CN103006789A - Preparation method of Glossy privet fruit and radix astragali sustained release preparations and product - Google Patents
Preparation method of Glossy privet fruit and radix astragali sustained release preparations and product Download PDFInfo
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- CN103006789A CN103006789A CN2012105634112A CN201210563411A CN103006789A CN 103006789 A CN103006789 A CN 103006789A CN 2012105634112 A CN2012105634112 A CN 2012105634112A CN 201210563411 A CN201210563411 A CN 201210563411A CN 103006789 A CN103006789 A CN 103006789A
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Abstract
The invention discloses a preparation method of glossy privet fruit and radix astragali sustained release preparations and a product. The preparation method comprises the following steps: pulverizing glossy privet fruit and radix astragali into coarse powder, performing extraction with ethanol or water, performing purification with macroporous resin, adding a proper amount of sustained release adjuvant and other pharmaceutic adjuvant into purified extractive to prepare various sustained release preparations. Compared with the prior art, the invention has the advantages that macroporous resin is adopted for extraction and purification of herbs, so that the concentration and purity of active ingredients of the Chinese herbs of glossy privet fruit and radix astragali are improved by 15 time than those in the prior art; the dosage of the prepared sustained release preparations is greatly reduced, and pharmacological ingredients are released synchronously during sustained release so as to be conducive to giving a full play to the curative effect of the medicine; and the medicine effect is lasting, and the toxic side effect is low.
Description
Technical field
The present invention relates to a kind of preparation method and product of loyal stilbene slow releasing preparation, belong to the Chinese drug preparation technique field.
Background technology
People's immune system is being played the part of considerable role in body, play the protection human body, prevents the effect of the opportunistic infection that virus, antibacterial, fungus, parasite etc. cause.The medical expert of the world today is devoted to the research of immune science always, tries hard to seek immunologic function potentiator, improves biological effect, to strengthen, to adjust and protect people's immunologic function.
Chinese medicine is transferred inherent resistance against diseases aspect and is had distinctive feature in conditioning patient body condition.Loyal stilbene preparation utilizes the genuine Chinese prescription such as benefiting qi and nourishing yin the kidney invigorating to develop.Through clinical practice and proof, be immunologic function potentiator at present good, safety; Have and improve immune function of human body, protection bone marrow, adrenal cortex and liver function, deficient, the prolonged illness (liver cirrhosis, chronic atrophic gastritis, diabetes, tuberculosis etc.) that is applicable to that various diseases causes, postoperative, puerperal the patient recovery; To during the cancer patient Radiotherapy chemotherapy auxiliary therapeutic action being arranged, can obviously improve patient's late result, promote the recovery of normal function.
Existing loyal stilbene preparation mostly is the common formulations such as tablet, capsule, granule, pill or oral liquid on the market, wherein the concentration of contained drug active component and purity are lower, and dose is large, are unfavorable for giving full play to of drug effect, lack slow release effect, so long-term efficacy is not good enough.
Summary of the invention
The object of the invention is to, a kind of preparation method and product of loyal stilbene slow releasing preparation is provided.The present invention adopts macroporous adsorbent resin and gel filtration chromatography, and the concentration of active ingredient of Chinese herbs and purity are improved more than 15 times than prior art, has the slow release effect, and the slow releasing preparation dosage that makes greatly reduces.
The present invention is achieved in that a kind of preparation method of loyal stilbene slow releasing preparation is: Fructus Ligustri Lucidi, astragalus membranaceus powder are broken into coarse powder, extract with ethanol or water, adopt macroporous adsorbent resin to carry out purification, the purification thing behind the purification adds an amount of slow-release auxiliary material and other pharmaceutic adjuvants are made various slow releasing preparation again.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, extract purification step and be: get Fructus Ligustri Lucidi 30 weight portions, the Radix Astragali 60 weight portion powder become fine powder, cross 40 mesh sieves; Take purified water as extracting medium, boiling is extracted three times, and each 20～120 minutes, solid-liquid ratio was respectively 1:25,1:15,1:10, merged three times extracting solution; Extracting solution after merging is filtered with 200 eye mesh screens, and the usefulness molecular weight that dams is that 50000 hollow fiber ultrafiltration membrane is carried out ultrafiltration again, and filtrate concentrates, and decompression recycling ethanol gets concentrated solution; Macroporous adsorptive resins carries out eluting on the concentrated solution, mixes the solution of twice eluting, is drying to obtain the purification thing.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, slow-release auxiliary material is one or more in hydroxypropyl methylcellulose, ethyl cellulose, the stearic acid.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, other pharmaceutic adjuvants comprise filler, binding agent and lubricant; Filler is lactose; Binding agent is one or both of ethanol-water solution of polyvinylpyrrolidone, various proportionings; Lubricant is Pulvis Talci or magnesium stearate.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, described slow releasing preparation is slow releasing tablet, slow releasing capsule or slow releasing pill.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, the preparation technology of described loyal stilbene slow releasing tablet, slow releasing capsule, slow releasing pill is: purification thing 1～10 weight portion that the purification with macroreticular resin of learning from else's experience obtains, add slow-release auxiliary material 35～45 weight portions, mix homogeneously, add again filler 40～45 weight portions, binding agent 10～20 weight portions, lubricant 0.5～2 weight portion, take water as medium, granulate with 16 mesh sieves; With particle drying, make slow-releasing granules, tabletting, film coating namely gets slow releasing tablet; Or with the hollow capsule for medicine of packing into behind the slow-releasing granules coating, namely get slow releasing capsule; Or with slow-releasing granules piller processed, film coating namely gets slow releasing pill.
In the preparation method of aforementioned loyal stilbene slow releasing preparation, the compound method of coating solution is: get hydroxypropyl emthylcellulose 21.6 weight portions, PEG-400 3 weight portions, Tween-80 0.8 weight portion, lemon yellow 0.2 weight portion, be configured to 800 weight portions with 60% ethanol.
The loyal stilbene slow releasing preparation for preparing of the preparation method of loyal stilbene slow releasing preparation as mentioned above.
Below the release of loyal stilbene slow releasing preparation of the present invention is carried out research and experiment.
1, prescription (seeing Table 1)
Table 1
2, vitro release test
Medicine of the present invention is through the vitro release verification experimental verification, its result of the test can reach " regulation of 2010 editions slow releasing preparation of Chinese pharmacopoeia, it is as follows that the release of loyal stilbene slow releasing preparation is investigated test:
The loyal stilbene slow releasing preparation of table 2 vitro release result of the test
Can be found out the in vivo sustainable stable release 12 hours of this slow releasing preparation by table 2 data.
3, release contrast test
Medicine of the present invention and ordinary preparation (ZhenQi capsule) are carried out the vitro release contrast test, and it the results are shown in Table 3.
The loyal stilbene slow releasing preparation of table 3 and common loyal stilbene preparation vitro release comparative test result
| 0 hour | 0.5 hour | 1 hour | 2 hours | 4 hours | 8 hours | 12 hours | |
| ZhenQi capsule | 0.00% | 65.00% | 98.00% | --- | --- | --- | --- |
| Prescription 1 | 0.00% | 6.50% | 15.78% | 21.30% | 39.53% | 69.26% | 95.20% |
| Prescription 2 | 0.00% | 8.470% | 19.10% | 25.70% | 43.15% | 76.80% | 98.80% |
| Prescription 3 | 0.00% | 7.71% | 16.92% | 23.44% | 41.25% | 73.70% | 96.10% |
Result of the test by table 3 can find out that loyal stilbene slow releasing preparation is compared with common loyal stilbene preparation, can stablize in vivo the release that continues, thereby prolonged the action time of medicine, and the blood concentration fluctuation of minimizing because frequently taking medicine and causing, improved curative effect, increased the safety of medicine.
Compared with prior art, the present invention adopts macroporous adsorbent resin that medical material is extracted purification, compare with traditional extraction, it is few that the absorption with macroporous adsorbent resin partition method has consumption of organic solvent, save power consumption and energy expenditure, thereby the advantages such as decrease cost, so that the concentration of loyal stilbene active ingredient of Chinese herbs and purity improve more than 15 times than prior art, the slow releasing preparation dosage that makes greatly reduces, and can make each pharmaceutical component in slow release, reach synchronous release, be conducive to giving full play to of curative effect of medication, and drug action is lasting, toxic and side effects is low.
The specific embodiment
Embodiments of the invention 1:
(1) extracts purification: get Fructus Ligustri Lucidi 30 grams, the Radix Astragali 60 gram powder become fine powder, cross 40 mesh sieves; Take purified water as extracting medium, boiling is extracted three times, and each 20 minutes, solid-liquid ratio was respectively 1:25,1:15,1:10, merged three times extracting solution; Extracting solution after merging is filtered with 200 eye mesh screens, and the usefulness molecular weight that dams is that 50000 hollow fiber ultrafiltration membrane is carried out ultrafiltration again, and filtrate concentrates, and decompression recycling ethanol gets concentrated solution; Macroporous adsorptive resins carries out eluting on the concentrated solution, mixes the solution of twice eluting, is drying to obtain the purification thing.
(2) preparations shaping: purification thing 1 gram that the purification with macroreticular resin of learning from else's experience obtains, add hydroxypropyl methylcellulose 45 grams, mix homogeneously, to add lactose 41.6 gram again, add concentration be 5%, contain alcoholic solution, magnesium stearate 0.5 gram of 17g polyvinylpyrrolidone, take water as medium, granulate with 16 mesh sieves; With particle drying, make slow-releasing granules, tabletting, film coating namely gets slow releasing tablet.
The compound method of above-mentioned coating solution is: get the HPMC(hydroxypropyl emthylcellulose) 21.6 grams, PEG-400 3 grams, Tween-80 0.8 gram, lemon yellow 0.2 gram are configured to 800 milliliters with purified water.
Embodiments of the invention 2:
(1) extracts purification: get Fructus Ligustri Lucidi 30 grams, the Radix Astragali 60 gram powder become fine powder, cross 40 mesh sieves; Take purified water as extracting medium, boiling is extracted three times, and each 70 minutes, solid-liquid ratio was respectively 1:25,1:15,1:10, merged three times extracting solution; Extracting solution after merging is filtered with 200 eye mesh screens, and the usefulness molecular weight that dams is that 50000 hollow fiber ultrafiltration membrane is carried out ultrafiltration again, and filtrate concentrates, and decompression recycling ethanol gets concentrated solution; Macroporous adsorptive resins carries out eluting on the concentrated solution, mixes the solution of twice eluting, is drying to obtain the purification thing.
(2) preparations shaping: purification thing 5 grams that the purification with macroreticular resin of learning from else's experience obtains, add ethyl cellulose 50 grams, stearic acid 5 grams, mix homogeneously adds lactose 41 grams, 90% ethanol, 20 grams, Pulvis Talci 2 grams again, take water as medium, granulates with 16 mesh sieves; With the hollow capsule for medicine of packing into behind the slow-releasing granules coating, namely get slow releasing capsule.
The compound method of above-mentioned coating solution is: get the HPMC(hydroxypropyl emthylcellulose) 21.6 grams, PEG-400 3 grams, Tween-80 0.8 gram, lemon yellow 0.2 gram are configured to 800 milliliters with purified water.
Embodiments of the invention 3:
(1) extracts purification: get Fructus Ligustri Lucidi 30 grams, the Radix Astragali 60 gram powder become fine powder, cross 40 mesh sieves; Take purified water as extracting medium, boiling is extracted three times, and each 120 minutes, solid-liquid ratio was respectively 1:25,1:15,1:10, merged three times extracting solution; Extracting solution after merging is filtered with 200 eye mesh screens, and the usefulness molecular weight that dams is that 50000 hollow fiber ultrafiltration membrane is carried out ultrafiltration again, and filtrate concentrates, and decompression recycling ethanol gets concentrated solution; Macroporous adsorptive resins carries out eluting on the concentrated solution, mixes the solution of twice eluting, is drying to obtain the purification thing.
(2) preparations shaping: purification thing 10 grams that the purification with macroreticular resin of learning from else's experience obtains, add ethyl cellulose 36.25 grams, mix homogeneously adds lactose 43 grams, 30% ethanol, 10 grams, magnesium stearate 0.5 gram again, take water as medium, granulates with 16 mesh sieves; With slow-releasing granules piller processed, film coating namely gets slow releasing pill.
The compound method of above-mentioned coating solution is: get the HPMC(hydroxypropyl emthylcellulose) 21.6 grams, PEG-400 3 grams, Tween-80 0.8 gram, lemon yellow 0.2 gram are configured to 800 milliliters with purified water.
Claims (8)
1. the preparation method of a loyal stilbene slow releasing preparation, it is characterized in that: Fructus Ligustri Lucidi, astragalus membranaceus powder are broken into coarse powder, extract with ethanol or water, adopt macroporous adsorbent resin to carry out purification again, the purification thing behind the purification adds an amount of slow-release auxiliary material and other pharmaceutic adjuvants are made various slow releasing preparation.
2. according to the preparation method of the described loyal stilbene slow releasing preparation of claim 1, it is characterized in that: extracting purification step is: get Fructus Ligustri Lucidi 30 weight portions, the Radix Astragali 60 weight portion powder become fine powder, cross 40 mesh sieves; Take purified water as extracting medium, boiling is extracted three times, and each 20～120 minutes, solid-liquid ratio was respectively 1:25,1:15,1:10, merged three times extracting solution; Extracting solution after merging is filtered with 200 eye mesh screens, and the usefulness molecular weight that dams is that 50000 hollow fiber ultrafiltration membrane is carried out ultrafiltration again, and filtrate concentrates, and decompression recycling ethanol gets concentrated solution; Macroporous adsorptive resins carries out eluting on the concentrated solution, mixes the solution of twice eluting, is drying to obtain the purification thing.
3. according to the preparation method of the described loyal stilbene slow releasing preparation of claim 1, it is characterized in that: slow-release auxiliary material is one or more in hydroxypropyl methylcellulose, ethyl cellulose, the stearic acid.
4. according to the preparation method of the described loyal stilbene slow releasing preparation of claim 1, it is characterized in that: other pharmaceutic adjuvants comprise filler, binding agent and lubricant; Filler is lactose; Binding agent is one or both of ethanol-water solution of polyvinylpyrrolidone, various proportionings; Lubricant is Pulvis Talci or magnesium stearate.
5. according to the preparation method of the described loyal stilbene slow releasing preparation of claim 1, it is characterized in that: described slow releasing preparation is slow releasing tablet, slow releasing capsule or slow releasing pill.
6. according to the preparation method of claim 3 or 4 or 5 described loyal stilbene slow releasing preparation, it is characterized in that: the preparation technology of described loyal stilbene slow releasing tablet, slow releasing capsule, slow releasing pill is: purification thing 1～10 weight portion that the purification with macroreticular resin of learning from else's experience obtains, add slow-release auxiliary material 35～45 weight portions, mix homogeneously, add again filler 40～45 weight portions, binding agent 10～20 weight portions, lubricant 0.5～2 weight portion, take water as medium, granulate with 16 mesh sieves; With particle drying, make slow-releasing granules, tabletting, film coating namely gets slow releasing tablet; Or with the hollow capsule for medicine of packing into behind the slow-releasing granules coating, namely get slow releasing capsule; Or with slow-releasing granules piller processed, film coating namely gets slow releasing pill.
7. according to the preparation method of the described loyal stilbene slow releasing preparation of claim 6, it is characterized in that: the compound method of coating solution is: get hydroxypropyl emthylcellulose 21.6 weight portions, PEG-400 3 weight portions, Tween-80 0.8 weight portion, lemon yellow 0.2 weight portion, be configured to 800 weight portions with 60% ethanol.
8. such as the preparation method of loyal stilbene slow releasing preparation prepares as described in each among the claim 1-7 loyal stilbene slow releasing preparation.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104013680A (en) * | 2014-05-28 | 2014-09-03 | 王庚禹 | Extractive for preparing astragalus membranaceus-ligustrum healthy-qi-reinforcing preparation |
| CN106974966A (en) * | 2016-01-18 | 2017-07-25 | 北京海吉星医疗科技有限公司 | Double release capsules of a kind of body resistance-strengthening Zhenqi and preparation method thereof |
| CN108968068A (en) * | 2018-08-09 | 2018-12-11 | 魏鹏 | A kind of Halth-care composition and preparation method thereof for alleviating diabetes complications |
| CN115671165A (en) * | 2022-11-16 | 2023-02-03 | 刘凤和 | Gastrointestinal detoxification powder and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1454642A (en) * | 2003-04-01 | 2003-11-12 | 贵州信邦远东药业有限公司 | Tonifying capsule preparing process |
| CN1899361A (en) * | 2006-07-14 | 2007-01-24 | 贵州信邦制药股份有限公司 | Zhenqi medicinal composition and its preparation |
-
2012
- 2012-12-21 CN CN2012105634112A patent/CN103006789A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1454642A (en) * | 2003-04-01 | 2003-11-12 | 贵州信邦远东药业有限公司 | Tonifying capsule preparing process |
| CN1899361A (en) * | 2006-07-14 | 2007-01-24 | 贵州信邦制药股份有限公司 | Zhenqi medicinal composition and its preparation |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104013680A (en) * | 2014-05-28 | 2014-09-03 | 王庚禹 | Extractive for preparing astragalus membranaceus-ligustrum healthy-qi-reinforcing preparation |
| CN106974966A (en) * | 2016-01-18 | 2017-07-25 | 北京海吉星医疗科技有限公司 | Double release capsules of a kind of body resistance-strengthening Zhenqi and preparation method thereof |
| CN108968068A (en) * | 2018-08-09 | 2018-12-11 | 魏鹏 | A kind of Halth-care composition and preparation method thereof for alleviating diabetes complications |
| CN115671165A (en) * | 2022-11-16 | 2023-02-03 | 刘凤和 | Gastrointestinal detoxification powder and preparation method thereof |
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Application publication date: 20130403 |