CN1186668A - Sinomenine hydrocloride preparation and its preparing process - Google Patents
Sinomenine hydrocloride preparation and its preparing process Download PDFInfo
- Publication number
- CN1186668A CN1186668A CN96114020A CN96114020A CN1186668A CN 1186668 A CN1186668 A CN 1186668A CN 96114020 A CN96114020 A CN 96114020A CN 96114020 A CN96114020 A CN 96114020A CN 1186668 A CN1186668 A CN 1186668A
- Authority
- CN
- China
- Prior art keywords
- weight portion
- sinomenine
- pharmaceutical preparation
- starch
- mesh sieves
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The Sinomenine hydrocloride preparation contains sinomenine hydrochloride in 10-40 wt% and excipient in 60-90 wt% with analgesia, antiphlogosis, immunodepression and other functions, the said medicine preparation is used to cure various rheumatism.
Description
The present invention is the rheumatismal medicine of a kind of treatment, specifically relates to a kind of sinomenine preparation, particularly sinomenine hydrochloride enteric coatel tablets, and this medicine can be used for treating various rheumatisms, and has effects such as analgesia, antiinflammatory, immunosuppressant.
As far back as the Ming Dynasty, the famous medical scholar's Li Shizhen (1518-1593 A.D.) of China order in Compendium of Material Medica: " Caulis Sinomenii dispelling the wind and dampness pathogens multiple abscess, severe and migratory arthralgia crane knee joint, paralysis pruritus ... "." book on Chinese herbal medicine converge with speech " day: " Caulis Sinomenii, the medicine of dispersing wind and cold arthralgia chiefly caused by damp pathogen also, can relaxing muscles and tendons to promote blood circulation, the sharp marrow that bonesets is obeyed informal dress for a long time and is made outstanding contributions greatly." Chinese Pharmacopoeia 77 editions, 90 editions, 95 editions all records.Because Caulis Sinomenii has significant curative effect to the treatment rheumatism, therefore caused the great interest of the domestic and international expert of the world of medicine.Sinomenine (sinomenine) is one of alkaloid that extracts from the stem of menispermaceous plants Sinomenium acutum Sinomenium acutum (Thunb.) R.et Wils. and root.Although for the pharmaceutical research of sinomenine, existing more bibliographical information,,, still do not see disclosed document record about the pharmaceutical preparation of sinomenine.Because sinomenine has multiple pharmacological effect, it is developed as a kind of pharmaceutical preparation that is suitable for clinical use, be to the further developing of sinomenine research, also provide new medicine for various rheumatismal treatments clinically.
The object of the invention provides a kind of pharmaceutical preparation of sinomenine, particularly sinomenine hydrochloride enteric coated tablet preparation.
Another object of the present invention provides the preparation technology of sinomenine hydrochloride enteric coated tablet.
The said sinomenine preparation of the present invention contains:
The sinomenine of 10-40% weight portion
The excipient of 90-60% weight portion.
In the above-mentioned sinomenine preparation, sinomenine preferably uses sinomenine hydrochloride; According to the preparation process of routine, according to above-mentioned group and consumption proportion, can be prepared into the various pharmaceutical preparatioies that are suitable for clinical practice, as, tablet, capsule, pill, powder, syrup, unguentum etc.
Consisting of of sinomenine hydrochloride tablet of the present invention:
Sinomenine hydrochloride 0.005-0.1 weight portion
Sodium Hydroxymethyl Stalcs 0.005-0.1 weight portion
Medical starch 0.01-0.1 weight portion
Dextrin 0.01-0.1 weight portion
The optimum amount proportioning of above-mentioned each drug component is:
Sinomenine hydrochloride 0.02 weight portion
Sodium Hydroxymethyl Stalcs 0.025 weight portion
Medical starch 0.04 weight portion
Dextrin 0.05 weight portion
Above-mentioned tablet can also add the magnesium stearate of 0.0001-0.0005 weight portion.
The preparation technology of sinomenine hydrochloride tablet of the present invention is:
One, supplementary material is handled:
1, sinomenine hydrochloride is crossed 100 mesh sieves, the crystalline solid of failing to pass through should be with omnipotent mill pulverizer grinding and sieving;
2, carboxymethyl starch sodium, starch, dextrin are crossed 100 mesh sieves, and magnesium stearate is crossed 40 mesh sieves.
Two, batching and granulation:
1, calculates inventory by prescription, accurately take by weighing supplementary material, drop into mixer mixing 4-10 minute, add 10% starch slurry, stirred 2-8 minute, make soft material;
2, granulate in granulation machine with 8 order glue sieve, wet grain is loose and complete, is with fine powder less.
Three, drying:
1, the shop sieve should be even, and thickness is suitable, and 60-70 ℃ of aeration-drying is stirred once when baking is extremely half-dried;
2, the granule water content is controlled between the 6-8%.
Four, dried joining:
In granulation machine,, and add lubricating substance gradually, in the V-type machine, mixed 8-10 minute with 16 order iron wire sieve granulate.
Five, tabletting:
1, with 7% shallow molded tablet;
2, heavily about 0.125 gram of sheet.
Six, coating:
Adopt film coating method bag enteric film clothing.
Seven, packing:
The plastic-aluminum packing.
The application's applicant has carried out number of research projects to sinomenine, and physicochemical property, pharmacology, toxicity, preparation process, the quality standard of medicine of the present invention carried out systematic research, carried out preliminary clinical verification work, Clinical results shows medicine of the present invention and has that but curative effect height, side reaction are little, the characteristics of patient's prolonged application, is the ideal medicament for the treatment of rheumatism at present.
Sinomenine preparation of the present invention has following pharmacological action:
1, analgesic activity;
2, antiinflammatory, antiinflammatory action;
3, immunosuppressive action is to multiple body fluid and cell immune response index performance inhibitory action;
4, treat rheumatismal effect, several rheumatism 263 examples of Drug therapy of the present invention, and compare with aspirin matched group 59 examples, treatment group total effective rate is 89%, matched group is 86.5% (P＞0.05).
5, to the influence of blood rheology parameter:
For the rabbit stasis syndrome model that causes with glucosan, sinomenine hydrochloride can make animal's whole blood viscosity and plasma viscosity and packed cell volume descend.Show that sinomenine has the improvement effect to microcirculation disturbance.
6, sedation:
Sinomenine hydrocloride preparation has significant sedation.Experimental result shows that it can obviously reduce mice autonomic activities, passive activity ability; Also can eliminate electricity irritation mice caused " excite state " reaction, illustrate that sinomenine has stable effect.Give the sinomenine of cat lumbar injection 5mg/kg, positive defensive conditionedreflex is obviously prolonged incubation period, trained reflex partly disappears.
7, discharge the histamine effect:
Sinomenine is a kind of strong histamine liberator, and remarkable swelling of rat ascites mastocyte and granule are reduced, and granule reduces and be accompanied by histamine release, thereby the prompting sinomenine has the histamine effect in the emptying mast cell granule.This effect of sinomenine not only slackens its analgesic activity, also is to produce gastrointestinal reaction and urticarial main cause.As use antihistaminic, and not only can strengthen its analgesic activity, can also resist its excited gastrointestinal reaction and urticarial appearance.
8, hypotensive effect.
Embodiment 1
Sinomenine hydrochloride 0.005 gram
Sodium Hydroxymethyl Stalcs 0.005 gram
Medical starch 0.01 gram
Dextrin 0.01 gram
Technology:
1, sinomenine hydrochloride is crossed 100 mesh sieves, the crystalline solid of failing to pass through should be with omnipotent mill pulverizer grinding and sieving;
2, carboxymethyl starch sodium, starch, dextrin are crossed 100 mesh sieves, and magnesium stearate is crossed 40 mesh sieves;
3, calculate inventory by prescription, accurately take by weighing supplementary material, drop into mixer and mixed 6 minutes, add 10% starch slurry, stirred 5 minutes, make soft material;
4, granulate in granulation machine with 8 order glue sieve, wet grain is loose and complete, is with fine powder less;
5, the shop sieve should be even, and thickness is suitable, and 60-70 ℃ of aeration-drying is stirred once when baking is extremely half-dried;
6, the granule water content is controlled between the 6-8%;
7, in granulation machine with 16 order iron wire sieve granulate, and add the lubricating substance magnesium stearate gradually, in the V-type machine, mixed 8-10 minute;
8, with 7% shallow molded tablet, heavily about 0.125 gram of sheet;
9, adopt film coating method bag enteric film clothing, plastic-aluminum packing.
Embodiment 2
Sinomenine hydrochloride 0.1 gram
Sodium Hydroxymethyl Stalcs 0.1 gram
Medical starch 0.1 gram
Dextrin 0.1 gram
Technology:
1, sinomenine hydrochloride is crossed 100 mesh sieves, the crystalline solid of failing to pass through should be with omnipotent mill pulverizer grinding and sieving;
2, carboxymethyl starch sodium, starch, dextrin are crossed 100 mesh sieves, and magnesium stearate is crossed 40 mesh sieves;
3, calculate inventory by prescription, accurately take by weighing supplementary material, drop into mixer and mixed 6 minutes, add 10% starch slurry, stirred 5 minutes, make soft material;
4, granulate in granulation machine with 8 order glue sieve, wet grain is loose and complete, is with fine powder less;
5, the shop sieve should be even, and thickness is suitable, and 60-70 ℃ of aeration-drying is stirred once when baking is extremely half-dried;
6, the granule water content is controlled between the 6-8%;
7, in granulation machine with 16 order iron wire sieve granulate, and add the lubricating substance magnesium stearate gradually, in the V-type machine, mixed 8-10 minute;
8, with 7% shallow molded tablet, heavily about 0.125 gram of sheet;
9, adopt film coating method bag enteric film clothing, plastic-aluminum packing.
Embodiment 3
Sinomenine hydrochloride 0.02 gram
Sodium Hydroxymethyl Stalcs 0.025 gram
Medical starch 0.04 gram
Dextrin 0.05 gram
Technology:
1, sinomenine hydrochloride is crossed 100 mesh sieves, the crystalline solid of failing to pass through should be with omnipotent mill pulverizer grinding and sieving;
2, carboxymethyl starch sodium, starch, dextrin are crossed 100 mesh sieves, and magnesium stearate is crossed 40 mesh sieves;
3, calculate inventory by prescription, accurately take by weighing supplementary material, drop into mixer and mixed 6 minutes, add 10% starch slurry, stirred 5 minutes, make soft material;
4, granulate in granulation machine with 8 order glue sieve, wet grain is loose and complete, is with fine powder less;
5, the shop sieve should be even, and thickness is suitable, and 60-70 ℃ of aeration-drying is stirred once when baking is extremely half-dried;
6, the granule water content is controlled between the 6-8%;
7, in granulation machine with 16 order iron wire sieve granulate, and add the lubricating substance magnesium stearate gradually, in the V-type machine, mixed 8-10 minute;
8, with 7% shallow molded tablet, heavily about 0.125 gram of sheet;
9, adopt film coating method bag enteric film clothing, plastic-aluminum packing.
Claims (7)
1, a kind of sinomenine pharmaceutical preparation is characterized in that it contains:
The sinomenine of 10-40% weight portion
The excipient of 90-60% weight portion.
2, pharmaceutical preparation according to claim 1 is characterized in that described pharmaceutical preparation is tablet, capsule, pill, powder, syrup, any in the unguentum.
3, pharmaceutical preparation according to claim 1 is characterized in that it contains:
Sinomenine hydrochloride 0.005-0.1 weight portion
Sodium Hydroxymethyl Stalcs 0.005-0.1 weight portion
Medical starch 0.01-0.1 weight portion
Dextrin 0.01-0.1 weight portion
4, pharmaceutical preparation according to claim 3 is characterized in that it contains:
Sinomenine hydrochloride 0.02 weight portion
Sodium Hydroxymethyl Stalcs 0.025 weight portion
Medical starch 0.04 weight portion
Dextrin 0.05 weight portion
5,, it is characterized in that it also contains the magnesium stearate of 0.0001-0.0005 weight portion according to claim 3 or 4 described pharmaceutical preparatioies.
6, pharmaceutical preparation according to claim 5 is characterized in that said preparation is a tablet.
7, the preparation technology of the said tablet of claim 6 is characterized in that it comprises the steps:
1), sinomenine hydrochloride 100 mesh sieves excessively, the crystalline solid of failing to pass through should be with omnipotent mill pulverizer grinding and sieving;
2), carboxymethyl starch sodium, starch, dextrin cross 100 mesh sieves, magnesium stearate is crossed 40 mesh sieves;
3), calculate inventory, accurately take by weighing supplementary material, drop into mixer mixing 4-10 minute, add 10% starch slurry, stirred 2-8 minute, make soft material by prescription;
4), granulate in granulation machine with 8 order glue sieves, wet grain is loose and complete, is with fine powder less;
5), 60-70 ℃ aeration-drying, baking is stirred once when half-dried;
6), control granule water content is between 6-8%;
7), in granulation machine with 16 order iron wire sieve granulate, and add lubricating substance gradually, mixed 8-10 minute;
8), tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96114020A CN1186668A (en) | 1996-12-31 | 1996-12-31 | Sinomenine hydrocloride preparation and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96114020A CN1186668A (en) | 1996-12-31 | 1996-12-31 | Sinomenine hydrocloride preparation and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1186668A true CN1186668A (en) | 1998-07-08 |
Family
ID=5121895
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96114020A Pending CN1186668A (en) | 1996-12-31 | 1996-12-31 | Sinomenine hydrocloride preparation and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1186668A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1076604C (en) * | 1998-12-24 | 2001-12-26 | 湖南正清制药集团股份有限公司 | Slow releasing agent of tuduvanine and its preparing method |
| CN1078467C (en) * | 1998-10-15 | 2002-01-30 | 湖南正清制药集团股份有限公司 | Application of sinomenine in preparing analgesic |
| CN1332669C (en) * | 2004-12-13 | 2007-08-22 | 北京正大绿洲医药科技有限公司 | Dripping pills for reducing swelling and easing pain and its preparing method |
-
1996
- 1996-12-31 CN CN96114020A patent/CN1186668A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1078467C (en) * | 1998-10-15 | 2002-01-30 | 湖南正清制药集团股份有限公司 | Application of sinomenine in preparing analgesic |
| CN1076604C (en) * | 1998-12-24 | 2001-12-26 | 湖南正清制药集团股份有限公司 | Slow releasing agent of tuduvanine and its preparing method |
| CN1332669C (en) * | 2004-12-13 | 2007-08-22 | 北京正大绿洲医药科技有限公司 | Dripping pills for reducing swelling and easing pain and its preparing method |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1032402C (en) | Granulated medicinal composition and the prepn thereof | |
| CN1211078C (en) | Regulated release preparations | |
| CN101073563A (en) | Chiral composition containing dextrothyroxine buprofenli and levomethadyl cysteliqin and its double slow-releasing tablet | |
| CN1186097C (en) | Pharmaceutical compositions comprising an aldose reductase inhibitor and an ACE inhibitor | |
| CN1044445C (en) | Tibetan preparatory medicine and preparation method thereof | |
| CN1608621A (en) | Fine bicyclic alcohol powder and oral bicyclic alcohol release controlling prepn | |
| CN1186668A (en) | Sinomenine hydrocloride preparation and its preparing process | |
| CN1709451A (en) | Underleaf pearl formulation for treatig liver-gallbladder diseases and its preparing method | |
| CN1443535A (en) | Tegasevod maleate oral preparation and its preparation process-for curing intestinal irritability syndrome | |
| CN101028329A (en) | Production and use for phyllanthin dispersing tablet preparation | |
| CN1074134A (en) | Granulated medicinal composition and preparation method thereof | |
| CN1159029C (en) | Blood lipoid regulating medicine and its prepn | |
| CN1234361C (en) | Method for preparing medicine of levo-stephandinine | |
| CN1810242A (en) | Slow-released vincamine capsule and its prepn process | |
| CN1799603A (en) | Chinese traditional medicine composition for treating rheumatic or rheumatoid disease and preparation method thereof | |
| CN101040850A (en) | Colchicine sustained-release pellets and the preparing method | |
| CN1679887A (en) | Chinese medicine composition for treating hepatitis | |
| CN1827117A (en) | Sustained release medicament of compound gossypol acetate | |
| CN1241572C (en) | Slow and control release aspirin capsule formulation and method for making same | |
| CN1389208A (en) | Orally taken pulsed releasing system of phenyl diazepine medicine and its prepn. | |
| CN1650992A (en) | Yinzhi huang capsule, its preparation method and use | |
| CN1535686A (en) | Slowly-released preparation containing loratadine and pseudoephedrine sulfate and its preparation method | |
| CN1954815A (en) | Anti-tuberculosis compound medicine quick-slow double-release preparation and its preparation method | |
| CN1660267A (en) | 'Yankening' pharmaceutical preparation and preparing method | |
| CN1194694C (en) | Slow-releasing maclobemide capsule |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C06 | Publication | ||
| PB01 | Publication | ||
| C01 | Deemed withdrawal of patent application (patent law 1993) | ||
| WD01 | Invention patent application deemed withdrawn after publication | ||
| REG | Reference to a national code |
Ref country code: HK Ref legal event code: GR Ref document number: 1043834 Country of ref document: HK |