CN110354129A - A kind of new drug pharmaceutical composition that treating hepatitis B and preparation method - Google Patents
A kind of new drug pharmaceutical composition that treating hepatitis B and preparation method Download PDFInfo
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- CN110354129A CN110354129A CN201910764223.8A CN201910764223A CN110354129A CN 110354129 A CN110354129 A CN 110354129A CN 201910764223 A CN201910764223 A CN 201910764223A CN 110354129 A CN110354129 A CN 110354129A
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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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
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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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
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Abstract
The invention discloses a kind of new drug pharmaceutical composition for treating hepatitis B and preparation methods, include Formulas I compound represented or its officinal salt, and pharmaceutically receptible auxiliary material.New drug group prepared by the present invention is combined into oral tablet, convenient to take, has dissolution rate block, and rapid-action advantage has the double action for inhibiting hepatitis B, stablizing the state of an illness and attenuation synergistic；HepG2.2.15 cell secretion hepatitis B S antigen, e antigen are significantly inhibited and the effect of apparent attenuation synergistic is securely and reliably conducive to the popularization and use of new drug combination.
Description
Technical field
The present invention relates to technical field of medicine, the new drug pharmaceutical composition of specifically a kind for the treatment of hepatitis B and preparation
Method.
Background technique
Hepatitis type B virus abbreviation hepatitis B, is a kind of DNA virus, belongs to Hepadnaviridae, belong in infection
Section；Genome is about 3.2kb, is partially double stranded cyclic DNA；The resistance of HBV is stronger, but 10 hours in 65 DEG C, boil 10
Minute or high pressure steam can inactivate HBV；Chlorine-containing agent, ethylene oxide, glutaraldehyde, Peracetic acid and Iodophor etc. also have preferably
Inactivating efficacy；According to currently known, HBV just only has neurological susceptibility to people and orangutan, causes virus B hepatitis disease；Completely
Hepatitis B can also be referred to as red Na particle at graininess.
The hepatitis B virus infection rate about 60%-70% in China；Hepatitis B surface antigen carrying rate accounts for about the 7.18% of total population,
It is calculated with this, the whole nation is there are about 93,000,000 people's Hepatitis B carriers, wherein chronic hepatitis B patient about 20,000,000；Main disease
Because family spreads through sex intercourse, infantile period virus infection lacks prevention consciousness, fails to pinpoint a disease in diagnosis, immunologic hypofunction person's virus infection, previously
There is other hepatitis histories virus infection person, there is stronger infectiousness, cardinal symptom is fatigue out of strength, and liver function is abnormal, mainly
The position of morbidity is liver, gall-bladder；Group clinically using Anti-HBV drugs come suppression therapy HBV, mostly in immunity intersection
Middle propagation.
Nowadays Anti-HBV drugs clinically, adverse reaction is more after patient takes, easy to recur after drug withdrawal, makes for a long time
With drug resistance can be generated, easily there are the adverse reactions such as renal toxicity, bone marrow suppression, while anti-liver antiviral activity is poor, safety is poor.
Summary of the invention
The purpose of the present invention is to provide a kind of new drug pharmaceutical composition for treating hepatitis B and preparation methods, on solving
State the problem of proposing in background technique.
To achieve the above object, the invention provides the following technical scheme:
A kind of new drug pharmaceutical composition for treating hepatitis B includes Formulas I compound represented or its officinal salt and medicine
Receptible auxiliary material on,
Wherein, it is calculated according to the weight percent of new drug combination, the content of compound of formula I or its officinal salt is
0.03%-0.3%.
In some embodiments of the present invention, the new drug group is combined into solid tablet, and new drug combination is for as work
Property ingredient preparation antibacterial anti-hepatitis virus drug.
In some embodiments of the present invention, the accessory package contains filler, lubricant, adhesive, disintegrating agent, packet
One of clothing agent, inhibitor are a variety of.
In some embodiments of the present invention, (1) described filler is selected from lactose, cornstarch, microcrystalline cellulose, paste
One of essence, pregelatinized starch are a variety of；
(2) lubricant is in magnesium stearate, talcum powder, fumaric acid sodium, superfine silica gel powder, sodium dodecyl benzene sulfonate
It is one or more；
(3) it is fine to be selected from hydroxypropyl methyl cellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, methyl for described adhesive
One of dimension element and ethyl cellulose are a variety of；
(4) disintegrating agent is selected from croscarmellose sodium, crospovidone, sodium carboxymethyl starch, hydroxypropyl and forms sediment
In powder, generation, replace one of hydroxypropyl cellulose or a variety of；
(5) coating agent is selected from one of hydroxypropyl first vitamin, stomach dissolution type pharmaceutical films coating pre-mixing agent or a variety of；
(6) wetting agent is selected from one of pure water, ethyl alcohol, ethanol water.
In some embodiments of the present invention, wherein calculated according to the weight percent of new drug combination: 50%-60%
Filler, 0.4%-2% lubricant, 1%-5% adhesive, 6%-10% disintegrating agent, 4%-6% coating agent, 25%-28% profit
Humectant.
In some embodiments of the present invention, a kind of preparation method of new drug pharmaceutical composition, includes the following steps:
S1, the bulk pharmaceutical chemicals of compound of formula I or its officinal salt are subjected to micronization processes, obtain micro mist A；
S2, filler, disintegrating agent are uniformly mixed, obtain mixture a；
Adhesive is added in wetting agent and obtains mixture b by S3；
After S4, mixture a and mixture b are mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
S5, micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
S6, lubricant is added into dry particle C, after mixing, then tabletting obtains bare die；
S7, the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
In some embodiments of the present invention, the auxiliary material further includes tenofovir disoproxil, and tenofovir disoproxil is nucleus
Thuja acid class reverse transcriptase inhibitor is calculated according to the weight percent of new drug combination: tenofovir ester content is 5%-10%.
In some embodiments of the present invention, a kind of preparation method of new drug pharmaceutical composition, includes the following steps:
(1) bulk pharmaceutical chemicals of compound of formula I or its officinal salt progress micronization processes are obtained into micro mist A, by tenofovir
Ester carries out micronization processes and obtains micro mist B；
(2) filler, disintegrating agent are uniformly mixed, obtain mixture a, adhesive is added in wetting agent and obtains mixture
b；
(3) after mixture a and mixture b is mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
(4) micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
(5) mixing D is obtained after mix lubricant being added into dry particle C, micro mist B is added in mixing D and is uniformly mixed,
Then tabletting obtains bare die；
(6) the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
The beneficial effects of the present invention are:
The resulting compounding method of preparation of the present invention succinctly facilitates, and is suitble to industrialized production, and pass through In vitro cell experiment
It proving, tablet has the function of inhibiting hepatitis B virus duplication and stablizes the state of an illness, liver-protective function is played to a certain extent,
To HepG2.2.15 cell secretion hepatitis B S antigen, e antigen significantly inhibits and the work of significantly attenuation synergistic
With securely and reliably.
New drug group prepared by the present invention is combined into oral tablet, and process flow simple operations are convenient, convenient to take, has molten
Rate block out, absorbs that fast effect is good, rapid-action advantage, have inhibit hepatitis B, stablize the state of an illness and attenuation synergistic it is double
Recast is used, and has better antibacterial and bacteriostasis, and toxic side effect is small, and drug content is high, safety and stability, is conducive to new drug combination
Popularization and use
Detailed description of the invention
Fig. 1 is Formulas I schematic diagram of the invention.
Specific embodiment
Following will be combined with the drawings in the embodiments of the present invention, and technical solution in the embodiment of the present invention carries out clear, complete
Site preparation description, it is clear that described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, it is obtained by those of ordinary skill in the art without making creative efforts every other
Embodiment shall fall within the protection scope of the present invention.
A kind of new drug pharmaceutical composition for treating hepatitis B includes Formulas I compound represented or its officinal salt and medicine
Receptible auxiliary material on,
Wherein, it is calculated according to the weight percent of new drug combination, the content of compound of formula I or its officinal salt is
0.03%-0.3%.
New drug group is combined into solid tablet, and new drug combination is for the medicine as active constituent preparation antibacterial anti-hepatitis virus
Object.
Accessory package contains one of filler, lubricant, adhesive, disintegrating agent, coating agent, inhibitor or a variety of；Institute
It states filler and is selected from one of lactose, cornstarch, microcrystalline cellulose, dextrin, pregelatinized starch or a variety of；The lubricant
Selected from one of magnesium stearate, talcum powder, fumaric acid sodium, superfine silica gel powder, sodium dodecyl benzene sulfonate or a variety of；The bonding
Agent is in hydroxypropyl methyl cellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, methylcellulose and ethyl cellulose
It is one or more；The disintegrating agent is selected from croscarmellose sodium, crospovidone, sodium carboxymethyl starch, hydroxypropyl and forms sediment
In powder, generation, replace one of hydroxypropyl cellulose or a variety of；The coating agent is selected from hydroxypropyl first vitamin, stomach dissolution type pharmaceutical films
It is coated one of pre-mixing agent or a variety of；The wetting agent is selected from one of pure water, ethyl alcohol, ethanol water.
Wherein, according to new drug combination weight percent calculate: 50%-60% filler, 0.4%-2% lubricant,
1%-5% adhesive, 6%-10% disintegrating agent, 4%-6% coating agent, 25%-28% wetting agent.
Auxiliary material further includes tenofovir disoproxil, and tenofovir disoproxil is novel nucleoside acids reverse transcriptase inhibitor, according to new drug
Combined weight percent calculates: tenofovir ester content is 5%-10%.
Embodiment I, a kind of preparation method for treating hepatitis B new drug pharmaceutical composition of the invention include the following steps:
S1, the bulk pharmaceutical chemicals of compound of formula I or its officinal salt are subjected to micronization processes, obtain micro mist A；
S2, filler, disintegrating agent are uniformly mixed, obtain mixture a；
Adhesive is added in wetting agent and obtains mixture b by S3；
After S4, mixture a and mixture b are mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
S5, micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
S6, lubricant is added into dry particle C, after mixing, then tabletting obtains bare die；
S7, the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
Embodiment II, a kind of preparation method for treating hepatitis B new drug pharmaceutical composition of the invention include the following steps:
(1) bulk pharmaceutical chemicals of compound of formula I or its officinal salt progress micronization processes are obtained into micro mist A, by tenofovir
Ester carries out micronization processes and obtains micro mist B；
(2) filler, disintegrating agent are uniformly mixed, obtain mixture a, adhesive is added in wetting agent and obtains mixture
b；
(3) after mixture a and mixture b is mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
(4) micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
(5) mixing D is obtained after mix lubricant being added into dry particle C, micro mist B is added in mixing D and is uniformly mixed,
Then tabletting obtains bare die；
(6) the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
Embodiment 1-3 carries out being prepared into tablet using embodiment II preparation method
Embodiment 1
A kind of new drug pharmaceutical composition for treating hepatitis B, by 50% filler, 0.4% lubricant, 1% adhesive, 6%
Disintegrating agent, 4% coating agent, 25% wetting agent, 5% tenofovir disoproxil are prepared into the new drug pharmaceutical composition that specification is 0.5mg/ piece
Oral tablet.
Embodiment 2
A kind of new drug pharmaceutical composition for treating hepatitis B, by 60% filler, 2% lubricant, 5% adhesive, 10%
Disintegrating agent, 6% coating agent, 28% wetting agent, 10% tenofovir disoproxil are prepared into the new drug medicine group that specification is 1mg/ piece and heal up
Take tablet.
Embodiment 3
A kind of new drug pharmaceutical composition for treating hepatitis B, by 55% filler, 1.2% lubricant, 3% adhesive, 8%
Disintegrating agent, 5% coating agent, 27% wetting agent, 8% tenofovir disoproxil are prepared into the new drug pharmaceutical composition that specification is 2.5mg/ piece
Oral tablet.
Wherein, a kind of oral tablet for treating hepatitis B new drug pharmaceutical composition of the present invention, usage and dosage are oral every
Day 1 time, each 10mg, with food with clothes.
The resulting tablet of embodiment 1-3 tests the inhibition of HBV
Influence of the tablet of different volumes concentration to HBV-DNA in cell culture fluid and surface antigen and e antigen is detected,
Specific steps are as follows:
(1) select the HepG2.2.15 cell of logarithmic growth phase, trypsin digestion at single cell suspension, according to 2 ×
The concentration of 10000 mL-1 is inoculated in 24 orifice plates (every hole 1mL), 3 holes of each concentration；
(2) it is affixed on bottom hole to cell after 1d, sucks old culture medium, 1640 trainings containing different volumes strength tablet are added
Base is supported, and sets the normal cell without tablet as blank control group, 3TC (100 μ g/ml) is used as positive controls；
(3) culture medium can suitably then be replaced according to cell growth status；
(4) collect third day, the 6th day, the 9th day cell supernatant be in -20 DEG C of preservations (i.e. sample to be tested)；
(5) glimmering with enzyme-linked immunization (ELISA) measurement third day, the 6th day, the 9th day e antigen and surface antigen, use
Fluorescent Quantitative PCR method measures the 9th day HBV-DNA copy value.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention
Made any modifications, equivalent replacements, and improvements etc., should be included within the scope of the present invention within mind and principle.
Claims (8)
1. a kind of new drug pharmaceutical composition for treating hepatitis B, which is characterized in that comprising Formulas I compound represented or its is pharmaceutically acceptable
Salt, and pharmaceutically receptible auxiliary material,
Wherein, it is calculated according to the weight percent of new drug combination, the content of compound of formula I or its officinal salt is 0.03%-
0.3%.
2. a kind of new drug pharmaceutical composition for treating hepatitis B according to claim 1, which is characterized in that the new drug group
It is combined into solid tablet, new drug combination is for the drug as active constituent preparation antibacterial anti-hepatitis virus.
3. a kind of new drug pharmaceutical composition for treating hepatitis B according to claim 1, which is characterized in that the accessory package
Contain one of filler, lubricant, adhesive, disintegrating agent, coating agent, inhibitor or a variety of.
4. a kind of new drug pharmaceutical composition for treating hepatitis B according to claim 3, which is characterized in that (1) described to fill out
It fills agent and is selected from one of lactose, cornstarch, microcrystalline cellulose, dextrin, pregelatinized starch or a variety of；(2) lubricant
Selected from one of magnesium stearate, talcum powder, fumaric acid sodium, superfine silica gel powder, sodium dodecyl benzene sulfonate or a variety of；(3) described
Adhesive is selected from hydroxypropyl methyl cellulose, hydroxypropyl cellulose, sodium carboxymethylcellulose, methylcellulose and ethyl cellulose
One of or it is a variety of；(4) disintegrating agent is selected from croscarmellose sodium, crospovidone, sodium carboxymethyl starch, hydroxyl
In propyl starch, generation, replace one of hydroxypropyl cellulose or a variety of；(5) coating agent is selected from hydroxypropyl first vitamin, soluble in the stomach
Type pharmaceutical films are coated one of pre-mixing agent or a variety of；(6) wetting agent is in pure water, ethyl alcohol, ethanol water
It is a kind of.
5. a kind of new drug pharmaceutical composition for treating hepatitis B according to claim 3 or 4, which is characterized in that wherein, press
It is calculated according to the weight percent of new drug combination: 50%-60% filler, 0.4%-2% lubricant, 1%-5% adhesive, 6%-
10% disintegrating agent, 4%-6% coating agent, 25%-28% wetting agent.
6. a kind of new drug pharmaceutical composition for treating hepatitis B according to claim 3, which is characterized in that the auxiliary material is also
Including tenofovir disoproxil, tenofovir disoproxil is novel nucleoside acids reverse transcriptase inhibitor, the weight percent combined according to new drug
Than calculating: tenofovir ester content is 5%-10%.
7. a kind of method for preparing new drug pharmaceutical composition described in any claim in claim 1-5, which is characterized in that packet
Include following step:
S1, the bulk pharmaceutical chemicals of compound of formula I or its officinal salt are subjected to micronization processes, obtain micro mist A；
S2, filler, disintegrating agent are uniformly mixed, obtain mixture a；
Adhesive is added in wetting agent and obtains mixture b by S3；
After S4, mixture a and mixture b are mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
S5, micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
S6, lubricant is added into dry particle C, after mixing, then tabletting obtains bare die；
S7, the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
8. a kind of method for preparing new drug pharmaceutical composition described in any claim in claim 1-6, which is characterized in that packet
Include following step:
(1) by the bulk pharmaceutical chemicals of compound of formula I or its officinal salt progress micronization processes obtain micro mist A, by tenofovir disoproxil into
Row micronization processes obtain micro mist B；
(2) filler, disintegrating agent are uniformly mixed, obtain mixture a, adhesive is added in wetting agent and obtains mixture b；
(3) after mixture a and mixture b is mixed, grain is controlled by wet process, then whole grain, drying obtain particle B；
(4) micro mist A is uniformly sprayed on particle B, is then dried, obtain dry particle C；
(5) mixing D is obtained after mix lubricant being added into dry particle C, micro mist B is added in mixing D and is uniformly mixed, then
Tabletting obtains bare die；
(6) the obtained tablet of enrobing processes is carried out after coating agent is added in bare die, the tablet of new drug combination is obtained with this.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910764223.8A CN110354129A (en) | 2019-08-19 | 2019-08-19 | A kind of new drug pharmaceutical composition that treating hepatitis B and preparation method |
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| CN201910764223.8A CN110354129A (en) | 2019-08-19 | 2019-08-19 | A kind of new drug pharmaceutical composition that treating hepatitis B and preparation method |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546046A (en) * | 2003-12-08 | 2004-11-17 | 杨喜鸿 | Adefovir dipivoxil dispersing tablet and its preparation |
| CN1732944A (en) * | 2005-09-02 | 2006-02-15 | 北京阜康仁生物制药科技有限公司 | Entecavir dispersible tablet and its preparation process |
| US20150110869A1 (en) * | 2012-05-31 | 2015-04-23 | Pharmascience, Inc. | Pharmaceutical composition of entecavir and process of manufacturing |
-
2019
- 2019-08-19 CN CN201910764223.8A patent/CN110354129A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546046A (en) * | 2003-12-08 | 2004-11-17 | 杨喜鸿 | Adefovir dipivoxil dispersing tablet and its preparation |
| CN1732944A (en) * | 2005-09-02 | 2006-02-15 | 北京阜康仁生物制药科技有限公司 | Entecavir dispersible tablet and its preparation process |
| US20150110869A1 (en) * | 2012-05-31 | 2015-04-23 | Pharmascience, Inc. | Pharmaceutical composition of entecavir and process of manufacturing |
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