CN105641008A - Pseudo-ginseng tablets and preparation method thereof - Google Patents
Pseudo-ginseng tablets and preparation method thereof Download PDFInfo
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- CN105641008A CN105641008A CN201610055741.9A CN201610055741A CN105641008A CN 105641008 A CN105641008 A CN 105641008A CN 201610055741 A CN201610055741 A CN 201610055741A CN 105641008 A CN105641008 A CN 105641008A
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/2022—Organic macromolecular compounds
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- A61K2236/30—Extraction of the material
- A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
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Abstract
The invention discloses pseudo-ginseng tablets and a preparation method thereof. The pseudo-ginseng tablets are tablets prepared from pseudo-ginseng. The preparation method of the pseudo-ginseng tablets comprises the steps that one half of pseudo-ginseng is subjected to superfine grinding, and the other half of pseudo-ginseng is subjected to supercritical extraction after being subjected to superfine grinding. The pseudo-ginseng tablets and the preparation method thereof have the advantages that the improved process is free of pollution after superfine grinding, chromium or nickel or cadmium or titanium or iron or copper or zinc or lead or arsenic or other heavy metal cutting particles are not peeled off or released, extract obtained after supercritical extraction enables the effective ingredients of the tablets not to be damaged, the effective ingredients of medicine are extracted more completely, the medicine is high in dissolution rate, long in medicine effect retention time and high in bioavailability, and the medicine effect is remarkably improved.
Description
Technical field
The present invention relates to the pharmaceutical formulation of a kind of field of medicaments, particularly relate to a kind of Radix Notoginseng Tabellae and preparation method thereof.
Background technology
Radix Notoginseng Tabellae is that Chinese Pharmacopoeia records kind. The tablet being made up of Radix Notoginseng, has repercussive hemostasis, reducing swelling and alleviating pain. For spitting blood, spitting blood, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, chest and abdomen twinge and tumbling and swelling etc.
Current Radix Notoginseng Tabellae preparation technology is substantially and continues to use Conventional processing methods, and Radix Notoginseng powder is broken into fine powder. Due to common grinder be open pulverizing can there is granulation time particle diameter big, heavy metal pollution can be caused, drug-eluting speed is slow, the shortcomings such as bioavailability is low. And all the active ingredient that can promote its crude drug of being used as medicine of pulverizing medicinal materials fine powder is unstable, the content of the effect that the long traditional Chinese medicine disease prevention of disintegration time is cured the disease and the method for making of medical material, extract and effective ingredient has direct relation. If extraction process is unreasonable, not science, destruction and the loss of effective ingredient certainly will be caused, thus affecting the quality of preparation, curative effect. Additionally, the disintegration time of existing Radix Notoginseng Tabellae is longer, after long-term especially placement, having the phenomenon beyond standards of pharmacopoeia, the long meeting of disintegration time has a strong impact on the absorption of medicine.
Along with clinically to drug quality, the improving constantly and the development of pharmaceutical technology of effect requirements, this technique can not meet current demand, it is badly in need of a kind of pollution-free, drug dissolution is fast, bioavailability is high, effective ingredient is more stable and disintegration time is fast preparation process, to play the medical value of Radix Notoginseng Tabellae classics prescription better.
Summary of the invention
It is an object of the invention to for the deficiencies in the prior art, there is provided the preparation technology of a kind of pollution-free, drug dissolution is fast, bioavailability is high, effective ingredient is more stable and disintegration time is fast Radix Notoginseng Tabellae, thus playing the medical value of this tradition proved recipe better.
Present invention aim at providing a kind of Radix Notoginseng Tabellae preparation.
Another object of the present invention is to the preparation method that a kind of Radix Notoginseng Tabellae is provided.
The present invention is achieved through the following technical solutions:
Radix Notoginseng Tabellae of the present invention is made up of following crude drug and adjuvant:
Radix Notoginseng 250-750 weight portion polyvinylpolypyrrolidone 5-15 weight portion
Carboxymethyl starch sodium 2.5-7.5 weight portion cross-linking sodium carboxymethyl cellulose 2.5-7.5 weight portion.
Radix Notoginseng Tabellae of the present invention is preferably as follows crude drug and adjuvant composition:
Radix Notoginseng 400-600 weight portion polyvinylpolypyrrolidone 8-12 weight portion
Carboxymethyl starch sodium 4-6 weight portion cross-linking sodium carboxymethyl cellulose 4-6 weight portion.
Radix Notoginseng Tabellae of the present invention is it is also preferred that following crude drug and adjuvant form:
Radix Notoginseng 500 weight portion polyvinylpolypyrrolidone 10 weight portion
Carboxymethyl starch sodium 5 weight portion cross-linking sodium carboxymethyl cellulose 5 weight portion.
Radix Notoginseng Tabellae of the present invention is it is also preferred that following crude drug and adjuvant form:
Radix Notoginseng 700 weight portion polyvinylpolypyrrolidone 6 weight portion
Carboxymethyl starch sodium 7 weight portion cross-linking sodium carboxymethyl cellulose 3 weight portion.
Radix Notoginseng Tabellae of the present invention is it is also preferred that following crude drug and adjuvant form:
Radix Notoginseng 300 weight portion polyvinylpolypyrrolidone 14 weight portion
Carboxymethyl starch sodium 3 weight portion cross-linking sodium carboxymethyl cellulose 7 weight portion.
The present invention provides a kind of Radix Notoginseng Tabellae, and this Radix Notoginseng Tabellae is prepared from by following methods:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 30-90 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of more than 85% is less than 6 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 4-6 micron, superfine powder is placed on CO2Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20-30MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 3-9MPa, heats to 20-60 DEG C, keeps 2.5-7.5 hour, CO2Flow maintain 20-40Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
The present invention provides a kind of Radix Notoginseng Tabellae, and the preferred following methods of this Radix Notoginseng Tabellae is prepared from:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
The preparation method of Radix Notoginseng Tabellae of the present invention is: take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 30-90 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of more than 85% is less than 6 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 4-6 micron, superfine powder is placed on CO2Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20-30MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 3-9MPa, heats to 20-60 DEG C, keeps 2.5-7.5 hour, CO2Flow maintain 20-40Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
The preparation method of Radix Notoginseng Tabellae of the present invention is preferably: take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
Radix Notoginseng Tabellae of the present invention is made up of following crude drug, adjuvant and preparation method:
Described weight portion is with g for unit of account;
Radix Notoginseng 500g polyvinylpolypyrrolidone 10g
Carboxymethyl starch sodium 5g cross-linking sodium carboxymethyl cellulose 5g;
Preparation method is:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g).
Radix Notoginseng Tabellae of the present invention preparation treatment spitting of blood, haematemesis, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, chest and abdomen twinge or tumbling and swelling medicine in application.
Inventor finds in screening process, only the Radix Notoginseng of 1/2 amount is carried out micronizing, all the other 1/2 amount Radix Notoginseng carry out again after carrying out micronizing supercritical extraction form be used as medicine, make tablet effective, will not mutually destroy active ingredient so that active ingredient is more stable, dissolution is higher, therapeutic effect is also significantly increased. If be used as medicine with other proportionings or additive method form, the tablet effect made is bad, and active ingredient is unstable, and dissolution is low, and therapeutic effect does not improve.
The advantage of Radix Notoginseng Tabellae of the present invention is in that, by broken for the superfine notoginseng powder of 1/2 amount, chilled pretreatment before pulverizing, and in superfine powder, spray into dry ice as coolant, abrasive body can obtain effective cooling in very short time, makes pulverized Chinese crude drug reach the effect of micronizing in very short time and keep high biological activity. And the grain size of micropowder of micronizing is little, owing to micronizing process materials temperature is lower than-18 DEG C; Chinese crude drug superfine powder after micronizing, pollution-free, the heavy metal break flour microgranule such as Chrome-free, nickel, cadmium, titanium, ferrum, copper, zinc, lead, arsenic peels off and disengages.The another Radix Notoginseng by remaining 1/2 amount r carries out supercritical extraction, micronizing is first carried out before supercritical extraction, by the extract after supercritical extraction, its effective ingredient is not destroyed, the active ingredient extracting medicine is more complete, and the dissolution height of medicine, drug effect retention time length, bioavailability are high. Technique after simultaneously improving treatment spitting of blood, haematemesis, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, chest and abdomen twinge or tumbling and swelling therapeutic effect more former technique therapeutic effect have aobvious person to improve. The present invention improve after technique also added appropriate disintegrating agent, tablet disintegration times made after adding disintegrating agent at about 12 minutes, the also complete disintegrate at about 17 minutes after accelerating to place 6 months. Effectively prevent disintegrate and cross the slow adverse effect that curative effect is caused.
The present inventor investigates different process step and the parameter impact on Chinese medicinal tablet of the present invention by tests below.
Reiterate: tests below is the test of the illustrative in numerous tests in development process of the present invention, it is not covered by and is exhausted and invent all experiments that the artificial present invention does, only for purpose of partial routine and the result of setting forth Chinese medicinal tablet preparation method screening and optimizing of the present invention by those data.
Experimental example one:
1, the selection of disintegrating agent of the present invention
By the processing step (before being not added with adjuvant) of the invention process 1, disintegrating agent kind and consumption according to table 1 are screened. It is shown that polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose can substantially accelerate disintegration rate, particularly three with after the cooperation of 2:1:1 ratio, disintegration time significantly shortens. Refer to table 1.
The selection result of table 1 disintegrating agent
2, compare disintegration
2.1 medicament selection
Test sample 1 (preparing according to the embodiment of the present invention 1 method).
Test sample 2 (preparing according to the embodiment of the present invention 2 method)
Test sample 3 (prepared by present invention embodiment 3 method)
Reference substance 4 preparation method:
Take Radix Notoginseng 500g, be ground into fine powder, add polyvinylpolypyrrolidone 20g, make granule, be pressed into 1000 and get final product.
2.2 disintegrations checked: adopt Rotating shaker, lift disintegration tester, took each 6 of test sample 1, test sample 2, test sample 3 and reference substance 4, observed the situation by screen cloth, and percent of pass height then disintegrative is good, more preferably absorption of human body. In Table 2
Table 2
| Group | Accelerate to place in 1 month disintegration (min) | Accelerate to place 6-12 month disintegration (min) |
| Test sample 1 | 12.01 | 16.12 |
| Test sample 2 | 12.11 | 16.25 |
| Test sample 3 | 12.07 | 16.19 |
| Reference substance 4 | 22.25 | 33.84 |
2.3 conclusions
By above-mentioned table 2 it is known that 1 month interior disintegration time is placed in the acceleration of test sample of the present invention 1,2 and 3
Respectively 12.01,12.11 and 12.07 minutes, accelerate to place 6-12 month disintegration time also at 16.12,16.25 and 16.19 minutes, and reference substance 4 acceleration 1 month interior disintegration time of placement is 22.25 minutes, accelerating to place 6-12 month disintegration time is 33.84 minutes, and the disintegration time of test sample 1,2 and 3 of the present invention compares with the disintegration time of reference substance 4 that there were significant differences.
3, Dissolution experiments
Test sample 1 (preparing according to the embodiment of the present invention 1 method) of the present invention, test sample 2 (preparing according to the embodiment of the present invention 2 method), test sample 3 (prepared by present invention embodiment 3 method), reference substance 4 (identical with the preparation method testing 2 reference substances 4) are carried out dissolution investigation, adopts the FDA similarity estimate recommended to evaluate its dissolution. Result is in Table 3
Table 3
| Group | 30min | 60min | 90min |
| Test sample 1 | 93.9% | 88..2% | 86.8 |
| Test sample 2 | 91.9% | 87.8% | 85.8% |
| Test sample 3 | 92.3% | 88.6% | 86.1% |
| Reference substance 4 | 61.1% | 50.3% | 39.1% |
Owing to the preparation method of test sample 1,2 and 3 of the present invention all adopts micronizing and supercritical extraction, its particle diameter is less than 6 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%), dissolution when 30 minutes is more than 91%, when 60 minutes, dissolution was more than 87%, and when 90 minutes, dissolution was more than 85%.And reference substance 4 adopts Ordinary pulverization method, its particle diameter is big, and not easily dissolution, therefore the dissolution when 30 minutes is 61%, and when 60 minutes, dissolution was 50%, and when 90 minutes, dissolution was 39%. The dissolution of test sample 1,2 and 3 of the present invention compares with the dissolution of reference substance 4 that there were significant differences.
4, stability experiment
Weigh test sample 1 (preparing according to the embodiment of the present invention 1 method) of the present invention, test sample 2 (preparing according to the embodiment of the present invention 2 method), test sample 3 (prepared by present invention embodiment 3 method), reference substance 4 (identical with the preparation method testing 2 reference substances 4) each 4g respectively, inject chromatograph of liquid, being measured at 0,2,4,12,24 months respectively, measurement result is as follows: in Table 4
Table 4
As seen from the above table, the stability of test sample 1,2 and 3 of the present invention is fine, after study on the stability 24 months, the content of its active ingredient is substantially unchanged, and reference substance 4 is after study on the stability 24 months, the content of its active ingredient has significant change, and illustrates that the stability of inventive test sample 1,2 and 3 is significantly better than reference substance 4.
5, drug effect compares
Add up 200 example spitting of bloods, haematemesis, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage, chest and abdomen twinge or tumbling and swelling patient, age is in 28-65 year, wherein 100 examples take matched group medicine (preparing according to experimental example 1 reference substance 4 method), another 100 example patients take of the present invention group of medicine (preparing according to the embodiment of the present invention 1 method), and instructions of taking and curative effect are as follows: in Table 5
Table 5
| Group | Number | Day/time | Each serving consumption | Take natural law | Total effective rate |
| Matched group | 100 people | 3 times | 4 (0.5g/ sheet) | 10 | 81% |
| Of the present invention group | 100 people | 3 times | 2 (1.1g/ sheet) | 10 | 96% |
Conclusion: matched group is 81% at the total effective rate of the various hyperlipidemia for the treatment of, cerebrovascular sclerosis, Simple Obesity, habitual constipation and bleeding hemorrhoids 100 example patient, of the present invention group is 96% treating the total effective rate of the 100 example patients such as various hyperlipidemia, cerebrovascular sclerosis, Simple Obesity, habitual constipation and bleeding hemorrhoids, and the total effective rate of of the present invention group compares with matched group total effective rate that there were significant differences.
Following embodiment all can realize the effect of above-mentioned experimental example.
Detailed description of the invention
Embodiment 1
Radix Notoginseng 500g polyvinylpolypyrrolidone 10g
Carboxymethyl starch sodium 5g cross-linking sodium carboxymethyl cellulose 5g;
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g). Daily three times, each 2.
Embodiment 2
Radix Notoginseng 700g polyvinylpolypyrrolidone 6g
Carboxymethyl starch sodium 7g cross-linking sodium carboxymethyl cellulose 3g;
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g). Daily three times, each 2.
Embodiment 3
Radix Notoginseng 300g polyvinylpolypyrrolidone 14g
Carboxymethyl starch sodium 3g cross-linking sodium carboxymethyl cellulose 7g;
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns (in preferred micronizing grain size of micropowder 2-4 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g). Daily three times, each 2.
Embodiment 4
Radix Notoginseng 420g polyvinylpolypyrrolidone 11g
Carboxymethyl starch sodium 4.5g cross-linking sodium carboxymethyl cellulose 5.5g;
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 40g dry ice as coolant; After micronizing, the grain size of micropowder of 85-90% is less than 5 microns (in preferred micronizing grain size of micropowder 2-5 microns of 90-95%); The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 4 microns, superfine powder is placed on CO2Soaking 4 hours in extraction kettle, controlling pressure in extraction kettle is 22MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 8MPa, heats to 25 DEG C, keeps 7 hours, CO2Flow maintain 35Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet. Every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g), daily three times, each 2.
Embodiment 5
Radix Notoginseng 580g polyvinylpolypyrrolidone 9g
Carboxymethyl starch sodium 5.5g cross-linking sodium carboxymethyl cellulose 4.5g;
Take the superfine notoginseng powder of 1/2 amount broken micropowders;Micronizing process sprays into 80g dry ice as coolant; After micronizing, the grain size of micropowder of 85-90 is less than 5 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 6 microns (in preferred micronizing grain size of micropowder 2-6 microns of 90-95%), superfine powder is placed on CO2Soaking 2 hours in extraction kettle, controlling pressure in extraction kettle is 28MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 4MPa, heats to 55 DEG C, keeps 3 hours, CO2Flow maintain 25Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g (containing Radix Notoginseng crude drug 1.0g), daily three times, each 2.
Claims (10)
1. a Radix Notoginseng Tabellae, it is characterised in that this Radix Notoginseng Tabellae is made up of following crude drug and adjuvant:
Radix Notoginseng 250-750 weight portion polyvinylpolypyrrolidone 5-15 weight portion
Carboxymethyl starch sodium 2.5-7.5 weight portion cross-linking sodium carboxymethyl cellulose 2.5-7.5 weight portion.
2. Radix Notoginseng Tabellae as claimed in claim 1, it is characterised in that this Radix Notoginseng Tabellae is made up of following crude drug and adjuvant:
Radix Notoginseng 400-600 weight portion polyvinylpolypyrrolidone 8-12 weight portion
Carboxymethyl starch sodium 4-6 weight portion cross-linking sodium carboxymethyl cellulose 4-6 weight portion.
3. Radix Notoginseng Tabellae as claimed in claim 1, it is characterised in that this Radix Notoginseng Tabellae is made up of following crude drug and adjuvant:
Radix Notoginseng 500 weight portion polyvinylpolypyrrolidone 10 weight portion
Carboxymethyl starch sodium 5 weight portion cross-linking sodium carboxymethyl cellulose 5 weight portion;
Or
Radix Notoginseng 700 weight portion polyvinylpolypyrrolidone 6 weight portion
Carboxymethyl starch sodium 7 weight portion cross-linking sodium carboxymethyl cellulose 3 weight portion;
Or
Radix Notoginseng 300 weight portion polyvinylpolypyrrolidone 14 weight portion
Carboxymethyl starch sodium 3 weight portion cross-linking sodium carboxymethyl cellulose 7 weight portion.
4. the Radix Notoginseng Tabellae as described in one of claim 1-3, it is characterised in that this Radix Notoginseng Tabellae is prepared from by following methods:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 30-90 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of more than 85% is less than 6 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 4-6 micron, superfine powder is placed on CO2Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20-30MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 3-9MPa, heats to 20-60 DEG C, keeps 2.5-7.5 hour, CO2Flow maintain 20-40Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
5. Radix Notoginseng Tabellae as claimed in claim 4, it is characterised in that this Radix Notoginseng Tabellae is prepared from by following methods:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60 weight portion dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa;Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
6. Radix Notoginseng Tabellae as claimed in claim 1 or 2, it is characterised in that the unit of described weight portion is g, and this Radix Notoginseng Tabellae is made up of following crude drug, adjuvant and preparation method:
Radix Notoginseng 500g polyvinylpolypyrrolidone 10g
Carboxymethyl starch sodium 5g cross-linking sodium carboxymethyl cellulose 5g;
Preparation method is:
Take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet, every tablet weight 1.1g.
7. the preparation method of the Radix Notoginseng Tabellae as described in one of claim 1-3, it is characterised in that this preparation method is: take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 30-90g dry ice as coolant; After micronizing, the grain size of micropowder of more than 85% is less than 6 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 4-6 micron, superfine powder is placed on CO2Soaking 1.5-4.5 hour in extraction kettle, controlling pressure in extraction kettle is 20-30MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 3-9MPa, heats to 20-60 DEG C, keeps 2.5-7.5 hour, CO2Flow maintain 20-40Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
8. the preparation method of Radix Notoginseng Tabellae as claimed in claim 7, it is characterised in that this preparation method is: take the superfine notoginseng powder of 1/2 amount broken micropowders; Micronizing process sprays into 60g dry ice as coolant; After micronizing, the grain size of micropowder of 85-95% is less than 4 microns; The Radix Notoginseng of remaining 1/2 amount is carried out micronizing to 5 microns, superfine powder is placed on CO2Soaking 3 hours in extraction kettle, controlling pressure in extraction kettle is 25MPa; Being easily separated in separating still by superfine powder after soaking, controlling separating pressure value in separating still is 6MPa, heats to 40 DEG C, keeps 5 hours, CO2Flow maintain 30Kg/h; Extract after separation is dried and obtains extract; Superfine powder and supercritical extraction extract homogenizer are stirred uniformly, add polyvinylpolypyrrolidone, carboxymethyl starch sodium and cross-linking sodium carboxymethyl cellulose mixing and stirring, make granule, tabletted, film coating sheet.
9. the Radix Notoginseng Tabellae as described in one of claim 1-6 preparation treatment spitting of blood, haematemesis, epistaxis, have blood in stool, metrorrhagia, traumatic hemorrhage medicine in application.
10. the application in the medicine of preparation treatment chest and abdomen twinge or tumbling and swelling of the Radix Notoginseng Tabellae as described in one of claim 1-6.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610055741.9A CN105641008A (en) | 2016-01-27 | 2016-01-27 | Pseudo-ginseng tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610055741.9A CN105641008A (en) | 2016-01-27 | 2016-01-27 | Pseudo-ginseng tablets and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593439A (en) * | 2004-06-29 | 2005-03-16 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of notoginsen total saponins and its preparation |
| CN1742743A (en) * | 2005-09-21 | 2006-03-08 | 重庆康刻尔制药有限公司 | Pseudo-ginseng saponin oral disintegration tablet and preparing method |
| CN102327401A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Method for preparing medicament for treating uterine bleeding |
-
2016
- 2016-01-27 CN CN201610055741.9A patent/CN105641008A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593439A (en) * | 2004-06-29 | 2005-03-16 | 北京科信必成医药科技发展有限公司 | Orally disintegrating tablet of notoginsen total saponins and its preparation |
| CN1742743A (en) * | 2005-09-21 | 2006-03-08 | 重庆康刻尔制药有限公司 | Pseudo-ginseng saponin oral disintegration tablet and preparing method |
| CN102327401A (en) * | 2011-09-23 | 2012-01-25 | 江西普正制药有限公司 | Method for preparing medicament for treating uterine bleeding |
Non-Patent Citations (1)
| Title |
|---|
| 南京中医药大学: "《中药大辞典》", 31 March 2006 * |
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Application publication date: 20160608 |