CN106860464A - Pharmaceutical composition and application for combination antiviral therapy - Google Patents
Pharmaceutical composition and application for combination antiviral therapy Download PDFInfo
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- CN106860464A CN106860464A CN201710084881.3A CN201710084881A CN106860464A CN 106860464 A CN106860464 A CN 106860464A CN 201710084881 A CN201710084881 A CN 201710084881A CN 106860464 A CN106860464 A CN 106860464A
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- Prior art keywords
- pharmaceutical composition
- antiviral therapy
- acc007
- inhibitor
- combination antiviral
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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
-
- 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
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
-
- 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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of pharmaceutical composition for combination antiviral therapy, wherein containing at least one non-nucleoside reverse transcriptase inhibitor ACC007 as active component, and the pharmaceutically useful excipient with specific quantitative component ratio；The active component selected from other non-nucleoside reverse transcriptase inhibitors, nucleosides (acid) class RTI, protease inhibitors, integrase inhibitor, fusion/entry inhibitor and coreceptor inhibitor can also be included.The invention also discloses application of the aforementioned pharmaceutical compositions in antiviral and anti-hiv therapy.Prior art is compared to, synergy well is generated after pharmaceutical composition combination of the invention, expanded the product of the infection for the treatment of virus, particularly HIV；Every consumption per day of other ACC007 is small, can greatly reduce the amount of excipient, facilitates patient to use, and improves patient's drug compliance, reduces the generation of resistance phenomenon, increases the curative effect of AntiHIV1 RT activity.
Description
Technical field
The invention belongs to technical field of medicine, specifically, it is related to containing possessing antiviral activity (more specifically
With AntiHIV1 RT activity characteristic) pharmaceutical composition.
Background technology
Immune Deficiency Syndrome (Human Acquired Immunodeficiency Syndrome, AIDS),
Abbreviation AIDS, be it is a kind of by human immunodeficiency virus (human immunodeficiency virus, HIV) cause it is complete
Body sexually transmitted disease.Since finding the first HIV person from the U.S. in 1981, more than 3,400 ten thousand people have been had resulted in so far dead.According to the world
Health organization (WHO) and UNAIDS (UNAIDS) count, and by the end of the year 2014, the whole world is estimated to be 36,900,000 people
Inhibition of HIV is carried, new infeetioa virus Population size estimation is 2,000,000 within 2014, and death toll is 1,200,000.According to Chinese prevention from suffering from the diseases control
Center (CDC) statistics processed, by the end of the year 2015, existing HIV person living/patient AIDS 57.7 ten thousand of whole nation report；2015
It is newly-increased 11.5 ten thousand, dead 2.4 ten thousand.Current China's AIDS epidemic situation is overall still in rising trend, and previous infection person enter successively
Enter period of disease, it is necessary to the number for the treatment of is substantially increased.
Currently without the cure method infected for inhibition of HIV, but treated by inverase, can control HIV diseases
Poison, so that inhibition of HIV carrier can enjoy healthy and beneficial life.The first inverase Zidovudine from 1987
Since appearance, the mankind constantly explore in anti-HIV-1 research field.For the process of HIV attack T lymphocytes in human body：Adsorb, enter
Enter, shell, reverse transcription, integration, duplication, transcription, translation, assembling and maturation, anti-HIV-1 medicines can be divided into 7 classes.Including nucleosides
Class RTI (NRTI), nucleotide reverse transcriptase inhibitor (NtRTI), non-nucleoside reverse transcriptase inhibitor
(NNRTI), protease inhibitors (PI), integrase inhibitor (INSTI), fusion inhibitor (FI) and coreceptor inhibitor
(CRI).These antiviral drugs are used in combination, referred to as highly active antiretroviral therapy (highly active
antiretroviral therapy,HAART)。
Inhibition of HIV has the characteristics of higher duplication, Gao Gengxin, variation high, and using single medicine treatment, patient can be in the short time
Interior generation resistance, causes Endodontic failure.Although HAART cannot cure AIDS, drug resistance can be reduced, improve therapeutic effect, most
Limits ground suppresses the duplication of virus.Since being applied to clinic from HAART, the incidence and the death rate of AIDS greatly drop
It is low.The therapy is treated using 2~4 kinds of inverases for HIV different reproductive cycles difference link simultaneously, to reach suppression
The purpose of HIV-1.Treatment for AIDS, patient needs even lifelong medication for a long time, and multiple medicine is taken and often brings very big to patient
Inconvenience, also easily causes for the medicine of similar profile and wrongly takes, and lessens the curative effect, and produces side effect.The design of several inverases
Into the pharmaceutical composition of fixed dosage, patient can be avoided to take too much medicine and to be caused to wrongly take or missed, improve compliance, increase curative effect.
Therefore anti-HIV-1 compound preparation can Mutiple Targets suppress inhibition of HIV, and medication is convenient, substantially increases the quality of life of patient, has
There is good prospect.As the U.S. has listed compound preparation Truvada, Atripla, Stribild.But existing above-mentioned preparation
Some defects are there is also, such as efavirenz in Atripla (containing emtricitabine, tenofovir disoproxil fumarate, efavirenz)
Consumption is more, and 600mg has been reached per consumption per day, on the one hand causes amount of excipient many, and patient is inconvenient to use；On the other hand can produce
Raw nervous system side effect is, it is necessary to strict control safety using amount.
The content of the invention
Object of the present invention is to provide a kind of pharmaceutical composition for combination antiviral therapy.
The present invention also aims to provide application of the aforementioned pharmaceutical compositions in antiviral and anti-hiv therapy.
A kind of pharmaceutical composition for combination antiviral therapy of the present invention, including active components A CC007 and medicine
Acceptable excipient on.
The ACC007, chemical name is that { [2,3,6- tetrahydrochysenes are phonetic for 3- ethyl -2,6- dioxies -5- (propyl group -2- bases) -1 for 3-
Pyridine -4- bases] carbonyl } -5- methyl cyanophenyls, it is a kind of new non-nucleoside reverse transcriptase inhibitor, can be used for inhibition of HIV infection pre-
Anti- and treatment, its English is entitled
3-[[3-ethyl-1,2,3,6-tetrahydro-5-(1-methylethyl)-2,6-dioxo-4-
Pyrimidinyl] carbonyl] -5-methylbenzonitrile, its chemical structural formula is as follows：
Molecular formula：C18H19N3O3Molecular weight：325.14
No. CAS of the compound is 1097628-00-6, is once included with code name：GS9441 (Gilid Science Co.),
KM023 (Kaino Medicine) and ACC007 (Jiangsu Ai Di pharmaceutcal corporation, Ltds).
Preferably, the amount of the ACC007 accounts for the 5%~70% of total composition, other pharmaceutically acceptable excipient
Amount accounts for the 30~95% of total composition, except coat weight.
The above-mentioned pharmaceutical composition for combination antiviral therapy, also including second active ingredient, and shared by each component
Percentage composition is：
ACC007 15~25%
Second active ingredient 30~50%
Excipient 25~55%,
Wherein, the second active ingredient is nucleosides (acid) class RTI (NRTI).The nucleosides (acid)
Class RTI (NRTI) is selected from Zidovudine (AZT), stavudine (D4T), Lamivudine (3TC), emtricitabine
(FTC) one or more and in tenofovir disoproxil fumarate (TDF)
The above-mentioned pharmaceutical composition for combination antiviral therapy, also including the third active component, and shared by each component
Percentage composition is：
Wherein, described the third active component is integrase inhibitor (INSTI).Described integrase inhibitor
(INSTI) selected from Merck (MK-0518), Ai Weitegewei (GS-9137), Du Lutewei and many Lu Tegewei (DTG)
One or more.
The above-mentioned pharmaceutical composition for combination antiviral therapy, also including the 4th kind of active component, and shared by each component
Percentage composition is：
Wherein, the 4th kind of active component is non-nucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitors
(PI), one or more in fusion/entry inhibitor (FI/EI) and coreceptor inhibitor (CRI).
Described non-nucleoside reverse transcriptase inhibitor (NNRTI) be selected from NVP (NVP), delavirdine (DLV), according to
One or more in Fei Weilun (EFV), etravirine (ETR) and rilpivirine (RPV)；Described protease inhibitors (PI)
Selected from Ritonavir (RTV), indinavir (IDV), Nai Feinawei (NFV), VX-478 (APV), An Zhanawei (ATV), good fortune
One or more in department's VX-478 (FAPV), that Wei (TIV) of TEPA and TMC114 (DRV)；Described fusion/entrance suppression
Preparation (FI/EI) be selected from En Fuwei peptides (T-20) and Mai Ruiweiruoke (MVC) in one or two.
In the above-mentioned pharmaceutical composition for combination antiviral therapy, ACC007 uses micronization processes, and particle diameter is 1~50
μm.ACC007 is insoluble in water, is to reach effective blood drug concentration in vivo, need to carry out micronization processes to ACC007, and
Surfactant SDS is added in prescription.
The excipient includes filler, adhesive, disintegrant, lubricant and surfactant.
Specifically, filler includes one or more in starch, pregelatinized starch, lactose, microcrystalline cellulose.
Specifically, adhesive includes hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polypyrrole alkanone, carboxymethyl cellulose
One or more in element, sodium carboxymethylcellulose, methylcellulose.
Specifically, disintegrant includes Ac-Di-Sol, sodium carboxymethyl starch, PVPP, low substitution hydroxyl
One or more of propyl cellulose.
Specifically, surfactant is lauryl sodium sulfate.
Due to the difference of active constituents of medicine granular size, shape and density, active component may be caused in final agent
Disperse in type uneven.Lubricant by reducing the friction between particulate, for improving the flow behavior of granule and powder.Profit
Lubrication prescription can be applied to improve the mixture homogeneity of component in inverase preparation.The present invention is in order that each activity in final formulation
Composition is obtained and keeps uniformity, can contain lubricant.
Specifically, lubricant includes one or more in magnesium stearate, superfine silica gel powder, talcum powder.
Preferably, described pharmaceutical composition is tablet, can be single-layer sheet or double-layer tablets.
The preparation method of described pharmaceutical composition is comprised the following steps：(1) weigh, sieve：Raw material is weighed according to recipe quantity
And sieve；(2) pelletize：According to the property of each composition, the well mixed granulation of each composition or respectively mixing carry out wet granulation or
Dry granulation or additional mixing, using water as wetting agent, depending on amount of water is according to each composition；(3) whole grain：Dry particl sieving is whole
Grain；(4) it is total mixed：The conforming particle of each composition, is correspondingly mixed according to different compressing tablet requirements (mono-/bis-layer), and mixing is equal
It is even；(5) compressing tablet：Adjust pressure and piece weight, compressing tablet；(6) it is coated：The coating solution of solid content 10~20% is prepared, label is entered
Row is coated, and during coating weight gain 1%~5%, collects coating tablet.
The coating solution isThe solid content of coating solution is 10~20%.
Oval white tablets composite tablet is prepared into, uniform color is consistent, unilateral smooth；Piece is less than 1.5g again.
Application of the above-mentioned pharmaceutical composition for combination antiviral therapy in antiviral and anti-hiv therapy is also in this hair
In bright protection domain.When using, it is administered orally, once a day.
Beneficial effect：Prior art is compared to, pharmaceutical composition of the invention has used antiviral compound ACC007,
ACC007 is better than efavirenz to the activity of NNRTI persisters, will not produce the nervous system side effect of similar efavirenz, poison
Property is small, and safe-dosaging limits are wide.In addition to ACC007, pharmaceutical composition of the present invention is also included selected from identical or different effect machine
System anti HIV-1 virus effect medicine, generated after combination well synergy, expanded treatment virus infection, especially
It is the product of HIV；Every consumption per day of other ACC007 is small, can greatly reduce the amount of excipient, facilitates patient to use, and carries
Patient's drug compliance high, reduces the generation of resistance phenomenon, increases the curative effect of AntiHIV1 RT activity.
Specific embodiment
The present invention is explained in detail with reference to specific embodiment.
Raw material sources：
Lamivudine (3TC) is purchased from：Shijiazhuang Long Ze Pharmacy stock Co., Ltd；
Tenofovir disoproxil fumarate (TDF) is purchased from：Shijiazhuang Long Ze Pharmacy stock Co., Ltd；
ACC007：It is prepared by commission Sangdiya Pharmaceutical Technology (Shanghai) CLC；
Emtricitabine：Shijiazhuang Long Ze Pharmacy stock Co., Ltd；
Du Lutewei：Hubei Vad profit chemistry Science and Technology Ltd..
Embodiment 1
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient and excipient.
The prescription component table of 1 embodiment of table 1
| ACC007 | 150mg |
| Tenofovir disoproxil fumarate | 300mg |
| Lauryl sodium sulfate | 5mg |
| Ac-Di-Sol | 100mg |
| Lactose | 120mg |
| Microcrystalline cellulose | 155mg |
| Hydroxypropyl cellulose | 15mg |
| Magnesium stearate | 15mg |
| Amount to | 860mg |
Embodiment 2
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient and excipient.
The prescription component table of 2 embodiment of table 2
| ACC007 | 150mg |
| Emtricitabine | 250mg |
| Lauryl sodium sulfate | 6mg |
| Ac-Di-Sol | 100mg |
| Lactose | 105mg |
| Microcrystalline cellulose | 110mg |
| Pregelatinized starch | 8mg |
| Hydroxypropyl cellulose | 6mg |
| Magnesium stearate | 15mg |
| Amount to | 750mg |
Embodiment 3
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient and excipient.
The prescription component table of 3 embodiment of table 3
| ACC007 | 150mg |
| Tenofovir disoproxil fumarate | 300mg |
| Lamivudine | 300mg |
| Lauryl sodium sulfate | 5mg |
| Ac-Di-Sol | 100mg |
| Lactose | 130mg |
| Microcrystalline cellulose | 135mg |
| Pregelatinized starch | 8mg |
| Hydroxypropyl cellulose | 7mg |
| Magnesium stearate | 15mg |
| Amount to | 1150mg |
Embodiment 4
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient and excipient.
The prescription component table of 4 embodiment of table 4
| ACC007 | 120mg |
| Tenofovir disoproxil fumarate | 250mg |
| Emtricitabine | 250mg |
| Lauryl sodium sulfate | 5mg |
| Ac-Di-Sol | 120mg |
| Lactose | 130mg |
| Microcrystalline cellulose | 165mg |
| Hydroxypropyl cellulose | 15mg |
| Magnesium stearate | 15mg |
| Amount to | 1070mg |
Embodiment 5
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient and excipient.
The prescription component table of 5 embodiment of table 5
| ACC007 | 150mg |
| Tenofovir disoproxil fumarate | 300mg |
| Emtricitabine | 300mg |
| Lauryl sodium sulfate | 5mg |
| Ac-Di-Sol | 120mg |
| Lactose | 170mg |
| Microcrystalline cellulose | 185mg |
| Hydroxypropyl cellulose | 20mg |
| Magnesium stearate | 20mg |
| Amount to | 1270mg |
Embodiment 6
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient, the 3rd active component and excipient.
The prescription component table of 6 embodiment of table 6
Embodiment 7
The pharmaceutical composition of the present embodiment includes ACC007, second active ingredient, the 3rd active component and excipient.
The prescription component table of 7 embodiment of table 7
| ACC007 | 150mg |
| Tenofovir disoproxil fumarate | 300mg |
| Lamivudine | 300mg |
| Du Lutewei | 200mg |
| Lauryl sodium sulfate | 5mg |
| Ac-Di-Sol | 200mg |
| Lactose | 220mg |
| Microcrystalline cellulose | 235mg |
| Hydroxypropyl cellulose | 40mg |
| Magnesium stearate | 20mg |
| Amount to | 1670mg |
Supplementary material is weighed according to embodiment 1-7 formula rates, oval white tablets composite tablet, uniform color one is prepared into
Cause, it is unilateral smooth；Piece is less than 1.7g again, is administered orally, once a day.
Claims (10)
1. a kind of pharmaceutical composition for combination antiviral therapy, it is characterised in that including active components A CC007 and pharmacy
Upper acceptable excipient, wherein, the ACC007 be compound 3- [3- ethyl -2,6- dioxies -5- (propyl group -2- bases) -1,
2,3,6- tetrahydropyrimidine -4- bases] carbonyl } -5- methyl cyanophenyls.
2. the pharmaceutical composition for combination antiviral therapy according to claim 1, it is characterised in that the peace
The amount of ACC007 accounts for the 5%~70% of total composition, the amount of other pharmaceutically acceptable excipient account for total composition 30~
95%, except coat weight.
3. the pharmaceutical composition for combination antiviral therapy according to claim 1, it is characterised in that also including second
Active component is planted, and percentage composition is shared by each component：
ACC007 15~25%
Second active ingredient 30~50%
Excipient 25~55%,
Wherein, the second active ingredient is nucleosides (acid) class RTI.
4. the pharmaceutical composition for combination antiviral therapy according to claim 3, it is characterised in that the nucleosides
(acid) class RTI is selected from Zidovudine, stavudine, Lamivudine, emtricitabine and tenofovir disoproxil fumarate
In one or more.
5. the pharmaceutical composition for combination antiviral therapy according to claim 3, it is characterised in that also including the 3rd
Active component is planted, and percentage composition is shared by each component：
Wherein, described the third active component is integrase inhibitor.
6. the pharmaceutical composition for combination antiviral therapy according to claim 5, it is characterised in that described integration
Enzyme inhibitor is selected from one or more in Merck, Ai Weitegewei and many Lu Tegewei.
7. the pharmaceutical composition for combination antiviral therapy according to claim 5, it is characterised in that also including the 4th
Active component is planted, and percentage composition is shared by each component：
Wherein, the 4th kind of active component is non-nucleoside reverse transcriptase inhibitor, protease inhibitors, fusion/entrance suppression
One or more in preparation and coreceptor inhibitor.
8. the pharmaceutical composition for combination antiviral therapy according to claim 7, it is characterised in that described non-core
Glycoside RTI be selected from NVP, delavirdine, efavirenz, etravirine and rilpivirine in one kind or
It is various；Described protease inhibitors is selected from Ritonavir, indinavir, Nai Feinawei, VX-478, An Zhanawei, good fortune department
One or more in that Wei of VX-478, TEPA and TMC114；Described fusion/entry inhibitor be selected from En Fuwei peptides and
One or two in Mai Ruiweiruoke.
9. according to any described pharmaceutical composition for combination antiviral therapy in claim 1-8, it is characterised in that institute
State ACC007 and use micronization processes, particle diameter is 1~50 μm；The excipient includes filler, adhesive, disintegrant, lubrication
Agent and surfactant.
10. the pharmaceutical composition of combination antiviral therapy answering in antiviral and anti-hiv therapy is used for described in claim 9
With.
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| CN201710084881.3A CN106860464A (en) | 2017-02-16 | 2017-02-16 | Pharmaceutical composition and application for combination antiviral therapy |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108498475A (en) * | 2018-07-06 | 2018-09-07 | 江苏艾迪药业有限公司 | For the oral pharmaceutical preparation and preparation method thereof for giving non-nucleoside reverse transcriptase inhibitor |
| CN111246851A (en) * | 2017-10-13 | 2020-06-05 | Viiv保健公司 | Bilayer pharmaceutical tablet formulation |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104995198A (en) * | 2012-12-21 | 2015-10-21 | 吉里德科学公司 | Polycyclic-carbamoylpyridone compounds and their pharmaceutical use |
-
2017
- 2017-02-16 CN CN201710084881.3A patent/CN106860464A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104995198A (en) * | 2012-12-21 | 2015-10-21 | 吉里德科学公司 | Polycyclic-carbamoylpyridone compounds and their pharmaceutical use |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111246851A (en) * | 2017-10-13 | 2020-06-05 | Viiv保健公司 | Bilayer pharmaceutical tablet formulation |
| CN108498475A (en) * | 2018-07-06 | 2018-09-07 | 江苏艾迪药业有限公司 | For the oral pharmaceutical preparation and preparation method thereof for giving non-nucleoside reverse transcriptase inhibitor |
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Address after: 225008 Liu Zhuang Road, Hanjiang District, Yangzhou, Jiangsu Province, No. 2 Applicant after: Jiangsu Aidi Pharmaceutical Co.,Ltd. Applicant after: NANJING ANSAILAI MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. Address before: 225008 Liu Zhuang Road, Hanjiang District, Yangzhou, Jiangsu Province, No. 2 Applicant before: JIANGSU AIDEA PHARMACEUTICAL CO.,LTD. Applicant before: NANJING ANSAILAI MEDICAL SCIENCE & TECHNOLOGY Co.,Ltd. |
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Application publication date: 20170620 |