CN102631395A - Rape pollen dispersible tablet for treating prostatitis and preparation method of rape pollen dispersible tablet - Google Patents
Rape pollen dispersible tablet for treating prostatitis and preparation method of rape pollen dispersible tablet Download PDFInfo
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- CN102631395A CN102631395A CN2012101522245A CN201210152224A CN102631395A CN 102631395 A CN102631395 A CN 102631395A CN 2012101522245 A CN2012101522245 A CN 2012101522245A CN 201210152224 A CN201210152224 A CN 201210152224A CN 102631395 A CN102631395 A CN 102631395A
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Abstract
The invention provides a conprata pulean dispersible tablet for treating acute and chronic prostatitis and benign prostatic hyperplasia, and a preparation method of the conprata pulean dispersible tablet and belongs to the field of medicines, food and health care products. The preparation method comprises the following steps of: smashing and sieving rape pollen or rape bee pollen, adding sieved disintegrating agent in the sieved rape pollen or rape bee pollen, uniformly mixing and sieving the pollen and the disintegrating agent, adding adhesive in the mixture, performing granulation, low-temperature drying and tabletting on the mixture, and coating the mixture to obtain the conprata pulean dispersible tablet after the mixture passes inspection. The conprata pulean dispersible tablet is simple in preparation technology, controllable in quality, low in cost and applicable to industrial production, the content of active ingredients of an extract is high, and the conprata pulean dispersible tablet is convenient to take and has the effect of treating the acute and chronic prostatitis and the benign prostatic hyperplasia.
Description
Technical field
The invention belongs to medicine, food, field of health care products, be specifically related to general Lean dispersible tablet of processing with Pollen Brassicae campestris and preparation method thereof.
Background technology
Existing patent report paracetamol has QI invigorating and consolidates effect.Be used for instability of kidney QI, soreness of the waist and knees, dribble of urine or incontinence, acute and chronic prostatitis, prostatic hyperplasia (CN200510032110.7).Adopted oral liquid formulation in this patent application.Chinese patent CN01100786.9 processes nanometer paracetamol medicine with Pollen Brassicae campestris.With the nanometer rape flower is raw material, and steps such as microwave extracting, concentrating under reduced pressure, supersonic jet technology spray drying are adopted in preparation in proportion, process new pharmaceutical preparation.
In addition, the report of Pollen Brassicae campestris being processed paracetamol is more, reports like Chinese patent CN101543521; The Pollen Brassicae campestris capsule 's content is made up of Pollen Brassicae campestris extract and adjuvant, and its preparation method is for to pour medicinal liquid in the encapsulating machine into, pelleting; Typing; Clean soft gelatin capsule, put the hothouse drying, promptly get.Chinese patent CN102106497A report: the present invention adopts the mixture of Pollen Brassicae campestris, soybean phospholipid, Radix Angelicae Sinensis extract, Lac regis apis lyophilized powder, tea polyphenols, vitamin, soft plantation white sugar and microcrystalline Cellulose; Through pulverizing, sieving, mix with soft plantation white sugar, process soft material; Granulate then, dry, process granule through granulate again; Mix with magnesium stearate at last, make the tablet of various different types, adopt damp-prrof packing promptly to get through the tablet machine tabletting.
In sum, the Pollen Brassicae campestris preparation formulation of patent report is less, and cost is high, and dissolution time is long, is unsuitable for application.Up to now, domestic do not see as yet any about adopting general Lean to disperse
Summary of the invention
The present invention provides a kind of general Lean dispersible tablet that is used to treat prostatosis and preparation method thereof, and Pollen Brassicae campestris is difficult for absorbing in vivo in the prior art to solve, and technological obsolescence, is unsuitable for the problem of use.After changing dosage form, general Lean dispersible tablet dissolution time shifts to an earlier date, and dissolution is good.The technical scheme that the present invention takes is:
(1) Pollen Brassicae campestris or Brassica campestris L pollen are pulverized, sieved.
(2) get Pollen Brassicae campestris or Brassica campestris L pollen after sieving, add the disintegrating agent that sieves equally, mixing sieves, and adds binding agent, granulate, cold drying, tabletting.
(3) coating; Through after the assay was approved, get general Lean dispersible tablet.
After Pollen Brassicae campestris described in the present invention comprised the Pollen Brassicae campestris of pulverizing through common pulverizer and process nano-pulverization, particle diameter was nano level Pollen Brassicae campestris.
Disintegrating agent PVPP described in the present invention, L-HPC, MCC, carboxymethyl starch sodium, polyethylene glycol 6000 one or both or two or more mixture wherein wherein preferentially selected PVPP, MCC.
Disintegrating agent adding method described in the present invention comprise interior addition, outer addition and in add a kind of in the combined techniques, add combined techniques in wherein preferential the selection.
Binding agent described in the present invention is selected from wherein a kind of of 10%～90% alcoholic solution and 1～50%PVP alcoholic solution, wherein preferentially selects 1～50%PVP alcoholic solution.
An important feature of the present invention is, change original ordinary tablet into dispersible tablet after, solve that Pollen Brassicae campestris is difficult for absorbing in vivo in the prior art, and technological obsolescence, be unsuitable for the problem of use.After changing dosage form, general Lean dispersible tablet dissolution time shifts to an earlier date, and dissolution is good.Be prone to absorb in vivo, rapid-action, easy operating and quality control, and taking convenience meet patient's demand.
Obviously, according to foregoing of the present invention,, under the precursor that does not break away from the above-mentioned basic fundamental thought of the present invention, can also make modification, replacement or the change of other various ways according to the ordinary skill knowledge and the customary means of this area.
Below, foregoing of the present invention is remake further detailed description through instantiation.But should this be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following instance, all technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1: the preparation of general Lean dispersible tablet
Get Brassica campestris L pollen 25g, pulverizer is pulverized the back and is crossed sieve No. 2.Getting each 12.5g of microcrystalline Cellulose and crospolyvinylpyrrolidone is the associating disintegrating agent, mixes crushing screening.With 25g Brassica campestris L pollen and the common granulate of 12.5g associating disintegrating agent, 40 ℃ of cold drying in the baking oven add 12.5g associating disintegrating agent, mixing, tabletting after the taking-up with the 10%PVP alcoholic solution.
Embodiment 2: the preparation of general Lean dispersible tablet
Get Brassica campestris L pollen 25g, pulverizer is pulverized the back and is crossed sieve No. 2.Getting each 12.5g of microcrystalline Cellulose and crospolyvinylpyrrolidone is the associating disintegrating agent, mixes crushing screening.With 25g Brassica campestris L pollen and the common granulate of 12.5g associating disintegrating agent, 40 ℃ of cold drying in the baking oven add associating disintegrating agent 12.5g, mixing, tabletting with the 10%PVP alcoholic solution.
Embodiment 3: the preparation of general Lean dispersible tablet
Get Brassica campestris L pollen 25g, cross sieve behind the nano-pulverization No. 2.Taking polyethylene glycol 6000 is the associating disintegrating agent with each 12.5g of crospolyvinylpyrrolidone, mixes crushing screening.With 10%PVP alcoholic solution granulate, 40 ℃ of cold drying in the baking oven add 25g associating disintegrating agent, mixing, tabletting.
Embodiment 4: the preparation of general Lean dispersible tablet
Get Brassica campestris L pollen 25g, pulverizer is pulverized the back and is crossed sieve No. 2.Getting each 12.5g of carboxymethyl starch sodium and L-HPC is the associating disintegrating agent, mixes crushing screening.With the 10%PVP alcoholic solution 25g Brassica campestris L pollen and 25g are united the common granulate of disintegrating agent, 40 ℃ of cold drying in the baking oven, tabletting.
Embodiment 5: the preparation of general Lean dispersible tablet
Get Brassica campestris L pollen 25g, pulverizer is pulverized the back and is crossed sieve No. 2.Taking polyethylene glycol 6000 is the associating disintegrating agent with each 12.5g of L-HPC, mixes crushing screening.With 25g Brassica campestris L pollen and the common granulate of 12.5g associating disintegrating agent, 40 ℃ of cold drying in the baking oven add associating disintegrating agent 12.5g, mixing, tabletting with the 10%PVP alcoholic solution.
Embodiment 6: pharmacodynamic experiment
100 of laboratory animal Male Kunming strain mice, body weight 24g～26g.The animal sub-cage rearing, the feed of freely drinking water, standard feed is fed.100 mices are divided into normal control group, model group at random, 5 groups of the ball group of being open to the custom paracetamol groups, general Lean dispersible tablet group, 20 every group.Normal control group, model group give normal saline and irritate stomach, and the ball group of being open to the custom is given the ball decocting liquid 10g/kg that is open to the custom and irritated stomach, and paracetamol group and general Lean dispersible tablet group are given general Lean suspension 1.9g/kg and irritated stomach, every day 1 time, 31d altogether.
To experiment mice prostata tissue pathological change influence the prostata tissue sample with 10% formaldehyde fixed, dehydration, embedding, section, HE dyeing, mirror is observed down.
Statistical method: handle with SAS software one factor analysis of variance, the measurement data data are with (x ± sd) expression.
One, to experiment mice prostate weight in wet base and exponential influence
To experiment mice prostate weight in wet base and exponentially put to death mice after influencing last administration 24h, cut open and get the mice prostate and weigh, calculate the prostate index.
The result sees table 1.
Table 1 pair mice prostate weight in wet base and exponential influence (x ± sd)
Annotate: compare P＜0.01 with model group
Can find out by table 1, compare that the ball group of being open to the custom, general Lean group, general Lean dispersible tablet group mice prostate weight in wet base and index obviously reduce (P＜0.01) with model group, but three's comparing difference not statistically significant.
Two, to the influence of experiment mice caused by dimethylbenzene xylene auricular concha inflammation
Behind the last administration 1h, ear melted paraxylene 0.05mL causes inflammation on a mice left side.Behind the 30min, cut two ears, take by weighing ears symmetry place auricle weight, calculate swelling degree and inhibitory rate of intumesce.
Mice auricular concha swelling degree: the normal control group is (16.8 ± 2.58) mg, and model group is (16.53 ± 2.78) mg, and the ball group of being open to the custom is (13.55 ± 3.87) mg, and general Lean group is (10.18 ± 2.54) mg, and general Lean dispersible tablet group is (10.18 ± 2.44) mg.Inhibitory rate of intumesce: the ball group of being open to the custom is 17.42%, and the paracetamol group is 38.31%, and general Lean dispersible tablet group is 38.31%.Compare with model group, general Lean dispersible tablet group caused by dimethylbenzene xylene auricular concha swelling degree obviously reduces (P＜0.01).
Three, Dichlorodiphenyl Acetate causes the influence of experiment mice writhing response
Dichlorodiphenyl Acetate cause the experiment mice writhing response influence last administration 30min after, lumbar injection 0.7% acetic acid 0.01mL/g, that observes 10min, each Mus of 20min turns round the body number of times, calculates the writhing response suppression ratio.
The result sees table 2.
Table 2 Dichlorodiphenyl Acetate causes the influence (x ± sd) of experiment mice writhing response
Annotate: compare * P＜0.01 with model group
Can find out by table 2, compare that general Lean dispersible tablet group mouse writhing reaction times obviously reduces (P＜0.01) with model group.
Four, to the influence of experiment mice blood-serum P ACP vigor and T level
To experiment mice blood-serum P ACP and T influence last administration 24h after, postcava is got blood, separation of serum according to test kit description operation, is measured vigor and the serum T level of blood-serum P ACP.
The result sees table 3.
The influence of table 3 pair experiment mice blood-serum P ACP vigor and T level (x ± sd)
Annotate: compare * P＜0.05, * * P＜0.01 with model group
Can find out by table 3, compare that the ball group of being open to the custom, general Lean group, general Lean dispersible tablet group blood-serum P ACP vigor and T level obviously reduce (P＜0.01, P＜0.05) with model group, but the two comparing difference not statistically significant.
Five, to the influence of experiment mice prostata tissue pathological change
The prostatic body of gland size of control group mice is relatively more consistent, and queueing discipline, and most glandular epitheliums are high columnar arrangement, and nucleus is positioned at basilar part, marshalling.No obvious secretions in the lumen of gland has the monolayer smooth muscle cell to hold on every side.Not of uniform size the causing of model group mice prostate body of gland arranged irregularly, and part enlarges and to be cryptomere, and glandular epithelium is low columnar arrangement more, and level is by 1 layer of hypertrophy to 3 layer～4 layers.Part glandular epithelium hypertrophy is mamillary, to the intracavity projection, red secretions is arranged in the lumen of gland, matter smooth muscle cell and proliferation of fibrous tissue between prostate, be of five storeys outside the chamber～8 layers of smooth muscle cell hold.General Lean group alleviates with the ball group mice prostate glandular hyperplasia of being open to the custom, and proliferation of smooth muscle also has more obviously improvement outside interstitial edema and the chamber.
Claims (7)
1. general Lean dispersible tablet that is used to treat acute and chronic prostatitis, prostatic hyperplasia; It is characterized in that to meet the dispersible tablet that the rapid disintegrate of water forms even stickiness suspension by what obtain behind the Pollen Brassicae campestris behind the crushing screening and the common granulate of disintegrating agent, the tabletting; Have rapid-action, absorbefacient characteristics.
2. according to claim 1ly be used to treat prostatitic general Lean dispersible tablet, it is characterized in that: the Pollen Brassicae campestris crushing technology comprises that common pulverizer is pulverized with nanorize and pulverizes.
3. according to claim 2ly be used to treat prostatitic general Lean dispersible tablet, it is characterized in that: disintegrating agent is selected from PVPP, L-HPC, MCC, CMC-NA, polyethylene glycol 6000 one or both or two or more mixture wherein.
4. according to claim 3ly be used to treat prostatitic general Lean dispersible tablet, it is characterized in that: disintegrating agent adding method comprise interior addition, outer addition and in add a kind of in the combined techniques, add combined techniques in wherein preferential the selection.
5. according to claim 4ly be used to treat prostatitic general Lean dispersible tablet, it is characterized in that: binding agent is selected from wherein a kind of of 10%～90% alcoholic solution and 1～50%PVP alcoholic solution, wherein preferentially selects 1～50%PVP alcoholic solution.
6. according to claims 5 said dosage forms, it is characterized in that being made into dispersible tablet, the method for preparing of dispersible tablet is following:
Pollen Brassicae campestris or Brassica campestris L pollen are pulverized, sieved.Get Pollen Brassicae campestris or Brassica campestris L pollen after sieving, add the disintegrating agent that sieves equally, mixing sieves, and adds binding agent, granulate, cold drying, tabletting.
7. method of quality control that is used to treat prostatitic general Lean dispersible tablet comprises:
[character] these article are Film coated tablets, remove coating after, displaing yellow or pale brown color; It is sweet, little puckery to distinguish the flavor of.
These article are got in [discriminating] (1), and put microscopically and observe: pollen grain is spherical in shape or subsphaeroidal, and polar view is for splitting circle, diameter 30～35 μ m; Three germinal furrows of tool, no endoporus, the about 1.5 μ m of outer wall thickness, skin is thicker; The pilum end expands slightly, causes the spherical profile undulate, the netted decorative pattern of surperficial tool; Mesh is tiny, and is irregular, is fuzzy graininess on murus and the furrow membrane.
(2) get these article, remove coating, porphyrize is got powder 5g, adds ethanol 5ml, puts and soaks 10 minutes in the tepidarium, filters, and filtrating is shone following method test:
1. get filtrating and drip on filter paper, dried slightly, filter paper behind ammonia cure, is shown the glassy yellow speckle.
2. get filtrating and drip on filter paper, dried slightly, spray is with 1% aluminum chloride alcoholic solution, and after the drying, the displaing yellow speckle is put under the ultra-violet lamp (365nm) and inspected, and shows yellow-green fluorescence.
[assay] measured according to HPLC (appendix V I D).
Chromatographic condition and system suitability test are filler with the octadecyl silane; With methanol: 0.4% phosphoric acid (52: 48) is mobile phase; Flow velocity 1mLmin
-1Detect wavelength 360nm; 25 ℃ of column temperatures.Theoretical cam curve is calculated by kaempferol and is not less than 2500.
The preparation precision of reference substance solution takes by weighing kaempferol reference substance 6.50mg, places the brown volumetric flask of 25ml, adds dissolve with methanol and is diluted to scale.Shake up, the reference substance of configuration c=260 μ g/ml, both.
10 of general Lean dispersible tablets are got in the preparation of need testing solution, pulverize.Take by weighing mixed powder 1g, put in the 250ml round-bottomed flask.Add 25% hydrochloric acid: the solution 40ml of methanol=process at 1: 6, put on the water-bath, 80 ℃ of water-bath reflux, extract, 1h are cooled to room temperature rapidly.Add methanol constant volume to the 50ml volumetric flask, shake up, microporous filter membrane (0.45 μ m) filters, and gets subsequent filtrate, both.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, and promptly get.
The total amount that contains kaempferol in every of these article must not be less than 0.3019mg.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012101522245A CN102631395A (en) | 2012-05-17 | 2012-05-17 | Rape pollen dispersible tablet for treating prostatitis and preparation method of rape pollen dispersible tablet |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012101522245A CN102631395A (en) | 2012-05-17 | 2012-05-17 | Rape pollen dispersible tablet for treating prostatitis and preparation method of rape pollen dispersible tablet |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106822091A (en) * | 2017-02-14 | 2017-06-13 | 天津中医药大学 | Purposes of the Kaempferol in preparing for preventing and/or treating the medicine by the too high disease for causing of testosterone levels |
| CN110651980A (en) * | 2019-10-08 | 2020-01-07 | 山西农业大学 | Peony pollen buccal tablet and preparation process thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733003A (en) * | 2005-08-31 | 2006-02-15 | 郭凌云 | Oral liquor with pollen and preparation method thereof |
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2012
- 2012-05-17 CN CN2012101522245A patent/CN102631395A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733003A (en) * | 2005-08-31 | 2006-02-15 | 郭凌云 | Oral liquor with pollen and preparation method thereof |
Non-Patent Citations (4)
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| 《***颁中药标准 第14册》 19971231 国家药典委员会 普乐安片 , * |
| 国家药典委员会: "《***颁中药标准 第14册》", 31 December 1997 * |
| 杨锡等: "普乐安胶囊质量标准研究", 《中国药事》 * |
| 阮征等: "HPLC法测定油菜蜂花粉中黄酮含量及六种破壁方法对黄酮提取的影响", 《食品科学》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106822091A (en) * | 2017-02-14 | 2017-06-13 | 天津中医药大学 | Purposes of the Kaempferol in preparing for preventing and/or treating the medicine by the too high disease for causing of testosterone levels |
| CN110651980A (en) * | 2019-10-08 | 2020-01-07 | 山西农业大学 | Peony pollen buccal tablet and preparation process thereof |
| CN110651980B (en) * | 2019-10-08 | 2023-05-16 | 山西农业大学 | Peony pollen buccal tablet and preparation process thereof |
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Application publication date: 20120815 |