CN107714714A - A kind of Sebivo piece and preparation method thereof - Google Patents
A kind of Sebivo piece and preparation method thereof Download PDFInfo
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- CN107714714A CN107714714A CN201711216987.0A CN201711216987A CN107714714A CN 107714714 A CN107714714 A CN 107714714A CN 201711216987 A CN201711216987 A CN 201711216987A CN 107714714 A CN107714714 A CN 107714714A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/47—Euphorbiaceae (Spurge family), e.g. Ricinus (castorbean)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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- Natural Medicines & Medicinal Plants (AREA)
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Abstract
The present invention provides a kind of Sebivo piece and preparation method thereof, is related to pharmaceutical technology field, including Pharmaceutical composition is made up of active constituents of medicine and pharmaceutic adjuvant；The active constituents of medicine includes following composition：50 63 parts of Sebivo；The pharmaceutic adjuvant includes：Filler, adhesive, sweetener, antioxidant, lubricant, dispersant.The present invention is using Sebivo as main active, and using silymarin, dai medicine Common Leafflower Herb, radix glycyrrhizae, Huang Shi as Supplementary active ingredients, manufactured Sebivo piece, which can not only treat hepatitis B virus antiviral, can also preferably protect liver, strengthen immunity；The various pharmaceutic adjuvants of addition, it can effectively control the rate of release of medicine；The present invention is rapid-action, and bioavilability is high, convenient to take, reduces stimulation of the medicine to oesophagus and intestines and stomach.
Description
Technical field
The present invention relates to pharmaceutical technology field, more particularly to a kind of Sebivo piece and preparation method thereof.
Background technology
Sebivo is the Anti-HBV drugs of U.S. FDA approval listing in 2006, and it is a species specificity, the core of selectivity
Former times analog, there is strong, the rapid-action advantage such as low with resistant rate of Anti-HBV activity effect.
Hepatitis B is due to a kind of disease caused by infection HBV, and after people infects HBV, viral persistence 6 months is not yet
Purgee is referred to as chronic hepatitis B.The final home to return to of chronic hepatitis B is to be developing progressively as hepatic sclerosis and liver cancer.
Chronic hepatitis B is in world pop, and in global 6,000,000,000 populations, about 2,000,000,000 people once infect HBV, the wherein people of 3.5-4 hundred million
For chronic HBV infection, population in the world 6% is accounted for.China carry out national epidemiological investigation show, HBV infection without
Obvious gender differences, but after male's infection HBV, it is easily made into the carrier of Chronic Asymptomatic, it is prone to hepatitis, liver occurs
Easily develop into chronic liver disease after inflammation.There are some researches show chronic hepatitis B and early-phase hepatocirrhosis male on Sex distribution are big
In women, it was demonstrated that hepatitis easily occurs for male, and easily develops into hepatic sclerosis.And analyzed from the age, chronic hepatitis B, early stage liver
For sclerosis patients' average age at 35 years old to one's mid-40s, the liver cirrhosis patient age was higher than chronic hepatitis B patient, is ground from the course of disease
From the point of view of studying carefully, the early-phase hepatocirrhosis patient course of disease is apparently higher than the course of disease of chronic hepatitis B patient, and different points of chronic hepatitis B
The course of disease of type
No significant difference, illustrate increase of the hepatitis B patient with the course of disease, suffer from the probability increase of early-phase hepatocirrhosis, and it is chronic
Hepatitis B is slight, moderate, the parting of severe are unrelated with the course of disease.
For chronic hepatitis B patient, the overall goal for the treatment of is：Suppress for a long time to greatest extent or eliminate HBV, subtract
The light necrosis of liver cell inflammation and liver fibrosis, delay and prevent progression of disease, reduce and prevent Liver failure, hepatic sclerosis, liver
The generation of cell liver cancer (HCC) and its complication, so as to quality and the extension time-to-live of making the life better.Treatment of chronic
Mainly including antiviral, immunological regulation, anti-inflammatory liver protection, anti-fibrosis and symptomatic treatment, wherein antiviral therapy is crucial, as long as
Conditions permit, it should just carry out the antiviral therapy of specification.
It is convenient that nucleoside medicine is administered orally, and suppression virus function is stronger, and adverse reaction is few and slight, available for liver function
Decompensation person, but its course for the treatment of is not fixed relatively, curative effect is not lasting enough, prolonged application can resistance, may occur in which that sb.'s illness took a turn for the worse after drug withdrawal.
Nucleoside medicine is mainly acted on by acting on HBV polymerase area to play Anti-HBV activity.Phosphorylation first after medicine enters in vivo
For triphosphate or diphosphate form, polymerase chain extends the similar core of required structure during then substituting hbv replication
Glycosides, so as to the extension of terminating chain, reach and suppress the purpose that HBV-DNA is replicated.
Lamivudine is the ddC analog of synthesis, and it is combined with varial polymerases, can compete suppression
The activity of polymerase processed causes HBV-DNA synthesis to terminate, and so as to suppressing virus replication, mitigates inflammation, liver function is extensive
It is multiple, and can effectively suppress the activation of sternzellen and the synthesis of collagenous fibres, so as to prevent the occurrence and development of liver fibrosis.This
Outside, Lamivudine can delay hepatitis B, hepatic sclerosis and fibrosis progression, reduce the incidence of liver decompensation and hepatocellular carcinoma.As
It is oral Anti-HBV drugs that first granted, and Lamivudine has promoted the process for the treatment of of chronic.
Sebivo was approved by the fda in the United States for treating hepatitis B in 2006, ratified to use by Chinese SFDA within 2007
In Chinese chronic hepatitis B patient antiviral therapy.Sebivo is thymidine class medicine, into human body after it is thin
Born of the same parents' kinase phosphorylation turns to active triphosphoric acid Sebivo, and polymerase binding site is competed with HBV-DNA natural substrate dTTP
Point, it is incorporated into HBV-DNA and terminates HBV-DNA chain elongations, so as to suppresses HBV-DNA duplication.Sebivo is to HBV-DNA
With high selectivity, and human DNA and other viral DNAs are not acted on.
The production cost of Sebivo piece in the market is higher, and manufactured tablet bioavailability is relatively low, function
It is more single.To solve the above problems, the present invention proposes a kind of Sebivo piece and preparation method thereof.
The content of the invention
It is an object of the invention to provide a kind of Sebivo piece and preparation method thereof, to solve above-mentioned technical problem.
The present invention using following technical scheme in order to solve the above technical problems, realized：
A kind of Sebivo piece, the Pharmaceutical composition are made up of active constituents of medicine and pharmaceutic adjuvant；The medicine is lived
Property composition includes following composition：Sebivo 50-63 parts, the pharmaceutic adjuvant include：Filler, adhesive, sweetener, antioxygen
Agent, lubricant, dispersant.
Preferably, the active component also includes silymarin, dai medicine Common Leafflower Herb, radix glycyrrhizae, Huang Shi.
Preferably, the parts by weight of other active components are silymarin 3-4 parts, dai medicine Common Leafflower Herb 1-2 parts, radix glycyrrhizae
2-3 parts, Huang Shi 1-3 parts.
Preferably, the filler is the one or more in gelling starch PC-10, lactose, mannitol；Described adhesive
For：PVP K30, dried starch, hydroxypropyl methylcellulose, cross-linked carboxymethyl cellulose receive in one or more；The sweetener
For the one or more in honey, fructose, sucrose, aspartame；The antioxidant be sodium hydrogensulfite, sodium pyrosulfite,
One or more in D-araboascorbic acid, glutathione, methionine；The lubricant is in magnesium stearate or superfine silica gel powder
One kind, the dispersant are medicinal soybean oil.
Preferably, the parts by weight of the pharmaceutic adjuvant are：Filler 15-20 parts, adhesive 2-8 parts, sweetener 2-5
Part, antioxidant 0.3-0.8 parts, lubricant 0.1-0.9 parts, dispersant 0.6-1.2 parts.
A kind of preparation method of Sebivo piece, tabletting after direct powder compression and wet granulation can be used；Using powder
Each supplementary material should be dried before last direct tablet compressing；During using wet granulation process tabletting, it can be carried out according to conventional formulation.
The beneficial effects of the invention are as follows：
The present invention is using Sebivo as main active, using silymarin, dai medicine Common Leafflower Herb, radix glycyrrhizae, Huang Shi as auxiliary
Help active component, it is manufactured replace than
Husband's stator, which can not only treat hepatitis B virus antiviral, can also preferably protect liver, strengthen immunity；That adds is various
Pharmaceutic adjuvant, it can effectively control the rate of release of medicine；The present invention is rapid-action, and bioavilability is high, convenient to take, reduces
Stimulation of the medicine to oesophagus and intestines and stomach.
Embodiment
In order that the technical means, the inventive features, the objects and the advantages of the present invention are easy to understand, tie below
Specific embodiment is closed, the present invention is expanded on further, but following embodiments are only the preferred embodiments of the present invention, and it is not all.
Based on the embodiment in embodiment, those skilled in the art obtain other realities on the premise of creative work is not made
Example is applied, belongs to protection scope of the present invention.Experimental method in following embodiments, it is conventional method unless otherwise specified,
Material used, reagent etc., unless otherwise specified, are commercially obtained in following embodiments.
Embodiment 1
A kind of Sebivo piece, Pharmaceutical composition are made up of active constituents of medicine and pharmaceutic adjuvant；Active constituents of medicine bag
Containing following composition：50 parts of Sebivo, 3 parts of silymarin, 1 part of dai medicine Common Leafflower Herb, 2 parts of radix glycyrrhizae, 1 part of Huang Shi；Pharmaceutic adjuvant bag
Include：Gelling starch PC-1015 parts, 8 parts of hydroxypropyl methylcellulose, 2 parts of honey, 0.3 part of D-araboascorbic acid, 0.1 part of magnesium stearate,
0.6 part of pharmaceutical grade soybean oil.
A kind of preparation method of Sebivo piece, takes the supplementary material of corresponding amount, low-temperature vacuum drying is carried out respectively, multidirectional
5-10min is mixed in movement mixer, after being well mixed, tabletting is carried out using the method for direct powder compression, is made required
Sebivo piece.
Embodiment 2
A kind of Sebivo piece, Pharmaceutical composition are made up of active constituents of medicine and pharmaceutic adjuvant；Active constituents of medicine bag
Containing following composition：63 parts of Sebivo, 4 parts of silymarin, 2 parts of dai medicine Common Leafflower Herb, 3 parts of radix glycyrrhizae, 13 parts of Huang Shi；Pharmaceutic adjuvant bag
Include：15 parts of mannitol, 8 parts of hydroxypropyl methylcellulose, 5 parts of honey, 0.8 part of sodium pyrosulfite, 0.9 part of magnesium stearate, pharmaceutical grade are big
Soya-bean oil 0.6-1.2 parts.
A kind of preparation method of Sebivo piece, takes the supplementary material of corresponding amount, low-temperature vacuum drying is carried out respectively, multidirectional
5-10min is mixed in movement mixer, after being well mixed, tabletting is carried out using the method for direct powder compression, is made required
Sebivo piece.
Embodiment 3
A kind of Sebivo piece, Pharmaceutical composition are made up of active constituents of medicine and pharmaceutic adjuvant；Active constituents of medicine bag
Containing following composition：58 parts of Sebivo, 3 parts of silymarin, 1 part of dai medicine Common Leafflower Herb, 2 parts of radix glycyrrhizae, 1 part of Huang Shi；Pharmaceutic adjuvant bag
Include：15 parts of lactose, 8 parts of hydroxypropyl methylcellulose, 2 parts of sucrose, 0.3 part of D-araboascorbic acid, 0.1 part of magnesium stearate, pharmaceutical grade are big
0.6 part of soya-bean oil.
A kind of preparation method of Sebivo piece, the supplementary material of corresponding amount is taken, add purified water, be delivered to multidirectional mixer
Middle mixing 5-10min, after being well mixed, be delivered in efficient wet granulator pelletized, tabletting, required replace than husband is made
Stator.
General principle, principal character and the advantages of the present invention of the present invention has been shown and described above.The technology of the industry
Personnel it should be appreciated that the present invention not by
It is only the preference of the present invention described in the limitation of above-described embodiment, above-described embodiment and specification, and does not have to
To limit the present invention, without departing from the spirit and scope of the present invention, various changes and modifications of the present invention are possible, these
Changes and improvements all fall within the protetion scope of the claimed invention.The claimed scope of the invention by appended claims and
Its equivalent thereof.
Claims (6)
- A kind of 1. Sebivo piece, it is characterised in that：The Pharmaceutical composition is made up of active constituents of medicine and pharmaceutic adjuvant；Institute State active constituents of medicine and include following composition：Sebivo 50-63 parts；The pharmaceutic adjuvant includes：Filler, adhesive, sweet tea Taste agent, antioxidant, lubricant, dispersant.
- 2. Sebivo piece according to claim 1, it is characterised in that：The active component also includes silymarin, the Dai Nationality Medicine Common Leafflower Herb, radix glycyrrhizae, Huang Shi.
- 3. Sebivo piece according to claim 2, it is characterised in that：The parts by weight of other active components are water Fly silibin 3-4 parts, dai medicine Common Leafflower Herb 1-2 parts, radix glycyrrhizae 2-3 parts, Huang Shi 1-3 parts.
- 4. Sebivo piece according to claim 1, it is characterised in that：The filler is gelling starch PC-10, breast One or more in sugar, mannitol；Described adhesive is：PVP K30, dried starch, hydroxypropyl methylcellulose, cross-linked carboxymethyl Cellulose receive in one or more；The sweetener is the one or more in honey, fructose, sucrose, aspartame；It is described Antioxidant is the one or more in sodium hydrogensulfite, sodium pyrosulfite, D-araboascorbic acid, glutathione, methionine；Institute Lubricant is stated as one kind in magnesium stearate or superfine silica gel powder, the dispersant is pharmaceutical grade soybean oil.
- 5. Sebivo piece according to claim 4, it is characterised in that：The parts by weight of the pharmaceutic adjuvant are：Fill out Fill agent 15-20 parts, adhesive 2-8 parts, sweetener 2-5 parts, antioxidant 0.3-0.8 parts, lubricant 0.1-0.9 parts, dispersant 0.6-1.2 parts.
- A kind of 6. preparation method of Sebivo piece described in claim 1-5 any one, it is characterised in that：Powder can be used Tabletting after direct tablet compressing and wet granulation；Each supplementary material should be dried using before direct powder compression；Using wet granulation process During tabletting, it can be carried out according to conventional formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711216987.0A CN107714714A (en) | 2017-11-28 | 2017-11-28 | A kind of Sebivo piece and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711216987.0A CN107714714A (en) | 2017-11-28 | 2017-11-28 | A kind of Sebivo piece and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107714714A true CN107714714A (en) | 2018-02-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711216987.0A Pending CN107714714A (en) | 2017-11-28 | 2017-11-28 | A kind of Sebivo piece and preparation method thereof |
Country Status (1)
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| CN (1) | CN107714714A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108159010A (en) * | 2018-03-20 | 2018-06-15 | 李益香 | A kind of drug Sebivo preparation and its preparation process being used for anti-hepatitis virus |
-
2017
- 2017-11-28 CN CN201711216987.0A patent/CN107714714A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108159010A (en) * | 2018-03-20 | 2018-06-15 | 李益香 | A kind of drug Sebivo preparation and its preparation process being used for anti-hepatitis virus |
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Application publication date: 20180223 |