spheroidal, and three bronzing seeds of intension claim Semen Hoveniae (Fructus Hoveniae).Compendium of Material Medica record, and " Semen Hoveniae (Fructus Hoveniae) is made again the trifoliate orange Chinese holly, all the flexing meaning of not stretching; tree racemosus and song, and its son is also curling, thus with name it ", " bloom summer; the end of the branch is solid; such as the chicken feet shape, the sweet in the mouth of chewing such as honey for four zhang of Semen Hoveniae (Fructus Hoveniae) wood Senior Three, Ye Yuanda such as Mulberry girder ", and can " the relieving restlessness heat on diaphragm of quenching the thirst; moistening five ZANG-organs, diuresis, the same Mel of function ".The successive dynasties physician also often is used in it and does principal agent in the side of relieving the effect of alcohol, and curative effect is fine.Semen Hoveniae (Fructus Hoveniae), nature and flavor are sweet, sour, flat, nontoxic, and the effect of clearing away heat and promoting diuresis, alcoholic intoxication is arranged, and cure mainly the diseases such as wine disease, dysphoria with smothery sensation, thirsty, vomiting, difficulty in urination and defecation.Modern study shows, Semen Hoveniae (Fructus Hoveniae) contains the compositions such as saponin, flavone, alkaloid, glucose, fructose, potassium nitrate, peroxidase, has anti peroxidation of lipid, protects the liver, alcoholic intoxication and suppress many-sided pharmacological action such as nervus centralis.
In some embodiments of the invention, in the extracting method of LEx, press dry product and calculate in the compositions provided by the invention, contain trypsin vigor 600～840U in the described pancreatin of every 1g, pancreatic amylase vigor 7000～9800U, pancreatic lipase vigor 4000～5600U.In some embodiments of the invention, in the extracting method of LEx, the mass percent that pancreatin accounts for homogenate is 0.1～5% in the compositions provided by the invention.
In some embodiments of the invention, in the compositions provided by the invention in the extracting method of LEx, the first post processing comprises the step of ultrafiltration, concentrated, lyophilization, pulverizing.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), add starch during lyophilization and do excipient in the compositions provided by the invention.
As preferably, in the extracting method of LEx, the ultrafiltration in the first post processing is used the nanofiltration of 6KD ultrafilter membrane again for the ultrafiltration of 20KD ultrafilter in the compositions provided by the invention.
As preferably, in the extracting method of LEx, be filtered into 300 order filter-cloth filterings in the compositions provided by the invention.
As preferably, in the compositions provided by the invention in the extracting method of LEx, be cooled to and be cooled to below 40 ℃.Preferred, be cooled to 10～40 ℃.
As preferably, in the extracting method of LEx, the addition of normal saline is 1～3 times of liver quality in the compositions provided by the invention.As preferably, in the extracting method of LEx, regulate pH value and get the sodium hydroxide solution that reagent is 2mol/L in the compositions provided by the invention.
As preferably, in the extracting method of LEx, the first pretreatment is for removing fascia and fat in the compositions provided by the invention.
As preferably, animal is pig, more preferably piglets.
In some embodiments of the invention, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), the addition of 75～95% ethanol is at least 3 times of Semen Hoveniae (Fructus Hoveniae) quality in the compositions provided by the invention.As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), the addition of 75～95% ethanol is 3 times of Semen Hoveniae (Fructus Hoveniae) quality in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), the concentration of ethanol is 75% in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), reflux temperature is 60 ℃ in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), return time is 3h in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), the second post processing comprises the step of vacuum-concentrcted, lyophilization, pulverizing in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), when lyophilization, add starch and do figuration in the compositions provided by the invention.
As preferably, in the extracting method of Semen Hoveniae extract (Fructus Hoveniae extract), the second pretreatment comprises oven dry, the step of pulverizing in the compositions provided by the invention.
The present invention also provides the purposes of above-mentioned composition for the preparation of hepatoprotective, antialcoholic drugs or health product.
The present invention also provides a kind of pharmaceutical preparation, comprises compositions provided by the invention and pharmaceutically acceptable adjuvant.
As preferably, pharmaceutically acceptable adjuvant comprises starch and Pulvis Talci.Starch: tasteless, odorless, white powder, hygroscopicity is not strong, is insoluble to cold water, ethanol and ether, is dissolved in 55～60 ℃ of hot water becoming gelatinized corn starch.Being carbohydrate main in the meals, is the main source of human and animal's energy.In pharmaceuticals industry, be used as excipient, thickening agent, diluent, disintegrating agent of medicine etc.Pulvis Talci is lubricant, can increase the flowability of powder body, is conducive to the smooth filling of capsule.Studies confirm that by experiment, starch, Pulvis Talci and principal agent do not interact, good stability.
As preferably, the mass percent that compositions accounts for pharmaceutical preparation is 9.8%～85.1%.
As preferably, the mass percent that starch accounts for pharmaceutical preparation is 13.9%～88.4%.
As preferably, the mass percent that Pulvis Talci accounts for pharmaceutical preparation is 1%～3%.
The mass percent sum of each component is 100% in the pharmaceutical preparation provided by the invention.
As preferably, the dosage form of preparation is capsule.
The present invention also provides a kind of health product, comprises acceptable auxiliary agent in compositions provided by the invention and the health product.
As preferably, the mass percent that compositions accounts for health product is 4.9%～42.6%.
The mass percent sum of each component is 100% in the health product provided by the invention.
The invention provides a kind of compositions, preparation and purposes.Adopt low-temperature homogenate in the liver extraction process in the said composition, toolenzyme extracts, and the method that the low-molecular-weight ultrafiltration combines is extracted micromolecule polypeptide class active substance, and method is easy, and is safe and effective, do not relate to too much chemical reagent, and yield is high; In the Semen Hoveniae (Fructus Hoveniae) extraction process, adopt ethanol extraction method, extract the natural plants total flavones, improved yield, safe and effective; Extracting solution after concentrated adds an amount of starch as excipient, and directly lyophilization has guaranteed that the product effective ingredient is not destroyed.Piglets liver extract and Semen Hoveniae (Fructus Hoveniae) flavone are mixed, have preferably hepatoprotective, antialcoholism action.Can be developed as pharmaceutical preparation or health food.
The specific embodiment
The invention discloses a kind of compositions and purposes, pharmaceutical preparation and health product, those skilled in the art can use for reference this paper content, suitably improve technological parameter and realize.Special needs to be pointed out is, all similarly replace and change apparent to those skilled in the art, and they all are deemed to be included in the present invention.Method of the present invention and application are described by preferred embodiment, the related personnel obviously can change or suitably change and combination methods and applications as herein described within not breaking away from content of the present invention, spirit and scope, realizes and use the technology of the present invention.
Raw materials used and pharmaceutically acceptable adjuvant all can be buied by market in compositions provided by the invention, pharmaceutical preparation and the health product.
Below in conjunction with embodiment, further set forth the present invention:
The preparation of embodiment 1 compositions
The liver extraction process:
Get fresh (freezing) piglets liver 10kg, remove fascia and fat, add the normal saline homogenate that clean liver weighs 1.5 times of amounts; Homogenate is regulated pH value to 7.5 with the NaOH solution of 2mol/L, presses 0.2% adding pancreatin of homogenate weight and (presses dry product and calculate, contain trypsin vigor 840U in every 1g pancreatin, pancreatic amylase vigor 7000U, pancreatic lipase vigor 4800U.), 38 ℃ ± 2 ℃ stirring in water bath reaction 2h are heated to 85 ℃, and insulation 30min gets thermal denaturation solution; After insulation finishes, 300 order filter-cloth filterings, water-bath is cooled to 10 ℃, the centrifugal 10min of 4000r; Get centrifuged supernatant, regulate pH value to 6.5, with the ultrafiltration of 20KD ultrafilter, again with 6KD ultrafilter membrane nanofiltration, concentrated, add appropriate amount of starch and carry out frozen drying, pulverize, get piglets liver extract dry powder 790g, content of peptides is 36.7%, activity 5.6, and extraction ratio is 2.9%.
The Semen Hoveniae (Fructus Hoveniae) extraction process:
Get Semen Hoveniae (Fructus Hoveniae) 10kg, oven dry, pulverizing, 95% ethanol of 3 times of amounts of adding Semen Hoveniae (Fructus Hoveniae) quality, reflux, extract, is 3 hours under 60 ℃ of conditions, and sucking filtration is collected extracting solution 1 and filtering residue 1; Add in the filtering residue 1 and 95% ethanol of equivalent for the first time, reflux, extract, is 3 hours under 60 ℃ of conditions, collects extracting solution 2 and filtering residue 2, removes filtering residue, extracts to get extracting solution 3 and filtering residue 3 with method; Merge extractive liquid, 1,2,3 carries out vacuum-concentrcted, adds a certain amount of starch frozen drying, pulverizes, and gets Semen Hoveniae extract (Fructus Hoveniae extract) dry powder 1270g, and general flavone content 38.4%. total flavones yield is 4.9%.
Get newborn liver extract dry powder (in polypeptide) and Semen Hoveniae extract (Fructus Hoveniae extract) dry powder (take flavone) according to mass ratio as 1:1 mixes, namely get pharmaceutical composition, the total effective ingredient of compositions (polypeptide and flavone) content is 37.6%.
The preparation of embodiment 2 compositionss
The liver extraction process:
Get fresh (freezing) piglets liver 10kg, remove fascia and fat, add the normal saline homogenate that clean liver weighs 1 times of amount; Homogenate is regulated pH value to 8.0 with the NaOH solution of 2mol/L, presses 0.1% adding pancreatin of homogenate weight and (presses dry product and calculate, contain trypsin vigor 600U in every 1g pancreatin, pancreatic amylase vigor 8200U, pancreatic lipase vigor 5600U.), 38 ℃ ± 2 ℃ stirring in water bath reaction 2h are heated to 80 ℃, insulation 15min), get thermal denaturation solution; After insulation finishes, 300 order filter-cloth filterings, water-bath is cooled to 40 ℃, the centrifugal 10min of 4000r; Get centrifuged supernatant, regulate pH value to 6.0, with the ultrafiltration of 20KD ultrafilter, again with 6KD ultrafilter membrane nanofiltration, concentrated, add appropriate amount of starch and carry out frozen drying, pulverize, get piglets liver extract dry powder 753g, content of peptides is 39.6%, activity 5.9, and extraction ratio is 3.0%.
The Semen Hoveniae (Fructus Hoveniae) extraction process:
Get Semen Hoveniae (Fructus Hoveniae) 10kg, oven dry, pulverizing, 75% ethanol of 3 times of amounts of adding Semen Hoveniae (Fructus Hoveniae) quality, reflux, extract, is 2.5 hours under 70 ℃ of conditions, and sucking filtration is collected extracting solution 1 and filtering residue 1; Add in the filtering residue 1 and 75% ethanol of equivalent for the first time, reflux, extract, is 2.5 hours under 70 ℃ of conditions, collects extracting solution 2 and filtering residue 2, removes filtering residue, extracts to get extracting solution 3 and filtering residue 3 with method; Merge extractive liquid, 1,2,3 carries out vacuum-concentrcted, adds a certain amount of starch frozen drying, pulverizes, and gets Semen Hoveniae extract (Fructus Hoveniae extract) dry powder 1154g, and general flavone content 41.2%. total flavones yield is 4.8%.
Get newborn liver extract dry powder (in polypeptide) and Semen Hoveniae extract (Fructus Hoveniae extract) dry powder (take flavone) according to mass ratio as 0.5:1.5 mixes, namely get pharmaceutical composition, the total effective ingredient of compositions (polypeptide and flavone) content is 40.8%.
The preparation of embodiment 3 compositionss
The liver extraction process:
Get fresh (freezing) piglets liver 10kg, remove fascia and fat, add the normal saline homogenate that clean liver weighs 3 times of amounts; Homogenate is regulated pH value to 7.0 with the NaOH solution of 2mol/L, presses 5% adding pancreatin of homogenate weight and (presses dry product and calculate, contain trypsin vigor 750U in every 1g pancreatin, pancreatic amylase vigor 9800U, pancreatic lipase vigor 4000U.), 38 ℃ ± 2 ℃ stirring in water bath reaction 2h are heated to 95 ℃, and insulation 35min gets thermal denaturation solution; After insulation finishes, 300 order filter-cloth filterings, water-bath is cooled to 25 ℃, the centrifugal 10min of 4000r; Get centrifuged supernatant, regulate pH value to 7.0, with the ultrafiltration of 20KD ultrafilter, again with 6KD ultrafilter membrane nanofiltration, concentrated, add appropriate amount of starch and carry out frozen drying, pulverize, get piglets liver extract dry powder 776g, content of peptides is 39.1%, activity 5.9, and extraction ratio is 3.0%.
The Semen Hoveniae (Fructus Hoveniae) extraction process:
Get Semen Hoveniae (Fructus Hoveniae) 10kg, oven dry, pulverizing, 85% ethanol of 3 times of amounts of adding Semen Hoveniae (Fructus Hoveniae) quality, reflux, extract, is 3.5 hours under 55 ℃ of conditions, and sucking filtration is collected extracting solution 1 and filtering residue 1; Add in the filtering residue 1 and 85% ethanol of equivalent for the first time, under 55-70 ℃ of condition reflux, extract, 2.5-3.5 hour, collect extracting solution 2 and filtering residue 2, remove filtering residue, extract to get extracting solution 3 and filtering residue 3 with method; Merge extractive liquid, 1,2,3 carries out vacuum-concentrcted, adds a certain amount of starch frozen drying, pulverizes, and gets Semen Hoveniae extract (Fructus Hoveniae extract) dry powder 1245g, and general flavone content 38.8%, total flavones yield are 4.8%.
Get newborn liver extract dry powder (in polypeptide) and Semen Hoveniae extract (Fructus Hoveniae extract) dry powder (take flavone) according to mass ratio as 1.5:0.5 mixes, namely get pharmaceutical composition, the total effective ingredient of compositions (polypeptide and flavone) content is 39.0%.
The preparation of embodiment 4 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 1 preparation, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 1 preparation is 10.6% in the capsule, and the mass percent of starch in capsule is 88.4%, and the mass percent of Pulvis Talci in capsule is 1%.
Wherein, polypeptide active is 5.9, and it is 101.3% that polypeptide indicates content, and it is 100.1% that total flavones indicates content.
The preparation of embodiment 5 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 1 preparation, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 1 preparation is 42.6% in the capsule, and the mass percent of starch in capsule is 56.4%, and the mass percent of Pulvis Talci in capsule is 1%.
Wherein, polypeptide active is 5.9, and it is 100.7% that polypeptide indicates content, and it is 99.3% that total flavones indicates content.
The preparation of embodiment 6 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 1 preparation, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 1 preparation is 85.1% in the capsule, and the mass percent of starch in capsule is 13.9%, and the mass percent of Pulvis Talci in capsule is 1%.
Wherein, polypeptide active is 5.8, and it is 99.6% that polypeptide indicates content, and it is 100.6% that total flavones indicates content.
The preparation of embodiment 7 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 2 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
In the capsule mass percent of the compositions of the embodiment of the invention 2 preparation be 9.8%,, the mass percent of starch in capsule is 88.2%, the mass percent of Pulvis Talci in capsule is 2%.
Wherein, polypeptide active is 5.6, and it is 99.7% that polypeptide indicates content, and it is 99.8% that total flavones indicates content.
The preparation of embodiment 8 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 2 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 2 preparations is 39.2% in the capsule, and the mass percent of starch in capsule is 58.8%, and the mass percent of Pulvis Talci in capsule is 2%.
Wherein, polypeptide active is 5.4, and it is 100.1% that polypeptide indicates content, and it is 100.4% that total flavones indicates content.
The preparation of embodiment 9 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 2 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 2 preparations is 78.4% in the capsule, and the mass percent of starch in capsule is 19.6%, and the mass percent of Pulvis Talci in capsule is 2%.
Wherein, polypeptide active is 5.6, and it is 98.9% that polypeptide indicates content, and it is 100.3% that total flavones indicates content.
The preparation of embodiment 10 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 3 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
In the capsule mass percent of the compositions of the embodiment of the invention 3 preparation be 10.3%,, the mass percent of starch in capsule is 86.7%, the mass percent of Pulvis Talci in capsule is 3%.
Wherein, polypeptide active is 5.8, and it is 99.1% that polypeptide indicates content, and it is 98.5% that total flavones indicates content.
The preparation of embodiment 11 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 3 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 3 preparations is 41.0% in the capsule, and the mass percent of starch in capsule is 86.7%, and the mass percent of Pulvis Talci in capsule is 3%.
Wherein, polypeptide active is 5.9, and it is 100.7% that polypeptide indicates content, and it is 99.9% that total flavones indicates content.
The preparation of embodiment 12 pharmaceutical preparatioies
Get the compositions of the embodiment of the invention 3 preparations, add starch and Pulvis Talci, prepare capsule according to conventional method.
The mass percent of the compositions of the embodiment of the invention 3 preparations is 82.1% in the capsule, and the mass percent of starch in capsule is 14.9%, and the mass percent of Pulvis Talci in capsule is 3%.
Wherein, polypeptide active is 5.9, and it is 98.6% that polypeptide indicates content, and it is 99.4% that total flavones indicates content.
The preparation of embodiment 13 health product
Get the compositions of the embodiment of the invention 1 preparation, add acceptable auxiliary agent in the health product, prepare health product according to conventional method.Wherein, compositions mass percent in health product of the embodiment of the invention 1 preparation is 42.6%.
The preparation of embodiment 14 health product
Get the compositions of the embodiment of the invention 2 preparations, add acceptable auxiliary agent in the health product, prepare health product according to conventional method.Wherein, compositions mass percent in health product of the embodiment of the invention 2 preparations is 27.8%.
The preparation of embodiment 15 health product
Get the compositions of the embodiment of the invention 3 preparations, add acceptable auxiliary agent in the health product, prepare health product according to conventional method.Wherein, compositions mass percent in health product of the embodiment of the invention 3 preparations is 4.9%.
The clinical test of pesticide effectiveness of embodiment 16 pharmaceutical compositions
Case is selected hepatopath's totally 600 examples, all meets diagnostic criteria, age 18-65 year, and the course of disease 3 months-20 years, age 18-80 year, course of disease 3-30, wherein the male patient is 440,160 of female patients.Wherein, alcoholic liver disease 440 examples, fatty liver 100 examples, liver cirrhosis 60 examples.Be divided at random two groups, each 300 people of test group and matched group.
Test group: take the pharmaceutical composition that the embodiment of the invention 1 to 3 provides.
Positive controls: take commercially available liver and stand strong.
0.2-0.3g for oral administration, every day 2-3 time, taking 30 days is a course for the treatment of, takes altogether 2 courses for the treatment of.
Efficacy result sees Table 1.
Table 1 efficacy result
| Group | Total case load | Recovery from illness | Produce effects | Effectively | Invalid |
| Test group | 300 | 156 | 106 | 32 | 6 |
| Positive controls | 300 | 103 | 87 | 94 | 16 |
Can be found out by the above results, pharmaceutical composition provided by the invention (test group) is 87.3 to the treatment obvious effective rate of hepatopathy, and effective percentage is 98%; Positive controls is 63.3% to the treatment obvious effective rate of hepatopathy, and effective percentage is 94.7%, is better than positive controls, can be used for the treatment of hepatopathy, stable curative effect, nontoxic pair
Therefore effect is suitable for long-term taking, is a kind of medicine of desirable treatment hepatopathy equally.
Embodiment 17 Detection of Stability
The pharmaceutical preparation that the embodiment of the invention 4 to 12 provides is through hot test, high wet test, strong illumination test, product colour is slightly deepened (in acceptability limit), wherein composition levels provided by the invention slightly reduces, and all the other indices have no significant change.
(25 ± 2 ℃, relative humidity are to place under 60% ± 10% condition through accelerated test (be that 40 ± 2 ℃, relative humidity be to place 6 months under 75 ± 5% the condition in temperature), long term test in the pharmaceutical preparation that the embodiment of the invention 4 to 12 provides, respectively at the 3rd, 6,9,12,18,24,36 sampling at the end of month once) slightly deepen (in acceptability limit) except product colour, outside content slightly reduces, other indices have no significant change, and all up to specification.
Embodiment 18 effect assessment of relieving the effect of alcohol
Choose at random respectively 1080 altogether of each age group, every profession and trade personages in national northwest, southwest, northeast, North China, the southeast, Central China, be divided into 36 groups according to age, engaged in trade, every group of 30 surveyees, the effect of relieving the effect of alcohol to the embodiment of the invention 4 to 12 each pharmaceutical preparatioies that provide is carried out functional evaluation, the sense evaluation criterion sees Table 2, and evaluation result sees Table 3.
Table 2 official can evaluation criterion
The table 3 effect assessment result of relieving the effect of alcohol
Being shown by survey result, from national northwest, southwest, northeast, North China, the southeast, Central China's each age group, every profession and trade personage altogether among 1080 surveyees, is 92.67% to the good results rate of relieving the effect of alcohol of pharmaceutical preparation provided by the invention.
Embodiment 19 effect assessment of relieving the effect of alcohol
Choose at random respectively 1080 altogether of each age group, every profession and trade personages in national northwest, southwest, northeast, North China, the southeast, Central China, be divided into 36 groups according to age, engaged in trade, every group of 30 surveyees, the effect of relieving the effect of alcohol to the embodiment of the invention 13 to 15 each health product that provide is carried out functional evaluation, the sense evaluation criterion sees Table 4, and evaluation result sees Table 5.
Table 4 official can evaluation criterion
The table 5 effect assessment result of relieving the effect of alcohol
Being shown by survey result, from national northwest, southwest, northeast, North China, the southeast, Central China's each age group, every profession and trade personage altogether among 1080 surveyees, is 88.33% to the good results rate of relieving the effect of alcohol of pharmaceutical preparation provided by the invention.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (10)
1. a compositions is characterized in that, it is comprised of LEx and Semen Hoveniae extract (Fructus Hoveniae extract), and described LEx (in polypeptide) is 0.5～1.5:0.5～1.5 with the mass ratio of described Semen Hoveniae extract (Fructus Hoveniae extract) (take flavone);
The extracting method of described LEx is: get animal livers after the first pretreatment, mix rear homogenate with normal saline and obtain homogenate, after regulating pH value to 7.0～8.0, add pancreatin, enzymolysis 1.5～3h under 36～40 ℃ condition, be incubated 15～35min after being heated to 80～95 ℃, supernatant is collected in filtration, cooling, centrifugal, regulates pH value to 6.0～7.0, obtain the liver extracting solution, after the first post processing and get final product;
The extracting method of described Semen Hoveniae extract (Fructus Hoveniae extract) is: get Semen Hoveniae (Fructus Hoveniae) after the second pretreatment, and after 75～95% ethanol mixes, the 2.5～3.5h that under 55～70 ℃ condition, refluxes, sucking filtration is collected the first filtrate and the first filtering residue; After getting described the first filtering residue and 75～95% ethanol mixing, the 2.5～3.5h that under 55～70 ℃ condition, refluxes, sucking filtration is collected the second filtrate and the second filtering residue; Get described the second filtering residue, after 75～95% ethanol mixed, 2.5～3.5h refluxed under 55～70 ℃ condition, sucking filtration is collected the 3rd filtrate, merges described the first filtrate, described the second filtrate, described the 3rd filtrate, obtain Semen Hoveniae extracting solution, through the second post processing and get final product.
2. compositions according to claim 1 is characterized in that, in the extracting method of described LEx, pressing dry product calculates, contain trypsin vigor 600～840U in the described pancreatin of every 1g, pancreatic amylase vigor 7000～9800U, pancreatic lipase vigor 4000～5600U.
3. compositions according to claim 1 is characterized in that, in the extracting method of described LEx, the mass percent that described pancreatin accounts for described homogenate is 0.1～5%.
4. compositions according to claim 1 is characterized in that, in the extracting method of described LEx, described the first post processing comprises the step of ultrafiltration, concentrated, lyophilization, pulverizing.
5. compositions according to claim 1 is characterized in that, in the extracting method of described Semen Hoveniae extract (Fructus Hoveniae extract), the addition of described 75～95% ethanol is at least 3 times of described Semen Hoveniae (Fructus Hoveniae) quality.
6. according to claim 1 to the purposes of 5 each described compositionss for the preparation of hepatoprotective, antialcoholic drugs or health product.
7. a pharmaceutical preparation is characterized in that, comprises such as each described compositions of claim 1 to 5 and pharmaceutically acceptable adjuvant.
8. pharmaceutical preparation according to claim 6 is characterized in that, the mass percent that described compositions accounts for described pharmaceutical preparation is 9.8%～85.1%.
9. health product is characterized in that, comprise such as acceptable auxiliary agent in each described compositions of claim 1 to 5 and the health product.
10. health product according to claim 9 is characterized in that, the mass percent that described compositions accounts for described pharmaceutical preparation is 9.8%～85.1%.
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| CN103734767A (en) * | 2013-12-30 | 2014-04-23 | 徐州绿之野生物食品有限公司 | Health-care food |
| CN108424220A (en) * | 2018-04-03 | 2018-08-21 | 共同科技开发有限公司 | A kind of organic fertilizer and preparation method thereof rich in iodine |
| CN110559327A (en) * | 2019-09-30 | 2019-12-13 | 杭州华缔集团有限公司 | Liver-protecting product and preparation method thereof |
| CN110772539A (en) * | 2019-11-07 | 2020-02-11 | 广东海洋大学 | Liver-protecting and alcohol-dispelling composition of pork liver extract, and preparation method and application thereof |
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| CN1903357A (en) * | 2005-07-27 | 2007-01-31 | 武汉同源药业有限公司 | Liver hydrolytic peptide for injection and prepn. method therefor |
| CN101185688A (en) * | 2007-11-13 | 2008-05-28 | 南方医科大学 | Application of seeds of Hovenia acerba extraction in medicine for resisting senility |
| CN101757194A (en) * | 2008-12-25 | 2010-06-30 | 沃德（天津）营养保健品有限公司 | Product for disintoxication and preparation method thereof |
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| CN1903357A (en) * | 2005-07-27 | 2007-01-31 | 武汉同源药业有限公司 | Liver hydrolytic peptide for injection and prepn. method therefor |
| CN101185688A (en) * | 2007-11-13 | 2008-05-28 | 南方医科大学 | Application of seeds of Hovenia acerba extraction in medicine for resisting senility |
| CN101757194A (en) * | 2008-12-25 | 2010-06-30 | 沃德（天津）营养保健品有限公司 | Product for disintoxication and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103734767A (en) * | 2013-12-30 | 2014-04-23 | 徐州绿之野生物食品有限公司 | Health-care food |
| CN103734767B (en) * | 2013-12-30 | 2015-07-08 | 江苏三益堂保健食品有限公司 | Health-care food |
| CN108424220A (en) * | 2018-04-03 | 2018-08-21 | 共同科技开发有限公司 | A kind of organic fertilizer and preparation method thereof rich in iodine |
| CN110559327A (en) * | 2019-09-30 | 2019-12-13 | 杭州华缔集团有限公司 | Liver-protecting product and preparation method thereof |
| CN110559327B (en) * | 2019-09-30 | 2021-10-22 | 浙江华缔药业集团有限责任公司 | Liver-protecting product and preparation method thereof |
| CN110772539A (en) * | 2019-11-07 | 2020-02-11 | 广东海洋大学 | Liver-protecting and alcohol-dispelling composition of pork liver extract, and preparation method and application thereof |
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