CN106511290A - Lamiophlomis rotata(Benth.) Kudo solid dispersion preparation and preparation method thereof - Google Patents
Lamiophlomis rotata(Benth.) Kudo solid dispersion preparation and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Lamiophlomis rotata(Benth.) Kudo preparation and a preparation method thereof. A Lamiophlomis rotata(Benth.) Kudo extract is prepared into a solid dispersion through a hot-melt extrusion technology, the dispersity and specific surface area are increased, leaching of effective components is promoted, the hydrophilicity of medicine is increased, the solubility and dissolving-out speed of the Lamiophlomis rotata(Benth.) Kudo solid dispersion are increased, the bioavailability of the medicine is improved, and medicine curative effect exerting is promoted.
Description
Technical field：
The invention belongs to pharmaceutical technology field, and in particular to a kind of Radix Lamiophlomidis Rotatae solid dispersion preparation and its preparation side
Method.
Technical background：
Radix Lamiophlomidis Rotatae be hide, cover, the national folk medical herbs such as Nahsi, be labiate Lamiophlomis Rotata
(Benth.) herb of Kudo.Tibetan medicine's masterpiece is loaded in earliest《Four doctor's allusion quotations》、《Month king's medicine is examined》.Modern pharmacology grinds
Study carefully and show, Radix Lamiophlomidis Rotatae has a hemostasis, analgesia, antibacterial, acute, and the effect such as antitumor, small toxicity are secondary
Effect is few, moreover it is possible to improve Non-specific and non-Non-specific immunologic function.
The current listing dosage form of Radix Lamiophlomidis Rotatae is tablet, capsule, granule, soft capsule；Can ease pain, stop blooding.
Jing after water extraction, appropriate amount of auxiliary materials is added to be prepared by Radix Lamiophlomidis Rotatae medical material.One mesh of preparation shortcoming of existing granule
So, oral consumption is big every time, and needs are taken after mixing it with water after first being melted with boiled water, and medicine bitterness itself is very heavy, this administration
Amount is big, poor taste and take the administering mode of inconvenience, and inconvenient to carry etc. easily causes patient using complying with
Property is poor；And granule is difficult storage, easily moisture absorption microbiological contamination is further mouldy.Production and clinical practice for many years proves,
Existing Radix Lamiophlomidis Rotatae hard capsule and Radix Lamiophlomidis Rotatae piece have certain defect, and for example, disintegration time is slow, biological profit
Expenditure is low；Useful life is short, and long-term storage easily occurs the phenomenons such as content deliquescence, hardened in bulk；And in reality
Affected by environment big in the use of border, often i.e. failure or character are unqualified before the deadline for Jing；The smell is awful for tablet,
Compliance difference of pain patients etc..Although soft capsule is slow compared with other dosage form disintegration rates, rapid-action and energy is significantly
Strengthen the beneficial effect of Radix Lamiophlomidis Rotatae extract, it is more excellent with more significant stability and treatment than presently commercially available product
Point.But, due to Radix Lamiophlomidis Rotatae extract property determine, made by preparation dissolution it is low, bioavailability is paid no attention to
Want there is the defects such as drug effect is unstable.
Carrying out secondary development to old medicine is tcm product clinic urgent needss and further improves the market competitiveness
An important channel, therefore, common lamiophlomis root preparation is carried out it is secondary explore exploitation, improve medicine effect, offer
Drug safety is significant.
The content of the invention：
It is an object of the invention to provide a kind of preparation method of Radix Lamiophlomidis Rotatae solid dispersion preparation, its technology design
It is：Radix Lamiophlomidis Rotatae extract and solid dispersion carrier are made into solid dispersion, pharmaceutically acceptable adjuvant
Preparation is made, obtained common lamiophlomis root preparation can improve the dissolution of medicine and bioavailability, significantly improve medicine
Thing therapeutic effect, can more meet the application of clinic.
Specifically, the invention provides a kind of common lamiophlomis root preparation, described common lamiophlomis root preparation is by weight
It is made up of Radix Lamiophlomidis Rotatae 800-1200 parts, solid dispersion carrier material 200-400 parts and pharmaceutic adjuvant.
More specifically, the preparation is common lamiophlomis root preparation, by weight, it is by 1000 parts of Radix Lamiophlomidis Rotatae, admittedly
300 parts of body dispersion carrier material and pharmaceutic adjuvant are made.
Solid dispersion carrier of the present invention is：Polyvinylcaprolactame-polyvinyl acetate-Polyethylene Glycol
Graft copolymer (soluplus).
Pharmaceutic adjuvant of the present invention may be selected from：Povidone K 30, polyvinylpolypyrrolidone, Microcrystalline Cellulose, sugar
Powder, carboxymethyl starch sodium, hypromellose, low-substituted hydroxypropyl cellulose, glucose, starch, Lactose,
Mannitol, glycerol, dextrin, magnesium stearate, micropowder silica gel, Pulvis Talci, polyethylene glycol 6000, poly- second two
Alcohol 4000 one of which or several.
Present invention also offers a kind of preparation method for preparing common lamiophlomis root preparation as above, including following step
Suddenly：
1) Radix Lamiophlomidis Rotatae is taken, plus the ethanol soaked overnight of the 80% of 3 times of amounts, reflux, extract, 2h, filter, obtain
Extracting solution, filtrate recycling ethanol are simultaneously concentrated into the extractum that relative density is about 1.20, and drying is made in vacuum drying
Rhizoma Rodgersiae extract extract powder, medicinal residues add 5-6 times of water, and decocting in water extracts 2h again, filters, and filtrate concentrates, is dried
Crush, medicated powder is extracted in merging twice, standby；
2) set Haake minipool flow graph controls temperature as 110 DEG C, and screw speed is 30r/min, turns round
Square power 20N.cm；By drug carrier material Soluplus and step 1) be obtained Radix Lamiophlomidis Rotatae extract extractum be placed in
In hopper, extruded with bar character by head nib after material is extruded, room temperature cooling is crushed, crosses 80
Mesh sieve, obtains medicine solid dispersion standby.
3) by step 2) obtained in medicine solid dispersion, pharmaceutically acceptable is medicinal for obtained addition
Adjuvant makes various dosage forms.
Dosage form of the present invention can be dispersible tablet, capsule, soft capsule, microcapsule, granule, ball
Agent, micropill, powder, drop pill, slow releasing preparation, controlled release preparation or gel.It is preferably made tablet, flexible glue
Wafer.
Wherein, described tablet is prepared：By step 2) obtained in add in solid dispersion it is appropriate
Starch, 4% Lactose, 6% part of Microcrystalline Cellulose, are sufficiently mixed, and 85% ethanol makes granule as binding agent,
20 mesh sieves are crossed, adds 1.5% micropowder silica gel, 1% part of magnesium stearate to mix, make tablet, Europe with tablet machine
Bar is obtained final product for coating.
Wherein, described soft capsule is prepared：By step 2) obtained in solid dispersion medicated powder add
Enter PEG400 and appropriate glycerol, mixed with colloid mill, 1000 soft capsules are obtained.
Beneficial effects of the present invention are：It is slow, biological sharp mostly to there is In Vitro Dissolution for common lamiophlomis root preparation in the present invention
Radix Lamiophlomidis Rotatae extract is made solid dispersion using torching mark, increased medicine by the low shortcoming of expenditure
Dispersion and specific surface area, be more beneficial for the leaching of effective ingredient, increase the hydrophilic of medicine, so as to increase
The dissolubility of Radix Lamiophlomidis Rotatae solid dispersion, dissolution rate, improve the bioavailability of medicine, are more beneficial for medicine
Curative effect is played；And, the present invention selects soluplus (Polyvinylcaprolactames-polyvinyl acetate-poly- second
Glycol graft copolymer) as carrier, not only made by solid dispersion quality preferably, and soluplus is carried
Body compressibility, mobility are preferable, are advantageous to granulation, tabletting, it is easy to industrialized production.
In order to be illustrated to present disclosure and beneficial effect, the present invention has also carried out tests below, it is intended to
The present invention is illustrated, is not limited the scope of the invention.
Experiment 1：The selection of solid dispersion carrier material：
Using solid dispersion index components content obtained in different carriers with dissolution in vitro as investigation item.
According to version in 2010《Chinese Pharmacopoeia》Relevant regulations in (two) annex, are tested using paddle method.
Take solid dispersion appropriate, accurately weighed, uniform point is spread in stripping rotor, and meson is 0.2% dodecyl
Sodium sulfate 900ml, rotating speed is 100r/min, and temperature is 37 ± 0.5 DEG C, respectively at 5,15,30,45,
60min is measured by sampling, and calculates accumulation dissolution percentage ratio, investigates result such as table 1 below, table 2：
Table 1：Solid dispersion index components content measurement result made by different carriers：
| Kind of carrier | Total flavones % in terms of rutin | Luteolin content % | Index content sum % |
| Soluplus | 10.23 | 0.7 | 10.93 |
| Kollidon12PF | 8.26 | 0.5 | 8.76 |
| Poloxamer 188 | 7.81 | 0.4 | 8.21 |
| KollidonVA64 | 8.43 | 0.5 | 8.93 |
| PEG6000 | 7.52 | 0.3 | 7.82 |
Table 2：Solid dispersion accumulation dissolution test result made by different carriers：
To sum up result of the test：Dispersion material cumulative defaultlogic made by solid dispersion material each group is big
In raw material group is extracted, wherein soluplus prepares solid dispersion performance optimal as carrier material, its work
Property component content it is high, also, made by solid dispersion dissolution is high, dissolution rate is fast, tire out in 30min
Product dissolution percentage rate has just reached 75%, also, soluplus is used as carrier material compressibility, mobility
Preferably, granulation and tabletting, therefore preferably soluplus are more beneficial for as carrier material.
Test 2 of the invention that common lamiophlomis root preparation is investigated：
1st, accelerated stability test：
According to version in 2010《Chinese Pharmacopoeia》The relevant regulations of (two) accelerated stability test are tried
Test, its result of the test such as table 3 below：
Table 3：Common lamiophlomis root preparation accelerated stability test testing result：
Result of the test shows：The said goods are investigated through acceleration test, and Jing meets the requirements, but the present invention is obtained solely
Better stability of preparation simply, more commercially available Duyiwei soft capsule are more excellent.
2nd, common lamiophlomis root preparation dissolution in vitro test：
Table 4：Common lamiophlomis root preparation dissolution in vitro is tested：
Result of the test shows：Obtained in of the invention, the more commercially available Duyiwei soft capsule of common lamiophlomis root preparation is more excellent,
Cumulative in vitro dissolution percentage rate can be up to more than 90% in 60min, and dissolution in vitro is greatly enhanced.
3rd, pharmacodynamics test：
3.1 common lamiophlomis root preparation pain relievings are investigated：
(45 DEG C) detection threshold of pains of leaching tail method：
Kunming mouse 50, is randomly divided into 5 groups：Matched group (normal saline), commercially available soft capsule group, city
Sell tablet group, Tablets group, soft capsule group of the present invention.One will be done with picric acid at the 3cm of mouse tail tip
Labelling, and this position is immersed in 45 DEG C of hot water, contract the water surface as pain reaction indicator with rat-tail, with rat-tail
It is the threshold of pain to be immersed in the water to the time of the water surface that contracts.(interval 10min is determined 2 times to determine Basic Pain Threshold first
The threshold of pain, the threshold of pain based on 2 means).Then each group is distinguished successively：Commercially available soft capsule group, commercially available is administered
Tablet group, Tablets group, soft capsule group.Result of the test such as table 5 below：
Table 5：Impact (χ ± s) of the Radix Lamiophlomidis Rotatae capsule to the mice threshold of pain
Above-mentioned test shows：Test group is respectively provided with prolongation effect compared with matched group to the mice threshold of pain, and the present invention is obtained
Common lamiophlomis root preparation effect be better than existing commercially available prod.
3.2 pairs of mice bleeding times and the impact of blood plasma recalcification time
3.2.1 the impact to the bleeding time
22～25g mices 50 are taken, male and female half and half are randomly divided into matched group (normal saline), commercially available flexible glue
Capsule group, marketed tablet group, Tablets group, soft capsule group of the present invention；Totally 5 groups, fasting for solids and liquids 24 is little
When, by 0.02mL/g weights, gavage gives the medicine of normal saline and corresponding dosage respectively.After 45 minutes
Cutting off rat-tail 3mm just has blood to flow out, timing immediately, gently wipes blood 1 time every 10s filter paper, directly
To after wiping no longer bleeding.From bleeding is started to stopped bleeding, elapsed time is the mice bleeding time.
3.2.2 the impact to blood plasma recalcification time
Take 22～25g mices 50, male and female half and half, experiment packet ibid, 24 hours fasting for solids and liquids.Pluck eye
Ball takes blood 1mL, is put in the centrifuge tube added with 0.1mL sodium citrate solutions (38mg/mL), after mixing with
1000r/min is centrifuged 10 minutes, takes 1, internal diameter 8mm test tubes, adds pooled plasma and normal saline each
80 μ L, are put into 37 DEG C of middle temperature baths of water-bath 2 minutes immediately, are subsequently adding 80 μ L calcium chloride solutions (2.8
Mg/mL), mix, after place in 37 DEG C of water-baths, timing immediately, record from plus calcium after to fibrin shape
Into, the motionless required time of liquid level, as physiological saline group blood plasma recalcification time.Remaining group is by same procedure and bar
Part measures the blood plasma recalcification time of each group.Result of the test is as follows：
Table 6：Impact (χ ± s) of the Radix Lamiophlomidis Rotatae capsule to mice bleeding time and blood plasma recalcification time
| Test group | Number of animals (n) | Dosage mg/kg | Bleeding time (min) | Recalcification time (min) |
| Matched group | 10 | -- | 6.67±0.19 | 2.17±0.19 |
| Marketed tablet group | 10 | 460 | 6.21±0.23 | 2.05±0.23 |
| Commercially available soft capsule group | 10 | 460 | 6.14±0.43 | 2.03±0.31 |
| Tablets group | 10 | 460 | 6.04±0.23 | 1.52±0.24 |
| Soft capsule group of the present invention | 10 | 460 | 6.02±0.23 | 1.45±0.27 |
Upper table shows：Common lamiophlomis root preparation obtained in of the invention has aobvious to mice bleeding time and blood plasma recalcification time
Works is used, and more existing commercially available prod effect is more excellent, and pharmacy is more notable.
Specific embodiment：
Embodiment 1：The preparation of Radix Lamiophlomidis Rotatae tablet
(1) Radix Lamiophlomidis Rotatae 800g, plus the ethanol soaked overnight of the 80% of 3 times of amounts is taken, reflux, extract, 2h is filtered,
Extracting solution is obtained, filtrate recycling ethanol is simultaneously concentrated into the extractum that relative density is about 1.20, and vacuum drying is made
Rhizoma Rodgersiae extract extract powder is dried, medicinal residues add 5 times of water, and decocting in water extracts 2h again, filters, and filtrate concentrates, does
Medicated powder is extracted in dry crushing, merging twice, standby；
(2) set Haake minipool flow graph controls temperature as 110 DEG C, and screw speed is 30r/min,
Torsional forces 20N.cm；By 200g drug carrier materials Soluplus and step 1) Radix Lamiophlomidis Rotatae extract medicine is obtained
Powder is placed in hopper, is extruded with bar character by head nib after material is extruded, room temperature cooling, is crushed,
80 mesh sieves are crossed, medicine solid dispersion is obtained standby.
(3) by step 2) obtained in add appropriate amount of starch, 4% Lactose, 6% part of crystallite fibre in solid dispersion
Dimension element, is sufficiently mixed, and 85% ethanol makes granule as binding agent, crosses 20 mesh sieves, adds 1.5% micropowder
Silica gel, 1% part of magnesium stearate are mixed, make tablet with tablet machine, and OPADRY coating is obtained final product.
Embodiment 2：The preparation of Duyiwei soft capsule
(1) Radix Lamiophlomidis Rotatae 1000g, plus the ethanol soaked overnight of the 80% of 3 times of amounts, reflux, extract, 2h, mistake are taken
Filter, obtains extracting solution, and filtrate recycling ethanol is simultaneously concentrated into the extractum that relative density is about 1.20, vacuum drying
Make and be dried Rhizoma Rodgersiae extract extract powder, medicinal residues add 5 times of water, and decocting in water extracts 2h again, filters, filtrate concentration,
Drying and crushing, merging extract medicated powder twice, standby；
(2) set Haake minipool flow graph controls temperature as 110 DEG C, and screw speed is 30r/min,
Torsional forces 20N.cm；By 300g drug carrier materials Soluplus and step 1) Radix Lamiophlomidis Rotatae extract medicine is obtained
Powder is placed in hopper, is extruded with bar character by head nib after material is extruded, room temperature cooling, is crushed,
80 mesh sieves are crossed, medicine solid dispersion is obtained standby.
(3) by step 2) obtained in solid dispersion medicated powder add PEG400 and appropriate glycerol, use colloid
Mill is mixed, and 1000 soft capsules, every 0.6g is obtained.
Embodiment 3：The preparation of Duyiwei soft capsule
(1) Radix Lamiophlomidis Rotatae 1200g, plus the ethanol soaked overnight of the 80% of 3 times of amounts, reflux, extract, 2h, mistake are taken
Filter, obtains extracting solution, and filtrate recycling ethanol is simultaneously concentrated into the extractum that relative density is about 1.20, vacuum drying
Make and be dried Rhizoma Rodgersiae extract extract powder, medicinal residues add 5 times of water, and decocting in water extracts 2h again, filters, filtrate concentration,
Drying and crushing, merging extract medicated powder twice, standby；
(2) set Haake minipool flow graph controls temperature as 110 DEG C, and screw speed is 30r/min,
Torsional forces 20N.cm；By 400g drug carrier materials Soluplus and step 1) Radix Lamiophlomidis Rotatae extract medicine is obtained
Powder is placed in hopper, is extruded with bar character by head nib after material is extruded, room temperature cooling, is crushed,
80 mesh sieves are crossed, medicine solid dispersion is obtained standby.
(3) by step 2) obtained in solid dispersion medicated powder add PEG400 and appropriate glycerol, use colloid
Mill is mixed, and 1000 soft capsules, every 0.8g is obtained.
Claims (8)
1. a kind of common lamiophlomis root preparation, described common lamiophlomis root preparation is by weight, it is characterised in that：It is made up of Radix Lamiophlomidis Rotatae 800-1200 parts, solid dispersion carrier material 200-400 parts and pharmaceutic adjuvant.
2. common lamiophlomis root preparation according to claim 1, by weight, it is characterised in that：It is made up of 1000 parts of Radix Lamiophlomidis Rotatae, 300 parts of solid dispersion carrier material and pharmaceutic adjuvant.
3. solid dispersion carrier according to claim 1 and 2, it is characterised in that：Described solid dispersion carrier material is Polyvinylcaprolactame-polyvinyl acetate-polyethyleneglycol-graft copolymer（soluplus）.
4. pharmaceutic adjuvant according to claim 1 and 2, it is characterised in that：It is selected from Povidone K 30, polyvinylpolypyrrolidone, Microcrystalline Cellulose, Icing Sugar, carboxymethyl starch sodium, hypromellose, low-substituted hydroxypropyl cellulose, glucose, starch, Lactose, Mannitol, glycerol, dextrin, magnesium stearate, micropowder silica gel, Pulvis Talci, polyethylene glycol 6000, Macrogol 4000 one of which or several.
5. a kind of preparation method for preparing common lamiophlomis root preparation, it is characterised in that：Comprise the following steps：
A, take Radix Lamiophlomidis Rotatae, plus the ethanol soaked overnight of the 80% of 3 times of amounts, reflux, extract, 2h, filter, obtain extracting solution, filtrate recycling ethanol is simultaneously concentrated into the extractum that relative density is about 1.20, and vacuum drying is made and is dried Rhizoma Rodgersiae extract extract powder, and medicinal residues add 5-6 times of water, and decocting in water extracts 2h again, filter, filtrate concentration, drying and crushing, medicated powder is extracted in merging twice, standby；
B, set Haake minipool flow graph control temperature as 110 DEG C, screw speed is 30r/min, torsional forces 20N.cm；By drug carrier material Soluplus and step 1）Prepared Radix Lamiophlomidis Rotatae extract extractum is placed in hopper, is extruded with bar character by head nib after material is extruded, room temperature cooling, is crushed, is crossed 80 mesh sieves, obtains medicine solid dispersion, adds pharmaceutically acceptable pharmaceutic adjuvant to make various dosage forms.
6. dosage form according to claim 5, it is characterised in that：Can be made into dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation or gel.
7. tablet according to claim 6, it is characterised in that：Through the following steps that be prepared from：By step 2）Appropriate amount of starch, 4% Lactose, 6% part of Microcrystalline Cellulose being added in obtained solid dispersion, being sufficiently mixed, 85% ethanol makes granule as binding agent, 20 mesh sieves are crossed, 1.5% micropowder silica gel, 1% part of magnesium stearate is added, mix, make tablet with tablet machine, OPADRY coating is obtained final product.
8. soft capsule according to claim 6, it is characterised in that：It is prepared：By step 2）Obtained solid dispersion medicated powder adds PEG400 and appropriate glycerol, is mixed with colloid mill, and 1000 soft capsules are obtained.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010305A (en) * | 2018-10-16 | 2018-12-18 | 南京昂科利医药科技创新研究院有限公司 | A kind of rutin natrium capsule and preparation method thereof |
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|---|---|---|---|---|
| CN1565562A (en) * | 2003-06-18 | 2005-01-19 | 成都和康药业有限责任公司 | Medicine capable of promoting blood circulation to arrest pain |
| CN1672706A (en) * | 2004-03-25 | 2005-09-28 | 一笑堂（湖南）制药有限公司 | Dispersive tablet of common lamiophlomis rhizome and its prepn |
| CN103550158A (en) * | 2013-09-11 | 2014-02-05 | 复旦大学附属中山医院 | Emodin solid dispersion, drug-containing pellet core, colonic targeted micropill, and applications of three |
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2015
- 2015-09-15 CN CN201510585107.1A patent/CN106511290A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1565562A (en) * | 2003-06-18 | 2005-01-19 | 成都和康药业有限责任公司 | Medicine capable of promoting blood circulation to arrest pain |
| CN1672706A (en) * | 2004-03-25 | 2005-09-28 | 一笑堂（湖南）制药有限公司 | Dispersive tablet of common lamiophlomis rhizome and its prepn |
| CN103550158A (en) * | 2013-09-11 | 2014-02-05 | 复旦大学附属中山医院 | Emodin solid dispersion, drug-containing pellet core, colonic targeted micropill, and applications of three |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109010305A (en) * | 2018-10-16 | 2018-12-18 | 南京昂科利医药科技创新研究院有限公司 | A kind of rutin natrium capsule and preparation method thereof |
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