CN1554397A - Pulse and channel drop pill and soft capsule and its preparing method - Google Patents

Pulse and channel drop pill and soft capsule and its preparing method Download PDF

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Publication number
CN1554397A
CN1554397A CNA2003101146464A CN200310114646A CN1554397A CN 1554397 A CN1554397 A CN 1554397A CN A2003101146464 A CNA2003101146464 A CN A2003101146464A CN 200310114646 A CN200310114646 A CN 200310114646A CN 1554397 A CN1554397 A CN 1554397A
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China
Prior art keywords
mailuoning
soft capsule
filter
raw material
crude drug
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Pending
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CNA2003101146464A
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Chinese (zh)
Inventor
庞松涛
王晓莉
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YONGYAO MEDICNE SCIENCE AND TECHNOLOGY Co Ltd JINAN
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YONGYAO MEDICNE SCIENCE AND TECHNOLOGY Co Ltd JINAN
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Priority to CNA2003101146464A priority Critical patent/CN1554397A/en
Publication of CN1554397A publication Critical patent/CN1554397A/en
Pending legal-status Critical Current

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  • Medicines Containing Plant Substances (AREA)

Abstract

The present invention discloses Mailuoning dropping pill and soft capsule and their preparation process. Through extraction, alcohol deposition, macroporous resin adsorption, transferring the effective components to medicinal ethanol solution of 95% concentration, concentration and drying, the medicine component is prepared. Through adding supplementary material and further processing, Mailuoning dropping pill and soft capsule are prepared. Mailuoning dropping pill and soft capsule of the present invention have the features of less taking amount, convenient carrying about, easy storage, etc.

Description

Mailuoning dropping pills and soft capsule and preparation method thereof
Technical field
The present invention relates to two kinds of MAILUONING oral formulations drop pill and preparation of soft capsule method.
Background technology
MAILUONING " be the Chinese medicine compound intravenous injection for the treatment of thrombosiss such as vasculitis, form by Herba Dendrobii, Flos Lonicerae etc., extract, be prepared from through alcohol, esters solvent chemical method.Effect with replenishing YIN and removing heat, liver and kidney tonifying, blood circulation promoting and blood stasis dispelling.Its mechanism of action is relevant with anticoagulant, thrombolytic, spasmolytic, pain relieving, blood vessel dilating, improvement circulation and microcirculation, adjusting immunity, free radical resisting etc.The Blood stasis and the thrombus angiopathy of sections such as outer, interior, the woman of treatment, youngster are further used for the heart, cerebrovascular disease again, therapeutic effect height, instant effect at present clinically.Along with the accumulation of Clinical Experience, its range of application enlarges day by day.But also there are some problems in the technology of MAILUONING ZHUSHEYE, the effective ingredient that the most important thing is MAILUONING is flavonoid, alkaloid, Saponin and Coumarins, these are liposoluble constituent, and MAILUONING ZHUSHEYE adopts the mode of water extract-alcohol precipitation, ethyl acetate extraction to concentrate, change water-soluble at last again, cause the very big loss of medicinal ingredient.
Nanjing, Nanjing Pharmaceutical has been developed oral liquid again on the basis of original injection, take the mode of water extract-alcohol precipitation, has kept effective ingredient, so make that just the crude drug amount of taking descends greatly at every turn.Name is called in the patent of injecting Mailuoning and oral formulations thereof in Chinese patent prospectus in 2003, adopt the mode of methanol supersound extraction, chloroform extraction to carry out, though this mode makes last gained solid substance quantity few, but, be difficult to guarantee clinical safety because methanol and chloroform are the organic solvent to the toxic effect of human body.Therefore the oral formulations of developing MAILUONING still awaits the improvement of technology.
Summary of the invention
The invention reside in a kind of Mailuoning dropping pills and preparation of soft capsule technology are provided on the basis of MAILUONING oral liquid.
Technical scheme
Mailuoning dropping pills of the present invention and preparation of soft capsule method comprise the steps;
1. take by weighing medical material by prescription, steep half an hour with the water logging of 6 times of crude drug amounts earlier.Heat little boiling then and extract twice, each 1.5h.Filter merging filtrate.
2. concentrating under reduced pressure extracting solution to relative density is 1.17, adds ethanol precipitation impurity, makes that to contain alcohol amount at last be 66%.Cold putting spent the night.
3. filter, decompression filtrate recycling ethanol is to there being the ethanol flavor, adds water and makes every milliliter to contain the crude drug amount be 0.5g, and cold putting spent the night.
4. filter the good macroporous resin column of pretreatment on the filtrate.With the water of 10 times of crude drug amount volumes flushing impurity, carry out eluting with 70% ethanol then, collect 12 times of crude drug amount eluents, be evaporated to relative density 1.10, slowly add 95% medicinal alcohol, stir, cold putting spent the night.
5. filter, decompression filtrate recycling ethanol is concentrated into the extractum shape, and vacuum drying obtains the raw material of the said MAILUONING oral formulations of the present invention.
6. this raw material adds the Polyethylene Glycol of qdx, makes drop pill through dripping the system process.
7. this raw material is dissolved in an amount of PEG400, is pressed into soft capsule with the prepared soft capsule shell of glycerin gelatine.
Specific embodiments
Embodiment 1
Flos Lonicerae, Herba Dendrobii, Radix Scrophulariae, each 80g of Radix Achyranthis Bidentatae, with the water logging bubble half an hour of 6 times of amounts, little then boiling extracted 1.5h, extracts twice.Filter, be evaporated to relative density 1.17, add 95% medicinal alcohol and precipitate, making last medicinal liquid ethanol content is 66%.Cold putting spent the night.Filter, decompression recycling ethanol is to there being the ethanol flavor, adds water and makes every milliliter to contain the crude drug amount be 0.5g, and cold putting spent the night.Filter DM130 macroporous resin column on the filtrate, the water flushing impurity of 10 times of crude drug amounts, carry out eluting with 70% ethanol then, collect the eluent of 12 times of crude drug amount volumes, decompression recycling ethanol, be concentrated into relative density 1.10, add the volume of 10 times of concentrated solutions of 95% medicinal alcohol, cold putting spent the night.Filter, filtrate decompression is concentrated into the extractum shape, and 60 ℃ of vacuum dryings obtain the 6.4g crude drug.This crude drug adds the 12.8g polyethylene glycol 6000, and heated and stirred is even, drips through the drop pill instrument and makes 320 of drop pill.
Embodiment 2
Flos Lonicerae, Herba Dendrobii, Radix Scrophulariae, each 40g of Radix Achyranthis Bidentatae steep half an hour with the water logging of 6 times of amounts, and little then boiling extracted 1.5h, extracts twice.Filter, be evaporated to relative density 1.17, add 95% medicinal alcohol and precipitate, making last medicinal liquid ethanol content is 66%.Cold putting spent the night.Filter, decompression recycling ethanol is to there being the ethanol flavor, adds water and makes every milliliter to contain the crude drug amount be 0.5g, and cold putting spent the night.Filter DM130 macroporous resin column on the filtrate, the water flushing impurity of 10 times of crude drug amounts, carry out eluting with 70% ethanol then, collect the eluent of 12 times of crude drug amount volumes, decompression recycling ethanol, be concentrated into relative density 1.10, add the volume of 10 times of concentrated solutions of 95% medicinal alcohol, cold putting spent the night.Filter, filtrate decompression is concentrated into the extractum shape, and 60 ℃ of vacuum dryings obtain the 3.3g crude drug.This crude drug adds the 6.6g polyethylene glycol 6000, and heated and stirred is even, drips through the drop pill instrument and makes 160 of drop pill.
Embodiment 3
Flos Lonicerae, Herba Dendrobii, Radix Scrophulariae, each 40g of Radix Achyranthis Bidentatae steep half an hour with the water logging of 6 times of amounts, and little then boiling extracted 1.5h, extracts twice.Filter, be evaporated to relative density 1.17, add 95% medicinal alcohol and precipitate, making last medicinal liquid ethanol content is 66%.Cold putting spent the night.Filter, decompression recycling ethanol is to there being the ethanol flavor, adds water and makes every milliliter to contain the crude drug amount be 0.5g, and cold putting spent the night.Filter DM130 macroporous resin column on the filtrate, the water flushing impurity of 10 times of crude drug amounts, carry out eluting with 70% ethanol then, collect the eluent of 12 times of crude drug amount volumes, decompression recycling ethanol, be concentrated into relative density 1.10, add the volume of 10 times of concentrated solutions of 95% medicinal alcohol, cold putting spent the night.Filter, filtrate decompression is concentrated into the extractum shape, and 60 ℃ of vacuum dryings obtain the 3.4g crude drug.This crude drug adds the 10.2g PEG400, stirs to make dissolving, through being pressed into 68 of soft capsules (specification 0.2ml).
Embodiment 4
Flos Lonicerae, Herba Dendrobii, Radix Scrophulariae, each 80g of Radix Achyranthis Bidentatae, with the water logging bubble half an hour of 6 times of amounts, little then boiling extracted 1.5h, extracts twice.Filter, be evaporated to relative density 1.17, add 95% medicinal alcohol and precipitate, making last medicinal liquid ethanol content is 66%.Cold putting spent the night.Filter, decompression recycling ethanol is to there being the ethanol flavor, adds water and makes every milliliter to contain the crude drug amount be 0.5g, and cold putting spent the night.Filter DM130 macroporous resin column on the filtrate, the water flushing impurity of 10 times of crude drug amounts, carry out eluting with 70% ethanol then, collect the eluent of 12 times of crude drug amount volumes, decompression recycling ethanol, be concentrated into relative density 1.10, add the volume of 10 times of concentrated solutions of 95% medicinal alcohol, cold putting spent the night.Filter, filtrate decompression is concentrated into the extractum shape, and 60 ℃ of vacuum dryings obtain the 6.4g crude drug.This crude drug adds the 19.2g PEG400, stirs to make dissolving, drips 128 through being pressed into soft capsule.

Claims (5)

1, the preparation method of the oral raw material of a kind of MAILUONING and the drop pill and the soft capsule that utilize this feedstock production.
2, the preparation method as the raw material of right 1 described Mailuoning dropping pills and soft capsule is that prescription is:
Flos Lonicerae 40g Herba Dendrobii 40g Radix Scrophulariae 40g Radix Achyranthis Bidentatae 40g
3, be as method for preparing raw material as described in the right 1:
(1) take by weighing medical material by prescription, be soaked in water half an hour earlier, carry out little boiling then and extract twice, each time is 1.5h, and institute adds water 6 times for the crude drug amount of writing out a prescription.Filter merging filtrate.
(2) filtrate adds ethanol precipitation through being evaporated to relative density 1.17, makes that to contain alcohol amount at last be 66%.Cold putting spent the night.
(3) filter, decompression recycling ethanol is to there being the ethanol flavor, and adding water to every milliliter, to contain the crude drug amount be 0.5g.Cold putting spent the night.
(4) filter, the good macroporous resin column of pretreatment on the filtrate, with the water rinse resin post of 10 times of amounts, 70% ethanol with 12 times of crude drug volumes carries out eluting then.Decompression recycling ethanol to relative density is 1.10, slowly adds 95% medicinal alcohol of 10 times of volumes of concentrated solution, stirs, and cold putting spent the night.
(5) filter, filtrate decompression is concentrated into the extractum shape, 60 ℃ of drying under reduced pressure, the raw material of MAILUONING oral formulations.
(6) as above (4) described macroporous resin is styrene type, refers in particular to DM130, D101 and AB-8 type macroporous resin.
4, be that as right 1 described drop pill the MAILUONING raw material mixes with 1: 2 ratio mutually with adjuvant, drips through the drop pill instrument and makes drop pill.Wherein adjuvant refers in particular to polyethylene glycol 6000.
5, be that as right 1 described soft capsule the MAILUONING raw material adds the repressed one-tenth soft capsule of adjuvant.Wherein adjuvant refers to glycerin gelatine and PEG400.
CNA2003101146464A 2003-12-26 2003-12-26 Pulse and channel drop pill and soft capsule and its preparing method Pending CN1554397A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1698717B (en) * 2005-04-22 2010-04-28 江苏正大天晴药业股份有限公司 Chinese medicinal compound fat emulsion injection and its preparation method
CN101234137B (en) * 2007-01-30 2011-03-23 米金铎 Drug for curing coronary disease

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1698717B (en) * 2005-04-22 2010-04-28 江苏正大天晴药业股份有限公司 Chinese medicinal compound fat emulsion injection and its preparation method
CN101234137B (en) * 2007-01-30 2011-03-23 米金铎 Drug for curing coronary disease

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