CN1214245A - Application of sinomenine in preparing analgesic - Google Patents
Application of sinomenine in preparing analgesic Download PDFInfo
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- CN1214245A CN1214245A CN 98120610 CN98120610A CN1214245A CN 1214245 A CN1214245 A CN 1214245A CN 98120610 CN98120610 CN 98120610 CN 98120610 A CN98120610 A CN 98120610A CN 1214245 A CN1214245 A CN 1214245A
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Abstract
The present invention discloses new application of sinomenine in preparing analgesic, which has especially high pain relieving effect for postoperative pain.
Description
The invention relates to the new medicine use invention of sinomenine, specifically is the application of sinomenine in the preparation analgesic drug product, belongs to drug world.
Sinomenine (sinomenine) is one of alkaloid that extracts from the stem of menispermaceae plant Sinomenium acutum Sinomenium acutum (Thunb.) R.etWils. and root, is a kind of known medical substance.Modern pharmacology studies show that sinomenine has multiple pharmacological effect.Put it briefly, the main pharmacological of the sinomenine of having known at present is as follows: effect such as antiinflammatory, blood pressure lowering, inhibition maincenter, arrhythmia (Ling Xiuzhen, etc., Acta Pharmaceutica Sinica 1962,9 (7): 393: Zhao Dehua, Deng, Acta Pharmaceutica Sinica, 1985,20 (11): 856: Zhang Mingfa, joint is newly cured in Shaanxi, and 1981,10 (10): 57); Body nonspecific immunity, cellular immunization and humoral immunization all there is inhibitory action, especially the lymphocytic function of T there is stronger inhibitory action (Peng Huimin, Deng, the immunosuppressive action of sinomenine, Acta Pharmacologica Sinica 1988,9 (4) 377-380): sinomenine be again a kind of histamine liberators (Feng Jingyi, etc., the pharmacological action VII of sinomenine is to active influence of gastrointestinal and mechanism thereof, Acta Pharmaceutica Sinica 1965; 12:492); Be used for the treatment of clinically rheumatoid arthritis evident in efficacy (Zhang Xin, etc., the Shaanxi traditional Chinese medical science, 1980,5:13; Refined Pu, Hunan Province county institute of traditional Chinese medicine scientific research group, barefoot doctor's magazine, 1975,12:612); Someone also to the mechanism of action of sinomenine treatment rheumatoid arthritis carried out studying (Li Siying, etc., sinomenine to effect of immunologic function, Chinese herbal medicine, 1992,23 (2): 81-83).Up to the present, also there is not relevant sinomenine to be used for the analgesic report.
The inventor observes through clinical practice, finds that sinomenine has good analgesic effect, has finished the present invention.
Therefore, the object of the invention provides a kind of new purposes of sinomenine, is the application of sinomenine in the preparation analgesic drug product specifically.
Sinomenine has had product to sell as a kind of medicine, for example, the sinomenine that area, Qianyang, Hunan pharmaceutical factory produces (sinomenime, SIN), the sinomenine hydrochloride powder that connection pharmaceutical factory produces in the Wuhan City, etc.
Therefore, sinomenine is as treatment treatment of pain medicine, according to the formulation method of routine, can be prepared into any pharmaceutical dosage form that is suitable for using clinically, for example, tablet, pill, capsule, electuary, oral liquid, Emulsion, suspensoid, injection, suppository, unguentum, etc.
Except the said sinomenine of the present invention, acceptable salt on the materia medica of sinomenine, for example, sinomenine hydrochloride has the analgesic effect equally.Therefore, the application in the preparation analgesic drug product of sinomenine and pharmaceutical salts thereof all belongs to protection scope of the present invention.
Acceptable salt can add excipient commonly used on the materia medica on sinomenine and the materia medica thereof when being used to prepare analgesic drug product, as, binding agent, disintegrating agent, filler, lubricant, solubilizing agent, antiseptic, flavoring agent, solvent, emulsifying agent, etc.
Acceptable salt also can be made medicament by the medicine compatible with other together on sinomenine and the materia medica thereof when being used to prepare analgesic drug product.
Embodiment 1
Sinomenine hydrochloride powder 25000mg, available from joining pharmaceutical factory in the Wuhan City, medical starch 250g, an amount of pelletize of ethanol, drying is advanced the tablet machine tabletting, makes 1000, and every sheet heavily is 275mg, hydrochloric sinomenine 25mg.
Embodiment 2
Sinomenine 20000mg, starch 180g, the two fully mixes, and is encapsulated, makes 2000 capsules, and every 0.1g is heavy, hydrochloric sinomenine 10mg.
The invention discloses the application of acceptable salt in the preparation analgesic drug product on sinomenine and the materia medica thereof.According to the preparation technique of routine, sinomenine, sinomenine hydrochloride etc. can be made various medicaments, be used for pain relieving.
The commodity preparation of sinomenine is existing to be sold, and its active ingredient of commercially available ZHENGQINGFENGTONGNING promptly is a sinomenine.Therefore the application's experimental drug is with the statement of trade name ZHENGQINGFENGTONGNING, and the drug function of sinomenine has been represented in its effect.
Experimental example sinomenine treatment postoperative pain clinical summary.
People's Hospital, Hunan Prov., an attached hospital of Hunan College of Traditional Chinese Medicine, Changsha four-player people hospital adopted art pain 60 examples behind the ZHENGQINGFENGTONGNING injection for treating that the just clear pharmaceutical Co. Ltd in White Cloud Mountain, intramuscular injection Hunan produces on April 15th, 1998 to June 20, and compare with intramuscular injection rotundine 30 examples, obtained better curative effect, now be summarized as follows:
1, clinical data
1.1 case source and grouping: 90 routine patients are three hospitals surgical patient of being in hospital, and are divided into 2 groups at random by the operating time serial number.Wherein province the People's Hospital 30 examples were divided into groups by 2: 1; An attached hospital of Hunan College of Traditional Chinese Medicine 40 examples, by grouping in 3: 1, Changsha four hospitals were by grouping in 1: 1.Treatment batch total 60 examples, contrast batch total 30 examples, two groups of sexes, the age, operative site, anesthesia method, operating time, distribution situations such as incision length see Table 1, table 2, table 3, table 4.
Table 1 liang group patient ordinary circumstance constituent ratio
| Group | The example number | Sex men and women | Age | (X ± sd year) |
| Treatment group matched group | ?60 ?30 | ?38?32 ?19?11 | ?35.9±13.4 ?36.9±14.9 | ?t=0.3215 ?p＞0.05 |
Table 2 a liang group patient operative site constitutes situation
| Group | The example number | Outer wall of a city room portion | Epigastrium | Hypogastric region | Other |
| Treatment group matched group | ????60 ????30 | ????8 ????4 | ????16 ????6 | ????30 ????18 | ????6 ????2 |
X
2=0.9986?p＞0.05
Table 3 liang group patient anesthesia method constituent ratio
| Group | The example number | General anesthesia | Local anaesthesia | Connect hard outer fiber crops | Other |
| Treatment group matched group | ?60 ?30 | ?9 ?4 | ?9 ?6 | ????40 ????19 | ????2 ????1 |
(4) operative site: head, neck, breast, abdominal part, extremity, anorectal are divided.
4, therapeutic scheme
Test group: ZHENGQINGFENGTONGNING injection, 50mg (2ml), intramuscular injection.
Matched group: rotundine injection, 60mg (2ml), intramuscular injection.
5, efficacy evaluation
Clinic control: pain disappears, and score reduces more than 90%, does not have recurrence in 3 hours.
Produce effects: the pain pain is basic to be alleviated, and score reduces 70-89%, though there is recurrence slighter in 3 hours.
Effectively: pain relief, score reduces 30-69%, does not increase the weight of in 3 hours.
Invalid: pain degree no change before and after the medication, score reduces less than 30%.
6, therapeutic outcome
6.1 two groups of therapeutic outcomes see Table 5,6,7.
Table 5 liang group patient analgesic effect relatively
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate % |
| Treatment group matched group | ?60 ?30 | ????26 ????6 | ????8 ????2 | ????7 ????9 | 19 13 | ????68.33 ????56.67 |
U=1.996＞1.96?p＜0.05
The Ridiit check shows: two groups of postoperative analgesia curative effect differences have the significance meaning
(p＜0.05), the treatment group is better than matched group.
The different operative site curative effects of table 6 liang group patient relatively
| The position | Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate % |
| Breast upper abdomen lower abdomen other | Treatment group treatment of control group group treatment of control group group treatment of control group group control group | ?8 ?4 ?16 ?6 ?30 ?18 ?6 ?2 | ????3 ????2 ????0 ????0 ????20 ????3 ????3 ????1 | ????0 ????0 ????1 ????0 ????7 ????1 ????0 ????0 | ????0 ????0 ????4 ????1 ????3 ????8 ????0 ????0 | ????5 ????2 ????11 ????5 ????0 ????6 ????3 ????1 | ????37.5 ????50 ????31.25 ????20 ????100 ????66.7 ????50 ????50 |
Table 4 liang group patient's incision length and operating time are relatively
| Group | The example number | Incision length (mm) | Operating time (h) |
| Treatment group matched group | ?60 ?30 | ?92.5±48.6 ?90.4±54.7 | ????2.45±1.87 ????2.23±1.63 |
T
1=0.1853?P＞0.05????T
2=0.2741?P＞0.05
Learn by statistics to handle and show: two groups of patient's sexes, the age, operative site, anesthesia method, incision length, operating time constituent ratio difference does not have the significance meaning, has comparability.
2, medical diagnosis on disease
2. diagnostic criteria
(1) patient has recent history of operation.
(2) postoperative wound or operation influences position pain, are difficult to stand the palpus person that use the analgesic.
2.2 case is included standard in
All postoperative pain that meets diagnostic criteria are difficult to bear the receptor and all can include the test case in.
2.3 case exclusion standard
(1) history of drug abuse is arranged, morphine class medicine addict.
(2) postoperative had been used other analgesics person.
(3) pain is slight, the person that need not use the analgesic.
(4) be associated with serious diseases such as cardiovascular, liver, kidney, hemopoietic system, or stupor, the psychotic.
(5) not medication in accordance with regulations can't be judged curative effect person.
3, observation index
3.1 observation of curative effect
(1) analgesic effect: compare by pain degree 0-10 score before and after the medication.
(2) analgesic effect: pain duration of seizure, pain relieving time after the medication.
(3) dose-effect relationship: dosage and pain relief degree relation.
(4) have or not recurrence: time and degree.
3.2 untoward reaction is observed: the various untoward reaction that occur behind the recording medicine.
3.3 the project that other need write down:
(1) anesthesia method: local anaesthesia, which kind of mode of epidural fiber crops are adopted in operation.
(2) anesthesia dosage: the anesthetics consumption that uses in the art.
(3) incision length: in mm.
As can be seen from the above table, operation has better curative effect to two groups of patients to hypogastric region, especially treat effective percentage and reach 100%, and to breast portion, the epigastrium curative effect is relatively poor.
Table 7 liang group patient's curative effect and incision length relation are relatively
| Incision length≤80nm＞80nm | Group treatment group treatment of control group group matched group | Example several 35 16 25 14 | Clinic control 23 630 | Produce effects 3151 | Effective 2445 | Invalid 75 13 8 | Total effective rate % 80 68.75 48 42.86 |
As can be seen from the above table, two groups of curative effects and incision length have certain relation, and otch is long more, and curative effect is poor more, but the treatment group is better than matched group.
Suffer from the medication process and finding 6.2 60 examples are controlled the effect group, patient's upper abdominal surgery (stomach, gallbladder, kidney, intestinal) and operation on breast, because of long incision, time is long, postoperative analgesia effect heterodyne, but to hypogastric region operation (blue tail, gas, bladder), anorectal and mammary gland benign tumors enucleation etc., short because of otch, operating time is short, so analgesic effect is obvious.
7, untoward reaction: there are 3 application on human skin urticaria to occur in the medication process, skin pruritus, but disappear automatically after half an hour.Do not see other untoward reaction.
8, brief summary:
According to clinical program, we carry out the analgesic effect observation to " ZHENGQINGFENGTONGNING injection " to postoperative pain, and the result is as follows:
8.1 positive fresh breeze pain injection has better analgesic effect to postoperative pain, effective percentage reaches 68.33%, uses analgesic relatively with rotundine etc., and difference has significance meaning (p＜0.05).
8.2 ZHENGQINGFENGTONGNING injection analgesic effect and corrective surgery incision length, operating time, operative site have certain relation.To hypogastric region, anorectal portion, operations such as breast portion, the operative incision shorter one, analgesic effect is obvious.
8.3 ZHENGQINGFENGTONGNING injection analgesic effect and dosage do not have obvious relation.Behind the conventional use amount 50mg of patient, as alleviation person not, escalated dose goes out to reach analgesic effect.And the patient who has only annotates 25mg, also can produce obvious pain relieving.
8.4 the visible temporary skin pruritus of ZHENGQINGFENGTONGNING injection depolarization a few patients outside the urticaria, does not have other any toxic and side effects.
Claims (2)
1, sinomenine and pharmaceutical salts thereof the application in the preparation analgesic drug product.
2, sinomenine and pharmaceutical salts thereof the application in the medicine of preparation treatment postoperative pain.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98120610A CN1078467C (en) | 1998-10-15 | 1998-10-15 | Application of sinomenine in preparing analgesic |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN98120610A CN1078467C (en) | 1998-10-15 | 1998-10-15 | Application of sinomenine in preparing analgesic |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1214245A true CN1214245A (en) | 1999-04-21 |
| CN1078467C CN1078467C (en) | 2002-01-30 |
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ID=5226815
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN98120610A Expired - Lifetime CN1078467C (en) | 1998-10-15 | 1998-10-15 | Application of sinomenine in preparing analgesic |
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| Country | Link |
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| CN (1) | CN1078467C (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961295A (en) * | 2012-12-14 | 2013-03-13 | 柳州两面针股份有限公司 | Application of caulis sinomenii extract to preparation of oral care products |
| WO2013170711A1 (en) | 2012-05-17 | 2013-11-21 | Gao Tongqiang | Analgesic pharmaceutical composition |
| CN105998023A (en) * | 2016-05-17 | 2016-10-12 | 南通大学 | Application of N-demethylsinomenine in preparation of analgesic drug |
| CN111773221A (en) * | 2020-07-21 | 2020-10-16 | 李蕴麟 | Application of sinomenine and derivatives or pharmaceutically acceptable salts thereof in preparing medicine for treating breast diseases |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1186668A (en) * | 1996-12-31 | 1998-07-08 | 四川太极制药有限公司 | Sinomenine hydrocloride preparation and its preparing process |
-
1998
- 1998-10-15 CN CN98120610A patent/CN1078467C/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013170711A1 (en) | 2012-05-17 | 2013-11-21 | Gao Tongqiang | Analgesic pharmaceutical composition |
| CN102961295A (en) * | 2012-12-14 | 2013-03-13 | 柳州两面针股份有限公司 | Application of caulis sinomenii extract to preparation of oral care products |
| CN105998023A (en) * | 2016-05-17 | 2016-10-12 | 南通大学 | Application of N-demethylsinomenine in preparation of analgesic drug |
| CN105998023B (en) * | 2016-05-17 | 2019-12-20 | 南通大学 | Application of demethylsinomenine in preparation of analgesic |
| CN111773221A (en) * | 2020-07-21 | 2020-10-16 | 李蕴麟 | Application of sinomenine and derivatives or pharmaceutically acceptable salts thereof in preparing medicine for treating breast diseases |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1078467C (en) | 2002-01-30 |
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Granted publication date: 20020130 |