CN1615852A - Indirubin oral dripping pill and preparing process - Google Patents
Indirubin oral dripping pill and preparing process Download PDFInfo
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- CN1615852A CN1615852A CN 200310114063 CN200310114063A CN1615852A CN 1615852 A CN1615852 A CN 1615852A CN 200310114063 CN200310114063 CN 200310114063 CN 200310114063 A CN200310114063 A CN 200310114063A CN 1615852 A CN1615852 A CN 1615852A
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- indirubin
- drop pill
- dripping pill
- pill
- condensing agent
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Abstract
The indirubin dripping pill containing indirubin 1-12 mg and proper amount of dripping pill medium in each pill. The dripping pill medium is one or two of polyglycol-6000, polyglycol-4000, polyoxyethylene monostearate, sodium stearate, glycerin, gelatin, poloxamer, stearic acid, glycerin monostearate and insect wax. The preparation process of the indirubin dripping pill includes melting and mixing indirubin and dripping pill medium, dropping at 60-120 deg.c into condensating agent, and eliminating condensating agent. The condensating agent is one or two of dimethyl silicon oil, liquid paraffin, tea seed oil and rape seed oil. The indirubin dripping pill is dark red. The indirubin dripping pill is used in treating chronic granulocyte leukaemia, and has the features of less side effect, low dosage, high medicinal effect, no obvious inhibition on marrow of patient, etc.
Description
Technical field
The present invention relates to a kind of oral administration dripping pill, relate in particular to a kind of clearing away heat,cooling blood and removing toxin, be used for the indirubin drop pill and the preparation method of chronic myelocytic leukemia.
Background technology
The indirubin chemical name is 2,2 '-Lian Ya indole-3,3 '-diketone.The anti-cancer agent that to be China medical science man find at middle nineteen seventies with new structure, be the new structure from Indigo Naturalis, separated with anti-leukocythemia liveness cancer therapy drug, it is to the immune system unrestraint effect of human body.Because this chemical compound has the obvious suppression effect to chronic myelocytic leukemia, and it is reliable to have a clinical efficacy, and toxic and side effects is little, bone marrow is not had characteristics such as obvious inhibitory action.Therefore indirubin drop pill and preparation technology have been studied, with the effect of further performance indirubin treatment chronic myelocytic leukemia.
The indirubin drop pill means behind indirubin and the relevant substrate heat fused mixing, splashes in the immiscible condensing agent, shrinks cooling and the preparation made.Be characterized in having increased that stability of drug, dosage are little, Chinese medicine ingredients bioavailability height, the performance drug effect is rapid, side effect is little, be convenient to take and transportation, production equipment are simple, processing ease, weight differential is little, dosage is accurate, production cost is low.Also do not have a kind of indirubin of utilizing to make oral administration dripping pill at present, its effectiveness is not to give full play to.
Summary of the invention
The objective of the invention is to: a kind of Chinese patent medicine indirubin drop pill and preparation method are provided.
Chinese patent medicine indirubin drop pill advantage of the present invention is, the bioavailability of indirubin composition increases, and the performance drug effect is rapid, and side effect is little, and stability of drug is good.
Indirubin drop pill of the present invention is made up of indirubin and substrate.
The preparation method of indirubin drop pill of the present invention is: gets the indirubin of recipe quantity and an amount of drop pill substrate and mixes, splash in the condensing agent after heating in water bath melts, and cooling, drop pill is made in molding.
Contain indirubin 1-12mg and an amount of drop pill substrate in every of the indirubin drop pill of the present invention.
Drop pill substrate of the present invention contains polyethylene glycol 6000 0-60mg in being every, Macrogol 4000 0-60mg, polyoxyethylene monostearate 0-60mg, sodium stearate 0-60mg, glycerin gelatine 0-60mg, insect wax 0-60mg, stearic acid 0-60mg, glyceryl monostearate 0-60mg, poloxamer 0-6mg, one of or two or more.
Drop pill of the present invention required condensing agent when the preparation molding is one of liquid paraffin, dimethicone, vegetable oil, Oleum Camelliae or two or more.
Method for preparing drop pills of the present invention: with recipe quantity indirubin and a certain amount of substrate heat fused mixing, under 60 ℃ of-120 ℃ of states, the speed of dripping with per minute 20-150 splashes in the condensing agent of regulation, make drop pill, after the shaping, take out, remove condensing agent, check, pack finished product.
The method of inspection of indirubin drop pill is: this product character is cruentate drop pill.Content assaying method is a high performance liquid chromatography, and the employing octadecylsilane chemically bonded silica is a filler, is mobile phase with benzene one chloroform (1: 1); The detection wavelength is 289nm, and number of theoretical plate calculates by the indirubin peak and is not less than 1000, and the separating degree of main peak and each impurity peaks should meet the requirements.
Indirubin drop pill of the present invention, the patient of available dried chronic myelocytic leukemia, it is little to have a side effect, and dosage is little, and the drug effect height does not have characteristics such as obvious inhibitory action to patient's bone marrow.
The specific embodiment:
The present invention is described in detail below in conjunction with embodiment
Embodiment one:
Prescription: indirubin 25.0g
Polyethylene glycol 6000 15.0g
Macrogol 4000 25.0g
Poloxamer 0.5g
Make 1000, average every contains indirubin 25.0mg
Indirubin 25.0g is added Polyethylene Glycol 6000 15.0g, Macrogol 4000 25.0g poloxamer 0.5g is behind the heat fused mixing, under 70 ℃ of-95 ℃ of states, speed with 50 of per minutes splashes in the dimethicone condensation, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain indirubin 25.0g in per 1000 indirubin drop pill.
The method of inspection is: this product character is cruentate drop pill.Content assaying method is a high performance liquid chromatography, and the employing octadecylsilane chemically bonded silica is a filler, is mobile phase with benzene one chloroform (1: 1); The detection wavelength is 289nm, and number of theoretical plate calculates by the indirubin peak and is not less than 1000, and the separating degree of main peak and each impurity peaks should meet the requirements.
Assay method: get 50 of this product, the accurate title, decide, porphyrize, and precision takes by weighing fine powder an amount of (being equivalent to indirubin 20mg approximately), puts in the tool plug conical flask, and the accurate chloroform 50ml that adds shakes up, and claims to decide weight.Ultrasonic Treatment 1.5 hours is weighed, and the weight of replenish lost solvent shakes up, and filters, and discards filtrate just, and subsequent filtrate filters through microporous filter membrane again, as need testing solution.Getting indirubin reference substance chlorination copies into every 1ml and contains 0.4mg and shake up product solution in contrast; Accurate need testing solution and each 20 μ l of reference substance solution of drawing inject chromatograph of liquid respectively, the record chromatogram, by external standard method promptly with calculated by peak area.
Embodiment two:
Prescription: indirubin 10.0g
Polyoxyethylene monostearate 18.0g
Sodium stearate 20.0g
Polyethylene glycol 6000 5.0g
Make 1000, average every contains indirubin 10.0mg
Indirubin 10.0g is added Polyethylene Glycol 6000 5.0g, polyoxyethylene monostearate 18.0g, sodium stearate 20.0g, behind the heat fused mixing, under 80 ℃ of-95 ℃ of states, splash in the liquid paraffin cold oil, after the shaping with the speed of 100 of per minutes, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain indirubin 10.0g in per 1000 indirubin drop pill.
The method of inspection is: this product character is cruentate drop pill.Content assaying method is a high performance liquid chromatography, and the employing octadecylsilane chemically bonded silica is a filler, is mobile phase with benzene one chloroform (1: 1); The detection wavelength is 289nm, and number of theoretical plate calculates by the indirubin peak and is not less than 1000, and the separating degree of main peak and each impurity peaks should meet the requirements.
Assay method: get 40 of this product, the accurate title, decide, porphyrize, and precision takes by weighing fine powder an amount of (being equivalent to indirubin 20mg approximately), puts in the tool plug conical flask, and the accurate chloroform 50ml that adds shakes up, and claims to decide weight.Ultrasonic Treatment 1.5 hours is weighed, and the weight of replenish lost solvent shakes up, and filters, and discards filtrate just, and subsequent filtrate filters through microporous filter membrane again, as need testing solution.Getting indirubin reference substance chlorination copies into every 1ml and contains 0.4mg and shake up product solution in contrast; Accurate need testing solution and each 20 μ l of reference substance solution of drawing inject chromatograph of liquid respectively, the record chromatogram, by external standard method promptly with calculated by peak area.
Embodiment three:
Prescription: indirubin 5.0g
Polyoxyethylene monostearate 20.0g
Macrogol 4000 23.0g
Make 1000, average every contains indirubin 5.0mg
Indirubin 5.0g is added Polyethylene Glycol 4000 23.0g, and polyoxyethylene monostearate 20.0g is behind the heat fused mixing, under 85 ℃ of-100 ℃ of states, speed with 20 of per minutes splashes in the vegetable oil cold oil, after the shaping, takes out, and removes condensing agent, check into deal, qualified, packing gets finished product.Contain indirubin 5.0g in per 1000 indirubin drop pill.
The method of inspection is: this product character is cruentate drop pill.Content assaying method is a high performance liquid chromatography, and the employing octadecylsilane chemically bonded silica is a filler, is mobile phase with benzene one chloroform (1: 1); The detection wavelength is 289nm, and number of theoretical plate calculates by the indirubin peak and is not less than 1000, and the separating degree of main peak and each impurity peaks should meet the requirements.
Assay method: get 40 of this product, the accurate title, decide, porphyrize, and precision takes by weighing fine powder an amount of (being equivalent to indirubin 20mg approximately), puts in the tool plug conical flask, and the accurate chloroform 50ml that adds shakes up, and claims to decide weight.Ultrasonic Treatment 1.5 hours is weighed, and the weight of replenish lost solvent shakes up, and filters, and discards filtrate just, and subsequent filtrate filters through microporous filter membrane again, as need testing solution.Getting indirubin reference substance chlorination copies into every 1ml and contains 0.4mg and shake up product solution in contrast; Accurate need testing solution and each 20 μ l of reference substance solution of drawing inject chromatograph of liquid respectively, the record chromatogram, by external standard method promptly with calculated by peak area.
Embodiment four:
Prescription: indirubin 2.5g
Stearic acid 10.0g
Glyceryl monostearate 12.0g,
Macrogol 4000 13.0g
Make 1000, average every contains indirubin 2.5mg
Indirubin 2.5g is added Polyethylene Glycol 4000 13.0g stearic acid 10.0g, glyceryl monostearate 12.0g is behind the heat fused mixing, under 75 ℃ of-95 ℃ of states, speed with 80 of per minutes splashes in the Oleum Camelliae cold oil, after the shaping, take out, remove condensing agent, check into deal, qualified, packing gets finished product.Contain indirubin 2.5g in per 1000 indirubin drop pill.
The method of inspection is: this product character is cruentate drop pill.Content assaying method is a high performance liquid chromatography, and the employing octadecylsilane chemically bonded silica is a filler, is mobile phase with benzene one chloroform (1: 1); The detection wavelength is 289nm, and number of theoretical plate calculates by the indirubin peak and is not less than 1000, and the separating degree of main peak and each impurity peaks should meet the requirements.
Assay method: get 50 of this product, the accurate title, decide, porphyrize, and precision takes by weighing fine powder an amount of (being equivalent to indirubin 20mg approximately), puts in the tool plug conical flask, and the accurate chloroform 50ml that adds shakes up, and claims to decide weight.Ultrasonic Treatment 1.5 hours is weighed, and the weight of replenish lost solvent shakes up, and filters, and discards filtrate just, and subsequent filtrate filters through microporous filter membrane again, as need testing solution.Getting indirubin reference substance chlorination copies into every 1ml and contains 0.4mg and shake up product solution in contrast; Accurate need testing solution and each 20 μ l of reference substance solution of drawing inject chromatograph of liquid respectively, the record chromatogram, by external standard method promptly with calculated by peak area.
Claims (4)
1. indirubin drop pill and preparation technology is characterized in that containing indirubin 1-12mg and an amount of drop pill substrate in every of the described indirubin drop pill.
According to the substrate of the described indirubin drop pill of claim 1 for containing polyethylene glycol 6000 0-60mg, Macrogol 4000 0-60mg, polyoxyethylene monostearate 0-60mg, sodium stearate 0-60mg, glycerin gelatine 0-60mg, insect wax 0-60mg, stearic acid 0-60mg, glyceryl monostearate 0-60mg, poloxamer 0-6mg, one of or two or more.
3. the preparation method of indirubin drop pill according to claim 1 and 2, it is characterized in that, with indirubin recipe quantity and a certain amount of substrate heat fused mixing, under 60 ℃ of-120 ℃ of states, the speed of dripping with per minute 20-150 splashes in the condensing agent, make the recipe quantity drop pill, after the shaping, take out, remove condensing agent, the check, pack finished product.
4. be one of dimethicone, liquid paraffin, Oleum Camelliae, vegetable oil or two or more according to required condensing agent in the described indirubin drop pill preparation of claim 3.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310114063 CN1615852A (en) | 2003-11-10 | 2003-11-10 | Indirubin oral dripping pill and preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310114063 CN1615852A (en) | 2003-11-10 | 2003-11-10 | Indirubin oral dripping pill and preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1615852A true CN1615852A (en) | 2005-05-18 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310114063 Pending CN1615852A (en) | 2003-11-10 | 2003-11-10 | Indirubin oral dripping pill and preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1615852A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228433A (en) * | 2011-06-29 | 2011-11-02 | 上海中医药大学 | Supersaturated self-microemulsion as well as preparation method and application thereof |
| EP2863897A4 (en) * | 2012-06-21 | 2016-01-27 | Phosphorex Inc | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
-
2003
- 2003-11-10 CN CN 200310114063 patent/CN1615852A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228433A (en) * | 2011-06-29 | 2011-11-02 | 上海中医药大学 | Supersaturated self-microemulsion as well as preparation method and application thereof |
| EP2863897A4 (en) * | 2012-06-21 | 2016-01-27 | Phosphorex Inc | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
| US10039829B2 (en) | 2012-06-21 | 2018-08-07 | Phosphorex, Inc. | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
| EP3597178A1 (en) * | 2012-06-21 | 2020-01-22 | Phosphorex Inc. | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
| US10675350B2 (en) | 2012-06-21 | 2020-06-09 | Phosphorex, Inc. | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
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