CN1772093A - Tablet containing Chinese pearleaf crabapple composition and its prepn - Google Patents
Tablet containing Chinese pearleaf crabapple composition and its prepn Download PDFInfo
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- CN1772093A CN1772093A CN 200510030790 CN200510030790A CN1772093A CN 1772093 A CN1772093 A CN 1772093A CN 200510030790 CN200510030790 CN 200510030790 CN 200510030790 A CN200510030790 A CN 200510030790A CN 1772093 A CN1772093 A CN 1772093A
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- pearleaf crabapple
- chinese pearleaf
- crabapple
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Abstract
The present invention discloses one kind of tablet containing Chinese pearleaf crabapple composition and its preparation. The tablet contains Chinese pearleaf crabapple composition in effective treating dosage and pharmaceutically acceptable carrier, and the Chinese pearleaf crabapple composition contains quercetin accounting in C15H10O7 in 0.06-0.11 wt%. Owing to the oldenlandia quercetin content over 0.01 %, the medicine of the present invention is superior and has greatly lowered dosage and greatly raised treating effect compared with available technology.
Description
Technical field
The present invention relates to a kind of Chinese pearleaf crabapple composition for the treatment of female diseases, relate in particular to a kind of tablet that contains Chinese pearleaf crabapple composition.
Background technology
Pelvic inflammatory disease is a kind of commonly encountered disease, comprise the pelvic cavity genitals, as the inflammation of uterus body, fallopian tube, ovary etc. and pelvic peritoneum and periuterine connective tissue, the women of being mainly in property of pelvic inflammatory disease active phase, 21～30 years old is the age occurred frequently of pelvic inflammatory disease.Had a strong impact on people's live and work.For this reason, many scientific workers and relevant manufacturer of drugs disclose the medicine of treatment pelvic inflammatory disease separately, comprise Chinese medicine preparation and chemical synthetic drug, wherein, Chinese medicine preparation is helped with the monarch and his subjects mutually owing to its unique treating both the principal and secondary aspects of a disease, the reason that side effect is little, obtained people's favor, as the technology that Chinese patent publication number CN1586519A and CN1552371A are reported, " FUKE QIANJIN PIAN " of producing as Chinese Zhuzhou a thousand pieces of gold pharmaceutcal corporation, Ltd commercially produced, the golden pheasant series of products that Guangxi China Ling Feng Peak pharmaceutcal corporation, Ltd produces are as " JINJI PIAN " and " JINJI JIAONANG " etc.
Above-mentioned technology and product, not only therapeutic effect is unsatisfactory, and be the solid drugs that active component and solid drugs adjuvant are formed, what fill in the capsule also is solids content, especially the technology reported of Chinese patent CN1586519A and CN1552371A, in preparation process, not only the Herba Duchesneae Indicae with one of active medicine partly is crushed to powder, then with after other active component extract mixes again with excipient substance tabletting or pill or be filled in the capsule, and in preparation process, adopt high temperature drying.The defective of its existence is very significant, and baking temperature is more than 90 ℃, and the weight content of the Quercetin in the compositions makes therapeutic effect be subjected to great influence generally only below 0.0006%.
Summary of the invention
The technical issues that need to address of the present invention are to disclose a kind of tablet that contains Chinese pearleaf crabapple composition and preparation method thereof, to overcome the defective that prior art exists, improve therapeutic effect.
The tablet that the present invention contains Chinese pearleaf crabapple composition comprises the Chinese pearleaf crabapple composition for the treatment of effective dose and pharmaceutically acceptable carrier.
Said Chinese pearleaf crabapple composition is to adopt the feedstock production of following weight portion to become:
Herba Duchesneae Indicae 1500～2000 Herba Hedyotidis Diffusaes 500～1500 Radix Urenae Lobataes 1500～2000
Folium Malloti Apeltae 500～1500 Herba Thlaspiss 500～1500 Caulis Spatholobis 1000～1800
Radix Rhodomyrti 1500～2000
Preferred parts by weight are:
Herba Duchesneae Indicae 1667 Herba Hedyotidis Diffusaes 1000 Radix Urenae Lobataes 1667
Folium Malloti Apeltae 1000 Herba Thlaspiss 1000 Caulis Spatholobis 1333
Radix Rhodomyrti 1667
The inventor finds that in the compositions, the weight content of the composition Quercetin in the Herba Hedyotidis Diffusae has fairly obvious influence to therapeutic effect, must reach certain amount, therefore, compositions of the present invention, the known composition Quercetin in the Herba Hedyotidis Diffusae is with C
15H
10O
7: meter, weight content counts 0.06～0.11% with the gross weight of Chinese pearleaf crabapple composition.
The chemical structure of general formula of said Quercetin is as follows:
Different name: quercetin, Quercetin, Meletin, Sophretin.
Chemical name: 4H-1-Benzopyran-4-one, and 2-(3,4-dihydroxyphenyl)-3,5, the 7-trihydroxy-structural formula:
Molecular formula and molecular weight: C
15H
10O
7: 302.23
Physical behavior: dihydrate is yellow acicular crystal (Diluted Alcohol), becomes anhydride at 95-97 ℃, 314 ℃ of fusing points (decomposition).1g is dissolved in the 290ml dehydrated alcohol, and the 23ml ethanol that boils is dissolved in glacial acetic acid, and it is yellow, water-soluble hardly that alkaline aqueous solution is, and the alcoholic solution flavor is very bitter.
The preparation method of said Quercetin and relevant physical and chemical parameter have had disclosed report in " progress of preparation of Folium Ginkgo extraction of active ingredients and assay method " 2002-4-12 (Chinese health food net) document.
Said carrier is meant the pharmaceutical carrier that is used to prepare tablet of pharmaceutical field routine;
In the gross weight of tablet, preferred ingredients and parts by weight comprise:
20～30 parts of Chinese pearleaf crabapple compositions, 1～5 part of binding agent, 1～5 part of filler;
Said binding agent is selected from a kind of or its mixture in microcrystalline Cellulose, gelatin, polyvinylpyrrolidone, HPMC or the sucrose;
Said filler selects a kind of or its mixture in corn starch, tapioca, modified starch, powdered sugar, calcium hydrogen phosphate, micropowder silica gel, dextrin or the magnesium stearate;
Preparation of the present invention can put on the patient who needs this treatment by oral form, and general dosage is one day: the 2.25g/50kg body weight specifically can change according to patient's age, the state of an illness etc.
Preparation method of the present invention comprises the steps:
With above-mentioned seven flavor medicine material, the decocting that adds 10～20 times of weight boils, and decocting time is 2～4 hours, filters, filtrate is concentrated into the clear paste that relative density is 1.18～1.23 (80 ℃), add ethanol and make the weight content of alcohol to reach be 50～80%, left standstill 1～72 hour, filter, being concentrated into relative density is the clear paste of 1.25～1.30 (80 ℃), 60～80 ℃ of dryings, be ground into 100～300 purpose fine powders, promptly.
The inventor finds, baking temperature in the preparation process, influence to the quercetin content in the Herba Hedyotidis Diffusae is bigger, under higher temperature (＞90 ℃) condition, Quercetin becomes anhydride, cause in the compositions, the content of Quercetin reduces, and therefore controlling suitable baking temperature will seem very important.The present invention adopts vacuum drying method, makes the content of Quercetin be controlled in the compositions 0.005～0.019%, can improve the therapeutic effect of compositions greatly.
Temperature also can be relaxed, and 80～90 ℃ also can be effective, as at 40 ℃, but temperature be lower than 60 ℃ then drying time longer, extractum (more than the 50kg) in enormous quantities then needed 3～10 days or more of a specified duration could be fully dry, therefore undesirable.Optimum temperature exists: 60～80 ℃.
Drying means comprises oven drying method, drum-type seasoning, belt drying method, hygroscopic desiccation method, fluid-bed drying, spray drying method, decompression (vacuum) seasoning, freeze-drying, infrared drying, micro-wave drying method etc.
The clinical use result of medicine of the present invention shows that its advantage is very significant, because the content of Herba Hedyotidis Diffusae Quercetin can reach more than 0.01% in the compositions, therefore, the dosage that uses can reduce greatly, be generally 1/2 of prior art, and therapeutic effect improves greatly.
The specific embodiment
Embodiment 1
Raw material:
Herba Duchesneae Indicae 1667 gram Herba Hedyotidis Diffusaes 1000 gram Radix Urenae Lobataes 1667 grams
Folium Malloti Apeltae 1000 Ke Herba Thlaspiss 1000 gram Caulis Spatholobis 1333 grams
Radix Rhodomyrti 1667 grams.
Above seven flavor medicine material, the decocting that adds 15 times of weight boils secondary, 2 hours for the first time, 1.5 hours for the second time, merge decoction liquor, filter, filtrate is concentrated into the clear paste that relative density is 1.18～1.23 (80 ℃), adds ethanol and makes and contain alcohol amount and reach 65%, stirs evenly, left standstill 24 hours, filter, decompression filtrate recycling ethanol also is concentrated into the clear paste that relative density is 1.25～1.30 (80 ℃), at 60 ℃ of vacuum dryings, be ground into 100～300 order fine powders, promptly.
The detection of the content of Quercetin:
Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D)
Chromatographic condition and system suitability test:
With octadecylsilane chemically bonded silica is filler; With methanol-0.9% phosphoric acid solution (1: 1) is mobile phase; The detection wavelength is 370nm.Number of theoretical plate is pressed the Quercetin peak and is calculated, and should be not less than 2500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the Quercetin reference substance, adds methanol and make the solution that every 1ml contains Quercetin 5 μ g, promptly.
Quercetin can adopt the commercially available prod, the product of sweetening treatment company limited in Nat'l Pharmaceutical ﹠ Biological Products Control Institute, the Hangzhou;
The preparation of need testing solution:
Get compositions 0.27g, the accurate title, decide, and puts in the flask, accurate 50% methanol-hydrochloric acid (95: 5) mixed solution 20ml that adds, close plug claims to decide weight, reflux 2 hours is put coldly, supplies the weight that subtracts mistake with 50% methanol, shake up, filter, precision is measured subsequent filtrate 5ml, in the dislocation 10ml measuring bottle, add methanol and be diluted to scale, shake up, filter with microporous filter membrane (0.45 μ m), get subsequent filtrate, promptly.
Algoscopy:
Respectively accurate each the 10 μ l of reference substance solution and need testing solution that draw inject chromatograph of liquid, and mensuration is benchmark with the gross weight of compositions, contains Herba Hedyotidis Diffusae with Quercetin (C
15H
10O
7) count 0.08%, percentage by weight.
Embodiment 2
Prescription:
Herba Duchesneae Indicae 1500 gram Herba Hedyotidis Diffusaes 1500 gram Radix Urenae Lobataes 2000 grams
Folium Malloti Apeltae 500 Ke Herba Thlaspiss 500 gram Caulis Spatholobis 1800 grams
Radix Rhodomyrti 2000 grams.
Adopt and embodiment 1 same procedure, baking temperature is 80 ℃.Gross weight with compositions is a benchmark, contains Herba Hedyotidis Diffusae with Quercetin (C
15H
10O
7) count 0.010%, percentage by weight.
Detection method is with embodiment 1.
The comparative example 1
Adopt and embodiment 1 same procedure, baking temperature is 95 ℃.Gross weight with compositions is a benchmark, contains Herba Hedyotidis Diffusae with Quercetin (C
15H
10O
7) count 0.0004%, percentage by weight.
Detection method is with embodiment 1.
Can be reached a conclusion by embodiment 1,2 and comparative example 1: 60～80 ℃ are optimum temperature, and the Quercetin bottom line of Herba Hedyotidis Diffusae is in the compositions: 0.007%, otherwise can't produce qualified compositions.
Embodiment 3
Prescription:
Compositions 184 grams of embodiment 1
Adjuvant: corn starch 33 grams
Microcrystalline Cellulose 25 grams
Magnesium stearate 8 grams
Adopt method preparation well known in the art to become tablet, every of Film coated tablets heavily is 0.29g, and the Quercetin weight content is 0.07%.
Embodiment 4
Compositions 190 grams of prescription: embodiment 1
Adjuvant: modified starch 35 grams
Microcrystalline Cellulose 20 grams
Micropowder silica gel 8 grams
Adopt method preparation well known in the art to become tablet, every of Film coated tablets heavily is 0.28g, and the Quercetin weight content is 0.07%.
Embodiment 5
Compositions 220 grams of prescription: embodiment 1
Adjuvant: modified starch 100 grams
Powdered sugar 30 grams
Microcrystalline Cellulose 5 grams
Polyvinylpyrrolidone 5 grams
HPMC 2 grams
Calcium hydrogen phosphate 30 grams
Micropowder silica gel 5 grams
Dextrin 20 grams
Adopt method preparation well known in the art to become tablet, every of Film coated tablets heavily is 0.29g, and the Quercetin weight content is 0.06%.
The comparative example 2
Compositions with comparative example 1 is a raw material, adopts prescription and the preparation technology identical with embodiment 3, prepares tablet, and baking temperature is 95 ℃.Wherein: every weight is 0.25g, and composition weight is 9333g, and the Quercetin weight content is 0.0005%.
Embodiment 6
Clinical test results:
Tablet and the FUKE QIANJIN PIAN of clinical comparison: embodiment 3 are done contrast test, embodiment 3 observation groups 90 examples wherein, FUKE QIANJIN PIAN matched group 90 examples).
Therapeutic Method: " embodiment 1 " treatment group: 3 slices/time, 3 times/day, logotype 21 days; FUKE QIANJIN PIAN: 6 slices/time, 3 times/sheet, logotype 21 days.The Pharmaceuticals of all and this trial drug effectiveness something in common of forbidding during the treatment treatment.Result of the test is as follows:
1 liang of group general curative effect compares: embodiment 3 total effective rates are 93.3%, and total cure-remarkable-effectiveness rate is 60.0%; Traditional Chinese medical science disease curative effect total effective rate is 91.1%, and total cure-remarkable-effectiveness rate is 47.8%; Local sign curative effect total effective rate is 90.3%, and total cure-remarkable-effectiveness rate is 42.2%.The FUKE QIANJIN PIAN total effective rate is 86.6%, and total cure-remarkable-effectiveness rate is 20.0%; Traditional Chinese medical science disease curative effect total effective rate is 83.3%, and total cure-remarkable-effectiveness rate is 25.5%; Local sign curative effect total effective rate is 68.2%, and total cure-remarkable-effectiveness rate is 15.6%.Total cure-remarkable-effectiveness rate has significant difference, P＜0.05 between two groups; The total effective rate there was no significant difference, P＞0.05; The total cure-remarkable-effectiveness rate of traditional Chinese medical science disease curative effect has significant difference for two groups, P＜0.05, total effective rate there was no significant difference, P＞0.05; The total cure-remarkable-effectiveness rate of local sign curative effect has significant difference, and P all＜0.05; The total effective rate there was no significant difference, P＞0.05.
Symptom relatively before and after 2 liang of group treatments: symptom integral was respectively 21.80 ± 6.03,21.41 ± 6.40 before observation group, matched group were treated; Treat the back symptom integral and be respectively 8.09 ± 5.12,9.22 ± 6.04.Before two groups of treatment back symptom integral are starkly lower than and treat (P＜0.05), compare there was no significant difference (P＞0.05) between two groups.
Sign relatively before and after 3 liang of group treatments: the sign integration was respectively 9.91 ± 4.46,9.93 ± 5.14 before observation group, matched group were treated; Treat back sign integration and be respectively 3.18 ± 2.38,4.54 ± 3.11.Before two groups of treatment back sign integrations are starkly lower than and treat (P＜0.05), relatively, statistical significance (P＜0.05) is arranged between two groups.
Total white blood cells changes relatively before and after 4 liang of group treatments: observation group, matched group are treated the proleukocyte sum and are respectively 6.54 ± 1.79,5.92 ± 1.83; Treat the back total white blood cells and be respectively 6.82 ± 1.93,6.66 ± 1.97.Compare before and after two groups of treatments and between two groups, all not statistically significant (P＞0.05).
Neutrophilic leukocyte changes relatively before and after 5 liang of group treatments: neutrophilic leukocyte was respectively 63.06 ± 8.29,63.78 ± 7.27 before observation group, matched group were treated; Treat the back total white blood cells and be respectively 61.75 ± 7.94,63.44 ± 9.12.Compare before and after two groups of treatments and between two groups, all not statistically significant (P＞0.05).
Hematochrome changes relatively before and after 6 liang of group treatments: hematochrome was respectively 130.52 ± 12.37,127.20 ± 13.87 before observation group, matched group were treated; Treat back hematochrome sum and be respectively 130.15 ± 11.56,124.86 ± 16.48.Compare before and after two groups of treatments and between two groups, all not statistically significant (P＞0.05).
Pelvic hydrops changes relatively before and after 7 liang of group treatments: pelvic hydrops was respectively 0.27 ± 0.55,0.11 ± 0.34 before observation group, matched group were treated; Treat the back pelvic hydrops and be respectively 0.23 ± 0.95,0.09 ± 0.33.Compare before and after two groups of treatments and between two groups, all not statistically significant (P＞0.05).
3 groups of result: embodiment, FUKE QIANJIN PIAN group total effective rate are respectively 93.3%, 86.6% (P＞0.05), and total cure-remarkable-effectiveness rate is respectively 60.0%, 20.0% (P＜0.05); Traditional Chinese medical science disease curative effect total effective rate is respectively 91.1%, 83.3% (P＞0.05), and total cure-remarkable-effectiveness rate is respectively 47.8%, 25.5% (P＜0.05); Local sign curative effect total effective rate is respectively 90.3%, 68.2% (P＜0.05), and total cure-remarkable-effectiveness rate is respectively 42.2%, 15.6% (P＜0.05).Two groups of treatment back sign scorings all are starkly lower than treatment preceding (P＜0.05).
Conclusion: embodiment 3 is effective Chinese patent medicine that the damp and hot stasis of blood knot of treatment chronic pelvic inflammatory disease is demonstrate,proved with FUKE QIANJIN PIAN, the two is improving effect similar (P＞0.05) aspect the symptom of chronic pelvic inflammatory disease, and 3 couples of chronic pelvic inflammatory disease syndrome of stagnant dampness-heat patients' of embodiment sign is improved and obviously is better than FUKE QIANJIN PIAN (P＜0.05).
Claims (6)
1. a tablet that contains Chinese pearleaf crabapple composition is characterized in that, comprises the Chinese pearleaf crabapple composition for the treatment of effective dose and pharmaceutically acceptable carrier, and said Chinese pearleaf crabapple composition is to adopt the feedstock production of following weight portion to become:
Herba Duchesneae Indicae 1500～2000 Herba Hedyotidis Diffusaes 500～1500 Radix Urenae Lobataes 1500～2000
Folium Malloti Apeltae 500～1500 Herba Thlaspiss 500～1500 Caulis Spatholobis 1000～1800
Radix Rhodomyrti 1500～2000
In the Chinese pearleaf crabapple composition: Quercetin is with C
15H
10O
7: meter, weight content counts 0.06～0.11% with the gross weight of Chinese pearleaf crabapple composition;
Said carrier is meant that pharmaceutical field is used to prepare the pharmaceutical carrier of tablet.
2. according to the right right 1 described tablet that contains Chinese pearleaf crabapple composition, it is characterized in that Chinese pearleaf crabapple composition is to adopt the feedstock production of following weight portion to become:
Herba Duchesneae Indicae 1667 Herba Hedyotidis Diffusaes 1000 Radix Urenae Lobataes 1667
Folium Malloti Apeltae 1000 Herba Thlaspiss 1000 Caulis Spatholobis 1333
Radix Rhodomyrti 1667.
3. according to right right 1 or the 2 described tablets that contain Chinese pearleaf crabapple composition, it is characterized in that in the gross weight of tablet, component and parts by weight comprise:
20～30 parts of Chinese pearleaf crabapple compositions, 1～5 part of binding agent, 1～5 part of filler.
4. according to the right right 3 described tablets that contain Chinese pearleaf crabapple composition, it is characterized in that said binding agent is selected from a kind of or its mixture in microcrystalline Cellulose, gelatin, polyvinylpyrrolidone, HPMC or the sucrose; Said filler is selected from a kind of or its mixture in corn starch, tapioca, modified starch, powdered sugar, calcium hydrogen phosphate, micropowder silica gel, dextrin or the magnesium stearate.
5. according to right right 1～4 each described preparation method that contains the tablet of Chinese pearleaf crabapple composition, it is characterized in that, comprise the steps: above-mentioned seven flavor medicine material, the decocting that adds 10～20 times of weight boils, decocting time is 2～4 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.18～1.23 (80 ℃), add ethanol and make the weight content of alcohol to reach be 50～80%, left standstill 1～72 hour, filter, being concentrated into relative density is the clear paste of 1.25～1.30 (80 ℃), 60～90 ℃ of dryings, be ground into 100～300 purpose fine powders, promptly.
6. according to the right right 5 described preparation methoies that contain the tablet of Chinese pearleaf crabapple composition, it is characterized in that adopt vacuum drying, baking temperature is 60～80 ℃.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510030790 CN1772093A (en) | 2005-10-27 | 2005-10-27 | Tablet containing Chinese pearleaf crabapple composition and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510030790 CN1772093A (en) | 2005-10-27 | 2005-10-27 | Tablet containing Chinese pearleaf crabapple composition and its prepn |
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| Publication Number | Publication Date |
|---|---|
| CN1772093A true CN1772093A (en) | 2006-05-17 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113209086A (en) * | 2021-04-25 | 2021-08-06 | 广西壮族自治区花红药业集团股份公司 | Application of flavonoid compound in preparation of medicine for treating inflammatory diseases |
| CN113214157A (en) * | 2021-04-25 | 2021-08-06 | 广西壮族自治区花红药业集团股份公司 | Application of pyrrolidone compound in preparation of medicine for treating inflammatory diseases |
-
2005
- 2005-10-27 CN CN 200510030790 patent/CN1772093A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113209086A (en) * | 2021-04-25 | 2021-08-06 | 广西壮族自治区花红药业集团股份公司 | Application of flavonoid compound in preparation of medicine for treating inflammatory diseases |
| CN113214157A (en) * | 2021-04-25 | 2021-08-06 | 广西壮族自治区花红药业集团股份公司 | Application of pyrrolidone compound in preparation of medicine for treating inflammatory diseases |
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Open date: 20060517 |