CN1279920C - Slow release preparation of diammonium glycyrrhizate - Google Patents
Slow release preparation of diammonium glycyrrhizate Download PDFInfo
- Publication number
- CN1279920C CN1279920C CN 200410066144 CN200410066144A CN1279920C CN 1279920 C CN1279920 C CN 1279920C CN 200410066144 CN200410066144 CN 200410066144 CN 200410066144 A CN200410066144 A CN 200410066144A CN 1279920 C CN1279920 C CN 1279920C
- Authority
- CN
- China
- Prior art keywords
- diammonium glycyrrhizinate
- diammonium
- release
- glycyrrhizinate
- release preparation
- 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.)
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- SPPIIOPGDLITJE-VLQRKCJKSA-N diazanium;(2s,3s,4s,5r,6s)-6-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-5-[(2r,3r,4s,5s,6s)-6-carboxy-3,4,5-trihydroxyoxan-2-yl]oxy-3,4-dihy Chemical compound N.N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O SPPIIOPGDLITJE-VLQRKCJKSA-N 0.000 title claims abstract description 123
- 238000002360 preparation method Methods 0.000 title claims abstract description 60
- 239000000463 material Substances 0.000 claims abstract description 18
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000661 sodium alginate Substances 0.000 claims abstract description 8
- 235000010413 sodium alginate Nutrition 0.000 claims abstract description 8
- 229940005550 sodium alginate Drugs 0.000 claims abstract description 8
- -1 polyethylene Polymers 0.000 claims description 51
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 34
- 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 30
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- 238000000034 method Methods 0.000 claims description 21
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- 239000001856 Ethyl cellulose Substances 0.000 claims description 16
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 16
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 16
- 229920001249 ethyl cellulose Polymers 0.000 claims description 16
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- 238000000576 coating method Methods 0.000 claims description 13
- 239000000080 wetting agent Substances 0.000 claims description 13
- 239000004925 Acrylic resin Substances 0.000 claims description 11
- 239000011230 binding agent Substances 0.000 claims description 11
- 229920000178 Acrylic resin Polymers 0.000 claims description 10
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- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 10
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- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 10
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- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims description 7
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 6
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- 235000000346 sugar Nutrition 0.000 claims description 6
- 235000021355 Stearic acid Nutrition 0.000 claims description 5
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 5
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 5
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 5
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- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 3
- 229920002301 cellulose acetate Polymers 0.000 claims description 3
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- 239000004203 carnauba wax Substances 0.000 claims description 2
- 238000007906 compression Methods 0.000 claims description 2
- 230000006835 compression Effects 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
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- 239000003405 delayed action preparation Substances 0.000 claims 4
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 2
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- 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 2
- AQLLBJAXUCIJSR-UHFFFAOYSA-N OC(=O)C[Na] Chemical compound OC(=O)C[Na] AQLLBJAXUCIJSR-UHFFFAOYSA-N 0.000 claims 1
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- 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 abstract description 8
- 239000001768 carboxy methyl cellulose Substances 0.000 abstract description 8
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- 239000002552 dosage form Substances 0.000 abstract description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 56
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- 206010013786 Dry skin Diseases 0.000 description 13
- 230000001476 alcoholic effect Effects 0.000 description 13
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- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 6
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- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 4
- 235000006200 Glycyrrhiza glabra Nutrition 0.000 description 4
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- 239000012153 distilled water Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 235000011477 liquorice Nutrition 0.000 description 4
- 239000011159 matrix material Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 239000002202 Polyethylene glycol Substances 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 238000011978 dissolution method Methods 0.000 description 3
- 239000000706 filtrate Substances 0.000 description 3
- 150000002632 lipids Chemical class 0.000 description 3
- 230000003204 osmotic effect Effects 0.000 description 3
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- 108010062580 Concanavalin A Proteins 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- NTYJJOPFIAHURM-UHFFFAOYSA-N Histamine Chemical compound NCCC1=CN=CN1 NTYJJOPFIAHURM-UHFFFAOYSA-N 0.000 description 2
- VTAJIXDZFCRWBR-UHFFFAOYSA-N Licoricesaponin B2 Natural products C1C(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2)C(O)=O)C)(C)CC2)(C)C2C(C)(C)CC1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O VTAJIXDZFCRWBR-UHFFFAOYSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
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- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
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- YZXBAPSDXZZRGB-DOFZRALJSA-N arachidonic acid Chemical compound CCCCC\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O YZXBAPSDXZZRGB-DOFZRALJSA-N 0.000 description 2
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- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 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 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229940075507 glyceryl monostearate Drugs 0.000 description 2
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 description 2
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- ZEMPKEQAKRGZGQ-AAKVHIHISA-N 2,3-bis[[(z)-12-hydroxyoctadec-9-enoyl]oxy]propyl (z)-12-hydroxyoctadec-9-enoate Chemical compound CCCCCCC(O)C\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CC(O)CCCCCC)COC(=O)CCCCCCC\C=C/CC(O)CCCCCC ZEMPKEQAKRGZGQ-AAKVHIHISA-N 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
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- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 description 1
- 206010019799 Hepatitis viral Diseases 0.000 description 1
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- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 1
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Abstract
本发明是研究甘草酸二铵的缓释剂型及其制备方法，以羟丙基甲基纤维素、山榆酸甘油酯、乙基纤维素、丙烯酸树脂、卡波浦、十八醇、硬脂酸、羧甲基纤维素钠、海藻酸钠等作为缓释材料将甘草酸二铵制成缓释剂型，从而减少了给药次数，为患者提供了方便。The present invention is to study the sustained-release dosage form of diammonium glycyrrhizinate and its preparation method. Diammonium glycyrrhizinate is made into a sustained-release dosage form by using sodium carboxymethylcellulose, sodium alginate, etc. as sustained-release materials, thereby reducing the number of administrations and providing convenience for patients.
Description
Technical field: the present invention relates to slow releasing preparation of diammonium glycyrrhizinate and preparation method thereof.
Background technology: Radix Glycyrrhizae has the releasing drug intoxication, alimentary toxicosis, the function of interior metabolism product poisoning etc.The effective ingredient glycyrrhizic acid of Radix Glycyrrhizae, (OH), superoxide ion free radical (O2-), hydrogen peroxide (H2O2) etc. all have tangible elimination effect and significant lipoid peroxidization resistant to hydroxy radical for enoxolone and liquorice flavonoids compound.Diammonium glycyrrhizinate is the third generation product with research on the basis of effective ingredient of Radix Glycyrrhizae and derivant thereof and application, in clinical practice for many years, except that aspect the treatment viral hepatitis, obtaining the significant curative effect, it is widely used in clinical every field, treats the hepar damnification that multiple disease and chemical factors cause.Diammonium glycyrrhizinate has stronger and the similar nonspecific antiinflammatory action of hydrocortisone, can reduce hepatocellular edema, necrosis; Suppress mastocyte and discharge histamine, suppress arachidonic acid and PGE2, make the slow working substance of anaphylactic type generate minimizing and produce anti-allergic effects; Can alleviate the mouse writhing reaction that lumbar injection acetic acid causes, play analgesic activity; Glycyrrhizic acid can strengthen the ability of inductive people's peripheral blood lymphocyte of concanavalin A (Con-A) and NK cell generation gamma interferon; Protection hepatocyte and lysosome membrane structure and improve the effect of liver function; Diammonium glycyrrhizinate can block flow of calcium ions, to alleviate the infringement of cells of organs.Diammonium glycyrrhizinate is a clinical commonly used drug, prior dosage form has conventional capsule, enteric coated preparation, injection etc., peroral dosage form is taken 3 times every day, thereby brings inconvenience to the patient especially patient of long-term prescription, and how medicining times often causes the drug level big defective of undulatory property in vivo.
Summary of the invention: the present invention is the slow release formulation of research diammonium glycyrrhizinate, comprises medicine, adjuvant, it is characterized in that comprising slow-release auxiliary material, and said medicine is a diammonium glycyrrhizinate, diammonium glycyrrhizinate: the ratio of adjuvant is 1: 0.1～15.The present invention makes slow release formulation as slow-release material with diammonium glycyrrhizinate with hydroxypropyl emthylcellulose (HPMC), Rikemal B 200 (Comprital 888 ATO), ethyl cellulose, acrylic resin, Ka Bopu, octadecanol, stearic acid, sodium carboxymethyl cellulose, sodium alginate etc., thereby reduced administration number of times, blood drug level is kept steadily in a long time, not only overcome drug level that multiple dosing brings undulatory property big shortcoming in vivo, also provide convenience for the patient.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that diammonium glycyrrhizinate: hydrophilic gel matrix material, wax lipid framework material, insoluble framework material or the ratio that wherein makes up arbitrarily are 1: 0.1～15.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that: the adding hydrophilic gel matrix material is hydroxypropyl emthylcellulose, Ka Bopu, sodium carboxymethyl cellulose, sodium alginate; Wax lipid framework material is octadecanol, hexadecanol, Rikemal B 200, stearic acid, stearyl alcohol, Brazil wax; Insoluble framework material is ethyl cellulose, acrylic resin, polrvinyl chloride, polyethylene.
The slow releasing preparation of diammonium glycyrrhizinate, it is characterized in that: can add methylcellulose, polyvinylpyrrolidone, lactose, microcrystalline Cellulose, starch, Icing Sugar, sodium bicarbonate, sodium carbonate, sodium lauryl sulphate, and add binding agent, wetting agent routinely.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that: add diammonium glycyrrhizinate: ratio hydroxypropyl emthylcellulose, ethyl cellulose, Rikemal B 200 is 1: 0.1～15.
The slow releasing preparation of diammonium glycyrrhizinate, it is characterized in that diammonium glycyrrhizinate: the ratio of Ka Bopu, octadecanol, sodium carboxymethyl cellulose, stearic acid, glyceryl monostearate, Cera Flava, polyvinylpyrrolidone, ethyl cellulose, polyvinyl alcohol, acrylic resin is 1: 0.1～15.
The slow releasing preparation of diammonium glycyrrhizinate, it is characterized in that diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: the ratio of Ka Bopu, octadecanol, sodium carboxymethyl cellulose, Rikemal B 200, stearic acid, glyceryl monostearate, Cera Flava, polyvinylpyrrolidone, ethyl cellulose, polyvinyl alcohol, acrylic resin, sodium alginate is 1: 0.1～15: 0.1～15.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that, said preparation can be oral sustained release, controlled release capsule, and wherein implant is piller, film controlled release small pieces or the film controlled release piller of matrix type.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that, said preparation can be oral sustained release, controlled release tablet, and wherein these tablets are matrix tablet, floating in stomach sheet, film controlled release tablet, osmotic pump tablet.
The slow releasing preparation of diammonium glycyrrhizinate, it is characterized in that, with diammonium glycyrrhizinate: after hydrophilic gel matrix material, wax lipid framework material, insoluble framework material mix with 1: 0.1～15, direct compression, perhaps adopt the dry granulation tabletting, perhaps adopt wet granule compression tablet, perhaps adopt the solid dispersion method pelletizing press sheet.
The slow releasing preparation of diammonium glycyrrhizinate is characterized in that, with diammonium glycyrrhizinate: framework material mixes the back tablettings with 1: 0.1～15, perhaps make micropill, adopt ethyl cellulose, acrylic resin to carry out coating, perhaps adopt cellulose acetate to carry out coating, and punching.
Description of drawings:
Fig. 1 is comparative examples 1 a diammonium glycyrrhizinate capsule stripping curve
Fig. 2 is embodiment 2 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 3 is embodiment 3 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 4 is embodiment 4 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 5 is embodiment 5 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 6 is embodiment 6 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 7 is embodiment 7 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 8 is embodiment 8 diammonium glycyrrhizinate slow releasing tablet release profiles
Fig. 9 is embodiment 9 diammonium glycyrrhizinate slow releasing tablet release profiles
Figure 10 is embodiment 10 diammonium glycyrrhizinate slow releasing tablet release profiles
Figure 11 is embodiment 11 diammonium glycyrrhizinate slow releasing tablet release profiles
Figure 12 is embodiment 12 diammonium glycyrrhizinate floating in stomach sheet release profiles
Figure 13 is embodiment 13 diammonium glycyrrhizinate floating in stomach sheet release profiles
Figure 14 is embodiment 14 diammonium glycyrrhizinate floating in stomach sheet release profiles
Figure 15 is embodiment 15 diammonium glycyrrhizinate floating in stomach sheet release profiles
Figure 16 is embodiment 16 diammonium glycyrrhizinate sustained release coating sheet release profiles
Figure 17 is embodiment 17 diammonium glycyrrhizinate slow releasing capsule release profiles
Figure 18 is embodiment 18 diammonium glycyrrhizinate osmotic pump tablet release profiles
The specific embodiment:
The specific embodiment:
The preparation of comparative examples 1 diammonium glycyrrhizinate sheet (1000 amounts)
Diammonium glycyrrhizinate 75g
Microcrystalline Cellulose 50g
Lactose 40g
Magnesium stearate 2g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, microcrystalline Cellulose by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.
Dissolution determination:
By " 2000 editions two appendix XD first methods of Chinese pharmacopoeia adopt the device of dissolution method (appendix XC first method), extracting liquorice acid diammonium capsule, with the 1000ml distilled water is solvent, rotating speed is that per minute 100 changes, respectively at 10,20, got solution 5ml in 30 minutes, add the distilled water of uniform temp, equal volume simultaneously, institute's sample thief filters immediately, gets subsequent filtrate and measures.The results are shown in accompanying drawing 1, show that diammonium glycyrrhizinate capsule has tangible rapid release effect.
The preparation of embodiment 2 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 100g
Lactose 50g
Magnesium stearate 5g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, hydroxypropyl emthylcellulose (the happy Kanggong of Shanghai card department product), lactose by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.The drug release determination method of embodiment 2～12:
By " 2000 editions two appendix XD first methods of Chinese Pharmacopoeia adopt the device of dissolution method (appendix XC first method), and extracting liquorice acid diammonium slow releasing tablet is a solvent with the 1000ml distilled water, rotating speed is that per minute 100 changes, respectively at 1,2,3,4,6,8, get solution 5ml in 10,12 hours, add the distilled water of uniform temp, equal volume simultaneously, institute's sample thief filters immediately, gets subsequent filtrate and measures.
The release of embodiment 2 samples the results are shown in accompanying drawing 2, shows diammonium glycyrrhizinate: the diammonium glycyrrhizinate slow releasing tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 1.33 has tangible slow release characteristic, and the release of medicine can be kept 12 hours.
The preparation of embodiment 3 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 50g
Hydroxypropyl emthylcellulose (50cps) 50g
Microcrystalline Cellulose 50g
Lactose 40g
Magnesium stearate 4g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose (K4M), hydroxypropyl emthylcellulose (50cps), microcrystalline Cellulose by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose (K4M): hydroxypropyl emthylcellulose (50cps)=1: 0.67: 0.67, effectively slow release.
The preparation of embodiment 4 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Ethyl cellulose 300g
Microcrystalline Cellulose 50g
Magnesium stearate 5g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, ethyl cellulose, microcrystalline Cellulose by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: ethyl cellulose=1: 4, effectively slow release.
The preparation of embodiment 5 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Rikemal B 200 200g
Lactose 40g
Magnesium stearate 4g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, Rikemal B 200 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: Rikemal B 200=1: 2.67, effectively slow release.
The preparation of embodiment 6 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 30g
Rikemal B 200 100g
Lactose 40g
Magnesium stearate 4g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, Rikemal B 200 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: Rikemal B 200=1: 0.4: 1.33, effectively slow release.
The preparation of embodiment 7 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 30g
Acrylic resin II 100g
Lactose 60g
Magnesium stearate 5g
Wetting agent: 80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, acrylic resin II number by equivalent incremental method mixing, are added an amount of wetting agent and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: acrylic resin II number=1: 0.4: 1.33, effective slow release.
The preparation of embodiment 8 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 50g
Ethyl cellulose 100g
Icing Sugar 50g
Magnesium stearate 4g
Wetting agent: 80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, Icing Sugar, hydroxypropyl emthylcellulose, ethyl cellulose by equivalent incremental method mixing, are added an amount of wetting agent and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: ethyl cellulose=1: 0.67: 1.33, effectively slow release.
The preparation of embodiment 9 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 40g
Sodium carboxymethyl cellulose 50g
Lactose 40g
Pulvis Talci 20g
Preparation technology:
With diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, Pulvis Talci mixing, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: sodium carboxymethyl cellulose=1: 0.53: 0.67, effectively slow release.
The preparation of embodiment 10 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 30g
Ka Bopu 100g
Lactose 40g
Magnesium stearate 4g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
With diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, Ka Bopu mixing, add suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: Ka Bopu=1: 0.4: 1.33, effectively slow release.
The preparation of embodiment 11 diammonium glycyrrhizinate slow releasing tablet (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 50g
Sodium alginate 50g
Lactose 40g
Magnesium stearate 10g
Binding agent: 3%PVP80% alcoholic solution
Preparation technology:
With diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, sodium alginate mixing, add suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: sodium alginate=1: 0.67: 0.67, effectively slow release.
The preparation of embodiment 12 diammonium glycyrrhizinate floating in stomach sheets (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 50g
Octadecanol 100g
Lactose 40g
Magnesium stearate 5g
Preparation technology:
With diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, octadecanol mixing, the preparation solid dispersion is pulverized, and adds magnesium stearate, mix homogeneously, tabletting.
The drug release determination method of embodiment 12～15:
By " 2000 editions two appendix XD first methods of Chinese pharmacopoeia adopt the device of dissolution method (appendix XC first method), and extracting liquorice acid diammonium floating in stomach sheet is a solvent with the 1000ml simulated gastric fluid, rotating speed is that per minute 100 changes, respectively at 1,2,3,4,6,8, get solution 5ml in 10,12 hours, add the simulated gastric fluid of uniform temp, equal volume simultaneously, institute's sample thief filters immediately, gets subsequent filtrate and measures.
Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: octadecanol=1: 0.67: 1.33, effectively slow release.Tablet all floated in the simulated gastric fluid in 10 minutes.By prolonging diammonium glycyrrhizinate in the time of gastric, control the release of medicine, reach the purpose of slow release.
The preparation of embodiment 13 diammonium glycyrrhizinate floating in stomach sheets (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 75g
Hexadecanol 100g
Lactose 40g
Magnesium stearate 5g
Binding agent: 3%HPMC60% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, hexadecanol by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: hexadecanol=1: 1: 1.33, effectively slow release.Tablet all floated in the simulated gastric fluid in 10 minutes.
The preparation of embodiment 14 diammonium glycyrrhizinate floating in stomach sheets (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 20g
Octadecanol 200g
Lactose 60g
Sodium carbonate 5g
Magnesium stearate 5g
Wetting agent: 80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, octadecanol, sodium carbonate by equivalent incremental method mixing, are added an amount of wetting agent and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.
The release of embodiment 14 samples the results are shown in accompanying drawing 14, show diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: octadecanol: sodium carbonate=1: 0.27: 2.67: the diammonium glycyrrhizinate slow releasing tablet of 0.07 preparation has tangible slow release characteristic, and the release of medicine can be kept 12 hours.Tablet all floated in the simulated gastric fluid in 10 minutes.
The preparation of embodiment 15 diammonium glycyrrhizinate floating in stomach sheets (1000 amounts)
Diammonium glycyrrhizinate 75g
Hydroxypropyl emthylcellulose (K4M) 90g
Stearyl alcohol 80g
Lactose 60g
Sodium bicarbonate 20g
Magnesium stearate 5g
Wetting agent: 80% alcoholic solution
Preparation technology:
Diammonium glycyrrhizinate, lactose, hydroxypropyl emthylcellulose, stearyl alcohol by equivalent incremental method mixing, are added an amount of wetting agent and prepare soft material, cross 20 mesh sieves and granulate.50 ℃ of dryings, granulate adds magnesium stearate, mix homogeneously, tabletting.Diammonium glycyrrhizinate: hydroxypropyl emthylcellulose: stearyl alcohol=1: 1.20: 1.07, effectively slow release.By adding an amount of foaming agent sodium bicarbonate, bleach activator stearyl alcohol, tablet was all floated in the simulated gastric fluid in 10 minutes.
The preparation of embodiment 16 diammonium glycyrrhizinate sustained release coating sheets (1000 amounts)
Label
Diammonium glycyrrhizinate 75g
Pregelatinized Starch 30g
Microcrystalline Cellulose 50g
Coating material
Polyacrylic resin 19g
Polyethylene Glycol 2g
Oleum Ricini 1g
Acetone soln
Preparation technology:
With diammonium glycyrrhizinate, pregelatinized Starch, microcrystalline Cellulose mixing, add an amount of wetting agent and prepare soft material, cross 18 mesh sieves and granulate drying, 16 mesh sieve granulate, tabletting.Carry out coating with above-mentioned coating solution.
The preparation of embodiment 17 diammonium glycyrrhizinate slow releasing capsule (1000 amounts)
The core
Diammonium glycyrrhizinate 75g
Starch 30g
Icing Sugar 50g
Coating material
Ethyl cellulose 20g
Polyethylene Glycol is an amount of
Diethyl phthalate is an amount of
Acetone soln
Preparation technology:
With diammonium glycyrrhizinate, starch, Icing Sugar mixing, add an amount of wetting agent and prepare soft material, make micropill.Micropill is carried out coating.The fill capsule.
The preparation of embodiment 18 diammonium glycyrrhizinate osmotic pump tablets (1000 amounts)
The core
Diammonium glycyrrhizinate 75g
Mannitol 30g
Lactose 35g
Polyvinylpyrrolidone 5g
Coating material
Cellulose acetate 8g
Polyethylene Glycol is an amount of
Acetone soln
Preparation technology:
With diammonium glycyrrhizinate, mannitol, lactose, polyvinylpyrrolidone mixing, add an amount of wetting agent and prepare soft material, to cross 18 mesh sieves and granulate, drying is crossed 16 mesh sieve granulate, tabletting.Coating.On coated tablet, beat small delivery aperture.
Claims (5)
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| CN 200410066144 CN1279920C (en) | 2004-12-09 | 2004-12-09 | Slow release preparation of diammonium glycyrrhizate |
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| CN 200410066144 CN1279920C (en) | 2004-12-09 | 2004-12-09 | Slow release preparation of diammonium glycyrrhizate |
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| CN102552199A (en) * | 2012-02-03 | 2012-07-11 | 云南昊邦制药有限公司 | Bulleyaconitine a controlled release tablet |
| CN104000795A (en) * | 2014-06-03 | 2014-08-27 | 青岛市市立医院 | Diammonium glycyrrhizinate controlled release tablets and preparation method thereof |
| CN104825412A (en) * | 2015-05-04 | 2015-08-12 | 江苏天晟药业有限公司 | Monoammonium glycyrrhizinate sustained release preparation and preparation method thereof |
| CN106236726B (en) * | 2015-06-12 | 2018-03-20 | 湖南中南制药有限责任公司 | Orazamide coated slow release piece and preparation method thereof |
| CN105686974B (en) * | 2016-01-26 | 2019-05-14 | 华南理工大学 | A kind of natural amphiphilic small molecule-induced emulsion gel and rapid preparation method thereof |
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