CN1895405A - Garden-Burnet-Sheng-Bai capsules and preparation thereof - Google Patents
Garden-Burnet-Sheng-Bai capsules and preparation thereof Download PDFInfo
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- CN1895405A CN1895405A CN 200610200575 CN200610200575A CN1895405A CN 1895405 A CN1895405 A CN 1895405A CN 200610200575 CN200610200575 CN 200610200575 CN 200610200575 A CN200610200575 A CN 200610200575A CN 1895405 A CN1895405 A CN 1895405A
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- mannitol
- radix sanguisorbae
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Abstract
A Chinese medicine 'Shengbai capsule' for increasing white cells is prepared from sanguisorba root and additives. Its preparing process is also disclosed.
Description
Technical field: the present invention relates to a kind of garden-Burnet-Sheng-Bai capsules and preparation method thereof, belong to technical field of traditional Chinese medicine pharmacy.
Background technology: Radix Sanguisorbae is the dry root and rhizome of the rosaceous plant Radix Sanguisorbae Sanguisorba officinalis L. or Radix Sanguisorbae Sanguisorba officinalis L.var.longifolia (Bert.) the Yu et Li that comes into leaves.Its chemical constituent mainly contain zigu-glucoside I, II (ziyu-glycosideI, II), sangushsorbin A, B, E (sanguisorbin A, B, E) and gallic acid, tannin etc.Cold nature, bitter in the mouth, acid, puckery; Return liver, large intestine channel.Have cooling blood for hemostasis, the effect of skin ulcer is held back in detoxifcation.Be used to have blood in stool, hemorrhoidal bleeding, dysentery, hematuria, metrorrhagia, burn due to hot liquid or fire, carbuncle sore tumefacting virus.
Leukopenia belongs to the categories such as Hong Gao Han of the traditional Chinese medical science; it is a kind of commonly encountered diseases in our daily life; DIYU SHENGBAI PIAN is disclosed in " national standard for traditional Chinese medicines compilation " mouth neoplasm department of pediatrics fascicle, is prepared from by Radix Sanguisorbae and adjuvant, has the function of benefiting QI and nourishing blood, the kidney invigorating silt; can strengthen, protect the hemopoietic system function; regulate and improve body's immunity, cure mainly the leukopenia that multiple reason causes, also can be used for thrombocytopenia; immunologic hypofunction, aplastic anemia.DIYU SHENGBAI PIAN has obtained good and clinical curative effect, has been subjected to the welcome of extensive patients.But existing DIYU SHENGBAI PIAN exists stripping slow, and disintegration is long, the problem that bioavailability is low, thereby influenced the absorption and the utilization of medicine, and it takes inadequately conveniently, compliance is poor, if this product is made capsule, can satisfy patient's needs biglyyer.In addition because content of the present invention is the medical material fine powder, mobile poor, need add proper amount of diluting and fluidizer can be easy to filling and improve stability of drug, therefore, how to select suitable adjuvant, being prepared into the medicine of good fluidity, good stability, is the problem that those skilled in the art need study.
Summary of the invention: the objective of the invention is to: a kind of garden-Burnet-Sheng-Bai capsules and preparation method thereof is provided, the present invention is directed to the defective and the deficiency of existing DIYU SHENGBAI PIAN, the capsule stripping that is provided is rapid, and disintegrate is effective, the medicine good dispersion, absorb fully, steady quality, easy to carry and use, onset is rapid, compliance is good, and the bioavailability height can satisfy medical needs better.
In product research, at this content is fine powder, the shortcoming of mobile difference, add in pregelatinized Starch, starch, dextrin, the microcrystalline Cellulose any one and make up adjuvant as preparation of the present invention with mannitol, the result, the applicant is surprised to find, above adjuvant all can improve the flowability of preparation of the present invention, wherein, select pregelatinized Starch and the mannitol garden-Burnet-Sheng-Bai capsules as adjuvant for use, its flowability selects for use the capsule of other adjuvants much better.
The present invention constitutes like this: it is to be prepared from by Radix Sanguisorbae and adjuvant.Described adjuvant is the combination of any one and mannitol in pregelatinized Starch, starch, dextrin, the microcrystalline Cellulose.
Specifically, according to part by weight, it is to make with Radix Sanguisorbae 5-20 and adjuvant, and wherein adjuvant is the combination of any one and mannitol 10-30 among pregelatinized Starch 50-100, starch 50-100, dextrin 50-100, the microcrystalline Cellulose 50-100.
Preferred adjuvant is the combination of pregelatinized Starch and mannitol.
More precisely, according to part by weight, it is to be prepared from Radix Sanguisorbae 5-20, pregelatinized Starch 50-100 and mannitol 10-30.
The preparation method of garden-Burnet-Sheng-Bai capsules is: get Radix Sanguisorbae, be ground into fine powder, add adjuvant, mixing is made granule, and cold drying is encapsulated, promptly.
Specifically, its preparation method is: get Radix Sanguisorbae, be ground into fine powder, add adjuvant, mixing is granulated as wetting agent with 50%～70% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
The present invention is long disintegration in order to overcome conventional tablet, absorption difference, and the defective that bioavailability is low, the applicant has carried out the experimental study and the test of pesticide effectiveness to this capsular preparation technology, and is specific as follows:
One, technical study
This preparation content is the medical material fine powder, and is mobile poor, need add proper amount of diluting and fluidizer, and diluent commonly used has starch, soluble starch, pregelatinized Starch, mannitol, dextrin etc., so be to examine or check index, selection adjuvant and consumption with the flowability.
1, the selection of adjuvant: get the recipe quantity medical material, be ground into fine powder, by the medical material powder: adjuvant=0.1: 0.9 makes the about 100g of mixed material respectively.Adopt the fixed funnel method to measure, calculate angle of repose, the results are shown in following table.
Adjuvant is selected experiment
| Sample | Medical material powder and ratio of adjuvant (0.1: 0.9) | Angle of repose (°) |
| 1 | Medical material powder+(pregelatinized Starch+mannitol=3.5: 1) | 27.9 |
| 2 | Medical material powder+(starch+mannitol=3.5: 1) | 31.8 |
| 3 | Medical material powder+(dextrin+mannitol=3.5: 1) | 30.1 |
| 4 | Medical material powder+(microcrystalline Cellulose+mannitol=3.5: 1) | 30.6 |
Above result of the test shows, flowability all increased after the medical material powder added adjuvant, and silicon adjuvant is: pregelatinized Starch and mannitol.
2, granulating process research
Capsular content requires granularity tiny, evenly, so select certain density ethanol as wetting agent, the material powder 10g that gets it filled adds pregelatinized Starch 70g, mannitol 20g, totally 5 parts, mixing, use 50%, 55%, 60%, 65%, 70% alcohol granulation respectively, select used concentration of ethanol, the results are shown in following table by once making particulate yield.
The selection result of concentration of alcohol
| Granulation concentration of alcohol (%) | Granule yield (%) |
| 50 | 55 |
| 55 | 63 |
| 60 | 72 |
| 65 | 73 |
| 70 | 58 |
In the table result as can be seen, the alcohol granulation effect of 50-70% is all better, but it is best to do the wetting agent granulating efficiency with 60%～65% ethanol.
Determining of 3 particle drying temperature
Find in dry run behind the pelletizing forming that baking temperature is too low, required drying time is long, is unfavorable for big production, and temperature is too high, and granule is too hard, so select suitable baking temperature can further control product quality.
Getting wet granular, by following drying means test, serves as to investigate index with particle appearance and dry required time, determines baking temperature, the results are shown in following table.
Particle drying temperature The selection result
| Baking temperature (℃) | 40 | 50 | 60 | 70 |
| Particle appearance | Light brown granule | Light brown granule | The light brown granule | The granule color and luster is dark, hard |
| Drying time (h) | 30 | 24 | 18 | 12 |
In the table result as can be seen, dry under 50 ℃～60 ℃ conditions, the granule color and luster is shallow slightly, granule is more loose, required drying time is shorter.
Two, preparation of the present invention is to the leukopenic influence of white mice
1, experiment material:
1.1 medicine: preparation of the present invention (according to the garden-Burnet-Sheng-Bai capsules of the method for the invention preparation); DIYU SHENGBAI PIAN (commercially available); Cyclophosphamide; Hydrocortisone.
1.2 animal: Kunming kind white mice, body weight 18-22g, male and female half and half.
2, method and result
2.1 cyclophosphamide is caused the influence that murine interleukin reduces
40 of white mice, male and female half and half are divided into model group (cyclophosphamide 80mg/kg ip) at random, preparation group of the present invention, DIYU SHENGBAI PIAN group and normal control group (giving ordinary water 20mg/kg).Each organizes continuous ig administration 5d, (model group and the feedwater of normal control group).D5 is equal ip cyclophosphamide 80mg/kg except that the normal control group.D8 counts total white blood cells by tail vein blood.The result shows, can the raise murine interleukin of caused by cyclophosphamide of preparation of the present invention reduces.
2.2 it is right
60C
0Due to the leukopenic influence of white mice
Get 40 of mices, grouping is the same with medication, before the administration with 6Gy dosage (60cm, 8.5min)
60C
0Disposable irradiation, the normal control group is not shone.Below respectively organize continuous water feeding 7d, in d8 by tail vein blood meter total white blood cells.The results are shown in following table.
Chang'an rises white electuary cyclophosphamide is reached
60C
0The leukopenic influence of irradiation induced mice
| Group | Animal (only) | Dosage (g/kg) | Total white blood cells (10 9/L，x±s) | |
| Cyclophosphamide | 60C 0Irradiation | |||
| The model contrast | 10 | - | 2.78±0.96 | 2.96±0.78 |
| Preparation group of the present invention | 10 | 0.1 | 6.05±0.97 | 8.48±1.00 |
| The DIYU SHENGBAI PIAN group | 10 | 0.1 | 4.35±1.29 | 4.97±0.89 |
| The normal control group | 10 | - | 9.70±1.05 | 10.62±1.17 |
Preparation group of the present invention is compared with model control group, P＜0.01; Compare P＜0.05 with the DIYU SHENGBAI PIAN group.
2.3 influence to the low antibody horizontal of caused by cyclophosphamide immune function of mice
Get 40 of mices, grouping is the same with medication.Equal ip cyclophosphamide 20mg/kg, 3d continuously except that the normal control group.D4 ip 0.2ml 5% chicken red blood cell is given all animals, and every rathole socket of the eye 20 μ l that take a blood sample measure the hemolysin value behind the immune 7d.
Influence to the low antibody horizontal of caused by cyclophosphamide immune function of mice
| Group | Animal (only) | Dosage (g/kg) | OD×100(x±s) |
| Model control group | 10 | - | 19.60±5.26 |
| Preparation group of the present invention | 10 | 0.1 | 30.90±5.38 |
| The DIYU SHENGBAI PIAN group | 10 | 0.1 | 27.10±6.05 |
| The normal control group | 10 | - | 38.75±6.08 |
Preparation group of the present invention is compared with model control group, P＜0.01; Compare P＜0.05 with the DIYU SHENGBAI PIAN group.
Compared with prior art, after the present invention is prepared into capsule, overcome the defective and the deficiency of DIYU SHENGBAI PIAN, the capsule stripping that is provided is rapid, disintegrate is effective, and the medicine good dispersion absorbs fully, steady quality, easy to carry and use, onset is rapid, and compliance is good, the bioavailability height can satisfy medical needs better.
Further specify the present invention by the following examples, but not as limitation of the present invention.
The specific embodiment:
Embodiments of the invention 1: Radix Sanguisorbae 10, pregelatinized Starch 70, mannitol 20
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add pregelatinized Starch and mannitol, mixing is granulated as wetting agent with 60%～65% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, and makes 1000, promptly.This product oral, each 1～2, every day 3 times.
Embodiments of the invention 2: Radix Sanguisorbae 20, pregelatinized Starch 100, mannitol 30
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add pregelatinized Starch and mannitol, mixing is granulated as wetting agent with 50%～55% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 3: Radix Sanguisorbae 5, pregelatinized Starch 50, mannitol 10
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add pregelatinized Starch and mannitol, mixing is granulated as wetting agent with 55%～60% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 4: Radix Sanguisorbae 20, starch 100, mannitol 30
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add starch and mannitol, mixing is granulated as wetting agent with 65%～70% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 5: Radix Sanguisorbae 5, starch 50, mannitol 10
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add starch and mannitol, mixing is granulated as wetting agent with 50%～60% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 6: Radix Sanguisorbae 10, starch 70, mannitol 20
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add starch and mannitol, mixing is granulated as wetting agent with 55%～60% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 7: Radix Sanguisorbae 20, dextrin 100, mannitol 30
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add dextrin and mannitol, mixing is granulated as wetting agent with 50% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 8: Radix Sanguisorbae 5, dextrin 50, mannitol 10
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add dextrin and mannitol, mixing is granulated as wetting agent with 70% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 9: Radix Sanguisorbae 10, dextrin 70, mannitol 20
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add dextrin and mannitol, mixing is granulated as wetting agent with 60% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 10: Radix Sanguisorbae 20, microcrystalline Cellulose 100, mannitol 30
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add microcrystalline Cellulose and mannitol, mixing is granulated as wetting agent with 65% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 11: Radix Sanguisorbae 5, microcrystalline Cellulose 50, mannitol 10
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add microcrystalline Cellulose and mannitol, mixing is granulated as wetting agent with 60% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 12: Radix Sanguisorbae 10, microcrystalline Cellulose 70, mannitol 20
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add microcrystalline Cellulose and mannitol, mixing is granulated as wetting agent with 60%～65% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Embodiments of the invention 13: Radix Sanguisorbae 20g, starch 50g, mannitol 10g
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add mannitol powder, starch, mixing is granulated as wetting agent with 60%～65% ethanol, and is dry, encapsulated under 50 ℃～60 ℃ conditions, makes 1000, promptly.
Embodiments of the invention 14: Radix Sanguisorbae 5g, dextrin 100g, mannitol 10g
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add mannitol powder, dextrin, mixing is granulated as wetting agent with 65%～70% ethanol, and is dry, encapsulated under 50 ℃～60 ℃ conditions, makes 1000, promptly.
Embodiments of the invention 15: Radix Sanguisorbae 15g, microcrystalline Cellulose 80g, mannitol 25g
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add mannitol powder, microcrystalline Cellulose, mixing is granulated as wetting agent with 65% ethanol, and is dry, encapsulated under 50 ℃～60 ℃ conditions, makes 1000, promptly.
Embodiments of the invention 16: Radix Sanguisorbae 12g, pregelatinized Starch 65g, mannitol 12g
Preparation method is: get Radix Sanguisorbae, be ground into fine powder, add mannitol powder, pregelatinized Starch, mixing is made granule, and cold drying is encapsulated, makes 10000, promptly.
Claims (7)
1. garden-Burnet-Sheng-Bai capsules, it is characterized in that: it is to be prepared from by Radix Sanguisorbae and adjuvant.
2. according to the described garden-Burnet-Sheng-Bai capsules of claim 1, it is characterized in that: described adjuvant is the combination of any one and mannitol in pregelatinized Starch, starch, dextrin, the microcrystalline Cellulose.
3. according to claim 1 or 2 described garden-Burnet-Sheng-Bai capsules, it is characterized in that: according to part by weight, it is to make with Radix Sanguisorbae 5-20 and adjuvant, and wherein adjuvant is the combination of any one and mannitol 10-30 among pregelatinized Starch 50-100, starch 50-100, dextrin 50-100, the microcrystalline Cellulose 50-100.
4. according to the described garden-Burnet-Sheng-Bai capsules of claim 3, it is characterized in that: described adjuvant is the combination of pregelatinized Starch and mannitol.
5. according to the described garden-Burnet-Sheng-Bai capsules of claim 4, it is characterized in that: according to part by weight, it is to be prepared from Radix Sanguisorbae 5-20, pregelatinized Starch 50-100 and mannitol 10-30.
6. as the preparation method of garden-Burnet-Sheng-Bai capsules as described in each among the claim 1-5, it is characterized in that: get Radix Sanguisorbae, be ground into fine powder, add adjuvant, mixing is made granule, and cold drying is encapsulated, promptly.
7. according to the preparation method of the described garden-Burnet-Sheng-Bai capsules of claim 6, it is characterized in that: get Radix Sanguisorbae, be ground into fine powder, add adjuvant, mixing is granulated as wetting agent with 50%～70% ethanol, and is dry under 50 ℃～60 ℃ conditions, incapsulates, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610200575 CN1895405A (en) | 2006-06-16 | 2006-06-16 | Garden-Burnet-Sheng-Bai capsules and preparation thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610200575 CN1895405A (en) | 2006-06-16 | 2006-06-16 | Garden-Burnet-Sheng-Bai capsules and preparation thereof |
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| Publication Number | Publication Date |
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| CN1895405A true CN1895405A (en) | 2007-01-17 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200610200575 Pending CN1895405A (en) | 2006-06-16 | 2006-06-16 | Garden-Burnet-Sheng-Bai capsules and preparation thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100773A (en) * | 2009-05-26 | 2011-06-22 | 成都地奥制药集团有限公司 | Low dosage burnet root solid preparation |
| CN115998703A (en) * | 2022-12-14 | 2023-04-25 | 迪沙药业集团有限公司 | Sanguisorba composition and preparation method thereof |
-
2006
- 2006-06-16 CN CN 200610200575 patent/CN1895405A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102100773A (en) * | 2009-05-26 | 2011-06-22 | 成都地奥制药集团有限公司 | Low dosage burnet root solid preparation |
| CN115998703A (en) * | 2022-12-14 | 2023-04-25 | 迪沙药业集团有限公司 | Sanguisorba composition and preparation method thereof |
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