CN105412033A - Screwtree root tea dropping pill and preparation method thereof - Google Patents
Screwtree root tea dropping pill and preparation method thereof Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/30—Extraction of the material
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention discloses a screwtree root tea dropping pill and a preparation method thereof. The screwtree root tea dropping pill comprises, by mass parts, 1-4 parts of screwtree root tea extract, 13-35 parts of substrate and 0.1-0.4 part of cosolvent. The substrate is selected from polyethylene glycol 4000, polyethylene glycol 6000, polyoxyl(40) stearate or poloxamer and is preferably polyethylene glycol 6000. The cosolvent is selected from polysorbate 80. By dispersing screwtree root tea extract in the substrate and the cosolvent, and the solution is added dropwise into a condensing medium through an emitter to be condensed; and after the solution is condensed into a pill, oil shedding, wiping, drying and packaging are performed to obtain the screwtree root tea dropping pill. The dropping pill is convenient to use, the medicinal activity of screwtree is maintained to a great extent, and the screwtree is absorbed more easily.
Description
Technical field
The invention belongs to health food processing technique field, be specifically related to a kind of Radix Helicteris tea drop pill and preparation method thereof.
Background technology
Radix Helicteris tea is a kind of folks of china tradition beverage, and one of herbal tea that Cantonese often drinks, Radix Helicteris has heat clearing away of inducing sweat, effect of subduing swelling and detoxicating.May be used for cold, fever, headache, thirsty, mumps, measles, dysentery, enteritis, carbuncle, scrofula, sore, eczema, the diseases such as hemorrhoid.
At present, the use for Radix Helicteris tea generally still rests on traditional herbal tea and decocts, and use procedure is consuming time, loaded down with trivial details, owing to decocting for a long time, the medicinal efficacy of Radix Helicteris is obviously reduced simultaneously, greatly hinders the promotion and application of Radix Helicteris tea.Therefore, at present in the urgent need to providing a kind of Radix Helicteris health beverage of conveniently drinking, to adapt to the demand of consumers in general, significantly promoted the quality of life of people.
Drop pill has the following feature: 1, equipment simple, easy to operate, be beneficial to labor protection, process cycle is short, productivity ratio is high; 2, process conditions are easy to control, steady quality, and dosage is accurate, and heated time is short, after the volatile medicine of oxidizable and tool is dissolved in substrate, can increase its stability; 3, substrate holds liquid drug amount greatly, therefore liquid drug can be made to solidify; 4, have the advantages that absorption is rapid, bioavailability is high with drop pill prepared by solid dispersion technology.Clathrate has the following advantages: cover bad stink, reduces zest; Increase drug dissolution and bioavailability; Improve medicine stability.
Herbal tea is as Chinese tradition beverage, and the herbal tea paving big and small in In Guangdong Province is seen everywhere, and pouplarity has some idea of.But traditional herb tea decocts to waste time and energy, the rhythm of life of urbanite is but more and more faster now, and younger generation few people are ready to buy specially a clay pot and spend several hours and go decoction one to take herbal tea.Therefore, drops is used for, in traditional herb tea, having easy to use; Its stability is increased after the volatile medicine of oxidizable and tool in herbal tea is dissolved in substrate; Mask the taste of herbal tea simultaneously, be more suitable for child, old man and working clan and use.Drops and traditional herb tea are organically combined, are convenient to produce and carry, namely rush namely with, old and young suitable, solve the problem that traditional herb tea is in use consuming time, loaded down with trivial details, improve the value of herbal tea greatly.
Summary of the invention
The present invention is directed in the use procedure of existing Radix Helicteris tea consuming time, loaded down with trivial details, and the state of the art of Radix Helicteris tea medicinal efficacy can not be given full play to, aim to provide a kind of Radix Helicteris tea drop pill and preparation method thereof, this Radix Helicteris tea drop pill is easy to use, has and absorbs the feature rapid, bioavailability is high.
The present invention realizes especially by following technical scheme:
A kind of Radix Helicteris tea drop pill, comprises following component according to mass parts: Radix Helicteris tea extract 1 ~ 4 part, substrate 13 ~ 35 parts, cosolvent 0.1 ~ 0.4 part.Described substrate is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer, is preferably polyethylene glycol 6000; Described cosolvent is selected from polyoxyethylene sorbitan monoleate.
Further, Radix Helicteris tea extract of the present invention is prepared by the following method:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 55 ~ 95 DEG C, extraction time is 2 ~ 3 times, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
In described reflux, extract, process, the solid-liquid ratio of reflux, extract, is 1:13 ~ 15 for the first time, and the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10.
The preparation method additionally providing described Radix Helicteris tea drop pill of the present invention, specifically comprises the following steps:
1) preparation of Radix Helicteris tea extract;
2) following component is taken by recipe quantity: Radix Helicteris tea extract 1 ~ 4 part, substrate 13 ~ 35 parts, cosolvent 0.1 ~ 0.4 part;
3) melting at 70 ~ 100 DEG C by substrate and cosolvent, being well dispersed in substrate by preparing gained Radix Helicteris tea extract, being placed in heating container and heating while stirring, until the fused solution obtained containing Radix Helicteris tea extract and substrate is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the cooling medium of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and condensing agent reach described state of temperature respectively, by the fused solution containing described extract and substrate, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Further, in step (1), the preparation process of Radix Helicteris tea extract is specially: after broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 55 ~ 95 DEG C, extraction time is 2 ~ 3 times, the solid-liquid ratio of reflux, extract, is 1:13 ~ 15 for the first time, the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Further, the substrate described in step (2) is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer, is preferably polyethylene glycol 6000; Described cosolvent is selected from polyoxyethylene sorbitan monoleate.
Further, the condensing agent described in step (3) is selected from one or more in dimethicone, liquid paraffin or vegetable oil.
Another object of the present invention is the application of Radix Helicteris tea drop pill described above as the disease medicament such as treatment cold, fever, headache, thirsty, mumps, measles, dysentery, enteritis, carbuncle, scrofula, sore, eczema, hemorrhoid.
The above-mentioned method preparing Radix Helicteris tea extract is also within protection scope of the present invention.
Beneficial effect of the present invention is: Radix Helicteris tea drop pill of the present invention has easy to use; Its stability is increased after the volatile medicine of oxidizable and tool in herbal tea is dissolved in substrate; Mask the taste of herbal tea simultaneously, be more suitable for child, old man and working clan use.
The present invention makes drop pill traditional herb tea, be convenient to produce and carry, namely rush namely with, old and young suitable, solve the problem that traditional herb tea is in use consuming time, loaded down with trivial details, improve the value of herbal tea greatly.The Radix Helicteris tea drop pill that the present invention prepares has the effect of certain hypertension.
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described further, the following stated, only to preferred embodiment of the present invention, not do other forms of restriction to the present invention, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed to the Equivalent embodiments of equal change.Everyly do not depart from the present invention program's content, any simple modification done following examples according to technical spirit of the present invention or equivalent variations, all drop in protection scope of the present invention.
Radix Helicteris is a kind of folks of china tradition beverage, one of herbal tea that Cantonese often drinks, use for Radix Helicteris generally still rests on traditional herbal tea and decocts, use procedure is consuming time, loaded down with trivial details, owing to decocting for a long time, the medicinal efficacy of Radix Helicteris is obviously reduced simultaneously, greatly hinder the promotion and application of Radix Helicteris.The present invention organically combines drops and traditional herb tea, be convenient to produce and carry, namely rush namely with, old and young suitable, solve the problem that traditional herb tea is in use consuming time, loaded down with trivial details, improve the value of herbal tea greatly.
The invention provides a kind of Radix Helicteris tea drop pill, comprise following component according to mass parts: Radix Helicteris tea extract 1 part-4 parts, substrate 13 parts-35 parts, cosolvent 0.1 part-0.4 part.Described substrate is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer, is preferably polyethylene glycol 6000; Described cosolvent is selected from polyoxyethylene sorbitan monoleate.
The preparation method additionally providing above-mentioned Radix Helicteris tea drop pill of the present invention, specifically comprises the following steps:
1) preparation of Radix Helicteris tea extract:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 55 ~ 95 DEG C, extraction time is 2 ~ 3 times, the solid-liquid ratio of reflux, extract, is 1:13 ~ 15 for the first time, the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
2) following component is taken by recipe quantity: Radix Helicteris tea extract 1 part-4 parts, substrate 13 parts-35 parts, cosolvent 0.1 part-0.4 part;
Its mesostroma is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer, is preferably polyethylene glycol 6000; Cosolvent is selected from polyoxyethylene sorbitan monoleate.
3) melting at 70 ~ 100 DEG C by substrate and cosolvent, being well dispersed in substrate by preparing gained Radix Helicteris tea extract, being placed in heating container and heating while stirring, until the fused solution obtained containing Radix Helicteris tea extract and substrate is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the cooling medium of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and condensing agent reach described state of temperature respectively, by the fused solution containing described extract and substrate, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.Wherein condensing agent is selected from one or more in dimethicone, liquid paraffin or vegetable oil.
Embodiment 1
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 13 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 80 DEG C, extraction time is 2 times, the solid-liquid ratio of reflux, extract, is 1:13 for the first time, second time reflux, extract, solid-liquid ratio is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder,
Following component is taken: Radix Helicteris tea extract 1.5g, polyethylene glycol 6000 13.5g, polyoxyethylene sorbitan monoleate 0.15g by recipe quantity; The melting at 80 DEG C by polyethylene glycol 6000 and Polysorbate, be well dispersed in polyethylene glycol 6000 by preparing gained Radix Helicteris tea extract, be placed in heating container and heat while stirring, until the fused solution obtained containing Radix Helicteris tea extract and polyethylene glycol 6000 is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the dimethicone of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and dimethicone reach described state of temperature respectively, by the fused solution containing described extract and substrate, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Embodiment 2
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 70 DEG C, extraction time is 3 times, the solid-liquid ratio of reflux, extract, is 1:15 for the first time, the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Following component is taken: Radix Helicteris tea extract 3.75g, polyethylene glycol 6000 33.375g, polyoxyethylene sorbitan monoleate 0.375g by recipe quantity; The melting at 80 DEG C by polyethylene glycol 6000 and polyoxyethylene sorbitan monoleate, be well dispersed in polyethylene glycol 6000 by preparing gained Radix Helicteris tea extract, be placed in heating container and heat while stirring, until the fused solution obtained containing Radix Helicteris tea extract and polyethylene glycol 6000 is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the liquid paraffin of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and liquid paraffin reach described state of temperature respectively, by the fused solution containing described extract and substrate, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Embodiment 3
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 14 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 85 DEG C, extraction time is 2 times, the solid-liquid ratio of reflux, extract, is 1:14 for the first time, the solid-liquid ratio of second time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Following component is taken: Radix Helicteris tea extract 1kg, Macrogol 4000 13kg, polyoxyethylene sorbitan monoleate 0.1kg by recipe quantity; The melting at 80 DEG C by Macrogol 4000 and polyoxyethylene sorbitan monoleate, be well dispersed in Macrogol 4000 by preparing gained Radix Helicteris tea extract, be placed in heating container and heat while stirring, until the fused solution obtained containing Radix Helicteris tea extract and Macrogol 4000 is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the vegetable oil of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and vegetable oil reach described state of temperature respectively, by the fused solution containing described extract and Macrogol 4000, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Embodiment 4
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 12 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 75 DEG C, extraction time is 3 times, the solid-liquid ratio of reflux, extract, is 1:12 for the first time, the solid-liquid ratio of second time and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Following component is taken: Radix Helicteris tea extract 4kg, polyoxyethylene stearate (40) ester 35kg, polyoxyethylene sorbitan monoleate 0.4kg by recipe quantity; The melting at 80 DEG C by polyoxyethylene stearate (40) ester and polyoxyethylene sorbitan monoleate, be well dispersed in polyoxyethylene stearate (40) ester by preparing gained Radix Helicteris tea extract, be placed in heating container and heat while stirring, until the fused solution obtained containing Radix Helicteris tea extract and polyoxyethylene stearate (40) ester is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the vegetable oil of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and vegetable oil reach described state of temperature respectively, by the fused solution containing described extract and polyoxyethylene stearate (40) ester, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Embodiment 5
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 11 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 80 DEG C, extraction time is 3 times, the solid-liquid ratio of reflux, extract, is 1:11 for the first time, the solid-liquid ratio of second time and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Following component is taken: Radix Helicteris tea extract 2kg, poloxamer 25kg, polyoxyethylene sorbitan monoleate 0.3kg by recipe quantity; The melting at 80 DEG C by poloxamer and polyoxyethylene sorbitan monoleate, being well dispersed in poloxamer by preparing gained Radix Helicteris tea extract, being placed in heating container and heating while stirring, until the fused solution obtained containing Radix Helicteris tea extract and poloxamer is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the liquid paraffin of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and liquid paraffin reach described state of temperature respectively, by the fused solution containing described extract and poloxamer, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Embodiment 6
A kind of Radix Helicteris tea drop pill, prepares especially by following steps:
After broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 14 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 80 DEG C, extraction time is 2 times, the solid-liquid ratio of reflux, extract, is 1:14 for the first time, the solid-liquid ratio of second time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
Following component is taken: Radix Helicteris tea extract 3kg, poloxamer 30kg, polyoxyethylene sorbitan monoleate 0.2kg by recipe quantity; The melting at 80 DEG C by poloxamer and polyoxyethylene sorbitan monoleate, being well dispersed in poloxamer by preparing gained Radix Helicteris tea extract, being placed in heating container and heating while stirring, until the fused solution obtained containing Radix Helicteris tea extract and poloxamer is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the liquid paraffin of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and liquid paraffin reach described state of temperature respectively, by the fused solution containing described extract and poloxamer, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
Comparative example
The drop pill that common process prepares.
Below in conjunction with dissolving time limit, subjective appreciation, hardness, outward appearance and drug effect evaluate beneficial effect of the present invention:
1, the test of pesticide effectiveness
1.1, the routine patient of clinical observation 100, treatment group 50 example, matched group 50 example.Whole case history all meets case selection standard, man 56 example, female 44 example, age 35-48 year, the course of disease is the shortest 2 days, the longest 2 weeks, takes Radix Helicteris tea drop pill one week.
Diagnosis basis: disconnected standard is based on the standard of anemopyretic cold card relevant in " disease of tcm Standardization of diagnosis and curative effect ", and 1. heating, micro evil wind are trembled with fear, have a stuffy nose watery nasal discharge, sneeze, headache, general malaise.2. light red tongue or limit point red, platform book is yellow, floating and rapid pulse.3. unusual weather conditions or daily life cause accidentally, sudden onset.
Symptom and sign ranking criterion: according to correlation intergal standard in " traditional Chinese medical science Clinical Researches of New Drugs guideline ", the disappearance of headache, general pain, watery nasal discharge, pharyngalgia, pharyngeal congestion, cough, slight, moderate, severe long-pending 0,1,2,3 point respectively.
Inclusive criteria: meet the diagnostic criteria of traditional Chinese medical science anemopyretic cold card, body temperature is no more than 39 DEG C of persons, and the course of disease is person within 48h, and the age is between 18 ~ 65 years old.
Excluded cases standard: used medicine person as antibiotic, hormone or other cold medicines person or the person that do not bring down a fever; Merge other primary disease persons of pulmonary, as pulmonary tuberculosis, lung swelling and pain person; Merge serious cardiovascular, liver, kidney and disease of hematopoietic system person; Age is under-18s or over-65s person or be trimester of pregnancy, women breast-feeding their children, and body constitution allergy sufferers.
Matched group: common Radix Helicteris tea, drinks at any time, and 7d was 1 course for the treatment of.
Criterion of therapeutical effect: cardinal symptom sign curative effect determinate standard more than temperature decline 0.5C is onset, dropping to 37.4C is that temperature recovery is normal.Other symptom and sign integrations reduce by 1 and are divided into onset, and 0 is divided into disappearance.Comprehensive therapeutic effect criterion is fully recovered: within treatment 3d, temperature recovery is normal, and sings and symptoms all disappears, or symptom, somatic feature score decline more than 90% person; Effective: within treatment 3d, body temperature is normal, and most of sings and symptoms disappears, or symptom, somatic feature score decline more than 75% person; Effective: treatment 3d within body temperature reduce than before, cardinal symptom and sign partial disappearance, or symptom, somatic feature score decline more than 50% person; Invalid: within treatment 3d, body temperature does not fall or raises, cardinal symptom and sign are without improvement or improve <50%.Therapeutic outcome: in table 2.
The quality evaluation of table 1 Radix Helicteris tea of the present invention drop pill
| Dissolve scattered time limit (min) | Formability | Roundness | Fineness | Hardness | |
| Embodiment 1 | 14 | Be shaped | Good | Good | Good |
| Embodiment 2 | 13 | Be shaped | Good | Good | Good |
| Embodiment 3 | 15 | Be shaped | Good | Good | Good |
| Embodiment 4 | 13 | Be shaped | Good | Good | Good |
| Embodiment 5 | 16 | Be shaped | Better | Good | Slightly soft |
| Embodiment 6 | 15 | Be shaped | Good | Good | Good |
The observation of curative effect of this drop pill of table 2 treatment anemopyretic cold patient
| Group | Total number of cases | Recovery from illness | Effective | Effectively | Invalid | Total effective rate |
| Embodiment 1 | 50 | 42 | 6 | 2 | 0 | 100％ |
| Embodiment 2 | 50 | 45 | 3 | 1 | 1 | 98％ |
| Embodiment 3 | 50 | 35 | 9 | 3 | 3 | 94％ |
| Embodiment 4 | 50 | 38 | 8 | 1 | 3 | 94％ |
| Embodiment 5 | 50 | 34 | 11 | 4 | 1 | 98％ |
| Embodiment 6 | 50 | 37 | 5 | 6 | 2 | 96％ |
| Comparative example | 50 | 15 | 10 | 3 | 22 | 56％ |
As shown in Table 2, illustrate that the active ingredient ratio in drop pill of the present invention is easier to extract, drop pill treatment anemopyretic cold effect of the present invention is higher than existing Radix Helicteris tea, illustrate drop pill of the present invention very degree remain the medical active of Radix Helicteris, more easily played absorption by people simultaneously, have the advantages that utilization rate is high.
1.2 hypertension effect experiments
Sample liquid made by Example 1 ~ 6 medicine respectively, to normal rat oral gavage administration.
Result of the test shows: embodiment 1 ~ 6 all has obvious hypotensive effect, the ceiling effect time to be about after medication 2 ~ 3 hours, persistent period is more than 4.5 hours, systolic pressure/diastolic pressure declines 15%/17%, 17%/20%, 10%/12%, 21%/23% respectively, all there is significant difference (P < 0.05, P < 0.01) compared with before administration.
Similarly, renal hypertensive rat is tested, result shows: embodiment 1 ~ 6 reduces the effect of systolic pressure and diastolic pressure compared with before administration, significant difference (P < 0.05), namely administration was shown in obvious pressure reduction effect the same day, systolic pressure and the diastolic pressure range of decrease all reach 25% and 30%, before 10 days blood pressures of stopping using all are not back to administration.
Visible drop pill hypotensive effect of the present invention is obvious, stable, is used for the treatment of antihypertensive effect remarkable.
Claims (8)
1. a Radix Helicteris tea drop pill, is characterized in that, comprises following component according to mass parts: Radix Helicteris tea extract 1 ~ 4 part, substrate 13 ~ 35 parts, cosolvent 0.1 ~ 0.4 part; Described substrate is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer; Described cosolvent is selected from polyoxyethylene sorbitan monoleate.
2. a kind of Radix Helicteris tea drop pill according to claim 1, it is characterized in that, described Radix Helicteris tea extract is prepared by the following method: after broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 55 ~ 95 DEG C, extraction time is 2 ~ 3 times, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
3. a kind of Radix Helicteris tea drop pill according to claim 2, is characterized in that, in described reflux, extract, process, the solid-liquid ratio of reflux, extract, is 1:13 ~ 15 for the first time, and the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10.
4. a preparation method for Radix Helicteris tea drop pill, is characterized in that, comprises the following steps:
1) preparation of Radix Helicteris tea extract;
2) following component is taken by recipe quantity: Radix Helicteris tea extract 1 ~ 4 part, substrate 13 ~ 35 parts, cosolvent 0.1 ~ 0.4 part;
3) melting at 70 ~ 100 DEG C by substrate and cosolvent, being well dispersed in substrate by preparing gained Radix Helicteris tea extract, being placed in heating container and heating while stirring, until the fused solution obtained containing Radix Helicteris tea extract and substrate is for subsequent use; The temperature control system of adjustment pill dripping machine, the water dropper of pill dripping machine is heated and maintains the temperature at 65 DEG C ~ 75 DEG C, it is condensation in the cooling medium of 0 ~ 20 DEG C that fused solution is instilled temperature by the water dropper of diameter 0.8 ~ 5mm, and maintains the temperature at 40 DEG C ~-5 DEG C; When pill dripping machine water dropper and condensing agent reach described state of temperature respectively, by the fused solution containing described extract and substrate, be placed in the water dropper tank of pill dripping machine, shrink molding in instillation condensing agent, to obtain final product.
5. preparation method according to claim 4, it is characterized in that, in step (1), the preparation process of Radix Helicteris tea extract is specially: after broken for dry Radix Helicteris tea powder rear merceration 0.5h, add 10 ~ 15 times of water gagings and carry out reflux, extract, reflux, extract, temperature is 55 ~ 95 DEG C, extraction time is 2 ~ 3 times, the solid-liquid ratio of reflux, extract, is 1:13 ~ 15 for the first time, the solid-liquid ratio of second time reflux, extract, and for the third time reflux, extract, is 1:10, each 0.5 ~ 2 hour, extracting solution merges, filter, at 80 DEG C, under vacuum 0.07MPa, filtrate is concentrated into the extracting solution of relative density 1.25 ~ 1.35, cool, add 4 ~ 6 times of 50 ~ 80% ethanol, stir standing 24 ~ 72h, leach supernatant, 70 DEG C, under 0.07MPa, decompression recycling ethanol is extremely without alcohol taste, continue at 80 DEG C, be concentrated into the stiff paste that relative density is 1.20 ~ 1.30, proceed to vacuum drying oven, at 70 DEG C, under 0.09MPa, vacuum drying is to dry, pulverized 40 ~ 100 mesh sieves, obtain principal agent fine powder.
6. preparation method according to claim 4, is characterized in that, the substrate described in step (2) is selected from draws together one in Macrogol 4000, polyethylene glycol 6000, polyoxyethylene stearate (40) ester or poloxamer; Described cosolvent is selected from polyoxyethylene sorbitan monoleate.
7. preparation method according to claim 4, is characterized in that, the condensing agent described in step (3) is selected from one or more in dimethicone, liquid paraffin or vegetable oil.
8. sesame seed tea drop pill described in claim 1 is as the application for the treatment of cold, fever, headache, mumps, measles, dysentery, enteritis, carbuncle, scrofula, sore, eczema or hemorrhoid medicine.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108310019A (en) * | 2018-03-29 | 2018-07-24 | 浙江海洋大学 | A kind of preparation method of Wu Ling ginseng antidepression dripping pill |
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| CN1709460A (en) * | 2005-07-12 | 2005-12-21 | 北京正大绿洲医药科技有限公司 | Dropping pill of folium ilicis hainanensis and its preparing method |
| CN1872048A (en) * | 2006-04-25 | 2006-12-06 | 邵爱霞 | Drop pills of soybean aglycone, and preparation method |
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| CN1709460A (en) * | 2005-07-12 | 2005-12-21 | 北京正大绿洲医药科技有限公司 | Dropping pill of folium ilicis hainanensis and its preparing method |
| CN1872048A (en) * | 2006-04-25 | 2006-12-06 | 邵爱霞 | Drop pills of soybean aglycone, and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108310019A (en) * | 2018-03-29 | 2018-07-24 | 浙江海洋大学 | A kind of preparation method of Wu Ling ginseng antidepression dripping pill |
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