CN104116721B - A kind of Couoidal bismuth pectin capsules agent and preparation technology thereof - Google Patents
A kind of Couoidal bismuth pectin capsules agent and preparation technology thereof Download PDFInfo
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- CN104116721B CN104116721B CN201410391124.7A CN201410391124A CN104116721B CN 104116721 B CN104116721 B CN 104116721B CN 201410391124 A CN201410391124 A CN 201410391124A CN 104116721 B CN104116721 B CN 104116721B
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- pectin
- colloidal bismmth
- bismmth pectin
- kieselguhr
- adsorbate
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- 239000001814 pectin Substances 0.000 title claims abstract description 82
- 229920001277 pectin Polymers 0.000 title claims abstract description 82
- 235000010987 pectin Nutrition 0.000 title claims abstract description 82
- 239000002775 capsule Substances 0.000 title claims abstract description 38
- JCXGWMGPZLAOME-UHFFFAOYSA-N bismuth atom Chemical compound [Bi] JCXGWMGPZLAOME-UHFFFAOYSA-N 0.000 title claims abstract description 36
- 229910052797 bismuth Inorganic materials 0.000 title claims abstract description 35
- 238000002360 preparation method Methods 0.000 title claims abstract description 34
- 239000003795 chemical substances by application Substances 0.000 title claims abstract description 30
- 238000005516 engineering process Methods 0.000 title claims abstract description 21
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000002156 adsorbate Substances 0.000 claims description 25
- 235000010603 pastilles Nutrition 0.000 claims description 25
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000314 lubricant Substances 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 8
- 238000010298 pulverizing process Methods 0.000 claims description 8
- 229920002472 Starch Polymers 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 6
- 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 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 6
- 238000004132 cross linking Methods 0.000 claims description 6
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 6
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 3
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 3
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 13
- 239000003814 drug Substances 0.000 abstract description 8
- 230000000694 effects Effects 0.000 description 12
- 239000000084 colloidal system Substances 0.000 description 11
- 230000000052 comparative effect Effects 0.000 description 11
- 239000006185 dispersion Substances 0.000 description 7
- 210000001156 gastric mucosa Anatomy 0.000 description 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 6
- 239000000945 filler Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 5
- 208000025865 Ulcer Diseases 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000003094 microcapsule Substances 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 239000000741 silica gel Substances 0.000 description 4
- 229910002027 silica gel Inorganic materials 0.000 description 4
- 239000007921 spray Substances 0.000 description 4
- 238000001694 spray drying Methods 0.000 description 4
- 231100000397 ulcer Toxicity 0.000 description 4
- 239000005995 Aluminium silicate Substances 0.000 description 3
- 241000590002 Helicobacter pylori Species 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 235000012211 aluminium silicate Nutrition 0.000 description 3
- 239000007919 dispersible tablet Substances 0.000 description 3
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- 229940037467 helicobacter pylori Drugs 0.000 description 3
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
- 239000010318 polygalacturonic acid Substances 0.000 description 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
- 229920002230 Pectic acid Polymers 0.000 description 2
- 239000003463 adsorbent Substances 0.000 description 2
- 239000004599 antimicrobial Substances 0.000 description 2
- 239000011230 binding agent Substances 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 210000002421 cell wall Anatomy 0.000 description 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Natural products OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 2
- 210000004211 gastric acid Anatomy 0.000 description 2
- 239000002502 liposome Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 210000004877 mucosa Anatomy 0.000 description 2
- LCLHHZYHLXDRQG-ZNKJPWOQSA-N pectic acid Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)O[C@H](C(O)=O)[C@@H]1OC1[C@H](O)[C@@H](O)[C@@H](OC2[C@@H]([C@@H](O)[C@@H](O)[C@H](O2)C(O)=O)O)[C@@H](C(O)=O)O1 LCLHHZYHLXDRQG-ZNKJPWOQSA-N 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000002243 precursor Substances 0.000 description 2
- 239000011435 rock Substances 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 239000000725 suspension Substances 0.000 description 2
- FRXSZNDVFUDTIR-UHFFFAOYSA-N 6-methoxy-1,2,3,4-tetrahydroquinoline Chemical compound N1CCCC2=CC(OC)=CC=C21 FRXSZNDVFUDTIR-UHFFFAOYSA-N 0.000 description 1
- 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 1
- 235000019890 Amylum Nutrition 0.000 description 1
- 208000004300 Atrophic Gastritis Diseases 0.000 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 102000009024 Epidermal Growth Factor Human genes 0.000 description 1
- 101800003838 Epidermal growth factor Proteins 0.000 description 1
- 208000007882 Gastritis Diseases 0.000 description 1
- 208000036495 Gastritis atrophic Diseases 0.000 description 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 description 1
- 208000008469 Peptic Ulcer Diseases 0.000 description 1
- 206010073214 Peptic ulcer helicobacter Diseases 0.000 description 1
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 description 1
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- AEMOLEFTQBMNLQ-BKBMJHBISA-N alpha-D-galacturonic acid Chemical compound O[C@H]1O[C@H](C(O)=O)[C@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-BKBMJHBISA-N 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000037358 bacterial metabolism Effects 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000000035 biogenic effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000004568 cement Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 208000016644 chronic atrophic gastritis Diseases 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229910052681 coesite Inorganic materials 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
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- 229910052906 cristobalite Inorganic materials 0.000 description 1
- 230000007123 defense Effects 0.000 description 1
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- 238000001514 detection method Methods 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 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 1
- 238000011978 dissolution method Methods 0.000 description 1
- 229940116977 epidermal growth factor Drugs 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 229940075507 glyceryl monostearate Drugs 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 235000015110 jellies Nutrition 0.000 description 1
- 239000008274 jelly Substances 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 description 1
- 239000000395 magnesium oxide Substances 0.000 description 1
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
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- 239000002105 nanoparticle Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 208000011906 peptic ulcer disease Diseases 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 229910001414 potassium ion Inorganic materials 0.000 description 1
- 150000003180 prostaglandins Chemical class 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 229910052682 stishovite Inorganic materials 0.000 description 1
- 229910052905 tridymite Inorganic materials 0.000 description 1
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of Couoidal bismuth pectin capsules agent and preparation technology thereof, this capsule is formed by content-filled capsule shells, containing the kieselguhr adsorbing colloidal bismmth pectin in described content.Colloidal bismmth pectin and kieselguhr are added ball mill and pulverize by the present invention, and after the two is pulverized altogether, colloidal bismmth pectin is likely to because being adsorbed on equably in diatomaceous surface and hole, thus avoiding medicine easy pockets of problem in water.
Description
Technical field
The invention belongs to technical field of medicine, in particular to a kind of capsule containing colloidal bismmth pectin and preparation technology thereof.
Background technology
Colloidal bismmth pectin is a kind of novel colloidal state bismuth preparation, for the salt that biomacromolecule pectic acid (D-Poly Gal A Galacturonan) is formed with bismuth metal ion and potassium ion.Colloidal bismmth pectin mechanism of action is in that this product has stronger colloid property; colloidal bismmth pectin is the little molecule acid group that instead of in existing bismuth preparation with biomacromolecule pectic acid; such as carbonate, nitrate anion and citric acid radical etc.; thus changing the gel characteristics of colloidal bismuth; make it form high viscosity colloidal sol in acid medium, gastric mucosa is formed one layer of firmly protecting film.Strengthen the barrier action experiment in vitro of gastric mucosa also it has proven convenient that the collosol property that colloidal bismmth pectin is formed in acid medium will be good than other any colloidal bismuths.It can be deposited on the cell wall of helicobacter pylori, makes the cavity having in thalline in various degree, causes cell wall rupture, and suppresses the activity of bacterial enzyme, disturbs bacterial metabolism effect, makes it that the normal defense function of human body is become more sensitive.This product also directly stimulates the generation of prostaglandin and epidermal growth factor, makes ulcer surface and rotten to the corn face quickly-healing stop blooding.
The colloid pectin bismuth preparation of current domestic listing has capsule, dry suspension, granule, powder etc., it is adaptable to treatment peptic ulcer, particularly helicobacter pylori related ulcer, also can be used for chronic superficial and atrophic gastritis.But, the viscosity of colloidal bismmth pectin is relatively big, can be agglomerating in water, need to be stirred vigorously and just can scatter, and therefore, it tends not to quickly achieve good expansion under one's belt, it is impossible to ulcer surface is completely covered, and reduces the curative effect of this product.It addition, the mucosa insufficient strength that colloidal bismmth pectin is formed in some Stomach in Patients, it is easy to destroyed, it also it is one of reason that this product curative effect is inadequate.Owing to the impact of food can not be adsorbed on the surface of gastric mucosa preferably, weaken its curative effect further.
Patent CN100477999C discloses dispersible tablet of colloid petcin, and composition and the content weight proportion of this dispersible tablet of colloid petcin are as follows: colloidal bismmth pectin is calculated as 25-100, filler 60-400, disintegrating agent 42-280, fluidizer 1-6, lubricant 0.25-5 with bismuth；Filler is selected from lactose, white dextrin, amylum pregelatinisatum or/and starch.Disintegrating agent is selected from crospolyvinylpyrrolidone microcrystalline Cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium；Fluidizer is selected from micropowder silica gel；Lubricant is selected from magnesium stearate, or/and Pulvis Talci.The dispersible tablet of colloid petcin that this invention provides meets the requirements by the method detector dispersing uniformity of pharmacopeia.This invention has only carried out the detection of dispersing uniformity by the requirement of Chinese Pharmacopoeia, and does not close the situation that glue injection body is formed.Further, since colloidal bismmth pectin viscosity is relatively strong, in order to make dispersing uniformity meet the requirements, this invention employs substantial amounts of filler, disintegrating agent, so that the adhesiveness of colloidal bismmth pectin is substantially reduced, it is unfavorable for that it covers the surface of gastric mucosa, thus reducing curative effect.
Patent CN100340295C discloses a kind of oral administered compound colloid pectin bismuth preparation and preparation method, relate to a kind of pharmaceutical composition for treating peptic ulcer helicobacter pylori infections and comprise colloidal bismmth pectin, antibiotic and antimicrobial drug, it is that mix homogeneously is prepared from by excipient with colloidal bismmth pectin and pharmaceutically acceptable amount after antibiotic and antimicrobial drug fine pellet core respectively coating.This invention is relatively big from colloidal bismmth pectin viscosity, can be agglomerating and be not easy to the characteristic of rapid dispersion in water, solve it and tend not to good expansion under one's belt, it is impossible to the problem that ulcer surface is completely covered.
It is colloidal bismmth pectin (in bismuth) 50-300 part that patent CN1919170A discloses colloid pectin bismuth dry suspensoid and preparation method thereof, composition and content weight proportion, filler 600-2500 part, correctives 50-300 part, flocculant 5-60 part.This invention fundamentally solve colloidal bismmth pectin viscosity greatly, the problem of more difficult rapid dispersion.Only because it is dry suspension, acutely can rock after adding water, drink after being completely dispersed out, less to a certain extent be difficult to the impact on curative effect of the rapid dispersion problem.But, the mucosa insufficient strength that colloidal bismmth pectin is formed in some Stomach in Patients, it is easy to destroyed problem is not solved.
The preparation method that patent CN101732283B discloses a kind of colloidal pectin bismuth microcapsules, by pure colloidal bismmth pectin wet product or dry product, adds formation rubber cement in 50-100 DEG C of water, and the weight ratio adding disintegrating agent, disintegrating agent and colloidal bismmth pectin is 1-10:5-100；The weight ratio adding the aqueous solution of binding agent, binding agent and colloidal bismmth pectin is 0-10:10-200, and mixing, homogenizing, Direct spraying dries and forms microcapsule；Or dried, it is ground into micron-sized microcapsule powder with vibromill (or airflow milling).This invention adopts spray drying method to prepare microcapsule, owing to the solution viscosity of spray drying is relatively big, easily blocks spray gun and cause that production efficiency is low in spray process.
Patent CN101028281 discloses nano-gel pectin bismuth and granules medicine thereof, relate to a kind of with colloidal bismmth pectin for raw material prepare nano-gel pectin bismuth and granules medicine, by colloidal bismmth pectin and glyceryl monostearate liposome precursor, and then applied microwave technology makes a nanometer bismuth pectin.The preparation process of this invention includes preparing liposome precursor, microwave reaction forms nano fluid, spray drying is made nanoparticle, prepared the processes such as granule, and complex process, production cost is higher.Preparation process uses the organic solvents such as oxolane, is unfavorable for labor protection.Meanwhile, the solution viscosity of spray drying is relatively big, easily blocks spray gun and cause that production efficiency is low in spray process.
Finding by carefully retrieving document both domestic and external, prior art is not all provided that one dispersing uniformity in gastric acid environment is good, and the simple colloid pectin bismuth preparation of preparation technology.
Summary of the invention
In view of the deficiencies in the prior art, it is an object of the invention to provide that a kind of dispersing uniformity is good in gastric acid environment, the simple Couoidal bismuth pectin capsules agent of preparation technology and preparation technology thereof.
Owing to the viscosity of colloidal bismmth pectin is relatively big, can be agglomerating in water, need to be stirred vigorously and just can scatter, therefore it is diluted by inventor initially with conventional filler, but effect is poor, meeting water and be still easier to agglomerating, analysis is likely to more relevant with colloidal bismmth pectin granularity.Further, colloidal bismmth pectin is utilized ball mill to pulverize by inventor, controls mean diameter less than 30 microns, the filler mixing being then in that to commonly use, still can not solve preferably to meet water easily agglomerating, be difficult to the uniform problem of rapid dispersion.For this, inventor adopts antiplastering aid that it is diluted, and initially with micropowder silica gel, (main component is SiO2) adsorb, mixture finely dispersed time in water reduces to some extent, but owing to the two density variation is too big, it is difficult to mix homogeneously, therefore not adsorbed medicine still can be agglomerating；Increasing the consumption of micropowder silica gel further, mixture jitter time in water extends on the contrary, it may be possible to because a small amount of micropowder silica gel is anti-stick, but after consumption increase, it is relevant that this forms jelly in water.
Inventor creatively attempts again other adsorbent, such as kaolin, basic magnesium carbonate, light magnesium oxide, kieselguhr etc., finds through substantial amounts of experimental study, and diatomaceous effect is best, and other adsorbents are all undesirable.Kieselguhr is containing siliceous biogenic deposit rock, is namely diatom remains deposit.Colloidal bismmth pectin and kieselguhr are added ball mill and pulverize by the present invention, after the two is pulverized altogether, colloidal bismmth pectin may be adsorbed in diatomaceous surface and hole equably, thus avoiding medicine easy pockets of problem in water, reach beyond thought dispersion effect.
Based on above result of study, the technical scheme that the present invention is concrete is summarized as:
A kind of Couoidal bismuth pectin capsules agent, is formed by content-filled capsule shells, it is characterised in that containing the kieselguhr adsorbing colloidal bismmth pectin in described content.
Preferably, Couoidal bismuth pectin capsules agent as above, wherein said colloidal bismmth pectin is 1 3-10 with diatomaceous weight consumption ratio.
It is further preferred that Couoidal bismuth pectin capsules agent as above, wherein said colloidal bismmth pectin is 1 4.5-6.0 with diatomaceous weight consumption ratio.
Further preferably, Couoidal bismuth pectin capsules agent as above, possibly together with disintegrating agent and lubricant in wherein said content.Described disintegrating agent is polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose or carboxymethyl starch sodium.Described lubricant is hydrogenated vegetable oil, sodium stearyl fumarate or magnesium stearate.
Present invention also offers the preparation technology of above-mentioned Couoidal bismuth pectin capsules agent agent, adopt this technique can prepare the Couoidal bismuth pectin capsules that dispersion is rapid under one's belt and gastric mucosa adhesiveness is good.Specifically, this preparation technology comprises the steps:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate；
(2) by described pastille adsorbate with disintegrating agent, mix lubricant uniformly, capsule charge shell.
Preferably, the preparation technology of Couoidal bismuth pectin capsules agent as above, the mean diameter of wherein said pastille adsorbate is less than 30 microns.
Compared with prior art, colloidal bismmth pectin and kieselguhr are creatively added ball mill and pulverize by the present invention, after the two is pulverized altogether, colloidal bismmth pectin is likely to because being adsorbed in diatomaceous surface and hole equably, thus avoiding medicine easy pockets of problem in water, prepared capsule is after taking, can be uniformly dispersed rapidly after content contact gastric juice agglomerating without assembling, reach beyond thought dispersion effect.On the other hand, the pastille adsorbate that colloidal bismmth pectin and kieselguhr are pulverized through ball mill has less particle diameter, and gastric mucosa has stronger adsorption, it is easy to is adsorbed on gastric mucosa surface and forms the film that intensity is higher, is conducive to colloidal bismmth pectin to play curative effect.It addition, this preparation technology is by a relatively simple, it is easy to industrialized great production, relatively prior art has obvious advantage.
Detailed description of the invention
Preparation process and the implementation result of Couoidal bismuth pectin capsules agent of the present invention is now further described by following example, embodiment is only for illustration purposes, not limiting the scope of the invention, apparent change and modification that simultaneously those of ordinary skill in the art make according to the present invention are also contained within the scope of the invention.
Embodiment 1
Preparation technology:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with polyvinylpolypyrrolidone, sodium stearyl fumarate, capsule charge shell.
Embodiment 2
Preparation technology:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with cross-linking sodium carboxymethyl cellulose, hydrogenated vegetable oil, capsule charge shell.
Embodiment 3
Preparation technology:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with carboxymethyl starch sodium, magnesium stearate, capsule charge shell.
Embodiment 4
Preparation technology:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with carboxymethyl starch sodium, magnesium stearate, capsule charge shell.
Comparative example 1
Preparation technology:
(1) colloidal bismmth pectin and kieselguhr are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with cross-linking sodium carboxymethyl cellulose, hydrogenated vegetable oil, capsule charge shell.
Comparative example 2
Preparation technology:
Colloidal bismmth pectin is added in ball mill with lactose and pulverizes, control mean diameter less than 30 microns；Then mix homogeneously with cross-linking sodium carboxymethyl cellulose, hydrogenated vegetable oil, capsule charge shell.
Comparative example 3
Preparation technology:
(1) colloidal bismmth pectin and kaolin are added pulverizing in ball mill, obtain pastille adsorbate, control the mean diameter of pastille adsorbate less than 30 microns；
(2) step (1) gained pastille adsorbate is mixed homogeneously with cross-linking sodium carboxymethyl cellulose, hydrogenated vegetable oil, capsule charge shell.
Embodiment 5 colloid pectin bismuth preparation is uniformly dispersed timing
Take each embodiment respectively and capsule 's content 20g prepared by comparative example, according to dissolution method (small-radius curve track), with pH1.2 hydrochloric acid solution 100ml for solvent, rotating speed is 50 turns per minute, adding colloid pectin bismuth preparation, record medicine is completely dispersed uniform required time in stripping rotor.
The colloid pectin bismuth preparation time of being uniformly dispersed prepared by each embodiment of table 1 and comparative example compares
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Comparative example 1 | Comparative example 2 | Comparative example 3 |
| 52s | 35s | 41s | 50s | 183s | 347s | 226s |
By the result of the test of table 1 it can be seen that Couoidal bismuth pectin capsules content prepared by embodiment of the present invention 1-4 is completely dispersed uniformly in 1min；And comparative example 1 is relatively low due to kieselguhr content, colloidal bismmth pectin has agglomerating on a small quantity at pH1.2 hydrochloric acid solution, is completely dispersed non-uniform time and extends；Comparative example 2 and comparative example 3 are respectively adopted lactose, kaolin replaces kieselguhr, and colloidal bismmth pectin is easily agglomerating at pH1.2 hydrochloric acid solution, is completely dispersed non-uniform time longer.
Claims (6)
1. a Couoidal bismuth pectin capsules agent, formed by content-filled capsule shells, it is characterized in that, containing the kieselguhr adsorbing colloidal bismmth pectin in described content, described colloidal bismmth pectin is 1 3-10 with diatomaceous weight consumption ratio, and the preparation method of capsule is: is added in ball mill with kieselguhr by colloidal bismmth pectin and pulverizes, obtains the mean diameter pastille adsorbate less than 30 microns, with disintegrating agent, mix lubricant uniformly, capsule charge shell.
2. Couoidal bismuth pectin capsules agent according to claim 1, it is characterised in that described colloidal bismmth pectin is 1 4.5-6.0 with diatomaceous weight consumption ratio.
3. Couoidal bismuth pectin capsules agent according to claim 1 and 2, it is characterised in that possibly together with disintegrating agent and lubricant in described content.
4. Couoidal bismuth pectin capsules agent according to claim 3, it is characterised in that described disintegrating agent is polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose or carboxymethyl starch sodium.
5. Couoidal bismuth pectin capsules agent according to claim 3, it is characterised in that described lubricant is hydrogenated vegetable oil, sodium stearyl fumarate or magnesium stearate.
6. the preparation technology of a Couoidal bismuth pectin capsules agent, it is characterised in that this technique comprises the steps:
(1) colloidal bismmth pectin and kieselguhr being added pulverizing in ball mill, obtain the mean diameter pastille adsorbate less than 30 microns, described colloidal bismmth pectin is 1 3-10 with diatomaceous weight consumption ratio；
(2) by described pastille adsorbate with disintegrating agent, mix lubricant uniformly, capsule charge shell.
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| CN105616382A (en) * | 2016-03-28 | 2016-06-01 | 王平 | Colloidal bismuth pectin capsule preparation and preparation method |
| CN106038585A (en) * | 2016-05-27 | 2016-10-26 | 郑州思辩科技有限公司 | Colloidal bismuth pectin tablets and preparation method thereof |
| CN106038584A (en) * | 2016-05-27 | 2016-10-26 | 郑州思辩科技有限公司 | Colloidal bismuth pectin capsule preparation and preparation method thereof |
| CN113768899B (en) * | 2021-09-29 | 2023-06-27 | 广东彼迪药业有限公司 | Colloidal bismuth pectin capsule and preparation method thereof |
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| US3306819A (en) * | 1961-10-09 | 1967-02-28 | Roussel Uclaf | Derivative of pectin, its process of preparation and its method of use |
| CN101028281A (en) * | 2007-04-29 | 2007-09-05 | 于学敏 | Nano-gel pectin bismuth and its granules medicine |
| CN103142548A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Colloidal bismuth pectin capsule |
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| US3306819A (en) * | 1961-10-09 | 1967-02-28 | Roussel Uclaf | Derivative of pectin, its process of preparation and its method of use |
| CN101028281A (en) * | 2007-04-29 | 2007-09-05 | 于学敏 | Nano-gel pectin bismuth and its granules medicine |
| CN103142548A (en) * | 2013-03-21 | 2013-06-12 | 青岛正大海尔制药有限公司 | Colloidal bismuth pectin capsule |
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