CN109172610A - The preparation method of Leech capsule - Google Patents
The preparation method of Leech capsule Download PDFInfo
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- CN109172610A CN109172610A CN201811249256.0A CN201811249256A CN109172610A CN 109172610 A CN109172610 A CN 109172610A CN 201811249256 A CN201811249256 A CN 201811249256A CN 109172610 A CN109172610 A CN 109172610A
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- leech
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- capsule
- leech capsule
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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
- A61K35/56—Materials from animals other than mammals
- A61K35/62—Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- 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
- A61P9/12—Antihypertensives
Abstract
The invention belongs to the medicinal preparation technical fields containing leech, and in particular to a kind of preparation method of Leech capsule.The preparation method of the Leech capsule, including drying, cooling, crushing, sterilizing, mixing softwood, granulation, redrying, whole grain, total mix, filling and polishing process, described crush is that water-cooled crushes.Capsule stability made from method of the invention is good, and impurity content is low, and moisture content is low, and loading amount homogeneity is good, and disintegration rate is fast, and content of microorganisms is low；In preparation process, without the concern for electrostatic problem, it will not influence efficiency and crush next time, can be realized industrialized production.
Description
Technical field
The invention belongs to the medicinal preparation technical fields containing leech, and in particular to a kind of preparation side of Leech capsule
Method.
Background technique
Leech also known as leech, are the special medicinal aquatic animals of Chinese tradition, leech in history based on catching naturally, because
In recent years the pollution of the abuse such as pesticide, chemical fertilizer and industrial or agricultural " three wastes " to environment, wild natural resources falls sharply, as leech is medicinal
The deep development of value, there is a huge market demand potential.Southern china starts to catch nature seed, for the first time before and after nineteen ninety-five
Artificial feeding is carried out, is succeeded.Northern area does not have always cultivation because of seed and technical reason.
Leech (Chinese medicine) is the dry all of Hirudinidae animal whitmania, leech or willow leaf leech, has treatment apoplexy, high blood
Pressure, the clear stasis of blood, amenorrhoea, traumatic injury and other effects.Studies have shown that leech is in prevention and treatment cardiovascular and cerebrovascular disease, disease of digestive system, interior point
Secreting disease, kidney trouble, surgical disease, andrological diseases, skin disease, gynecological disease, Bone injury disease, type etc. has
Special efficacy (" clinical application of leech is summarized ", Li Ming etc., the 8th phase of volume 19 in 2006, the 62-64 pages, publication date 08 month 2006
31 days).
Using leech as in the technique of key agents active constituent, since the active pharmaceutical ingredient in leech joins preparation process
Number is more sensitive, and preparation process is improper, easily causes drug dissolution low, and active constituent content is low, the low (publication number of bioavilability
For CN104324055A).To solve this technical problem, the patent document of Publication No. CN104324055A discloses a kind of water
The preparation method of the pure powder ultramicro decoction piece of leech, comprising the following steps: by dry active pharmaceutical ingredient be crushed to 300 microns of partial size with
Under, then pulverize in airslide disintegrating mill, obtain ultramicro decoction piece, the condition of the ultramicro grinding are as follows: crush temperature 15-22
DEG C, pressure when into micronizer is 1-2Mpa, crush pressure 2-6Mpa, air velocity 200-285m/s, crushing when
Between 1-3h.Peroral dosage form good drug efficacy made from this method, stripping property is good, and stability is good, and bioavilability is high, and peroral dosage form
Smell and mouthfeel improved (Publication No. CN104324055A, publication date be on February 04th, 2015).However, Ultramicro-powder
Body single particle often plays pendulum, when being contacted with air easily adsorb air in moisture and agglomeration (" ultra micro of reuniting
The principle and application of crushing technology ", poplar again etc., feed review, the 19th phase in 2007, the 36-38 pages, publication date 2007 12
The moon 31).
Summary of the invention
In view of this, the purpose of the present invention is to provide a kind of preparation methods of Leech capsule.In this method preparation process,
Without the concern for electrostatic problem, it will not influence efficiency and crush next time, can be realized industrialized production.
In addition, inventor also found, it is super that the patent document of Publication No. CN104324055A discloses a kind of pure powder of leech
There are following technological deficiencies for the preparation method of micro- medicine materical crude slice: when powder is crushed to ultra micron diameter, needing to consider electrostatic problem, will affect
It efficiency and crushes next time, to be difficult to realize industrialized production (" application study of the superfine communication technique in the field of Chinese medicines ", king
Precious spring etc., modern health, the 10th phase in 2017, the 179-180 pages).
To achieve the above object, the technical solution of the present invention is as follows:
The preparation method of Leech capsule, including drying, cooling, crushing, sterilizing, mixing softwood, granulation, redrying,
Whole grain, total mix, filling and polishing process, which is characterized in that described crush is that water-cooled crushes.
Including drying, cooling, crushing, sterilizing, mixing softwood, granulation, redrying, whole grain, total mix, filling and polishing
Process, which is characterized in that described crush is that water-cooled crushes；Method prepare Leech capsule, will not be adsorbed when being contacted with air
Moisture in air and agglomeration of reuniting.
Further, which is characterized in that the crushing refers to that being crushed to partial size is.
In preparation process, without the concern for electrostatic problem, it will not influence efficiency and crush next time, can be realized industrialization
Production.
Further, the temperature of the drying is 70-80 DEG C, and the time is 8-10 hours.
Further, the cooling, which refers to, is cooled to 40 DEG C.
Further, the sterilizing is Co-60Irradiation sterilization, irradiation dose 9.8KGr.
Further, the mixing refers to that by the Leech of sterilization treatment and volume fraction be 95% ethanol solution and pure
Water is 60: according to mass ratio: then softwood is made in mixing.
Further, the whole grain, which refers to, carries out whole grain with the sieve of 18 mesh.
Further, the redrying refers to that the particle for obtaining granulation is laid in baking pan, and thickness is no more than 5 ㎝, so
It is 5-8 hours dry at a temperature of 70-80 DEG C afterwards.
Further, it is 0.228g-0.273g that loading amount is controlled in the filling process.
The beneficial effects of the present invention are:
Capsule stability made from method of the invention is good, and content is particle of the brown color to sepia, gas raw meat, taste
It is light, it is placed in the non-aggregated agglomeration of 5min in air.
In method preparation process of the invention, without the concern for electrostatic problem, it will not influence efficiency and crush next time, energy
Enough realize industrialized production.
Capsule impurity content made from method of the invention is low, total ash content 5.1%-5.7%, acid-insoluble ash
Content is 0.3%-0.5%.
Capsule moisture content made from method of the invention is low, moisture content 4.1%-4.6%.
Capsule loading amount homogeneity made from method of the invention is good, and content uniformity is ± 4.1.
Capsule disintegration rate made from method of the invention is fast, disintegration time limited 17-21min.
Capsule content of microorganisms made from method of the invention is low, aerobic bacteria sum be 5000-6000cfu/g, mould and
Saccharomycete sum is 32-35cfu/g, and bile tolerance Gram-negative bacterial content is 70-74cfu/g, and escherichia coli is not detected, husky
Door bacterium is not detected.
Specific embodiment
Illustrated embodiment is to preferably be illustrated to the contents of the present invention, but is not that the contents of the present invention only limit
In illustrated embodiment.So those skilled in the art carry out nonessential change to embodiment according to foregoing invention content
Into and adjustment, still fall within protection scope of the present invention.
Embodiment 1
The preparation method of Leech capsule, specific steps are as follows:
A. raw material selects:
Leech: it is in flat spindle, there is most links, long 4-10cm, wide 0.5-2cm.Back dark brown is dark brown, slightly
Protuberance, after water logging, it is seen that black splotch lines up 5 longitudinal grins；The outside of belly is flat, brown color.Two sides brown color, front end is slightly sharp, after
Blunt circle is held, both ends respectively have 1 sucker, and anterior sucker is not significant, and posterior sucker is larger.Matter is crisp, frangibility, section colloidal substance.The micro- raw meat of gas.
Leech: prolate is cylindrical, the more flexion torsions of body, long 2-5cm, wide 0.2-0.3cm.
Willow leaf leech: long and narrow and flat, long 5-12cm, wide 0.1-0.5cm.
B. it dries: the raw material leech, leech or willow leaf leech of selection is 8-10 hours dry under the conditions of 70-80 DEG C；
C. it cools down: dried raw material leech, leech or willow leaf leech is cooled to 40 DEG C,
D. it crushes: being cooled to 40 DEG C of raw material leech, leech or willow leaf leech and be placed in water-cooled pulverizer and be crushed to grain
Diameter is；
E. it sterilizes: raw material leech, leech or the use of willow leaf leech powder to being crushed and identifying, examine qualified crushing
Dosage is the Co of 9.8KGr-60Irradiation sterilization.
E. mix: by the Leech of sterilization treatment and volume fraction be 95% ethanol solution and pure water according to mass ratio
For 60:: then softwood is made in mixing.
F. it pelletizes: particle is made in softwood obtained.It is pelletized with the sieve of 18 mesh.
G. redrying: particle that granulation obtains is laid in baking pan, thickness is no more than 5 ㎝, is then fed into thermal cycle
It is 5-8 hours dry at a temperature of 70-80 DEG C in baking oven.
H. whole grain: the particle after redrying is added in oscillating granulator and carries out whole grain with 18 mesh screens.
I. total mix: particle after arrangement is placed in clean three-dimensional motion mixer, total mix 15 minutes.After total mix
Particle is connected from the double-layer plastic bag of discharge port cleaning, is weighed.
J. it fills: the charging of NJP-2200 type Autocapsulefillingmachine Capsules is added in 1# reddish yellow gelatin hollow capsule
In bucket, the particle handled through total mix is added in NJP-2200 type Autocapsulefillingmachine silo, requires 0.25g according to loading amount
Test run is carried out, checks content uniformity, control range 0.228g-0.273g, filling of driving after qualified.In filling process, examine at any time
Capsule appearance is looked into, filled capsule 10 is weighed within every 30 minutes, weighs, the loading amount of control filling at any time is in acceptability limit
It is interior.Filled Huoxuetongmai capsules body every must lock, and wabbler, elephant skin, notch, flat head be removed, sum must not
More than 1%.
K. polishing process: starting capsule polisher and dust catcher pour into filled capsule in polishing machine loading hopper, into
Row polishing.Quality of finish, shiny appearance must not have attached powder, rubber shell, fragment, ghost check at any time in polishing process.
Performance test
The character of Leech capsule made from detection embodiment 1, total ash content, acid-insoluble ash content, moisture content,
Content uniformity, disintegration time limited, aerobic bacteria sum, yeast and mold sum, bile tolerance Gram-negative bacterial content, large intestine angstrom are uncommon
Bacterial content and sramana's bacterial content, the results are shown in Table 1；
Wherein, the detection method of character are as follows: range estimation, smelling；
Antithrombin activity: according under " Chinese Pharmacopoeia 2015 editions " leech, antithrombin activity measuring method measures powder
Antithrombin activity in broken raw material leech, leech or willow leaf leech powder, every 1g leech containing antithrombin activity should be not less than
16.0U；Leech, willow leaf leech should be not less than 3.0U.
Total ash content is carried out according to total ash measuring method in 2302 Ash determination method of " Chinese Pharmacopoeia 2015 editions " general rule
Measurement；
Acid-insoluble ash content is according to acid-insoluble ash in 2302 Ash determination method of " Chinese Pharmacopoeia 2015 editions " general rule
Measuring method is measured；
Moisture content is measured according to 0832 the second method of aquametry of " Chinese Pharmacopoeia 2015 editions " general rule；
Content uniformity is measured according to 0942 Minimum loading capacity examination method of " Chinese Pharmacopoeia 2015 editions " general rule；
Disintegration time limited is measured according to 0921 disintegration time limit test of " Chinese Pharmacopoeia 2015 editions " general rule；
Aerobic bacteria is non-sterile micro- according to the non-sterile microbial decolorization of " Chinese Pharmacopoeia 2015 editions " general rule 1105 and 1106
Biological limit test method is measured；
Aerobic bacteria sum is non-according to the non-sterile microbial decolorization of " Chinese Pharmacopoeia 2015 editions " general rule 1105 and 1106
Sterile microbial decolorization is measured；
Yeast and mold sum according to the non-sterile microbial decolorization of " Chinese Pharmacopoeia 2015 editions " general rule 1105 and
1106 non-sterile microbial decolorizations are measured；
Bile tolerance Gram-negative bacterial content is examined according to the non-sterile microbial limit of " Chinese Pharmacopoeia 2015 editions " general rule 1105
It looks into method and 1106 non-sterile microbial decolorizations is measured；
Escherichia coli content according to the non-sterile microbial decolorization of " Chinese Pharmacopoeia 2015 editions " general rule 1105 and
1106 non-sterile microbial decolorizations are measured；
Sramana's bacterial content is non-according to the non-sterile microbial decolorization of " Chinese Pharmacopoeia 2015 editions " general rule 1105 and 1106
Sterile microbial decolorization is measured.
1 the performance test results of table
As shown in Table 1, capsule 's content made from method of the invention is particle of the brown color to sepia, gas raw meat, taste
It is light, it is placed in the non-aggregated agglomeration of 5min in air；Total ash content is 5.1%-5.7%, and acid-insoluble ash content is 0.3%-
0.5%, moisture content 4.1%-4.6%, content uniformity are ± 4.1, disintegration time limited 17-21min, and aerobic bacteria sum is
5000-6000cfu/g, yeast and mold sum are 32-35cfu/g, and bile tolerance Gram-negative bacterial content is 70-74cfu/
G, escherichia coli are not detected, and detection of Salmonella is not detected.Thus it proves, capsule stability of the invention is good, and impurity content is low, moisture
Content is low, and loading amount homogeneity is good, and disintegration rate is fast, and content of microorganisms is low.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (9)
1. the preparation method of Leech capsule, including it is drying, cooling, crushing, sterilizing, mixing softwood, granulation, redrying, whole
Grain, total mix, filling and polishing process, which is characterized in that described crush is that water-cooled crushes.
2. the preparation method of Leech capsule according to claim 1, which is characterized in that the crushing, which refers to, is crushed to partial size
For 0.125mm.
3. the preparation method of Leech capsule according to claim 1 or 2, which is characterized in that the temperature of the drying is 70-
80 DEG C, the time is 8-10 hours.
4. the preparation method of Leech capsule according to claim 1,2 or 3, which is characterized in that the cooling refers to cooling
To 40 DEG C.
5. the preparation method of Leech capsule according to claim 1,2,3 or 4, which is characterized in that the sterilizing is Co-60
Irradiation sterilization, irradiation dose 9.8KGr.
6. the according to claim 1, preparation method of Leech capsule described in 2,3,4 or 5, which is characterized in that the mixing refers to
By the Leech of sterilization treatment and volume fraction be 95% ethanol solution and pure water according to mass ratio be that 60:4:2 is mixed, so
After softwood is made.
7. the according to claim 1, preparation method of Leech capsule described in 2,3,4,5 or 6, which is characterized in that the whole grain is
Refer to and carries out whole grain with the sieve of 24 mesh.
8. the preparation method of Leech capsule according to claim 1,2,3,4,5,6 or 7, which is characterized in that described secondary
Dry to refer to that the particle for obtaining granulation is laid in baking pan, thickness is no more than 5 ㎝, then the dry 5-8 at a temperature of 70-80 DEG C
Hour.
9. the according to claim 1, preparation method of Leech capsule described in 2,3,4,5,6,7 or 8, which is characterized in that described to fill out
Control loading amount is 0.228g-0.273g during filling.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811249256.0A CN109172610A (en) | 2018-10-25 | 2018-10-25 | The preparation method of Leech capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811249256.0A CN109172610A (en) | 2018-10-25 | 2018-10-25 | The preparation method of Leech capsule |
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| CN109172610A true CN109172610A (en) | 2019-01-11 |
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| CN201811249256.0A Pending CN109172610A (en) | 2018-10-25 | 2018-10-25 | The preparation method of Leech capsule |
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Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1927363A1 (en) * | 2006-06-28 | 2008-06-04 | Zhenguo Li | An extract for preventing or treating thrombotic diseases |
| CN102028712A (en) * | 2010-12-20 | 2011-04-27 | 重庆时珍阁普生药业有限公司 | Method for preparing enteric capsules by taking leech as raw material |
| CN104324055A (en) * | 2014-10-17 | 2015-02-04 | 磐安县道地磐药中药研究所 | Leech pure powder ultramicro decoction piece and preparation method thereof |
| CN105031010A (en) * | 2015-08-13 | 2015-11-11 | 重庆多普泰制药股份有限公司 | Lucid ganoderma leech capsule as well as preparation method and application thereof |
| CN107875175A (en) * | 2017-11-16 | 2018-04-06 | 广西远程水蛭养殖有限公司 | Leech capsule |
| CN109091517A (en) * | 2018-11-06 | 2018-12-28 | 山西天致药业有限公司 | The preparation method of Gucining eapsule |
-
2018
- 2018-10-25 CN CN201811249256.0A patent/CN109172610A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1927363A1 (en) * | 2006-06-28 | 2008-06-04 | Zhenguo Li | An extract for preventing or treating thrombotic diseases |
| CN102028712A (en) * | 2010-12-20 | 2011-04-27 | 重庆时珍阁普生药业有限公司 | Method for preparing enteric capsules by taking leech as raw material |
| CN104324055A (en) * | 2014-10-17 | 2015-02-04 | 磐安县道地磐药中药研究所 | Leech pure powder ultramicro decoction piece and preparation method thereof |
| CN105031010A (en) * | 2015-08-13 | 2015-11-11 | 重庆多普泰制药股份有限公司 | Lucid ganoderma leech capsule as well as preparation method and application thereof |
| CN107875175A (en) * | 2017-11-16 | 2018-04-06 | 广西远程水蛭养殖有限公司 | Leech capsule |
| CN109091517A (en) * | 2018-11-06 | 2018-12-28 | 山西天致药业有限公司 | The preparation method of Gucining eapsule |
Non-Patent Citations (5)
| Title |
|---|
| CHEN,QIUYUE等: ""Effect of Leech Capsule on stability of carotid plaque and expression of platelet membrane glycoprotein"", 《CHINA JOURNAL OF TRADITIONAL CHINESE MEDICINE AND PHAMACY》 * |
| 倪立坚等: ""水蛭的3中炮制品质量分析比较"", 《海峡药学》 * |
| 孔令提: ""活血通络软胶囊的研制"", 《中国优秀硕士学位论文全文数据库（电子期刊）》 * |
| 杨流宽: ""水蛭软胶囊剂的研究"", 《中国优秀硕士学位论文全文数据库（电子期刊)》 * |
| 湖北省食品药品监督管理局编: "《湖北省医疗机构制剂规范》", 30 November 2012 * |
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Application publication date: 20190111 |