CN1634038A - Anethol trithione soft capsule and its preparation method - Google Patents
Anethol trithione soft capsule and its preparation method Download PDFInfo
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- CN1634038A CN1634038A CN 200310125422 CN200310125422A CN1634038A CN 1634038 A CN1634038 A CN 1634038A CN 200310125422 CN200310125422 CN 200310125422 CN 200310125422 A CN200310125422 A CN 200310125422A CN 1634038 A CN1634038 A CN 1634038A
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- anethol trithione
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Abstract
The invention relates to an anethol trithione soft capsule and its preparation method, wherein the soft capsule comprises soup and capsule casing, the soup contains medicinal active agent of anethol trithione and medicinal adjuvant, while the medicinal findings include diluent, anti-oxidant agent, suspension adjuvant and emulsifying agent. The invention has the advantages of high biological availability, good packing property and accurate content.
Description
Technical field
The present invention relates to the preparation method of a kind of anethol trithione dosage form and this dosage form.
Background technology
Anethol trithione is the function of gallbladder promoting hepatoprotective that research both at home and abroad in recent years enlivens very much, and its pharmacological action is extensive, except that hepatic cholagogic, the inhibition lipid peroxidation is arranged still, detoxifcation and immunoregulation effect.Along with further investigation and clinical observation to the anethol trithione pharmacological action, particularly have and urge absurd fantastic function, it urges birth is to bring into play by cholinergic effect, can significantly increase muscarinic acetylcholine number, thereby promotes to urge birth.
The anethol trithione application is more extensive clinically, but tablet (anethol trithione) is only arranged at present, and anethol trithione belongs to hydrophobic drug, and gastrointestinal absorption is low and bioavailability is poor.Like this, to having brought inconvenience in the clinical practice, greatly influenced the function of use of medicine.
Summary of the invention
The objective of the invention is to overcome the defective of prior art, the Anethol trithione soft capsule that a kind of content is accurate, bioavailability is high is provided.
Another object of the present invention is to provide the preparation method of Anethol trithione soft capsule.
Anethol trithione soft capsule of the present invention comprises medicinal liquid and softgel shell, and medicinal liquid contains the anethol trithione and the pharmaceutic adjuvant of medicinal effective dose, and pharmaceutic adjuvant comprises diluent, antioxidant, suspending agent and emulsifying agent.
Contain following medicine liquid ingredient in above-mentioned each Anethol trithione soft capsule: anethol trithione 0.01-0.1 gram, diluent 0.025-0.6 gram, antioxidant 0.0004-0.002 gram, suspending agent 0.002-0.05 gram, emulsifying agent 0.0031-0.05 gram.
The capsule softgel shell of above-mentioned each Anethol trithione soft capsule can be existing softgel shell, generally contains following composition: gelatin, glycerol, antiseptic, depend on the circumstances, and also can not contain antiseptic.
Above-mentioned diluent is one or more in vegetable oil, propylene glycol, Polyethylene Glycol (molecular weight 200～800), the mineral oil.
Above-mentioned antioxidant is one or more in L-cysteine salt, dithioglycollic acid, disodium EDTA, malic acid, glutathion, D-xylose, glycine, a-tocopherol, a tocopheryl acetate, sodium sulfite, inositol, ascorbic acid, phytic acid, dibenzylatiooluene, sodium ascorbate lecithin, hydroquinone, xylitol, gluconic acid lactone, succinic acid, sodium pyrosulfite, ethylenediamine first and second aldehyde.
Above-mentioned suspending agent is one or more in Carboxymethyl cellulose sodium, carbomer, polyvinyl alcohol, hydroxyethyl-cellulose, sodium alginate, chitin, chitose, hydroxypropyl emthylcellulose, ethyl cellulose, agar, hydroxyethylmethyl-cellulose, hyprolose, Cera Flava, xanthan gum, arabic gum, casein, the methylcellulose.
Above-mentioned emulsifying agent is one or more in methylcellulose, glyceryl monostearate, hydroxylated lecithin, acetylated monoglyceride, diethylene glycol distearyl, orthoformic acid, casein, ethylene glycol monostearate, ethylhydroxyethylcellulose, diacetyl monoglyceride, acetic acid one fat glycerides, xylitol list olein, sodium alginate, propylene glycol ester, the two triglycerol monolaurates.
The preparation method of Anethol trithione soft capsule of the present invention may further comprise the steps:
One, the preparation of capsule softgel shell: gelatin places the glue jar, adds the purified water of solubilized gelatin amount, 70～80 ℃ of glue jar temperature, and the in-depth back adds glycerol, antiseptic, with the cologne earth toning, stirs, and is incubated set aside for use after the vacuumize degassing;
Two, emulsifying agent, suspending agent are added in the diluent, add anethol trithione, treat to add antioxidant again behind the complete mixing, stir, room temperature leaves standstill;
Three, the medicinal liquid for preparing is poured in the pellet processing machine, typing, and drying is scraped promptly.
Anethol trithione soft capsule of the present invention compare with general formulation have the bioavailability height, characteristic such as good seal, content are accurate, specious.Hydrophobic drug for the bioavailability difference is very suitable, and anethol trithione is water-insoluble, and gastrointestinal absorption is low and bioavailability is poor, and soft capsule that itself and macromolecule carrier packed into after miscible can improve its bioavailability greatly.Anethol trithione soft capsule is a kind of anhydrous oily semi-fluid condition, oral back medicinal liquid adheres to the mucosa tissue surface, be beneficial to absorption of active agents, improved the bioavailability of anethol trithione, this dosage form than other anethol trithione dosage form have that the patient of convenience takes, steady quality, outstanding feature and application prospect such as be easy to carry about with one.The anethol trithione tablet is taken back onset after 15-30 minute, reaches plasma peaks after 1 hour, and Anethol trithione soft capsule is taken back just energy onset after 10-20 minute, just can reach plasma peaks in 40 minutes.
The specific embodiment
Embodiment 1:
Component content (gram/grain): anethol trithione 0.1, Polyethylene Glycol (molecular weight 400) 0.6, gelatin 0.3, glycerol 0.01, succinic acid 0.002, Cera Flava 0.05, hydroxylated lecithin 0.05, sorbic acid methyl ester 0.00009.
Preparation method:
(1) take by weighing gelatin and add 100L gelatin retort, under stirring, add the purified water of solubilized gelatin amount, airtight, treat that gelatin dissolves fully after, add glycerol again, add antiseptic sorbic acid methyl ester, stir, vacuumize degassing 2 hours is put into the gelatin heat-preserving container, the insulation set aside for use.
(2) under the room temperature emulsifying agent hydroxylated lecithin, suspending agent Cera Flava are added in the diluent Polyethylene Glycol, take by weighing anethol trithione, pulverize, sieve, join in the above-mentioned solution, treat to add the antioxidant succinic acid again behind the complete mixing, stir, room temperature leaves standstill.
(3) medicinal liquid for preparing is poured in the liquid bucket, change mould and begin to press soft capsule, adjust the soft capsule loading amount to scope of design, drying at room temperature two days, reject the soft gelatin capsule of presentation quality difference, the soft gelatin capsule marina is washed (removing lubricating oil in the pelleting process), again in 24 ℃ of dryings two days, the Anethol trithione soft capsule semi-finished product, the packing respectively of the qualified back of quality testing, labeling, packing, promptly get the Anethol trithione soft capsule finished product.
Embodiment 2:
Component content (gram/grain): anethol trithione 0.1, Semen Maydis oil 0.077, gelatin 0.068, glycerol 0.002, ascorbic acid 0.0006, hydroxyethyl-cellulose 0.008, casein 0.0072, butyl p-hydroxybenzoate calcium 0.000018.
Method for making is the same.
Embodiment 3:
Component content (gram/grain): anethol trithione 0.09, Oleum Helianthi 0.5, gelatin 0.21, glycerol 0.007, sodium sulfite 0.0018, chitose 0.021, diacetyl monoglyceride 0.04, benzyl alcohol 0.000075.
Method for making is the same.
Embodiment 4:
Component content (gram/grain): anethol trithione 0.08, Oleum Sesami 0.18, gelatin 0.06, glycerol 0.002, glutathion 0.001, sodium alginate 0.016, methylcellulose 0.0015, benzyl alcohol 0.00003.
Method for making is the same.
Embodiment 5:
Component content (gram/grain): anethol trithione 0.07, soybean oil 0.35, gelatin 0.15, glycerol 0.005, L-cysteine salt 0.0016, carbomer 0.028, acetylated monoglyceride 0.03, methyl parahydroxybenzoate 0.00006.
Method for making is the same.
Embodiment 6:
Component content (gram/grain): anethol trithione 0.06, Oleum Ricini 0.3, gelatin 0.12, glycerol 0.004, dibenzylatiooluene 0.0014, polyvinyl alcohol 0.02, diethylene glycol distearate 0.024, P-hydroxybenzoic acid phenyl ester .00005.
Method for making is the same.
Embodiment 7:
Component content (gram/grain): anethol trithione 0.05, hydrogenated vegetable oil 0.027, gelatin 0.04, glycerol 0.001, sodium sulfite 0.0004, chitin 0.0004, ethylhydroxyethylcellulose 0.0032, Oleum Caryophylli 0.00001.
Method for making is the same.
Embodiment 8:
Component content (gram/grain): anethol trithione 0.04, Oleum Gossypii semen 0.4, gelatin 0.18, glycerol 0.006, a-tocopherol 0.0017, Carboxymethyl cellulose sodium 0.03, orthoformic acid 0.035, benzoic acid 0.00007.
Method for making is the same.
Embodiment 9:
Component content (gram/grain): anethol trithione 0.03, Oleum Arachidis hypogaeae semen 0.23, gelatin 0.09, glycerol 0.003, dithioglycollic acid 0.0012, arabic gum 0.02, ethylene glycol monostearate 0.02, butyl p-hydroxybenzoate calcium 0.000038.
Method for making is the same.
Embodiment 10:
Component content (gram/grain): anethol trithione 0.02, rapeseed oil 0.13, gelatin 0.03, glycerol 0.0001, edetic acid 0.0008, hydroxypropyl emthylcellulose 0.012, glyceryl monostearate 0.011, benzoic acid 0.00002.
Method for making is the same.
Embodiment 11:
Component content (gram/grain): anethol trithione 0.01, propylene glycol 0.55, gelatin 0.25, glycerol 0.008, dibutyl first hydroxy toluene 0.0019, sodium alginate 0.04, propylene glycol alginate 0.045, Oleum Caryophylli 0.00008.
Method for making is the same.
Claims (7)
1, a kind of Anethol trithione soft capsule comprises medicinal liquid and softgel shell, it is characterized in that medicinal liquid contains the anethol trithione and the pharmaceutic adjuvant of medicinal effective dose, and pharmaceutic adjuvant comprises diluent, antioxidant, suspending agent and emulsifying agent.
2, according to the described Anethol trithione soft capsule of claim 1, it is characterized in that containing in each Anethol trithione soft capsule following medicine liquid ingredient: anethol trithione 0.01-0.1 gram, diluent 0.025-0.6 gram, antioxidant 0.0004-0.002 gram, suspending agent 0.002-0.05 gram, emulsifying agent 0.0031-0.05 gram.
3,, it is characterized in that described diluent is that vegetable oil, propylene glycol, molecular weight are 200～800 Polyethylene Glycol, in the mineral oil one or more according to claim 1,2 described Anethol trithione soft capsules.
4,, it is characterized in that described antioxidant is one or more in L-cysteine salt, dithioglycollic acid, disodium EDTA, malic acid, glutathion, D-xylose, glycine, a-tocopherol, a tocopheryl acetate, sodium sulfite, inositol, ascorbic acid, phytic acid, dibenzylatiooluene, sodium ascorbate lecithin, hydroquinone, xylitol, gluconic acid lactone, succinic acid, sodium pyrosulfite, ethylenediamine first and second aldehyde according to claim 1,2 described Anethol trithione soft capsules.
5,, it is characterized in that described suspending agent is one or more in Carboxymethyl cellulose sodium, carbomer, polyvinyl alcohol, hydroxyethyl-cellulose, sodium alginate, chitin, chitose, hydroxypropyl emthylcellulose, ethyl cellulose, agar, hydroxyethylmethyl-cellulose, hyprolose, Cera Flava, xanthan gum, arabic gum, casein, the methylcellulose according to claim 1,2 described Anethol trithione soft capsules.
6,, it is characterized in that described emulsifying agent is one or more in methylcellulose, glyceryl monostearate, hydroxylated lecithin, acetylated monoglyceride, diethylene glycol distearyl, orthoformic acid, casein, ethylene glycol monostearate, ethylhydroxyethylcellulose, diacetyl monoglyceride, acetic acid one fat glycerides, xylitol list olein, sodium alginate, propylene glycol ester, the two triglycerol monolaurates according to claim 1,2 described Anethol trithione soft capsules.
7,, it is characterized in that may further comprise the steps according to the preparation method of the described Anethol trithione soft capsule of claim 1:
(1), the preparation of capsule softgel shell: gelatin places the glue jar, adds the purified water of solubilized gelatin amount, and 70～80 ℃ of glue jar temperature add glycerol, antiseptic after the in-depth, with the cologne earth toning, stir, and are incubated set aside for use after the vacuumize degassing;
(2), emulsifying agent, suspending agent are added in the diluent, add anethol trithione, treat to add antioxidant again behind the complete mixing, stir, room temperature leaves standstill;
(3), the medicinal liquid for preparing pours in the pellet processing machine, typing, drying is scraped promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310125422 CN1634038A (en) | 2003-12-31 | 2003-12-31 | Anethol trithione soft capsule and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310125422 CN1634038A (en) | 2003-12-31 | 2003-12-31 | Anethol trithione soft capsule and its preparation method |
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| Publication Number | Publication Date |
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| CN1634038A true CN1634038A (en) | 2005-07-06 |
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| CN 200310125422 Pending CN1634038A (en) | 2003-12-31 | 2003-12-31 | Anethol trithione soft capsule and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1732926B (en) * | 2005-09-02 | 2010-08-18 | 姚俊华 | Medicine contained soft capsule |
| CN103610210A (en) * | 2013-11-19 | 2014-03-05 | 宜兴丹森科技有限公司 | Food preservative containing water-absorbent resin |
-
2003
- 2003-12-31 CN CN 200310125422 patent/CN1634038A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1732926B (en) * | 2005-09-02 | 2010-08-18 | 姚俊华 | Medicine contained soft capsule |
| CN103610210A (en) * | 2013-11-19 | 2014-03-05 | 宜兴丹森科技有限公司 | Food preservative containing water-absorbent resin |
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