CN1813778A - Method for preparing baicalin injection - Google Patents
Method for preparing baicalin injection Download PDFInfo
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- CN1813778A CN1813778A CN 200510101325 CN200510101325A CN1813778A CN 1813778 A CN1813778 A CN 1813778A CN 200510101325 CN200510101325 CN 200510101325 CN 200510101325 A CN200510101325 A CN 200510101325A CN 1813778 A CN1813778 A CN 1813778A
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Abstract
The present invention relates to a preparation method of baicalin injection. Said method is characterized by that firstly, the baicalin is dissolved by adopting composite solvent, the conventional injection technique can be utilized to obtain the baicalin injection. The composite solvent can be mixed solvent formed from ethyl alcohol and propylene alcohol or ethyl alcohol and glycerin.
Description
Technical field:
The present invention relates to a kind of preparation method of baicalin for injection liquid.
Background technology:
Radix Scutellariae is the root of labiate Radix Scutellariae, has heat clearing away, pathogenic fire purging, detoxifcation, hemostasis, effect such as antiabortive, and pharmacological action is extensive.In recent years, Chinese scholars has been carried out a large amount of research to it, and has reached higher level, and the main effective ingredient of modern study proof Radix Scutellariae is a baicalin.Baicalin is a flavone compound, it is removing interior free yl, alleviate the tissue ischemia reperfusion injury, regulate immunologic function, aspects such as hepatic cholagogic, infection, antitumor all have certain effect, be the constituent of plurality of Chinese preparation, but the baicalin for injection preparation that does not still have state approval production at present is used for clinical.This is that making injection type has certain difficulty because baicalin is insoluble in water.
Find a kind of preparation method of good baicalin for injection liquid, seem particularly urgent.
Summary of the invention:
The objective of the invention is baicalin is dissolved in certain solvent, and a kind of preparation method of baicalin for injection liquid is provided.
We provide a kind of preparation method of baicalin for injection liquid, adopt double solvents dissolving baicalin earlier, utilize the injection routine techniques to make injection again.
The purity of the baicalin that we are used is more than 90%.
The purity of preferred baicalin is more than 95%.
Wherein we determine double solvents by a large amount of experiment sievings: can select the mixed solvent of ethanol and glycerol for use, the ratio of ethanol and glycerol is 3-5: 5-7, and the ratio of preferred alcohol and glycerol is 4: 6; Also can select the mixed solvent of ethanol and propylene glycol for use, the ratio of ethanol and propylene glycol is 3-5: 5-7, and the ratio of preferred alcohol and propylene glycol is 4: 6.
With ethanol: propylene glycol (4: 6) is that the baicalin for injection liquid of double solvents can be finished according to the following steps:
1) getting ratio that baicalin fully is dissolved in ethanol and propylene glycol earlier is that cold preservation is spent the night in 4: 6 the double solvents;
2) solution titanium rod filters, and adds the active carbon of 0.05-0.15%, and 80 ℃ kept 30 minutes, and the titanium rod filters, be sub-packed in behind the fine straining in 2ml or the 5ml ampoule, and sealing by fusing, sterilization, promptly.
The present invention has solved present baicalin well because poorly water-soluble can not be made the problem of injection, dissolving baicalin that can be relatively large.The baicalin for injection liquid of making by method of the present invention further be studies show that advantage such as it is remarkable that said preparation has the anti-inflammation effect, and good stability is quality controllable, and toxic and side effects is little.
Specific embodiment:
Embodiment 1: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol propylene glycol (3: 7) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.40g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040115
Embodiment 2: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol propylene glycol (4: 6) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.32g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040120
Embodiment 3: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol propylene glycol (5: 5) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.50g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040125
Embodiment 4: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol glycerol (3: 7) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.28g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040205
Embodiment 5: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol propylene glycol (4: 6) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.40g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040210
Embodiment 6: the preparation of baicalin for injection liquid
Get baicalin 10g (Guanghan, Sichuan book on Chinese herbal medicine produce, baicalin purity is 97.0% after testing), add ethanol propylene glycol (5: 5) double solvents 350ml and fully dissolve evenly, cold preservation is spent the night to the freezer, filter, filtrate is replenished the corresponding proportion double solvents to 400ml, adds the 0.40g active carbon, keeps 80 ℃ of temperature 30 minutes, filter, fine straining is sub-packed in the 2ml ampoule sealing by fusing, sterilization promptly gets baicalin for injection liquid.Lot number: 040215
Embodiment 7: to the influence of mice thermostimulation pain reaction
The experiment medicine: baicalin for injection liquid, 50mg/ props up.Injection solution of the present invention preparation: get 100mg and 200mg, be diluted to 10mg/ml, the solution of two kinds of variable concentrations of 20mg/ml with the PBS buffer of pH7.4.
Aspirin is got 100mg, makes aspirin solution 10mg/ml with the PBS buffer dissolving of pH7.4.
The PBS buffer of PH7.4.Compound method, precision takes by weighing 8.5gNaCl, 2.2gNa2HPO4,0.2NaH2PO4 uses the 1000ml dissolved in distilled water, promptly gets the PH7.4PBS buffer.
Laboratory animal: 40 of Kunming mouses, female.
Experimental technique: getting 40 of female Kunming mouses, under 15-20 ℃ of room temperature condition, put 55 ± 5 ℃ of hot plates, is pain threshold with mice contact hot plate to licking the time that metapedes experienced; Reject the threshold of pain≤3s and 〉=the 30s mice.Qualified mice is divided into the sweet low dose group of baicalin high dose group (200mg/kg) Radix Scutellariae (100mg/kg), aspirin matched group (100mg/kg) and PBS buffer blank group at random.After each is organized mouse peritoneal injection and is subjected to the reagent thing, measure behind its medicine 15,30,60 respectively, the pain threshold during 90nin, (all pain thresholds＞60s person is in 60s) calculates the threshold of pain and improves behind the percentage rate %=[medicine pain threshold before pain threshold-medicine]/medicine before pain threshold * 100%].The results are shown in Table 1.
The influence of table 1 pair mice thermostimulation pain reaction
| Group | Dosage (mg/kg) | N (only) | Percentage rate (%) is improved in the threshold of pain | ||||
| Before the medication | 15min behind the medicine | 30min behind the medicine | 60min behind the medicine | 90min behind the medicine | |||
| The blank group | - | 10 | 17.65±4.54 | 5.63±0.36 | 8.18±2.13 | 15.20±1.28 | 14.44±1.37 |
| The aspirin group | 100 | 10 | 18.21±3.88 | 37.92±5.32 ** | 70.26±7.54 ** | 85.34±8.54 ** | 72.43±7.68 ** |
| Baicalin (height) | 200 | 10 | 17.65±2.56 | 36.65±4.24 ** | 68.32±5.33 ** | 81.63±7.87 ** | 70.53±6.88 ** |
| Baicalin (low) | 100 | 10 | 17.95±3.29 | 28.60±4.05 ** | 54.55±6.85 ** | 68.23±6.58 ** | 61.64±6.93 ** |
Annotate: compare with the blank group
*P＜0.05
*P＜0.01
Embodiment 8: to the influence of mice chemical stimulation pain reaction
The experiment medicine: baicalin for injection liquid, 50mg/ props up.Injection solution of the present invention preparation: get 100mg and 200mg, be diluted to 10mg/ml, the solution of two kinds of variable concentrations of 20mg/ml with the PBS buffer of pH7.4.
Aspirin is got 100mg, is dissolved into aspirin solution 10mg/ml with the PBS buffer of pH7.4.
The PBS buffer of PH7.4.Compound method, precision takes by weighing 8.5gNaCl, 2.2gNa2HPO4,0.2NaH2PO4 uses the 1000ml dissolved in distilled water, promptly gets the PH7.4PBS buffer.
Laboratory animal: 40 of Kunming mouses, male and female half and half.
Experimental technique: Kunming mouse, male and female half and half are divided into baicalin high dose group (200mg/kg) baicalin low dose group (100mg/kg), aspirin and PBS buffer blank group at random.Subcutaneous injection is subjected to reagent thing 30min pneumoretroperitoneum injection 0.1ml/LAA 0.2ml, and mouse writhing number of times in the counting 15min calculates pain suppression ratio (%)=[(matched group is turned round body number of times-experimental group and turned round the body number of times)/matched group is turned round body number of times * 100%].The results are shown in Table 2.
The influence of table 2 pair mice chemical stimulation pain reaction
| Group | Dosage (mg/kg) | N (only) | Turn round the body number of times | Suppression ratio (%) |
| Blank group aspirin baicalin (height) baicalin (low) | 100 200 100 | 10 10 10 10 | 44.75±16.15 24.39±17.52** 23.55±17.42** 27.78±16.84** | 45.5 46.3 37.9 |
Annotate: compare * P＜0.05**P＜0.01 with the blank group
Embodiment 9: the vitro antibacterial activity test
Experiment medicine: baicalin for injection liquid.PBS buffer with pH7.4 is diluted to 10mg/ml concentration.
The PBS buffer of PH7.4.Compound method, precision takes by weighing 8.5gNaCl, 2.2gNa2HPO4,0.2NaH2PO4 uses the 1000ml dissolved in distilled water, promptly gets the PH7.4PBS buffer.
Strain: staphylococcus aureus, Staphylococcus albus, bacillus pyocyaneus, hemophilus influenza, bacillus subtilis, escherichia coli, alpha streptococcus, group B streptococcus, streptococcus pneumoniae.
Experimental technique: preparation solid and fluid medium, transfer pH7.6,105 ℃ of sterilization 1h are standby.The medicinal liquid dilution, adopt continuous coubling dilution, get 10 of clean tube, add fluid medium 1.0ml respectively, the 1st pipe adds the baicalin solution 1.0ml of 10mg/ml concentration, takes out 1.0ml behind the mixing and adds the 2nd pipe, is diluted to the 9th pipe successively, take out 1.0ml and discard, the 10th pipe adds liquid culture medium 1.0ml and compares.Each pipe adds and plugs 105 ℃ of sterilizing pans sterilization 1h.Bacterium liquid preparation will preserve bacterium and respectively be got a little and be inoculated in respectively on the solid slant culture base, and 37 ℃ of cultivation 24h make actication of culture.Activated spawn is respectively got an inoculating loop be inoculated in respectively in the 1.0ml fluid medium, cultivate 8h for 37 ℃, get bacterium liquid 0.1ml subsequently again, add fluid medium to 1000 times of 100ml dilutions.The bacterium liquid of 1000 times of dilutions is respectively got 0.1ml add respectively in each medicinal liquid dilution tube, put in 37 ℃ of incubators and cultivate 24h, observe the variation of each pipe.Become turbid as test tube, showing has bacteria growing, and medicinal liquid does not have bacteriostasis; As the test tube clarification, then show asepsis growth, medicinal liquid has bacteriostasis.Minimum inhibitory concentration (MIC) is the medicinal liquid maximum dilution multiple of bacteria growing inhibiting.Each drug liquid tube of observing clarification, asepsis growth continues to put in 37 ℃ of incubators cultivates 48h, still clarifies the medicinal liquid maximum dilution multiple of asepsis growth, is minimum bactericidal concentration MBC.The results are shown in Table 3.
Minimum inhibitory concentration of table 3 baicalin (MIC) and minimum bactericidal concentration (MBC)
| Strain | Extension rate | Contrast | MIC | MBC | |||||||
| 20 | 40 | 80 | 160 | 320 | 640 | 1280 | 2560 | ||||
| Staphylococcus aureus staphylococcus albus Pseudomonas aeruginosa Bacillus influenzae hay bacillus Escherichia coli alpha streptococcus beta streptococcus pneumococcus | - - - - - - - - - | - - - - - - - - - | - - - - - (+) - - - | - - - - - + - - - | - - (+) - - + - - - | (+) (+) + - + + - - - | + + + - + + - - - | + + + + + + + + + | + + + + + + + + + | 640 640 320 1280 320 80 1280 1280 1280 | 320 320 160 1280 320 40 1280 1280 1280 |
Annotate: the clarification of-test tube, asepsis growth; + test tube muddiness has bacterium to give birth to; (+) continues to cultivate 48h, and the test tube muddiness has bacteria growing.
Embodiment 10: the influence of xylol induced mice auricle edema
The experiment medicine: baicalin for injection liquid, 50mg/ props up.Injection solution of the present invention preparation: get 100mg and 200mg, be diluted to 10mg/ml, the solution of two kinds of variable concentrations of 20mg/ml with the PBS buffer of pH7.4.
Aspirin is got 100mg, is dissolved into aspirin solution 10mg/ml with the PBS buffer of pH7.4.
The PBS buffer of PH7.4.Compound method, precision takes by weighing 8.5gNaCl, 2.2gNa2HPO4,0.2NaH2PO4 uses the 1000ml dissolved in distilled water, promptly gets the PH7.4PBS buffer.
Laboratory animal: 40 of Kunming mouses, male and female half and half.
Experimental technique: choose 40 of the healthy Kunming of body weight 18-22g kind white mice, male and female half and half are divided into the sweet low dose group of baicalin high dose group (200mg/kg) Radix Scutellariae (100mg/kg), aspirin and PBS buffer blank group, 10 every group at random.With each dosage group medicine lumbar injection, once a day, continuous 7 days, behind the last administration 0.5h, only to the wide evenly coating of white mice auris dextra dimethylbenzene 0.05ml/, after causing scorching 1h, put to death mice, cut left and right two ears, two ears are overlapping gets auricle with diameter 8mm hole device cutter, with weighing, be the swelling value with two auricle weight differences.The results are shown in Table 4.
The influence of table 4 xylol induced mice auricle edema
| Group | Dosage (mg/kg) | Swelling value (mg) |
| Blank group aspirin baicalin (height) baicalin (low) | - 100 200 100 | 19.2±3.1 8.5±3.6** 7.2±3.6** 9.4±3.7** |
Annotate: with blank group contrast * * P＜0.01
Embodiment 11: the foot swelling of rat Ovum Gallus domesticus album is influenced
The experiment medicine: baicalin for injection liquid, 50mg/ props up.Injection solution of the present invention preparation: get 100mg and 200mg, be diluted to 10mg/ml, the solution of two kinds of variable concentrations of 20mg/ml with the PBS buffer of pH=7.4.
Aspirin is got 100mg, is dissolved into aspirin solution 10mg/ml with the PBS buffer of pH7.4.
The PBS buffer of PH7.4.Compound method, precision takes by weighing 8.5gNaCl, 2.2gNa2HPO4,0.2NaH2PO4 uses the 1000ml dissolved in distilled water, promptly gets the PH7.4PBS buffer.
Laboratory animal: 40 of SD rats, male and female half and half.
Experimental technique: get 40 of SD rats, male and female half and half are divided into baicalin high dose group (200mg/kg) baicalin low dose group (100mg/kg), aspirin and PBS buffer blank group, 10 every group at random.Measure the right ankle girth of every rat earlier with soft narrow rule.With each dosage group medicine lumbar injection, once a day, continuous 7 days, behind the last administration 0.5h, the right sufficient sole of the foot subcutaneous injection 100% fresh Ovum Gallus domesticus album 0.1ml of portion caused inflammation in every rat, 1h behind the albumen injection, 2h, 3h, 4h measure right ankle girth respectively, so that scorching back girth deducts and causes scorching preceding right ankle girth, is inflammation swelling degree.The results are shown in Table 5.
Table 5 pair rat Ovum Gallus domesticus album foot swelling influence
| Group | Dosage (mg/kg) | Cause the swollen degree of foot (mm) of scorching back different time (h) | |||
| 1h | 2h | 3h | 4h | ||
| The blank group | - | 6.42±0.87 | 5.57±0.85 | 4.67±0.98 | 3.78±0.86 |
| Aspirin | 100 | 3.40±0.77 ** | 3.15±0.79 ** | 2.30±0.88 ** | 2.24±0.87 ** |
| Baicalin (height) | 200 | 3.54±0.86 ** | 3.05±0.87 ** | 2.10±0.89 ** | 2.05±0.74 ** |
| Baicalin (low) | 100 | 4.40±0.85 * | 4.35±0.98 * | 3.45±0.80 * | 2.64±0.78 * |
Annotate: contrast with the blank group
*P＜0.01
Claims (8)
1, a kind of preparation method of baicalin for injection liquid is characterized in that adopting earlier double solvents dissolving baicalin, utilizes the injection routine techniques to make injection again.
2, as the preparation method of claim 1 described baicalin for injection liquid, the purity that it is characterized in that used baicalin is more than 90%.
3, as claim 1 described baicalin for injection liquid and preparation method thereof, the purity that it is characterized in that used baicalin is more than 95%.
4, as the preparation method of claim 1 or 3 described baicalin for injection liquid, the ratio that it is characterized in that double solvents ethanol and glycerol is 3-5: 5-7.
5, as the preparation method of claim 1 or 3 described baicalin for injection liquid, the ratio that it is characterized in that used double solvents ethanol and propylene glycol is 3-5: 5-7.
6, as the preparation method of claim 4 described baicalin for injection liquid, it is characterized in that described double solvents ethanol: glycerol is 4: 6.
7, as the preparation method of claim 5 described baicalin for injection liquid, it is characterized in that described double solvents ethanol: propylene glycol is 4: 6.
8, the baicalin for injection liquid and preparation method thereof of narrating as claim 7 is characterized in that finishing according to the following steps:
1) getting ratio that baicalin fully is dissolved in ethanol and propylene glycol is that cold preservation is spent the night in 4: 6 the double solvents;
2) solution titanium rod filters, and adds the active carbon of 0.05-0.15%, and 80 ℃ kept 30 minutes, and the titanium rod filters, be sub-packed in behind the fine straining in 2ml or the 5ml ampoule, and sealing by fusing, sterilization, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510101325 CN1813778A (en) | 2005-11-18 | 2005-11-18 | Method for preparing baicalin injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510101325 CN1813778A (en) | 2005-11-18 | 2005-11-18 | Method for preparing baicalin injection |
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| CN1813778A true CN1813778A (en) | 2006-08-09 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104706577A (en) * | 2013-12-11 | 2015-06-17 | 天津安达生产力促进有限公司 | Veterinary baicalin injection liquid and preparing method thereof |
| CN107693805A (en) * | 2017-08-31 | 2018-02-16 | 芜湖杨燕制药有限公司 | A kind of sterilization process of insect-expelling saligna injection liquid |
-
2005
- 2005-11-18 CN CN 200510101325 patent/CN1813778A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104706577A (en) * | 2013-12-11 | 2015-06-17 | 天津安达生产力促进有限公司 | Veterinary baicalin injection liquid and preparing method thereof |
| CN107693805A (en) * | 2017-08-31 | 2018-02-16 | 芜湖杨燕制药有限公司 | A kind of sterilization process of insect-expelling saligna injection liquid |
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