A kind of preparation method of testis sheet
Technical field
The present invention relates to the preparation method of testis sheet, belong to medical technical field.
Technical background
Testis sheet is to be prepared from through special processing by the unmetamorphosed fresh or freezing cattle of health, Testis Caprae seu Ovis, and contained protein must not be less than 53.0% of labelled amount in testis powder requirement.Be used for the treatment of the diseases such as neurasthenia, hypoevolutism, male menopause obstacle.
Mainly contain in the market testis coated tablet, two kinds of preparations of testis Film coated tablets.
Its preparation method is as follows:
Get fresh cattle, Testis Caprae seu Ovis and clean, remove connective tissue, decoct with water 6 hours, by ripe testis shave, decocting liquid is abandoned it while hot, obtains ripe testis sheet; 80 ℃ of ripe testis sheets are dried to dry testis sheet, dry testis sheet are put to Universalpulverizer and be ground into fine powder, obtain testis powder, censorship content; According to testis powder content add appropriate amount of starch, dextrin (2 parts of starch, 1 part of dextrin) is mixed to get and is dry mixed powder; Using 10% hydroxypropyl methylcellulose aqueous solution as binding agent, be dry mixed powder and add suitable amount of adhesive and make suitable soft material, granulate, after granulate, granule and 1% magnesium stearate are always mixed, are dried tabletting, coating and get final product.
Testis sheet has abnormal smells from the patient raw meat, characteristic that oiliness is strong, and plain sheet is through after sugar coating, can cover bad in tablet and smells taste and reduce medicine irritation, makes patient acceptant and conveniently take.Because testis powder raw material oiliness is strong, and shared prescription ratio is large, causes producing aborning problems: sliver, sticking, hardness is low, outward appearance is rough, at storage period, occur the phenomenon that oil impregnate is revealed the exact details, and then affects product quality.
The invention provides the new preparation method of a kind of testis sheet, testis powder preparation technology adopts decoction, steams thoroughly, the traditional handicraft of oven dry, backflow oil removing, drying and crushing, the survivable effective ingredient of the method, can greatly improve drug effect, improve testis tablet stability, effectively solve sticking, sliver, hardness is low, product there will not be oil impregnate to reveal the exact details at storage period problem.
Summary of the invention
The invention provides a kind of preparation method of testis sheet, the method comprises fresh cattle, Testis Caprae seu Ovis is processed into testis powder, is further mixed with into testis sheet with medicine acceptable carrier.
Testis powder of the present invention is that raw material adds oil absorbent to make by fresh cattle, Testis Caprae seu Ovis, and wherein, the percentage by weight of fresh cattle, Testis Caprae seu Ovis is 92%, and the percentage by weight of oil absorbent is 8%.
Wherein said oil absorbent is selected from: micropowder silica gel
Testis sheet of the present invention, described medicine acceptable carrier is selected from: filler, disintegrating agent, lubricant, fluidizer.
Testis powder of the present invention, preparation method is as follows:
Get fresh cattle, Testis Caprae seu Ovis and clean, decoct with water 2 times, the 1st time 4 hours, collect decocting liquid, the white grease in surface is removed after cooling; The 2nd time 3 hours, collect decocting liquid, the white floating thing in surface is removed after cooling, merge 2 times decocting liquid; Collecting decoction is concentrated into proportion 1.22-1.25(80 ℃ survey), add the micropowder silica gel of thick paste amount 20%, 80 ℃ of oven dry, obtain the dry cream of testis standby; Ripe testis is thinly sliced with medicine cutter while hot, and 100 ℃ of oven dry, obtain dry testis; The micropowder silica gel and the dry cream of testis that add dry testis amount 8%, mix together, is ground into fine powder, obtains testis powder.
Or
Get fresh cattle, Testis Caprae seu Ovis and clean, by its Steam by water bath thoroughly after, with medicine cutter, thinly slice while hot, 100 ℃ of oven dry, obtain dry testis; Dry testis is added to 2 times of amount alcohol reflux 2 hours, and backflow is removed, and testis is dried, and adds the micropowder silica gel of dry testis amount 8%, mixes, and is ground into fine powder, obtains testis powder.
The preparation method of testis sheet of the present invention is as follows:
Above-mentioned testis powder and medicine acceptable carrier mix, with 70% ethanol as binding agent soft material processed; By soft material, further make wet granular; By granule granulate, add lubricant and mix, tabletting, as required can coating.
Medicine acceptable carrier of the present invention, preferably following material:
Carboxymethyl starch is received, cross-linked pvp, cross-linking sodium carboxymethyl cellulose, hyprolose.
Starch, dextrin, pregelatinized Starch, microcrystalline Cellulose, sucrose.
Semen Maydis gastral cavity, arabic gum, polyvinyl alcohol.
Magnesium stearate, Pulvis Talci.
Below data declaration beneficial effect of the present invention by experiment:
Experiment one, stability experiment
After testis sheet plate dress prepared by the embodiment of the present invention 1 method, accelerate experiment, accelerate 6 months, do not occur the phenomenon that oil impregnate is revealed the exact details, the result of detection is as follows:
Test item |
0 month |
January |
February |
March |
June |
Disintegration (minute) |
22 |
26 |
28 |
30 |
35 |
Differentiate |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
Protein labelled amount (%) |
61.0 |
60.6 |
61.2 |
60.1 |
60.8 |
Coated tablet outward appearance |
Up to specification |
Up to specification |
Up to specification |
Up to specification |
Up to specification |
After testis sheet plate dress prepared by the embodiment of the present invention 2 methods, accelerate experiment, accelerate 6 months, do not occur the phenomenon that oil impregnate is revealed the exact details, the result of detection is as follows:
Test item |
0 month |
January |
February |
March |
June |
Disintegration (minute) |
25 |
27 |
31 |
34 |
37 |
Differentiate |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
Protein labelled amount (%) |
62.0 |
61.8 |
61.2 |
60.8 |
60.5 |
Coated tablet outward appearance |
Up to specification |
Up to specification |
Up to specification |
Up to specification |
Up to specification |
After the testis sheet plate dress that uses prior art to prepare, accelerate experiment, accelerate 6 months, occur phenomenon and the defective problem of disintegrate that oil impregnate is revealed the exact details, the result of detection is as follows:
Test item |
0 month |
January |
February |
March |
June |
Disintegration (minute) |
35 |
48 |
50 |
55 |
65 |
Differentiate |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
All up to specification |
Protein labelled amount (%) |
61.0 |
60.6 |
61.2 |
60.1 |
60.6 |
Coated tablet outward appearance |
Up to specification |
Up to specification |
Up to specification |
A little is revealed the exact details |
Major part is revealed the exact details |
Experiment two, tabletting experiment
? |
Sticking |
Outward appearance |
Average hardness |
Disintegrate |
Prior art sample one |
Sticking |
A little sliver |
3.2kg |
36min |
Prior art sample two |
Sticking |
A little sliver |
3.5kg |
35min |
The embodiment of the present invention 1 method |
Sticking not |
Qualified |
5kg |
25min |
The embodiment of the present invention 2 methods |
Sticking not |
Qualified |
5.6kg |
28min |
In sum, preparation method one, two advantages of testis sheet of the present invention are as follows:
1, effectively solve sticking, the rough phenomenon of outward appearance, improve the quality of products and one-pass finished rate;
2, effectively improve plain sheet hardness, and reduce coating time and operation, be convenient to coating;
3, effectively solve and in product storage, occur the problem that oil impregnate is revealed the exact details.
The specific embodiment
Embodiment 1
Testis powder preparation technology
Fresh cattle, Testis Caprae seu Ovis: 5000g micropowder silica gel: 65g
Get fresh sheep, bull testis and clean, decoct with water 2 times, add for the first time 20 times of water gagings and decoct 4 hours, collect decocting liquid; Add for the second time 20 times of water gagings and decoct 3 hours, merge 2 times decocting liquid, be concentrated into proportion 1.25(80 ℃ survey), obtain thick paste 829g, dress pallet is put 80 ℃ of oven dry of baking oven, obtains the dry cream 448g of testis standby; Ripe testis is thinly sliced with medicine cutter while hot, and 100 ℃ of oven dry obtain dry testis 810g; Add the dry cream of above-mentioned testis and micropowder silica gel (dry testis amount 8%) to mix together, be ground into fine powder, obtain testis powder 1283g, chieftain 40g abandons it, testis powder pack, and sealing is preserved.
Moulding process
Preparation prescription
Remarks: testis powder content is 62.7%, theory feeds intake, and to indicate percentage composition be 62.1% to protein.
1, get testis powder, carboxymethyl starch sodium and pour trough type mixing machine into and add a cover and stir 15min, must be dry mixed powder;
2,70% ethanol is slowly poured into and is dry mixed powder, wet mixing 7-8min, makes suitable soft material;
3, soft material is put to oscillating granulator and crossed 18 eye mesh screens, make wet granular; Filled stainless steel disc and put 70 ℃ of constant temperature ovens and be dried to moisture 5-6%, obtained dry granule;
4, granule is put to oscillating granulator and crossed after 18 eye mesh screen granulate, pour granule, magnesium stearate into trough type mixing machine and add a cover stirring 5min, obtain granule, pack stand-by;
5, tabletting punch die is No. 9 deep-draws, and specification is 0.26g/s;
6, coating: first use 10% Semen Maydis gastral cavity alcoholic solution by plain sheet bag layer 2-4, then carry out sugar coating.
Embodiment 2
Testis powder preparation technology
Fresh cattle, Testis Caprae seu Ovis: 5000g ethanol: 2940g micropowder silica gel: 93g
Get fresh sheep, bull testis and clean, by its Steam by water bath thoroughly after, with medicine cutter, thinly slice while hot 100 ℃ of oven dry, must do testis 1468g, add 2 times of amount alcohol reflux 2 times, each 1 hour, gained backflow was abandoned it, take out the testis after refluxing, 100 ℃ of oven dry, obtain dry testis 1165g; The micropowder silica gel that adds dry testis amount 8%, mixes, and is ground into fine powder, obtains testis powder 1138g, and chieftain 124g abandons it, testis powder pack, and sealing is preserved.
Moulding process
Preparation prescription
Remarks: testis powder content is 64.8%, theory feeds intake, and to indicate percentage composition be 63.5% to protein.
1, get testis powder, carboxymethyl starch sodium, microcrystalline Cellulose, micropowder silica gel and pour trough type mixing machine into and add a cover and stir 15min, must be dry mixed powder;
2,70% ethanol is slowly poured into and is dry mixed powder, wet mixing 7-8min, makes suitable soft material;
3, soft material is put to oscillating granulator and crossed 18 eye mesh screens, make wet granular; Filled stainless steel disc and put 70 ℃ of constant temperature ovens and be dried to moisture 5-6%, obtained dry granule;
4, granule is put to oscillating granulator and crossed after 18 eye mesh screen granulate, successively granule, carboxymethyl starch sodium, micropowder silica gel, magnesium stearate are poured into trough type mixing machine and added a cover stirring 5min, obtain granule, pack stand-by;
5, tabletting punch die is No. 9 deep-draws, and specification is 0.26g/s;
6, coating: sugar coating.