CN112516172A - Preparation method of testis tablet - Google Patents
Preparation method of testis tablet Download PDFInfo
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- CN112516172A CN112516172A CN202011449962.7A CN202011449962A CN112516172A CN 112516172 A CN112516172 A CN 112516172A CN 202011449962 A CN202011449962 A CN 202011449962A CN 112516172 A CN112516172 A CN 112516172A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/48—Reproductive organs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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Abstract
The invention relates to a preparation method of testis tablets, which takes testis powder as an active ingredient, wherein the testis powder is prepared by the following steps of 1) cleaning fresh sheep and cattle testis, steaming the testis on a sieve for 1.5 hours, 2) drying the testis in an oven at 80 ℃, powdering and sieving with a 40-mesh sieve to obtain the testis powder.
Description
Technical Field
The invention relates to preparation of a traditional Chinese medicine preparation, in particular to a preparation method of a testicle tablet, belonging to the technical field of medicines.
Technical Field
The testis tablet is prepared from fresh or frozen testis bovis seu Bubali and sheep, and contains protein not less than 53.0% of the labeled amount. Can be used for treating neurasthenia, hypoevolutism, and male climacteric disorder.
At present, two preparations, namely a testis sugar-coated tablet and a testis film-coated tablet, are mainly available on the market.
The existing preparation method comprises the following steps:
cleaning fresh testis bovis Seu Bubali and testis Caprae Seu Ovis, removing connective tissue, decocting in water for 6 hr, slicing the mature testis while hot, and removing the decoction to obtain mature testis pill; drying the cooked testis slices at 80 deg.C to obtain dried testis slices, pulverizing the dried testis slices into fine powder with universal pulverizer to obtain testis powder, and detecting content; adding a proper amount of starch and dextrin (2 parts of starch and 1 part of dextrin) according to the content of the testis powder, and mixing to obtain dry mixed powder; taking 10% hydroxypropyl methylcellulose water solution as binder, adding appropriate amount of binder into dry powder to obtain soft material, granulating, mixing with 1% magnesium stearate, drying, tabletting, and coating.
According to the existing preparation method, the obtained testis powder sometimes appears in the tabletting process: the problems of splintering, sticking, low hardness, unsmooth appearance and oil penetration during storage are related to the preparation method of testis powder.
The invention provides a new preparation method of testis tablet, the preparation process of testis powder adopts the process of steaming, drying and crushing, the method is not easy to destroy the effective components, can greatly improve the drug effect, improve the stability of testis tablet, and can effectively solve the quality problems of sticking, cracking, low hardness and oil penetration during the storage period of the product.
Disclosure of Invention
The invention provides a preparation method of testis tablets, which comprises processing fresh testis of cattle and sheep into testis powder,
further mixing with pharmaceutically acceptable carrier to make into testis tablet.
The invention provides a preparation method of testis powder, which comprises the following steps:
1) cleaning fresh testis of sheep and cattle, steaming testis on a sieve for 1.5 hr,
2) drying in a drying oven at 80 ℃, powdering and sieving with a 40-mesh sieve to obtain testis powder;
the testis powder obtained by the method is further mixed with a pharmaceutically acceptable carrier, and 70% ethanol is used as an adhesive to prepare a soft material; preparing particles; granulating, adding a lubricant, mixing uniformly, tabletting and coating to obtain the testicle tablet.
Wherein, the pharmaceutically acceptable carrier is selected from: filler, oil absorbent, disintegrant, lubricant, glidant. Wherein the oil absorbing agent is selected from: the silica is further selected from: one or more of sodium carboxymethyl starch, PVPK30, microcrystalline cellulose, sucrose, corn grit, silicon dioxide, magnesium stearate and talcum powder.
The invention further researches the preparation method of the tablet, and the research results are as follows:
the preparation method of the testis tablet of the invention is as follows: mixing the testis powder with pharmaceutically acceptable carrier, and making soft material with 70% ethanol, 6% Pvpk 3060% ethanol solution as adhesive; further preparing the soft material into wet particles; granulating, adding lubricant, mixing, tabletting, and coating as required. The formula is designed with five schemes:
| scheme(s) | Scheme one | Scheme two | Scheme three | Scheme four | Scheme five |
| Testis powder | 270 | 270 | 270 | 270 | 270 |
| Microcrystalline cellulose | / | 26 | / | / | / |
| Sodium carboxymethyl starch | / | 28 | / | / | 15 |
| Silicon dioxide | 73.2 | 10 | 58 | 42 | 51 |
| 70% ethanol | / | 150 | / | / | / |
| 6% Pvpk 3060% ethanol solution | / | 45 | / | / | / |
| Magnesium stearate | / | 1.7 (addition) | / | / | / |
| Silicon dioxide | / | 3.5 (addition) | / | / | / |
| Sodium carboxymethyl starch | / | 10.5 (addition) | / | 28 | / |
| 3% sodium alginate | / | / | 10.8 | 10.8 | / |
| 3% xanthan gum | 7.29 | / | / | / | 19 |
| Trial production amount | 350g | 350g | 350 | 350 | 350 |
The following experimental data illustrate the beneficial effects of the present invention:
the testis tablets prepared by the tetragonal method have the disintegration time of 1 hour, are unqualified in disintegration and are directly abandoned; protocol-stability experiment
After the testis tablet plate prepared by the first scheme of the invention is loaded, an accelerated experiment is carried out, the testis tablet plate is accelerated for 6 months, the disintegration time limit is unqualified, and the phenomenon of oil penetration and bottom penetration occurs, and the detection result is as follows:
| detecting items | 0 month | 1 month | 2 month | 3 month | 6 month |
| Disintegration time limit (minutes) | 50 | 55 | 57 | 65 | 70 |
| Authentication | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Protein marker amount (%) | 57.6 | 57.0 | 57.1 | 56.2 | 56.7 |
| Appearance of sugar-coated tablet | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Oil bleeding | Without oil leakage | Without oil leakage | Without oil leakage | Oil-permeable bottom | Oil-permeable bottom |
After the testis plate prepared by the second scheme of the invention is loaded, an accelerated experiment is carried out, the acceleration is 6 months, the phenomenon of oil penetration and bottom penetration does not occur, and the detection result is as follows:
| detecting items | 0 month | 1 month | 2 month | 3 month | 6 month |
| Disintegration time limit (minutes) | 20 | 22 | 24 | 25 | 25 |
| Authentication | All meet the regulations | All meet the regulations | All meet the regulations | All meet the regulations | All meet the regulations |
| Protein marker amount (%) | 56.8 | 55.6 | 56.0 | 56.2 | 55.5 |
| Appearance of sugar-coated tablet | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Oil bleeding | Without oil leakage | Without oil leakage | Without oil leakage | Without oil leakage | Without oil leakage |
After the testis tablet plate prepared by the fifth scheme is loaded, an accelerated experiment is carried out, the testis tablet plate is accelerated for 6 months, the disintegration time limit is qualified, and the phenomenon of oil penetration and bottom penetration appears after 2 months of acceleration, and the detection result is as follows:
| detecting items | 0 month | 1 month | 2 month | 3 month | 6 month |
| Disintegration time limit (minutes) | 32 | 30 | 35 | 40 | 40 |
| Authentication | All meet the regulations | All meet the regulations | All meet the regulations | All meet the regulations | All meet the regulations |
| Protein marker amount (%) | 56.8 | 55.6 | 56.0 | 56.2 | 55.5 |
| Appearance of sugar-coated tablet | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations | Compliance with regulations |
| Oil bleeding | Without oil leakage | Oil penetration | Oil-permeable bottom | Oil-permeable bottom | Oil-permeable bottom |
The testis plate prepared by the prior art is subjected to an acceleration experiment after being loaded, the acceleration is 6 months, the phenomena of oil penetration and bottom penetration occur, and the disintegration is unqualified, and the detection result is as follows:
experiment two, tabletting experiment
| Sticking punch | Appearance of the product | Average hardness | Disintegration | |
| Prior Art sample No.) | A little sticking | Splinting | 2.5kg | 30min |
| Sample No. 2 | Sticking punch | Little splinter | 3.0kg | 45min |
| Scheme one of the invention | Sticking punch | / | 2.2kg | 50min |
| Scheme two of the invention | Is not adhered to | Qualified | 6.2kg | 24min |
| Scheme three of the invention | Is not adhered to | Splinting | 6.2kg | 24min |
| Scheme four of the invention | Sticking punch | Little splinter | 5.0kg | 55min |
In conclusion, the preparation scheme II of the testis tablet has the following advantages:
1. the phenomena of sticking and unsmooth appearance are effectively solved, and the product quality and the one-time yield are improved;
2. the hardness of the plain tablets is effectively improved;
3. thoroughly solves the problem of oil penetration and bottom penetration in the product storage process.
Therefore, the second embodiment of the present invention is the most preferable embodiment.
The invention improves the preparation process of the testis powder and further improves the formula and the process of the tablet, and the obtained testis tablet product is superior to the prior art in quality.
Detailed Description
The invention is further illustrated by the following examples.
Example 1
Testis powder preparation process
Fresh bovine and ovine testes: 10000g
Cleaning fresh sheep testis and cattle testis, steaming testis on a sieve for 1.5 hr, taking out, oven drying in an oven at 80 deg.C, pulverizing, sieving with 40 mesh sieve to obtain testis powder 2800g, bagging, sealing and storing.
Molding process
Formulation formula
Trial production volume 3500g
And (3) granulating:
1.1 weighing testis powder, sodium carboxymethyl starch, microcrystalline cellulose and micro-powder silica gel according to the prescription amount, loading into a trough type mixer, and stirring for 15min to obtain dry mixed powder;
1.2 slowly pouring 1500g of 70% ethanol, wet mixing for 8min, and adding appropriate amount of 6% Pvpk 3060% ethanol solution according to soft material condition to obtain suitable soft material;
1.3, putting the soft material into a swing granulator and screening the soft material by a screen with 18 meshes to prepare wet granules;
1.4 spreading the granules on a plate, placing the granules in a constant temperature oven at 70 ℃ to dry until the moisture content is 6.5%, taking out the granules, sieving the granules with a 18-mesh sieve for finishing, adding the sodium carboxymethyl starch, the silicon dioxide and the magnesium stearate according to the prescription amount, uniformly mixing, tabletting the mixture for 0.26g/s, and inspecting plain tablets.
1.5 coating: the vegetarian slices are coated with 2-4 layers of 10% of ethanol solution of the corncob and then sugar-coated.
Claims (4)
1. A preparation method of a testis tablet takes testis powder as an active ingredient, wherein the testis powder is prepared by the following steps:
1) cleaning fresh testis of sheep and cattle, steaming testis on a sieve for 1.5 hr,
2) drying in a drying oven at 80 ℃, powdering and sieving with a 40-mesh sieve to obtain testis powder;
2. the preparation method according to claim 1, wherein the testis powder is mixed with a pharmaceutically acceptable carrier, and a soft material is prepared by using 70% ethanol as a binder; further preparing the soft material into wet particles; granulating, adding lubricant, mixing, tabletting, and coating as required.
3. The process according to claim 1, wherein the pharmaceutically acceptable carrier is selected from the group consisting of: one or more of sodium carboxymethyl starch, PVPK30, microcrystalline cellulose, sucrose, corn grit, silicon dioxide, magnesium stearate and talcum powder.
4. The method of claim 1, wherein the tablet is formulated as follows:
the preparation method comprises the following steps:
weighing testis powder, sodium carboxymethyl starch, microcrystalline cellulose and micro-powder silica gel, loading into a trough type mixer, and stirring for 15min to obtain dry mixed powder;
slowly pouring 1500g of 70% ethanol, wet mixing for 8min, and adding appropriate amount of 6% Pvpk 3060% ethanol solution according to soft material condition to obtain suitable soft material;
putting the soft material into a swing granulator and screening the soft material by a 18-mesh screen to prepare wet granules;
spreading the granules on a plate, placing in a constant temperature oven, drying at 70 ℃ until the moisture content is 6.5%, taking out, sieving with a 18-mesh sieve, adding the sodium carboxymethyl starch, the silicon dioxide and the magnesium stearate according to the prescription amount, uniformly mixing, tabletting for 0.26g/s, and inspecting plain tablets;
coating: the vegetarian slices are coated with 2-4 layers of 10% of ethanol solution of the corncob and then sugar-coated.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011449962.7A CN112516172A (en) | 2020-12-12 | 2020-12-12 | Preparation method of testis tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011449962.7A CN112516172A (en) | 2020-12-12 | 2020-12-12 | Preparation method of testis tablet |
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| Publication Number | Publication Date |
|---|---|
| CN112516172A true CN112516172A (en) | 2021-03-19 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202011449962.7A Pending CN112516172A (en) | 2020-12-12 | 2020-12-12 | Preparation method of testis tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113425744A (en) * | 2021-07-29 | 2021-09-24 | 青海特健生物科技有限公司 | Preparation method of sheep testis decoction pieces |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1732986A (en) * | 2005-08-08 | 2006-02-15 | 曹永胜 | Concentrated tablet of animal testis and process for preparing the same |
| CN103638047A (en) * | 2013-11-25 | 2014-03-19 | 江西济民可信药业有限公司 | Preparation method of testicle tablet |
-
2020
- 2020-12-12 CN CN202011449962.7A patent/CN112516172A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1732986A (en) * | 2005-08-08 | 2006-02-15 | 曹永胜 | Concentrated tablet of animal testis and process for preparing the same |
| CN103638047A (en) * | 2013-11-25 | 2014-03-19 | 江西济民可信药业有限公司 | Preparation method of testicle tablet |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113425744A (en) * | 2021-07-29 | 2021-09-24 | 青海特健生物科技有限公司 | Preparation method of sheep testis decoction pieces |
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