CN113350375A - Medicinal composition and application thereof - Google Patents
Medicinal composition and application thereof Download PDFInfo
- Publication number
- CN113350375A CN113350375A CN202110566861.6A CN202110566861A CN113350375A CN 113350375 A CN113350375 A CN 113350375A CN 202110566861 A CN202110566861 A CN 202110566861A CN 113350375 A CN113350375 A CN 113350375A
- Authority
- CN
- China
- Prior art keywords
- component
- weight
- pharmaceutical composition
- pharmaceutical
- folic acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 29
- 201000009916 Postpartum depression Diseases 0.000 claims abstract description 20
- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 claims abstract description 16
- 229960004688 venlafaxine Drugs 0.000 claims abstract description 13
- 150000002505 iron Chemical class 0.000 claims abstract description 5
- 150000002224 folic acids Chemical class 0.000 claims abstract description 3
- OVBPIULPVIDEAO-LBPRGKRZSA-N Folic acid Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims description 46
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 36
- 239000008194 pharmaceutical composition Substances 0.000 claims description 33
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 claims description 26
- 229960000304 folic acid Drugs 0.000 claims description 26
- 235000019152 folic acid Nutrition 0.000 claims description 26
- 239000011724 folic acid Substances 0.000 claims description 26
- 229910052742 iron Inorganic materials 0.000 claims description 18
- 239000003826 tablet Substances 0.000 claims description 17
- 239000003814 drug Substances 0.000 claims description 15
- 238000000034 method Methods 0.000 claims description 15
- 229920002472 Starch Polymers 0.000 claims description 11
- 239000002775 capsule Substances 0.000 claims description 11
- 239000008107 starch Substances 0.000 claims description 11
- 235000019698 starch Nutrition 0.000 claims description 11
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 10
- 238000002360 preparation method Methods 0.000 claims description 10
- PMVSDNDAUGGCCE-TYYBGVCCSA-L Ferrous fumarate Chemical compound [Fe+2].[O-]C(=O)\C=C\C([O-])=O PMVSDNDAUGGCCE-TYYBGVCCSA-L 0.000 claims description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
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- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- 229940105150 5-methyltetrahydrofolic acid Drugs 0.000 claims description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 2
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- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 2
- 239000004222 ferrous gluconate Substances 0.000 claims description 2
- 235000013924 ferrous gluconate Nutrition 0.000 claims description 2
- 229960001645 ferrous gluconate Drugs 0.000 claims description 2
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- 235000003891 ferrous sulphate Nutrition 0.000 claims description 2
- 239000011790 ferrous sulphate Substances 0.000 claims description 2
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- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 2
- BAUYGSIQEAFULO-UHFFFAOYSA-L iron(2+) sulfate (anhydrous) Chemical compound [Fe+2].[O-]S([O-])(=O)=O BAUYGSIQEAFULO-UHFFFAOYSA-L 0.000 claims description 2
- 229910000359 iron(II) sulfate Inorganic materials 0.000 claims description 2
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 claims description 2
- ZNOVTXRBGFNYRX-ABLWVSNPSA-N levomefolic acid Chemical compound C1NC=2NC(N)=NC(=O)C=2N(C)C1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 ZNOVTXRBGFNYRX-ABLWVSNPSA-N 0.000 claims description 2
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- 230000002354 daily effect Effects 0.000 description 9
- 238000012360 testing method Methods 0.000 description 9
- FFFHZYDWPBMWHY-VKHMYHEASA-N L-homocysteine Chemical compound OC(=O)[C@@H](N)CCS FFFHZYDWPBMWHY-VKHMYHEASA-N 0.000 description 8
- 229930006000 Sucrose Natural products 0.000 description 8
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 8
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- 125000003929 folic acid group Chemical group 0.000 description 6
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- QZAYGJVTTNCVMB-UHFFFAOYSA-N serotonin Chemical compound C1=C(O)C=C2C(CCN)=CNC2=C1 QZAYGJVTTNCVMB-UHFFFAOYSA-N 0.000 description 6
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- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 3
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 2
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
-
- 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
- A61K31/28—Compounds containing heavy metals
- A61K31/295—Iron group metal compounds
-
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
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Abstract
The application discloses a medicinal composition and application thereof, wherein the medicinal composition comprises a component A, a component B and a component C; the component A comprises folic acid compounds; the component B comprises venlafaxine; the component C comprises iron salt. The medicinal composition has a particularly remarkable effect on postpartum depression, can realize a synergistic effect among components, shortens the treatment period, improves the treatment compliance of patients, has high safety, and is easy to popularize and apply.
Description
Technical Field
The application relates to a medicinal composition and application thereof, belonging to the field of medicines.
Background
The occurrence of postpartum depression in a parturient is called postpartum depression, which was first proposed in 1986 by Pitt and is the most common female mental disorder in the puerperium of women. Generally, the diseases are caused within one month after delivery of a pregnant woman, anxiety, irritability, terrorism, hypersomnia, confusion and the like sometimes occur within half a month after delivery, and the postpartum depression not only seriously affects the physical and mental health of the pregnant woman, but also has great influence on relationships between couples and families and harmony, and even has adverse influence on the personality, intelligence, action and the like of a newborn. In recent years, postpartum depression patients gradually increase, the incidence rate is 15% -30%, and the recurrence rate is 20% -30% when patients are pregnant again. There is therefore a great need to find effective methods for treating postpartum depression.
Folic acid, a water-soluble vitamin, is known as pteroglucamic acid (PGA), is purified from spinach leaves by michael (h.k. mitchell, 1941), and is known as folic acid, and has the effect of promoting maturation of immature cells in the bone marrow, and the deficiency of folic acid in humans can cause megaloblastic anemia and leukopenia. Homocysteine (hcy) is a neurotoxic amino acid, and hcy increase in serum has important effects on cardiovascular and cerebrovascular diseases and change of nervous consciousness, and is closely related to the formation of diseases with cognitive dysfunction and mental classification. Elevation of hcy in the body can prevent monoamine neurotransmitter metabolism, thereby causing depression. Studies have shown that hcy levels in the serum of patients with postpartum depression are elevated, presumably correlated with the onset of depression. Folic acid is a methyl donor for re-synthesizing methionine in the degradation pathway of hcy, and can effectively reduce homocysteine level in organism, and folic acid deficiency can cause metabolic pathway obstruction and hcy accumulation in blood.
Many studies have shown that maternal anemia is a potential risk factor for postpartum depression, with iron deficiency anemia being the most common. The incidence of postpartum anemia reaches 30% in developed countries and 50% -80% in developing countries. Medical studies have found that the underlying mechanism of action of the relationship between anemia and depression is related to the role of iron in mood regulation. The iron-deficiency anemia of the puerpera can finally affect the emotional behavior and the mental health of the puerpera by changing the steady state of neurotransmitter and monoamine metabolism. It has been found that iron deficiency can down-regulate the expression of dopamine receptor-1 and reduce the density of dopamine transporters, thereby altering the metabolism of dopamine, which is a brain neurotransmitter and helps to regulate the emotional response. Second, since iron is a cofactor for the rate-limiting enzymes in the synthesis of norepinephrine and 5-hydroxytryptamine, iron deficiency may alter the signaling of norepinephrine and 5-hydroxytryptamine, which in turn may lead to mood changes.
Venlafaxine can regulate the levels of norepinephrine and 5-hydroxytryptamine in organisms and inhibit reuptake of dopamine, belongs to three biogenic amine drugs, can generate multiple antidepressant effects after acting on the organisms, and can reduce the cAMP concentration of pineal bodies in the organisms by quickly reducing epinephrine beta receptors, thereby quickly generating a treatment effect.
The existing methods for treating postpartum depression mainly comprise drug therapy and psychological therapy, but the drug therapy may generate drug dependence, and has obvious side effects and more contraindications, so that patients are difficult to accept, and the treatment compliance is poor. Develops a combined medicine with high safety, quick response and simple and convenient taking, and has important social value and economic value for controlling the occurrence and the development of the postpartum depression.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and provides the pharmaceutical composition containing folic acid, venlafaxine and iron, the pharmaceutical composition has a synergistic effect among the components, is used for treating postpartum depression, can shorten the treatment period and improve the treatment compliance of patients, and has the advantages of low cost, high safety and easy popularization and application.
According to a first aspect of the present application, there is provided a pharmaceutical composition comprising component a, component B and component C;
the component A comprises folic acid compounds;
the component B comprises venlafaxine;
the component C comprises iron salt.
Optionally, the iron salt is selected from at least one of ferrous fumarate, ferrous gluconate, and ferrous sulfate;
the folic acid compound comprises at least one of folic acid and pharmaceutically acceptable salts thereof, and 5-methyltetrahydrofolic acid and pharmaceutically acceptable salts thereof.
Optionally, the pharmaceutical composition comprises the following components:
0.4-15 parts by weight of the component A;
75-225 parts by weight of component B;
100-200 parts by weight of a component C;
wherein the weight of the component A is calculated by the weight of folic acid contained in the component A, and the weight of the component C is calculated by the mass of iron contained in the component C.
Preferably, the pharmaceutical composition comprises the following components:
0.6-10 parts by weight of component A;
75-150 parts by weight of component B;
100-130 parts by weight of a component C;
wherein the weight of the component A is calculated by the weight of folic acid contained in the component A, and the weight of the component C is calculated by the mass of iron contained in the component C.
According to a second aspect of the present application, there is provided a pharmaceutical formulation comprising a pharmaceutical composition and a pharmaceutically acceptable excipient;
the medicinal composition is selected from the medicinal compositions.
Optionally, the dosage form of the pharmaceutical preparation is selected from any one of tablets, capsules, pills and granules.
Optionally, the pharmaceutically acceptable auxiliary material is at least one selected from a disintegrating agent, a diluent, a binder and a glidant.
Optionally, the disintegrant is selected from at least one of sodium carboxymethyl starch, low-substituted cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, starch;
the diluent is selected from at least one of lactose, starch and dextrin;
the binder is selected from at least one of microcrystalline cellulose, starch, polyvidone, polyethylene glycol, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose and sodium carboxymethylcellulose;
the glidant is selected from at least one of magnesium stearate, talcum powder and superfine silica gel powder.
Optionally, in the pharmaceutical formulation, the mass content of the glidant is 0.1-3%.
Optionally, the low-substituted cellulose is selected from low-substituted hydroxypropylcellulose.
The three components of the pharmaceutical composition can be directly purchased in the market, can be mixed with any pharmaceutically acceptable auxiliary materials, and can be prepared into tablets, capsules, pills, granules or other formulations by a conventional process.
Alternatively, the pharmaceutical composition may be administered in various conventional ways, preferably orally.
Specifically, the administration dosage and the administration frequency of the pharmaceutical composition are determined by doctors according to multiple factors such as the condition of illness and the weight of patients, and the daily administration dosage range is 0.4-15 mg of folic acid, 75-225 mg of venlafaxine and 100-200 mg of iron.
In the embodiment of the invention, the optional daily dosage is 0.6mg of folic acid, 75mg of venlafaxine and 120mg of iron; the optional daily dose is folic acid 3mg, venlafaxine 150mg, iron 150 mg; the optional daily dose is folic acid 3mg, venlafaxine 225mg, iron 150 mg; the optional daily dose is folic acid 15mg, venlafaxine 150mg, iron 195 mg; the optional daily dose is folic acid 3mg, venlafaxine 225mg, iron 195 mg.
According to a third aspect of the present application, there is provided a method of preparing the above pharmaceutical formulation, the method comprising:
the medicinal composition is mixed with the pharmaceutically acceptable auxiliary materials to obtain the medicinal preparation.
Optionally, the preparation method comprises:
(1) obtaining a mixture I containing a component A, a component B and a component C;
(2) adding a binder into the mixture I to obtain a mixture II;
(3) adding a diluent and a disintegrant into the mixture II to obtain a mixture III;
(4) and adding a glidant into the mixture III to obtain the pharmaceutical preparation.
Optionally, the pharmaceutical formulation is compressed to obtain a tablet.
Optionally, selecting a suitable capsule shell, and filling the pharmaceutical preparation into the capsule shell to obtain the capsule.
According to a fourth aspect of the present application, there is provided a method of use of the above pharmaceutical composition, the pharmaceutical composition being administered daily in the following amounts:
0.4-15 mg of the component A; 75-225 mg of the component B; 100-200 mg of component C;
wherein the weight of the component A is calculated by the weight of folic acid contained in the component A, and the weight of the component C is calculated by the mass of iron contained in the component C.
Alternatively, the pharmaceutical composition is administered orally.
According to a final aspect of the application, there is provided a use of any one of the above-mentioned pharmaceutical composition, the above-mentioned pharmaceutical preparation, and the pharmaceutical preparation prepared according to the above-mentioned method, as a medicament for postpartum depression.
The beneficial effects that this application can produce include:
the folic acid, the venlafaxine and the iron are combined for treating the postpartum depression, and the invention has the advantages of obvious treatment effect, synergistic effect, shortened treatment period, improved clinical safety and treatment compliance and easy popularization and application.
Detailed Description
The present invention will be described in detail with reference to examples, but the present invention is not limited to these examples.
The raw materials in the examples of the present invention were all purchased from commercial sources unless otherwise specified.
EXAMPLES 1-5 preparation of tablets of the compositions
The composition is formulated into tablet (1000 tablets) as shown in Table 1, and the daily dose is 3 tablets.
TABLE 1 tablet formulation composition
| Components | Example 1 | Example 2 | Example 3 | Example 4 | Example 5 |
| Folic acid | 0.2g | 1.0g | 1.0g | 5.0g | 1.0g |
| Venlafaxine | 25.0g | 50.0g | 75.0g | 50.0g | 75.0g |
| Ferrous fumarate (in terms of iron) | 40.0g | 50.0g | 50.0g | 65.0g | 65.0g |
| Microcrystalline cellulose | 80.0g | 80.0g | 80.0g | 80.0g | 80.0g |
| Lactose | 150.0g | 150.0g | 150.0g | 150.0g | 150.0g |
| Sodium carboxymethyl starch | 4.5g | 4.5g | 4.5g | 4.5g | 4.5g |
| Magnesium stearate | Proper amount of[1] | Proper amount of[1] | Proper amount of[1] | Proper amount of[1] | Proper amount of[1] |
[1]: the amount of magnesium stearate is 1% of the weight of the powder after dry blending
The preparation method comprises the following steps: sieving lactose and microcrystalline cellulose with 80 mesh sieve, and weighing folic acid, venlafaxine, ferrous fumarate, microcrystalline cellulose, lactose and sodium carboxymethyl starch according to the weight in the formula composition table. Mixing folic acid, venlafaxine and ferrous fumarate, adding microcrystalline cellulose, mixing, adding lactose and sodium carboxymethyl starch, and mixing to obtain dry mixed powder. The dry blended powder was weighed out and 1% by weight of magnesium stearate was added for total blending. And (4) measuring the content of the total mixed powder, and calculating the weight of the tablet according to the content measurement result. Installing and adjusting a tablet press, loading the total mixed powder, adjusting the tablet weight and pressure, tabletting, measuring the tablet weight and hardness at regular time, and preparing the compound tablet.
EXAMPLE 6 preparation of composition capsules
The preparation methods of the formula and the total mixed powder are the same as those of examples 1 to 4. And measuring the content of the total mixed powder, and calculating the filling amount of each capsule according to the content measurement result. Selecting proper capsule shell, installing a debugging machine to fill the capsule, measuring the filling quantity difference at regular time, and preparing the compound capsule.
EXAMPLE 7 Effect of pharmaceutical compositions on postpartum depressed rats
(1) Preparation of postpartum depression model
SD rats (Sprague-Dawley, Latin school name) with pregnancy of 16 days are selected, fed in a single cage, subjected to behavioral tests after adaptive feeding for 3 days, and 60 qualified pregnant rats are screened according to scoring results and randomly divided into a normal group, a model group, a folic acid group, a venlafaxine group, a ferrous fumarate group and a combined drug group (in example 2), wherein 10 pregnant rats are each group.
The method comprises the steps of preparing a postpartum depression animal model by adopting a maternal-fetal separation stress method for 5 groups of rats except a normal group, separating mothers and babies from day 1 to day 21 after delivery for 4 hours every day, wherein the separation time is from 9 am to 1 pm every day, moving young rats to another cage during separation, placing the young rats back to the corresponding maternal cages after the separation is finished, carrying out no treatment on the young rats, and weaning all the young rats on day 22 and separating and feeding the young rats from the maternal cages. And observing the behavioral changes of the mother mouse and the normal group after the model is made, and determining the success of the model making.
(2) Method of administration
After the molding was completed, drug intervention was performed, and the administration dose of rats was calculated to be 7 times the amount of adult human, and the administration dose is shown in table 2. The body weight of the rats was monitored weekly, and the administration dose was adjusted according to the body weight, and each group was administered with an aqueous solution of the corresponding dose of the drug by intragastric administration of 1ml per administration volume of 100g of the body weight daily for 6 weeks, and the normal control group and the model group were administered with pure water. During the experiment, the drinking and feed of the animals are not limited.
TABLE 2 dosage form for each group
Remarking: rat dose (mg/kg/day) human dose (mg/day)/70 kg 7, standard human body weight is given as 70 kg.
(3) Detecting the index
The behavioral tests of the rats of each group, including the open box experiment, the sucrose water consumption experiment and the elevated plus maze experiment, are carried out, and the treatment effect of the drugs of each group is evaluated by comparing each behavior.
And (3) carrying out an open box experiment: a single rat was placed in the center of a clean open box of 100cm by 40cm, the bottom of the open box was divided into 25 equilateral squares, and the inner surface was painted with black paint. Recording the action performance of the rat within 5min, scoring the horizontal movement by taking the number of squares for the animal to pass through the ground as the score, and scoring the animal to pass through 1 square (counting the squares for at least 3 claws to enter) as 1 score; the vertical movement is scored as the number of times of standing, and the two forepaws are emptied or attached to the wall no matter how long the animal stands until the feet are put down is 1 point. And adding the scores of the horizontal movement and the vertical movement to obtain the total score of the open box experiment.
Sucrose water consumption experiment: the rats were deprived of water for 24 hours, then 1% by mass of sucrose aqueous solution was administered while fasting, and after 24 hours, sucrose bottles were weighed and the amount of sucrose water consumed by the rats within 24 hours was calculated.
Elevated plus maze experiment: the elevated plus maze, a classic unconditional anxiety test, is widely used in anxiety-related neurobiology. The rats were placed on the central platform with the closed arms facing, the test time was 5 minutes, and the number of entries into the open arms (OE), time (OT) and number and time of entries into the closed arms were observed. The percentage OE to total number of entries into the arms (TE) OE/TE and the percentage OT/TT to total time spent in the arms (TT) OT/TT were calculated.
(4) Results
The results of the open-box experimental behavior test for each group of rats are shown in table 3.
Table 3 comparison of test results of open-box experimental behavior of rats in each group
Remarking: the data table indicates that significant differences exist after molding compared with before molding; + indicates a significant difference compared to the model group after 6 weeks of dosing; # indicates a significant difference compared to the combination drug group.
The results of the sugar water consumption experiments for each group of rats are shown in table 4.
TABLE 4 comparison of sugar water consumption in rats of each group
The results of the elevated plus maze test are shown in table 5.
TABLE 5 comparison of experimental results of elevated plus maze for various groups of rats
According to the data, the score of the rat subjected to molding in the open box experiment, the sucrose water consumption and the OT/TT of the elevated plus maze experiment are all lower than those before molding, which indicates that the rat subjected to postpartum depression is successfully molded. After 6 weeks of drug intervention, the venlafaxine group and the combined drug group have better effect of improving depression symptoms, and the combined drug group is obviously superior to the venlafaxine group, the folic acid group and the ferrous fumarate group, which shows that the venlafaxine, folic acid and iron combined drugs can be synergistic, the treatment period can be shortened, the toxic and side effects of taking a single antidepressant for a long time can be reduced, and the treatment compliance of patients can be improved.
Example 8 Effect of tablets prepared in examples 1-5 on postpartum depressed rats
(1) Preparation and grouping of postpartum depression model
The method for producing the postpartum depression rat model was the same as in example 7, and the rats successfully molded were divided into 10 rats per model group, example 1 administration group, example 2 administration group, example 3 administration group, example 4 administration group and example 5 administration group. Another 10 postpartum normal rats were taken as controls.
(2) Method of administration
After the molding is finished, drug intervention is carried out, the administration dose of the rat is calculated by 7 times of the dosage of the adult, the human dose of the examples 1-4 is 3 tablets/day, the standard weight of the adult is 70kg, and the administration dose of the rat is 0.3 tablets/kg/day.
The body weight of the rats was monitored weekly and the dose was adjusted according to the body weight. Taking the pharmaceutical composition tablets prepared in the examples 1-5, grinding into fine powder, calculating the weight of the required fine powder according to the weight of a rat, adding a proper amount of water to prepare a suspension, performing intragastric administration on each group according to the administration volume of 1ml per 100g of weight per day, administering the aqueous solution of the corresponding dose of the drug for 6 weeks continuously, and administering pure water to a normal control group and a model group. During the experiment, the drinking and feed of the animals are not limited.
(3) Detecting the index
The same as in example 7.
(4) Results
The results of behavioral tests of the rat open box test, sucrose water consumption test, and elevated plus maze test of each group are shown in table 6.
Table 6 comparison of results of behavioral testing in rats of each group
Remarking: data table indicates significant differences compared to model group 6 weeks after dosing.
The data show that the folic acid, venlafaxine and iron composition preparation prepared by mixing in each proportion in examples 1-5 can obviously improve the score of an open box experiment of a postpartum depressed rat, the sucrose water consumption and the OT/TT value of an elevated plus maze experiment, and has quite obvious treatment effect on postpartum depression.
Although the present application has been described with reference to a few embodiments, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the application as defined by the appended claims.
Claims (10)
1. A pharmaceutical composition comprising component a, component B and component C;
the component A comprises folic acid compounds;
the component B comprises venlafaxine;
the component C comprises iron salt.
2. The pharmaceutical composition of claim 1, wherein the iron salt is selected from at least one of ferrous fumarate, ferrous gluconate, and ferrous sulfate;
the folic acid compound comprises at least one of folic acid and pharmaceutically acceptable salts thereof, and 5-methyltetrahydrofolic acid and pharmaceutically acceptable salts thereof;
preferably, the pharmaceutical composition comprises the following components:
0.4-15 parts by weight of the component A;
75-225 parts by weight of component B;
100-200 parts by weight of a component C;
wherein the weight of the component A is calculated by the weight of folic acid contained in the component A, and the weight of the component C is calculated by the weight of iron contained in the component C.
3. The pharmaceutical preparation is characterized by comprising a pharmaceutical composition and pharmaceutically acceptable auxiliary materials;
the pharmaceutical composition is selected from the pharmaceutical compositions of claims 1 or 2.
4. The pharmaceutical preparation according to claim 3, wherein the dosage form of the pharmaceutical preparation is selected from any one of tablets, capsules, pills and granules.
5. The pharmaceutical formulation of claim 3, wherein the pharmaceutically acceptable excipients are selected from at least one of disintegrants, diluents, binders, glidants;
preferably, the disintegrant is selected from at least one of sodium carboxymethyl starch, low-substituted cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, and starch;
the diluent is selected from at least one of lactose, starch and dextrin;
the binder is selected from at least one of microcrystalline cellulose, starch, polyvidone, polyethylene glycol, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose and sodium carboxymethylcellulose;
the glidant is selected from at least one of magnesium stearate, talcum powder and superfine silica gel powder;
preferably, the mass content of the glidant in the pharmaceutical preparation is 0.1-3%.
6. A process for preparing a pharmaceutical formulation according to any one of claims 3 to 5, wherein the process comprises:
the medicinal composition is mixed with the pharmaceutically acceptable auxiliary materials to obtain the medicinal preparation.
7. The method of manufacturing according to claim 6, comprising:
(1) obtaining a mixture I containing a component A, a component B and a component C;
(2) adding a binder into the mixture I to obtain a mixture II;
(3) adding a diluent and a disintegrant into the mixture II to obtain a mixture III;
(4) and adding a glidant into the mixture III to obtain the pharmaceutical preparation.
8. The method of using the pharmaceutical composition of claim 1 or 2, wherein the amount of the pharmaceutical composition taken daily is as follows:
0.4-15 mg of the component A; 75-225 mg of component B; 100-200 mg of component C;
wherein the weight of the component A is calculated by the weight of folic acid contained in the component A, and the weight of the component C is calculated by the mass of iron contained in the component C.
9. The method of use of claim 8, wherein the pharmaceutical composition is administered orally.
10. Use of any one of the pharmaceutical composition of claim 1 or 2, the pharmaceutical formulation of any one of claims 3 to 5, or the pharmaceutical formulation prepared by the method of claim 6 or 7 as a medicament for postpartum depression.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999055338A1 (en) * | 1998-04-24 | 1999-11-04 | Scarista Limited | Treatment of depression and pharmaceutical preparations therefor |
| CN103655574A (en) * | 2013-12-20 | 2014-03-26 | 合肥九研医药科技开发有限公司 | Compound ferrous succinate and folic acid composition |
| CN109701027A (en) * | 2019-01-24 | 2019-05-03 | 北京斯利安药业有限公司 | A kind of folic acid pharmaceutical composition and folic acid pharmaceutical preparation of novel enhancing folic acid antioxidant |
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2021
- 2021-05-24 CN CN202110566861.6A patent/CN113350375A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999055338A1 (en) * | 1998-04-24 | 1999-11-04 | Scarista Limited | Treatment of depression and pharmaceutical preparations therefor |
| CN103655574A (en) * | 2013-12-20 | 2014-03-26 | 合肥九研医药科技开发有限公司 | Compound ferrous succinate and folic acid composition |
| CN109701027A (en) * | 2019-01-24 | 2019-05-03 | 北京斯利安药业有限公司 | A kind of folic acid pharmaceutical composition and folic acid pharmaceutical preparation of novel enhancing folic acid antioxidant |
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| Title |
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Application publication date: 20210907 |