CN115581681A - Novel calcium dobesilate capsule and preparation method thereof - Google Patents
Novel calcium dobesilate capsule and preparation method thereof Download PDFInfo
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- CN115581681A CN115581681A CN202210657377.9A CN202210657377A CN115581681A CN 115581681 A CN115581681 A CN 115581681A CN 202210657377 A CN202210657377 A CN 202210657377A CN 115581681 A CN115581681 A CN 115581681A
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- calcium dobesilate
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- QGNBTYAQAPLTMX-UHFFFAOYSA-L calcium dobesilate Chemical compound [Ca+2].OC1=CC=C(O)C(S([O-])(=O)=O)=C1.OC1=CC=C(O)C(S([O-])(=O)=O)=C1 QGNBTYAQAPLTMX-UHFFFAOYSA-L 0.000 title claims abstract description 86
- 229960005438 calcium dobesilate Drugs 0.000 title claims abstract description 86
- 239000002775 capsule Substances 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title abstract description 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 36
- 229920001661 Chitosan Polymers 0.000 claims abstract description 20
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 19
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims abstract description 19
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000001768 carboxy methyl cellulose Substances 0.000 claims abstract description 18
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 18
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims abstract description 18
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims abstract description 18
- 235000003145 Hippophae rhamnoides Nutrition 0.000 claims abstract description 17
- 239000008187 granular material Substances 0.000 claims abstract description 17
- 229920002261 Corn starch Polymers 0.000 claims abstract description 13
- 239000008120 corn starch Substances 0.000 claims abstract description 13
- 235000013399 edible fruits Nutrition 0.000 claims abstract description 13
- 239000000843 powder Substances 0.000 claims abstract description 13
- 241000229143 Hippophae Species 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 17
- 238000011049 filling Methods 0.000 claims description 15
- 239000000463 material Substances 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 15
- 235000003935 Hippophae Nutrition 0.000 claims description 11
- 239000008176 lyophilized powder Substances 0.000 claims description 11
- 238000005303 weighing Methods 0.000 claims description 10
- 238000005469 granulation Methods 0.000 claims description 9
- 230000003179 granulation Effects 0.000 claims description 9
- 239000002245 particle Substances 0.000 claims description 9
- 238000005096 rolling process Methods 0.000 claims description 7
- 230000001954 sterilising effect Effects 0.000 claims description 6
- 238000007599 discharging Methods 0.000 claims description 5
- 238000001035 drying Methods 0.000 claims description 5
- 238000007873 sieving Methods 0.000 claims description 5
- 238000005429 filling process Methods 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- 235000015203 fruit juice Nutrition 0.000 claims description 3
- 235000011389 fruit/vegetable juice Nutrition 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 238000004140 cleaning Methods 0.000 claims description 2
- 238000005259 measurement Methods 0.000 claims description 2
- 238000010298 pulverizing process Methods 0.000 claims description 2
- 238000009777 vacuum freeze-drying Methods 0.000 claims description 2
- 238000007908 dry granulation Methods 0.000 claims 2
- 239000003814 drug Substances 0.000 abstract description 10
- 240000000950 Hippophae rhamnoides Species 0.000 abstract description 3
- 239000000825 pharmaceutical preparation Substances 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 11
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 239000008188 pellet Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 208000034189 Sclerosis Diseases 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 206010062198 microangiopathy Diseases 0.000 description 1
- 230000000813 microbial effect Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 201000002282 venous insufficiency Diseases 0.000 description 1
Classifications
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Cardiology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Microbiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Vascular Medicine (AREA)
- Biotechnology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a novel calcium dobesilate capsule and a preparation method thereof. The novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 5-10g of cyclodextrin, 1-5g of magnesium stearate, 1-5g of sodium carboxymethylcellulose, 5-10g of corn starch, 10-30g of sea buckthorn fruit freeze-dried powder and 5-10g of chitosan. The invention also provides a preparation method of the novel calcium dobesilate capsule. The novel calcium dobesilate medicament prepared by the invention has obviously improved stability, and even if the novel calcium dobesilate medicament is placed for a long time, all indexes of the novel calcium dobesilate medicament are kept at relatively stable levels, thereby meeting the quality standard of capsules.
Description
Technical Field
The invention belongs to the field of pharmaceutical preparations, and particularly relates to a novel calcium dobesilate capsule and a preparation method thereof.
Background
The calcium dobesilate capsule is a clinical common medicine, has better curative effect on microangiopathy, varicose syndrome and venous insufficiency accompanied by microcirculatory disturbance, and is also commonly used for auxiliary treatment of vein stripping and vein sclerosis. However, the calcium dobesilate has the characteristics of hygroscopicity, light instability, easy oxidation and the like, so that the long-term stability of the calcium dobesilate capsule is influenced, and the storage and clinical use of the calcium dobesilate are directly influenced.
Disclosure of Invention
In order to overcome the defects, the application provides a novel calcium dobesilate capsule and a preparation method thereof, which can effectively solve the problems.
The technical scheme of the invention is realized as follows:
a novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 5-10g of cyclodextrin, 1-5g of magnesium stearate, 1-5g of sodium carboxymethylcellulose, 5-10g of corn starch, 10-30g of sea buckthorn fruit freeze-dried powder and 5-10g of chitosan.
Furthermore, each 1000 granules of the novel calcium dobesilate capsule comprise the following components in parts by weight: 500g of calcium dobesilate, 8g of cyclodextrin, 3g of magnesium stearate, 2.5g of sodium carboxymethylcellulose, 6g of corn starch, 20g of sea buckthorn fruit freeze-dried powder and 5.5g of chitosan.
A preparation method of a novel calcium dobesilate capsule comprises the following steps:
(1) Sieving calcium dobesilate, cyclodextrin, sodium carboxymethylcellulose, fructus Hippophae lyophilized powder and chitosan with 50-80 mesh sieve, and weighing and preparing materials; weighing magnesium stearate and preparing materials;
(2) Sequentially adding magnesium stearate, corn starch, sodium carboxymethylcellulose, cyclodextrin, fructus Hippophae lyophilized powder, chitosan and calcium dobesilate into a mixer, and mixing; discharging after mixing;
(3) Feeding the mixed material into a dry-process granulator for granulation to obtain calcium dobesilate granules; measuring the content of calcium dobesilate;
(4) And (3) adjusting the filling amount range according to the content measurement result in the calcium dobesilate particles, and filling the calcium dobesilate particles into hollow capsules.
Further, the preparation method of the sea buckthorn fruit freeze-dried powder comprises the following steps: cleaning fructus Hippophae, pulverizing, and separating to obtain fruit juice; sterilizing the fruit juice, and vacuum freeze-drying to obtain fructus Hippophae lyophilized powder.
Further, the sterilization conditions of the sea buckthorn juice are as follows: the temperature is 130-140 ℃, and the sterilization time is 3-5s.
Further, in the step (2), a universal motion mixer is adopted, the frequency is set to be 32Hz, and the mixing time is set to be: for 10 minutes.
Further, in the step (3), the process parameters of the dry granulator are set as follows: feeding speed: 25.00-30.00rpm, pinch roller speed: 8-12rpm, rolling pressure: 8.0-10.0Mpa, crushing speed: 100rpm, rate of pellet finishing 1: 80-100rpm, and the aperture of the screen mesh is phi 2.0mm; granulating at 2 rotating speeds: 80-100rpm, and the aperture of the screen mesh is 1.0mm.
Further, the dry granulator process parameters in the step (3) are set as follows: feeding speed: 25.00rpm, puck speed: 8rpm, rolling pressure: 9.09Mpa, crushing speed: 100rpm, rate of granulation 1: 100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; and (2) finishing the granules at a rotating speed: 100rpm, and the aperture diameter of the screen mesh is 1.0mm.
Further, the step (4) adopts a capsule filling machine to fill capsules, and the filling speed is set to be 1500-2100 grains/minute.
Further, the step (4) samples 1 time every 20 minutes during the filling process, and measures the grain weight difference.
Has the advantages that:
the stability of the novel calcium dobesilate medicament prepared by the invention is obviously improved, and after the medicament is placed for a long time, the content stability of the novel calcium dobesilate medicament can ensure the dosage stability of active ingredients of the medicament and not to be too different from the marked ingredients, so that the bioavailability of the novel calcium dobesilate medicament is better maintained, and the stability of the medicament effect is ensured. The indexes of the calcium dobesilate capsule prepared by the invention are kept at relatively stable levels even if the calcium dobesilate capsule is placed for a long time, and the calcium dobesilate capsule meets the quality standard of the capsule.
Detailed Description
The invention will be better understood by reference to the following description taken in conjunction with the specific embodiments.
Example 1
A novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 5g of cyclodextrin, 5g of magnesium stearate, 1g of sodium carboxymethylcellulose, 5g of corn starch, 30g of sea buckthorn fruit freeze-dried powder and 10g of chitosan.
A preparation method of the novel calcium dobesilate capsule comprises the following steps:
(1) Sieving calcium dobesilate, cyclodextrin, sodium carboxymethylcellulose, fructus Hippophae lyophilized powder and chitosan with 50-80 mesh sieve, and weighing and preparing materials; weighing magnesium stearate and preparing materials;
(2) Sequentially adding magnesium stearate, corn starch, sodium carboxymethylcellulose, cyclodextrin, sea buckthorn fruit freeze-dried powder, chitosan and calcium dobesilate into a universal mixer, mixing, setting the frequency to be 32Hz, and mixing for: for 10 minutes. (ii) a Discharging after mixing;
(3) Feeding the mixed materials into a dry-process granulator for granulation to obtain calcium dobesilate granules; measuring the content of calcium dobesilate; the dry granulator process parameters were set as follows: feeding speed: 25.00-30.00rpm, pinch roller speed: 8-12rpm, rolling pressure: 8.0-10.0Mpa, crushing speed: 100rpm, rate of granulation 1: 80-100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; and (2) finishing the granules at a rotating speed: 80-100rpm, and the aperture diameter of the screen mesh is phi 1.0mm;
(4) And respectively adding the calcium dobesilate particles and the hollow capsules into a capsule filling machine, and setting the filling speed to be 1500 particles/minute for filling. Sampling for 1 time every 20 minutes in the filling process, and detecting the grain weight difference, wherein the grain weight difference is controlled to be +/-5.0%.
Example 2
A novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 10g of cyclodextrin, 1g of magnesium stearate, 5g of sodium carboxymethylcellulose, 10g of corn starch, 10g of sea buckthorn fruit freeze-dried powder and 5g of chitosan.
A preparation method of a novel calcium dobesilate capsule comprises the following steps:
(1) Sieving calcium dobesilate, cyclodextrin, sodium carboxymethylcellulose, fructus Hippophae lyophilized powder and chitosan with 50-80 mesh sieve, and weighing and preparing materials; weighing magnesium stearate and preparing materials;
(2) Adding magnesium stearate, corn starch, sodium carboxymethylcellulose, cyclodextrin, sea buckthorn fruit freeze-dried powder, chitosan and calcium dobesilate into a universal mixer in sequence, mixing, setting the frequency to be 32Hz, and mixing time to be as follows: for 10 minutes. (ii) a Discharging after mixing;
(3) Feeding the mixed materials into a dry-process granulator for granulation to obtain calcium dobesilate granules; measuring the content of calcium dobesilate; the dry granulator process parameters were set as follows: feeding speed: 25.00-30.00rpm, pinch roller speed: 8-12rpm, rolling pressure: 8.0-10.0Mpa, crushing speed: 100rpm, rate of pellet finishing 1: 80-100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; granulating at 2 rotating speeds: 80-100rpm, and the aperture diameter of the screen mesh is phi 1.0mm;
(4) And respectively adding the calcium dobesilate particles and the hollow capsules into a capsule filling machine, and setting the filling speed to be 1500 particles/minute for filling. Sampling for 1 time every 20 minutes in the filling process, and detecting the grain weight difference, wherein the grain weight difference is controlled to be +/-5.0%.
Example 3
A novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 8g of cyclodextrin, 3g of magnesium stearate, 2.5g of sodium carboxymethylcellulose, 6g of corn starch, 20g of sea buckthorn fruit freeze-dried powder and 5.5g of chitosan.
A preparation method of the novel calcium dobesilate capsule comprises the following steps:
(1) Sieving calcium dobesilate, cyclodextrin, sodium carboxymethylcellulose, fructus Hippophae lyophilized powder and chitosan with 50-80 mesh sieve, and weighing and preparing materials; weighing magnesium stearate and preparing materials;
(2) Adding magnesium stearate, corn starch, sodium carboxymethylcellulose, cyclodextrin, sea buckthorn fruit freeze-dried powder, chitosan and calcium dobesilate into a universal mixer in sequence, mixing, setting the frequency to be 32Hz, and mixing time to be as follows: for 10 minutes. (ii) a Discharging after mixing;
(3) Feeding the mixed materials into a dry-process granulator for granulation to obtain calcium dobesilate granules; measuring the content of calcium dobesilate;
the dry granulator process parameters were set as follows: feeding speed: 25.00rpm, puck speed: 8rpm, rolling pressure: 9.09Mpa, crushing speed: 100rpm, rate of pellet finishing 1: 100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; and (2) finishing the granules at a rotating speed: 100rpm, and the aperture diameter of the screen mesh is 1.0mm.
Quality inspection of calcium dobesilate capsules prepared by the invention
The calcium dobesilate capsules prepared in 3 embodiments of the present invention were respectively tested according to the quality standards and related detection methods for calcium dobesilate capsules in the pharmacopoeia of the people's republic of China (2020 edition), and the specific results are as follows.
TABLE 1 quality inspection results of calcium dobesilate capsules
As can be seen from table 1, all the test items of the calcium dobesilate capsule described in 3 embodiments of the present invention all meet the standards of the calcium dobesilate capsule.
Comparison of the Performance parameters of calcium dobesilate capsules prepared by different preparation methods
The calcium dobesilate capsules prepared in 3 examples are respectively taken and subjected to aluminum-plastic packaging, and the capsules are placed for 6 months under the conditions that the temperature is 40 +/-2 ℃ and the relative humidity is 75 +/-5%. Samples were taken at the end of each of months 0, 1, 2, 3 and 6, respectively, during the experiment. The lyophilized powder of Hippophae rhamnoides is removed in the formula of comparative example 1, the chitosan is removed in the formula of comparative example 2, and the cyclodextrin, the lyophilized powder of Hippophae rhamnoides and the chitosan are removed in the formula of comparative example 3. Comparative examples 1 to 3 capsules were prepared according to the preparation method of example 3 and were subjected to aluminum-plastic packaging. Each treatment group was set up with 3 parallel experiments. The performance parameters of the calcium dobesilate capsules of each treatment group were counted, and the results are shown in table 2.
TABLE 2 comparison of appearance Properties of contents
TABLE 3 comparison of the total number of moulds and yeasts (cfu/g)
| Month 0 | Month 1 | Month 2 | Month 3 | Month 6 | |
| Example 1 | Is free of | Is free of | Is composed of | Is free of | Is composed of |
| Example 2 | Is composed of | Is free of | Is composed of | Is free of | Is free of |
| Example 3 | Is free of | Is free of | Is free of | Is free of | Is free of |
| Comparative example 1 | Is composed of | 10 | >100 | >100 | >100 |
| Comparative example 2 | Is free of | Is free of | 50 | >100 | >100 |
| Comparative example 3 | Is free of | >100 | >100 | >100 | >100 |
TABLE 4 comparison of total aerobic count (cfu/g)
TABLE 5 comparison of effective component content (%)
| Month 0 | Month 1 | Month 2 | Month 3 | Month 6 | |
| Example 1 | 101.85 | 101.84 | 101.03 | 101.02 | 100.84 |
| Example 2 | 99.75 | 99.75 | 99.41 | 99.24 | 99.04 |
| Example 3 | 100.03 | 100.03 | 100.15 | 100.08 | 100.01 |
| Comparative example 1 | 99.65 | 97.14 | 94.67 | 91.69 | 84.36 |
| Comparative example 2 | 98.98 | 97.42 | 95.89 | 92.78 | 86.20 |
| Comparative example 3 | 99.75 | 97.56 | 91.28 | 81.64 | 65.79 |
It can be seen from the data in tables 2-5 that the calcium dobesilate capsules prepared by 3 examples of the invention can keep stable content appearance, microbial limit and effective component content for a long time. In contrast, the calcium dobesilate capsules prepared in the comparative examples 1 to 3 have various parameters changed to different degrees in the experimental process, and the parameters can not reach the quality standard of the calcium dobesilate capsules.
The embodiments of the present invention have been described in detail, but the embodiments are only examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions to those skilled in the art are also within the scope of the present invention. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
The embodiments of the present invention have been described in detail, but the embodiments are merely examples, and the present invention is not limited to the embodiments described above. Any equivalent modifications and substitutions for the present invention are within the scope of the present invention for those skilled in the art. Accordingly, equivalent changes and modifications made without departing from the spirit and scope of the present invention should be covered by the present invention.
Claims (10)
1. A novel calcium dobesilate capsule is characterized in that each 1000 capsules comprise the following components in parts by weight: 500g of calcium dobesilate, 5-10g of cyclodextrin, 1-5g of magnesium stearate, 1-5g of sodium carboxymethylcellulose, 5-10g of corn starch, 10-30g of sea buckthorn fruit freeze-dried powder and 5-10g of chitosan.
2. The novel calcium dobesilate capsule according to claim 1, wherein the novel calcium dobesilate capsule comprises the following components in 1000 granules by weight: 500g of calcium dobesilate, 8g of cyclodextrin, 3g of magnesium stearate, 2.5g of sodium carboxymethylcellulose, 6g of corn starch, 20g of sea buckthorn fruit freeze-dried powder and 5.5g of chitosan.
3. A method for preparing the novel calcium dobesilate capsules according to claim 1 or 2, comprising the following steps:
(1) Sieving calcium dobesilate, cyclodextrin, sodium carboxymethylcellulose, fructus Hippophae lyophilized powder and chitosan with 50-80 mesh sieve, and weighing and preparing materials; weighing magnesium stearate and preparing materials;
(2) Sequentially adding magnesium stearate, corn starch, sodium carboxymethylcellulose, cyclodextrin, fructus Hippophae lyophilized powder, chitosan and calcium dobesilate into a mixer, and mixing; discharging after mixing;
(3) Feeding the mixed material into a dry-process granulator for granulation to obtain calcium dobesilate granules; measuring the content of calcium dobesilate;
(4) And (3) adjusting the filling amount range according to the content measurement result of the calcium dobesilate particles, and filling the calcium dobesilate particles into hollow capsules.
4. The method for preparing the novel calcium dobesilate capsule according to claim 3, wherein the method for preparing the seabuckthorn fruit freeze-dried powder comprises the following steps: cleaning fructus Hippophae, pulverizing, and separating to obtain fruit juice; sterilizing the juice, and vacuum freeze-drying to obtain fructus Hippophae lyophilized powder.
5. The method for preparing the novel calcium dobesilate capsules according to claim 4, wherein the sterilization conditions of the sea buckthorn juice are as follows: the temperature is 130-140 ℃, and the sterilization time is 3-5s.
6. The method for preparing a novel calcium dobesilate capsule according to claim 3, wherein in the step (2), a universal motion mixer is adopted, the set frequency is 32Hz, and the mixing time is as follows: for 10 minutes.
7. The method for preparing the novel calcium dobesilate capsule according to claim 3, wherein in step (3), the dry granulation machine process parameters are set as follows: feeding speed: 25.00-30.00rpm, pinch roller speed: 8-12rpm, rolling pressure: 8.0-10.0Mpa, crushing speed: 100rpm, rate of granulation 1: 80-100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; and (2) finishing the granules at a rotating speed: 80-100rpm, and the aperture of the screen mesh is phi 1.0mm.
8. The method for preparing a novel calcium dobesilate capsule according to claim 3, characterized in that the process parameters of the dry granulation machine in step (3) are set as follows: feeding speed: 25.00rpm, puck speed: 8rpm, rolling pressure: 9.09Mpa, crushing speed: 100rpm, rate of granulation 1: 100rpm, and the aperture diameter of the screen mesh is phi 2.0mm; and (2) finishing the granules at a rotating speed: 100rpm, and the aperture diameter of the screen mesh is 1.0mm.
9. The method for preparing a novel calcium dobesilate capsule according to claim 3, characterized in that in step (4), a capsule filling machine is used for filling the capsule, and the filling speed is set to 1500-2100 grains/min.
10. The method for preparing a novel calcium dobesilate capsule according to claim 3, characterized in that step (4) comprises sampling 1 time every 20 minutes during the filling process and detecting the difference in particle weight.
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| US20070149618A1 (en) * | 2004-02-17 | 2007-06-28 | Action Medicines, S.L. | Methods of use for 2,5-dihydroxybenzene sulfonic acid compounds for the treatment of cancer, rosacea and psoriasis |
| CN110290784A (en) * | 2017-02-22 | 2019-09-27 | 博拉克投资有限公司 | In the pharmaceutical composition and corresponding manufacturing method comprising 2,5- dihydroxy benzenes sulfonic acid or its pharmaceutically acceptable salt of personalized supply unit form |
| CN112021531A (en) * | 2020-08-17 | 2020-12-04 | 新疆棘仁康生物科技有限公司 | Preparation method of sea-buckthorn freeze-dried powder |
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| US20070010581A1 (en) * | 2002-11-29 | 2007-01-11 | Jose Esteve-Soler | Use of 2,5-dihydroxybenzenesulfonic compounds for the treatment of disorders based on an impairment of no production and/or of regulation of edhf function |
| US20070149618A1 (en) * | 2004-02-17 | 2007-06-28 | Action Medicines, S.L. | Methods of use for 2,5-dihydroxybenzene sulfonic acid compounds for the treatment of cancer, rosacea and psoriasis |
| CN1704048A (en) * | 2004-05-25 | 2005-12-07 | 孙明杰 | Compound calcium phenolsulfonic acid |
| CN1857297A (en) * | 2006-05-16 | 2006-11-08 | 北京国丹药物技术开发有限公司 | Medicine composition for treating microcirculation dysfunction and its preparing method |
| CN110290784A (en) * | 2017-02-22 | 2019-09-27 | 博拉克投资有限公司 | In the pharmaceutical composition and corresponding manufacturing method comprising 2,5- dihydroxy benzenes sulfonic acid or its pharmaceutically acceptable salt of personalized supply unit form |
| CN112021531A (en) * | 2020-08-17 | 2020-12-04 | 新疆棘仁康生物科技有限公司 | Preparation method of sea-buckthorn freeze-dried powder |
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