CN102631322B - 20 (S)-protopanoxadiol dry suspension agent and preparation method thereof - Google Patents
20 (S)-protopanoxadiol dry suspension agent and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a 20 (S)-protopanoxadiol dry suspension agent and a preparation method of the 20 (S)-protopanoxadiol dry suspension agent. The 20 (S)-protopanoxadiol dry suspension agent takes 20 (S)-protopanoxadiol as active ingredient, and the mass ratio between the active ingredient and pharmaceutic adjuvant is 1-20%: 80-99%; and the pharmaceutic adjuvant comprises suspending agent and wetting agent with the mass ratio of 5: 1, or sweetener with the mass ratio of 0-5%. The preparation method of the 20 (S)-protopanoxadiol dry suspension agent comprises the steps of: weighing the suspending agent and the wetting agent according to the prescription dosage, and then leading the suspending agent and the wetting agent to be evenly mixed with the 20 (S)-protopanoxadiol, or adding the sweetener. The 20 (S)-protopanoxadiol dry suspension agent is rapid to absorb and high in bioavailability, and overcomes the defect that tablets, capsules and the like are difficult to take, thus especially suitable for children and elderly patients; meanwhile, the preparation method is simple and high in industrial applicability.
Description
Technical field
The invention belongs to medical technical field, specifically relate to a kind of 20 (S)-protopanoxadiol dry suspension, the invention still further relates to the preparation method of this dry suspension.
Background technology
Numerous research reports, 20 (S)-protopanoxadiols have good anti-tumor activity, it all has obvious growth inhibited effect to pulmonary carcinoma, carcinoma of prostate, hepatocarcinoma, cervical cancer, gastric cancer and melanin tumour b16 cell strain, leukemia etc., and energy enhancing human body immunity ability, can be used as adjuvant therapy medicaments of tumor.This compound can obviously raise NE, 5-HT in depression model rat brain, HAV content, can obviously strengthen the 5-hydroxyryptophan effect of trembling and obviously strengthen the effect of levodopa behavior effect, can suppress absorbing again of 5-HT and NA.
The dosage form of existing 20 (S)-protopanoxadiols or be externally applied transdermal dosage form, as pharmacosomes (S. Korea and the USA China. Chinese Chinese medicine magazine .2010,35 (7): 842; Chen Jing. modern medicines and clinical .2009,24 (6): 354; S. Korea and the USA China. Chinese Journal of New Drugs, 2010,19 (10): the problems such as 888-890) existence and stability is poor; Or be liquid semi-finished product, as Benexate Hydrochloride (publication CN102178956A); Or be injection (publication CN1526407A, CN1850099A, CN1615901A); Or be solid dispersion (publication CN1879647A); Or be oil solution or Emulsion (Han MH, et al.AnalyticalSci.2010,26:749-751).
Present patent application inventor, through long-term study of pharmacy, has developed 20 (S)-protopanoxadiol dry suspension.Dry suspension is the Powdered or granular substance that a kind of slightly solubility solid drugs and proper auxiliary materials are made, and adds water jolting and can be dispersed into suspension and easily by body, be absorbed while taking.It is good that dry suspension has drug absorption, makes even particle distribution after suspension, large at gastrointestinal distribution area, absorb fast, bioavailability advantages of higher, the shortcoming that can avoid tablet, capsule difficulty to swallow, is especially beneficial to child simultaneously and gerontal patient takes.Document is not recorded to some extent to 20 (S)-protopanoxadiol dry suspension both at home and abroad.The present invention is for proposing first 20 (S)-protopanoxadiol dry suspension and preparation methoies.
Summary of the invention
For the deficiencies in the prior art, the object of this invention is to provide the dry mixed suspension preparation of a kind of 20 (S)-protopanoxadiol, another object of the present invention is to provide the preparation method of the dry mixed suspension preparation of this 20 (S)-protopanoxadiol.
The present invention is achieved through the following technical solutions:
20 (S)-protopanoxadiol dry suspension, 20 (the S)-protopanoxadiols of take are active component, the mass ratio of active component and pharmaceutic adjuvant is 1～20%: 80～99%.
Further, above-mentioned 20 (S)-protopanoxadiol dry suspension, the mass ratio of active component and pharmaceutic adjuvant is 2～10%: 90～98%.
Further, above-mentioned 20 (S)-protopanoxadiol dry suspension, the mass ratio of active component and pharmaceutic adjuvant is 3～5%: 95～97%.
Above-mentioned a kind of 20 (S)-protopanoxadiol dry suspension, pharmaceutic adjuvant comprises that mass ratio is suspending agent and the wetting agent of 5: 1; Pharmaceutic adjuvant can also comprise that mass ratio is the sweeting agent of 0-5% in addition.
20 above-mentioned (S)-protopanoxadiol dry suspension, suspending agent is one or more in Ai Wei element CL611, Ai Wei element CL591, hydroxypropyl cellulose, ethyl cellulose, methylcellulose, xanthan gum, sodium alginate, polyvinyl alcohol, PVPk-30, polyvidone k-90, carboxymethyl starch sodium; Wetting agent is one or more in PLURONICS F87, sodium lauryl sulphate, dodecyl sodium sulfate, PEG4000, CARBOPOL 974P.Sweeting agent is one or more in steviosin, saccharin sodium, xylitol, aspartame, sorbitol, acesulfame potassium.
Preferably, above-mentioned 20 (S)-protopanoxadiol dry suspension, while not adding sweeting agent, active component and pharmaceutic adjuvant proportioning are as follows:
20 (S)-protopanoxadiols 5.00%
Ai Wei element CL611 79.17%
PLURONICS F87 15.83%
Preferably, above-mentioned 20 (S)-protopanoxadiol dry suspension, while adding sweeting agent, active component and pharmaceutic adjuvant proportioning are as follows:
The preparation method of above-mentioned a kind of 20 (S)-protopanoxadiol dry suspension, is characterized in that its preparation methods steps is as follows: take recipe quantity suspending agent and wetting agent, then with 20 (S)-protopanoxadiols, or add sweeting agent, mix homogeneously.
In the present invention program, Ai Wei element CL611 is a kind of novel adjuvant, is that FMC Corp. is on sale by the physics complex of the sodium carboxymethyl cellulose of 85% microcrystalline Cellulose and 15%.
Beneficial effect of the present invention
The present invention 20 (S)-protopanoxadiol dry suspension, although active component and formulation method are all known, the present invention still has the characteristic of self.
1. before 20 (S)-protopanoxadiols being prepared into dry suspension, have no document openly, there is novelty.Meanwhile, 20 (S)-protopanoxadiols are prepared into dry suspension, there is the advantages such as drug absorption is fast, bioavailability is high, taking convenience, there is practicality.Because dry suspension of the present invention has adopted macromolecule suspending agent-Ai Wei element CL611, it has high thixotropic, and 20 (S)-protopanoxadiols are had to good suspending and dispersion effect; And PLURONICS F87 has good wetting action to 20 of slightly solubility (S)-protopanoxadiols, can reduce the surface tension of crude drug, increase the affinity of itself and water; Selected correctives-steviosin is a kind of efficient sweeting agent, and not only consumption is few, but also is applicable to diabetic to take.Therefore creative in the selection of adjuvant.
2. 20 (S)-protopanoxadiol dry suspension and preparation methoies provided by the invention, creative, concrete manifestation has:
(1) existing dry suspension patent contains relatively large diluent (excipient, filler) or a large amount of sucrose or lactose mostly in prescription, not only makes taking dose increase, and is not suitable for diabetics use; At preparation process, need to first be prepared into micropill or granule, need to be through heating, drying or the processes such as dry or fluid bed drying or film coating of spraying, technique is comparatively complicated, and cost is higher.And the present invention 20 (S)-protopanoxadiol dry suspension supplementary product consumption is less, taking dose is little; And do not contain diluent and sucrose, lactose etc., applicable diabetics is taken, preparation process does not need through processes such as heating or oven dry, and technique is simple, and production cost is low, is applicable to industrialized great production.
(2) existing dry suspension patent greatly mainly with hydroxypropyl emthylcellulose, guar gum and sodium carboxymethyl cellulose etc. as suspending agent, not only suspending effect is slow, and to insoluble drug suspending weak effect; Wetting agent mostly is distilled water, glycerol, ethanol, the propylene glycol of using in the soft material process processed of wet granulation, and the problem such as wet granulation exists that easily caking, particle drying time are long, granule is frangible and powder is more.And the wetting agent of the present invention 20 (S)-protopanoxadiol dry suspension is for medicine being had to the solid surfactant of certain solubilization, with suitable ratio, forms suspending-wetting agent with suspending agent and poorly water soluble drugs is had to good suspending and solubilizing effect later.
(3) in preparation method, because PLURONICS F87 is circular granule, thus first pulverized, and then mix with three-dimensional mixer with other adjuvant and principal agent, the medicament contg of final gained is even, and stripping is fast.
Accompanying drawing explanation
Fig. 1 suspension particle diameter
The blank intestinal perfusate of Fig. 2 HPLC chromatogram
Fig. 3 pastille intestinal perfusate HPLC chromatogram
Figure 42 0 (S)-protopanoxadiol reference substance HPLC chromatogram
The specific embodiment
Below in conjunction with specific embodiments and the drawings, further set forth the present invention.These embodiment are only interpreted as for the present invention being described rather than for limiting the scope of the invention.After having read the content of the present invention's record, those skilled in the art can make various changes or modifications the present invention, and these equivalences change and modification falls into the claims in the present invention book limited range equally.
Below in conjunction with specific embodiment, be described further, but content of the present invention is not limited to this.
Embodiment 1
Preparation method: PLURONICS F87 is pulverized and crossed after 100 mesh sieves, take PLURONICS F87 and the Ai Wei element CL611 of recipe quantity, again it is fully mixed to (67rpm, 2min) with three-dimensional mixer, pouch subpackage with 20 (S)-protopanoxadiols and steviosin.
Embodiment 2
Preparation method: take PVP K-30 and the sodium lauryl sulphate of recipe quantity, then it is fully mixed to (67rpm, 2min) with three-dimensional mixer, pouch subpackage with 20 (S)-protopanoxadiols and saccharin sodium.
Embodiment 3
Preparation method: PLURONICS F87 is pulverized and crossed after 100 mesh sieves, take PLURONICS F87 and the Ai Wei element CL611 of recipe quantity, again it is fully mixed to (67rpm, 2min) with three-dimensional mixer, pouch subpackage with 20 (S)-protopanoxadiol crude drug and xylitol.
Embodiment 4
20 (S)-protopanoxadiols 5.00%
Ai Wei element CL611 79.17%
PLURONICS F87 15.83%
Preparation method: the Ai Wei element CL611 and the PLURONICS F87 that take recipe quantity tentatively mix, then add gradually 20 (S)-protopanoxadiol crude drug mix homogeneously, pouch subpackage with equivalent incremental method.
Embodiment 5
Preparation method: 20 (S)-protopanoxadiol crude drug and the aspartames that take recipe quantity, cross 200 mesh sieves, xanthan gum and PLURONICS F87 are crossed respectively 100 mesh sieves, by 20 (S)-protopanoxadiol crude drug and aspartame, xanthan gum and PLURONICS F87, the equivalent mix homogeneously that progressively increases, pouch subpackage.
Embodiment 6
Preparation method: the sodium alginate and the PEG4000 that take recipe quantity mixed later 100 mesh sieves, then it were fully mixed to pouch subpackage with equivalent incremental method with principal agent and sorbitol
Embodiment 7
Preparation method: hydroxypropyl cellulose, CARBOPOL 974P and acesulfame potassium are crossed respectively to 100 mesh sieves, and 20 (S)-protopanoxadiol crude drug are crossed 200 mesh sieves, then after using three-dimensional mixer (100rpm, 1min) to mix, pouch subpackage.
Embodiment 8
Preparation method: the ethyl cellulose and the dodecyl sodium sulfate that take recipe quantity, both are tentatively mixed to rear 100 mesh sieves of crossing with aspartame, 20 (S)-protopanoxadiol crude drug are crossed 200 mesh sieves, again by adjuvant and three-dimensional mixer (100rpm for principal agent, 1min) after mixing, pouch subpackage.
Preparation evaluation experimental example:
One, dry suspension particle size determination
Adopt Naso-ZS90 laser particle analyzer to measure the particle size distribution in suspension, particle size distribution See Figure 1.
Adopt Naso-ZS90 laser particle analyzer to measure the particle size distribution in suspension, and 20 times of suspension dilutions are measured afterwards, recording mean diameter is 1.5 μ m.
Two, dry suspension release in vitro and evaluating in body intestinal absorption
In order to further illustrate two kinds of tablets in vitro situations containing 20 (S)-protopanoxadiol dry suspension and animal in body intestinal absorption feature, the present invention carries out the following studies embodiment 1 prescription.
The Study on Dissolution of 1 dry suspension
Get with 6 bags, batch sample, according to dissolution method (two appendix XC the second methods of < < Chinese Pharmacopoeia > > version in 2010), the 0.5% lauryl sodium sulfate aqueous solution 900mL of take is dissolution medium, rotating speed is 100rpm, medium temperature is 37.0 ℃, operation in accordance with the law, in 3,5,10,20,30, during 45min, get dissolution fluid appropriate, (supplementing equality of temperature same volume medium appropriate) with 0.45 μ m membrane filtration simultaneously, get subsequent filtrate as need testing solution, sample introduction.The dissolution of calculation sample, the results are shown in Table 1.
The dissolution rate of table 1 dry suspension
2 rats are at the unidirectional intestinal perfusion experiment of body
Dry suspension is mixed with to suspension and the emulsion that concentration is 428 μ g/ml concentration and carries out rat at the unidirectional intestinal perfusion experiment of body, concrete grammar is as follows:
With test liquid, pipe flushing is identical with test liquid concentration to liquid outlet drug level before test, with the impact of pipeline on Drug absorbability in Elimination test process.Get the rat of fasting 12h (can freely drink water), lumbar injection 20% Ethylurethanm solution anesthesia (1.0mg/g).Rat is fixed on constant operation table to keep body temperature, along ventrimeson, open abdominal cavity (the about 3cm of length), separated duodenum (length 10～15cm), with 20ml syringe (removing syringe needle), the normal saline that is preheated to 37 ℃ is rinsed well intestinal segment content, in two ends otch, insert silica gel tube, with cotton thread ligation, fix, wound is covered to moisturizing with the absorbent cotton that is soaked with normal saline.Take again that distilled water is mixed with for reagent liquid, first will be preheated to 37 ℃ of medicinal liquids and pump into fast intestinal segment (1ml/min rinses 10min), after flow velocity is down to (0.2ml/min), start to clock simultaneously, after about 30min, absorb and reach steady statue.Import department carries out perfusion with the tubule that test liquid is housed of known quality, every 15min, in exit, with another, oneself knows heavy tubule collection 1 time (simultaneously changing rapidly next test liquid tubule and collection liquid tubule) in beginning, weigh, the test liquid quality that compute pours into and collects.In exit, collect the perfusate flowing out until 120min (respectively at 45,60,75,90,105 after clocking, 120min sampling), when experiment finishes, cuts the intestinal segment of institute's perfusion, measure its length and internal diameter.Gained sample liquid and test liquid, draw in 0.5ml to 5ml volumetric flask with liquid-transfering gun, and add acetonitrile/ethanol and be settled to scale, close plug, and ultrasonic 20min,, get subsequent filtrate 20 μ L and carry out HPLC analysis, measure the concentration of 20 (S)-PPD.Adopt gravimetric method to be calculated as follows drug absorption speed constant (Ka) and medicine apparent absorption coefficient (Papp).
Ka，c＝(1-CoutQout/CinQin)·Q/V
In formula, Qin and Qout are respectively the volume (mL) that intestinal is imported and exported perfusate; Cin and Cout are respectively the mass concentration (μ g/mL) that intestinal is imported and exported perfusate; L and r are respectively by the length of perfusion intestinal segment (cm) and cross section radius (cm); Q is perfusion rate (0.2mL/min), and V is the volume of perfusion intestinal segment; Ka, c and Papp, c is the meansigma methods of (45～120min) sample of last 6 time periods.Fig. 2,3,4 is shown in by specificity collection of illustrative plates.Intestinal absorption the results are shown in Table 2.
The situation in body intestinal absorption of table 2 dry suspension (n=3)
Above-mentioned data show: dry suspension medicine in 45min can reach more than 95% and discharge, and all has good absorption at the full intestinal segment of rat.
Claims (7)
1. 20 (S)-protopanoxadiol dry suspension, 20 (the S)-protopanoxadiols of take are active component, it is characterized in that, the mass ratio of active component and pharmaceutic adjuvant is 1～20%:80～99%; Suspending agent and wetting agent that pharmaceutic adjuvant is 5:1 by mass ratio form;
Suspending agent is one or more in Ai Wei element CL611, Ai Wei element CL591, hydroxypropyl cellulose, ethyl cellulose, methylcellulose, xanthan gum, sodium alginate, polyvinyl alcohol, PVPk-30, polyvidone k-90, carboxymethyl starch sodium; Wetting agent is one or more in PLURONICS F87, sodium lauryl sulphate, dodecyl sodium sulfate, PEG4000, CARBOPOL 974P;
The preparation method of described 20 (S)-protopanoxadiol dry suspension is as follows: take recipe quantity suspending agent and wetting agent, then with 20 (S)-protopanoxadiols, evenly mix.
2. a kind of 20 (S)-protopanoxadiol dry suspension according to claim 1, is characterized in that, the mass ratio of active component and pharmaceutic adjuvant is 2～10%:90～98%.
3. a kind of 20 (S)-protopanoxadiol dry suspension according to claim 2, is characterized in that, the mass ratio of active component and pharmaceutic adjuvant is 3～5%:95～97%.
4. 20 (S)-protopanoxadiol dry suspension, 20 (the S)-protopanoxadiols of take are active component, it is characterized in that, the mass ratio of active component and pharmaceutic adjuvant is 1～20%:80～99%; The suspending agent that pharmaceutic adjuvant is 5:1 by mass ratio and wetting agent and account for total mass ratio and be less than 5% sweeting agent and form;
Suspending agent is one or more in Ai Wei element CL611, Ai Wei element CL591, hydroxypropyl cellulose, ethyl cellulose, methylcellulose, xanthan gum, sodium alginate, polyvinyl alcohol, PVPk-30, polyvidone k-90, carboxymethyl starch sodium; Wetting agent is one or more in PLURONICS F87, sodium lauryl sulphate, dodecyl sodium sulfate, PEG4000, CARBOPOL 974P;
The preparation method of described 20 (S)-protopanoxadiol dry suspension is as follows: take recipe quantity suspending agent and wetting agent, then with 20 (S)-protopanoxadiols, add sweeting agent, evenly mix.
5. 20 (S)-protopanoxadiol dry suspension according to claim 4, is characterized in that, sweeting agent is one or more in steviosin, saccharin sodium, xylitol, aspartame, sorbitol, acesulfame potassium.
6. according to 20 (S)-protopanoxadiol dry suspension described in claim 1 or 2 or 3, it is characterized in that, active component and pharmaceutic adjuvant proportioning are as follows:
20 (S)-protopanoxadiols 5.00%
Ai Wei element CL611 79.17%
PLURONICS F87 15.83%.
7. according to 20 described in claim 4 or 5 (S)-protopanoxadiol dry suspension, it is characterized in that, active component and pharmaceutic adjuvant proportioning are as follows:
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