CN104095885A - Preparation process for high-activity stone-like omphalia directly and orally taken - Google Patents
Preparation process for high-activity stone-like omphalia directly and orally taken Download PDFInfo
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- CN104095885A CN104095885A CN201410288553.1A CN201410288553A CN104095885A CN 104095885 A CN104095885 A CN 104095885A CN 201410288553 A CN201410288553 A CN 201410288553A CN 104095885 A CN104095885 A CN 104095885A
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Abstract
The invention discloses a preparation process for high-activity stone-like omphalia directly and orally taken. The preparation process comprises the following steps: 1, taking fresh stone-like omphalia and removing low-quality stone-like omphalia in the fresh stone-like omphalia; 2, cleaning the fresh and high-quality stone-like omphalia with a sodium bicarbonate solution, and draining; 3, placing the cleaned stone-like omphalia in pulping equipment, adding an acetic acid solution for pulping, wherein the amount of the solution is two times that of stone-like omphalia, or directly cutting the stone-like omphalia into slices, and soaking the slices into an acetic acid solution completely, and enabling the volume concentration of the final acetic acid solution including water content of the stone-like omphalia self to be 3.0-5.0%; 4, placing the semi-finished product obtained in the step 3 in the environment of 20-35 DEG C for still standing for 6-24 h; 5, loading the semi-finished product obtained in the step 4 in a freeze-dried plate in a clean workshop, and freeze-drying; 6, after freeze-drying, and taking the product out, so as to obtain the high-activity stone-like omphalia slices which can be taken directly and orally or obtain the stone-like omphalia powder which can be taken directly and orally through crushing. According to the invention, the high-activity stone-like omphalia can be taken orally and directly without irradiation sterilization while the high-activity stone-like omphalia can be obtained to the maximum extent, so that risks brought by irradiation sterilization can be reduced.
Description
Technical field
The present invention relates to the preparation technology of the direct oral Omphalia of a kind of high activity, belong to Chinese medicine manufacture field.
Background technology
Omphalia (Omphalia lapidescens Schroet) is a kind of medicinal fungi, claims again bamboo Siberian cocklebur, bamboo grove, bamboo bell sesame, Fructus Fici Pumilae, is the dry sclerotia of Eumycota Basidiomycetes Bai Mo section fungus Omphalia.Omphalia is all produced in NORTHWEST CHINA, southwest, various places, south China, but maximum with ground output such as Sichuan, Hubei, Yunnan, Guizhou.
Ancient books is recorded Omphalia and is had anthelmintic, treatment infantile malnutrition, and children's's night crying due to fright in infant, crazy epilepsy, clearing away heat-damp and promoting diuresis, purging FU-organs be the merit of heap soil or fertilizer over and around the roots certainly.Modern study shows, Omphalia, except effect brilliance in anthelmintic, also has the effect of good anticancer effect, blood coagulation and blood sugar lowering, antiinflammatory and enhancing immunity.
The good result of Omphalia is determined by composition wherein.The active component of Omphalia had both comprised water miscible composition, as materials such as Omphalia agglutinin, Omphalin, Omphalia polysaccharide, also comprised water insoluble ingredients, as sterols material, various trace element etc.This wherein most study surely belong to Omphalin, Omphalin is a kind of protein existing in Omphalia, has the effect of decomposing insects albumen, thereby the effect of performance parasite killing.It needs to be noted that Omphalin is thermo-labile, surpass 60 ℃, very fast inactivation.Therefore < < Zhejiang Province 2005 editions clear and definite drying modes of Chinese medicine processing standard > > be " cold drying ", < < Pharmacopoeia of People's Republic of China > > 2010 editions in it is concocted clearly " must not steaming and decocting or high-temperature baking ".Bibliographical information, this albumen is unstable under acidic condition, easily inactivation.In order to bring into play to greatest extent the effectiveness of Omphalia, on its instructions of taking, the scholar of numerous medical circles also advises not using the form of decocting soup to take (Omphalia such as Ding Huanying is concocted the simple analysis Zhejiang combination of Chinese and Western medicine impurity Volume Four fourth phase in 1994).< < Pharmacopoeia of People's Republic of China > > 2010 editions clear and definite " should not enter decoct " " general levigation clothes " or " by warm water, being taken after mixing with liquid after meal " in its usage.
In order to bring into play to greatest extent the function of Omphalia, current way is by Omphalia cold drying, then breaks into powder, directly takes.But do like this, have the grave danger that microorganism exceeds standard.Because having microorganism and parasite in Omphalia cannot kill.The pharmacopeia of China has been carried out the clear and definite regulation of limiting the quantity of for the microorganism in direct oral class medicine thing.Containing the preparation of the former powder of medical material, its total plate count must not surpass 10000cfu/g to solid-state, and liquid state must not surpass 500cfu/ml. yeast and mold number must not surpass 100cfu/g, 100cfu/ml respectively.Coliform must not distinguish over 100cfu/g, 10cfu/ml.Escherichia coli must not detect.Therefore, for oral drug preparation, a kind of can making of How to choose must microorganism reach oral requirement in medicine, can guarantee again the effective ingredient of medicine, especially heat sensitive composition do not lost, guarantees that the sterilizing methods of safety of medicine is a difficult point always.For containing heat sensitive active component, general way is to carry out by the mode of irradiation the high-energy ray that sterilizing produces by radioelement cobalt-60 at present, reaches the object of sterilizing, although this method is easy and simple to handle, cost is low.But easily cause natural drug in some compositions change, as protein degradation etc., and easily residual, have certain potential safety hazard, so its safety is queried always deeply.Some European countries always inverse correspondence carry out sterilizing with irradiation sterilization to food, or whether mandatory requirement manufacturer clear and definite indicating in its packing carries out irradiation sterilization.
The preparation method that discloses a kind of Chinese medicine preparation Omphalia powder for assistant treating cancer in the Chinese patent that Granted publication number is CN103349672A, scheme is: step a. raw material is chosen: choose fresh Omphalia raw material, take out inferior, impurity; Step b. cleans: the Omphalia of fresh high-quality is put into sodium bicarbonate solution and carry out ultrasonic cleaning 20min; Step c is predrying: cleaned Omphalia is put into ventilated chamber and be dried 25～35min; Steps d. pretreatment: predrying good Omphalia is cut into slices, and slice thickness is controlled at 2～5mm; Step e. sabot is freezing: after pretreated Omphalia sabot, put into after freeze drying box, start freeze dryer, until freeze drying box temperature, be down to after-30 ℃～-35 ℃, keep 2 hours; Step f. is dry: adopt one time sublimed method, product is heated up gradually, freeze drying box flaggy keeps respectively 2～3 hours at 0 ℃, 5 ℃, 10 ℃, 15 ℃, product ice crystal is disappeared, be warming up to again 25 ℃ and keep 2～3 hours, vacuum is changed when little, finish the dry of product; Step g. pulverizing: dried Omphalia sheet is added in freezing powder beater and beats powder, and sieve through 100 orders; Step h. breaking cellular wall: Omphalia powder is put into the wall-breaking machine of sealing, utilized two strands of ultrasonic air-flows to carry out physical wall breaking, obtain finished product after packing.Although the method can obtain highly active Omphalia, this technical scheme but fails to illustrate how to make its microorganism sterilizing methods up to standard.
Summary of the invention
Object of the present invention is exactly in order to address the above problem, the preparation technology of the direct oral Omphalia of a kind of high activity is provided, be intended to can make the active component in Omphalia not suffer a loss by this technique, and just can make the microbiological indicator of product reach the requirement of direct oral class medicine thing preparation without irradiation.
To achieve these goals, the present invention adopts following technical scheme:
A preparation technology for the direct oral Omphalia of high activity, step is as follows:
Step 1: get fresh Omphalia, reject Omphalia inferior wherein;
Step 2: the Omphalia of fresh high-quality is cleaned up with sodium bicarbonate solution, drain;
Step 3: the Omphalia cleaning up is placed in to beating equipment, adds the acetic acid solution making beating of 1-2 times of quality, or after directly thinly slicing, do not have with acetic acid;
Step 4: the semi-finished product in step 3 are placed in to the 20-35 ℃ of standing 6-24 hour of environment;
Step 5: the semi-finished product in step 4 are packed in lyophilizing dish in dust proof workshop into lyophilization;
Step 6: after lyophilizing completes, take out and obtain direct oral high activity Omphalia thin slice or further pulverize the direct oral Omphalia powder of acquisition.
Preferably, in step 2, sodium bicarbonate solution pH value is 8.
Preferably, in step 3, together with the water content of Omphalia itself, interior, make the acetic acid volumetric concentration of final solution maintain 3.0-5.0%.
Preferably, in step 4, time of repose is 6-12 hour.
Preferably, the order number of the direct oral Omphalia powder in step 6 is not less than 100 orders, is carrying out Omphalia while beating powder, and its temperature is not higher than 50 ℃.
The acid solution adding is more, and the dry energy consumption of unit mass is more, and acid solution consumption is the 1-2 doubly relatively rationally (ratio of Omphalia and acid solution is 1:1-2 (w/v)) of Omphalia quality.Although Omphalin is easy inactivation in acid solution, inventor studies and finds that Omphalin can activity recovery after removing disacidify.For killing microorganisms more thoroughly, the serosity after making beating needs standing certain hour, considers time cost, within 6-8 hour, is preferred value.In order to guarantee the maximum effect of Omphalia powder, the Omphalia powder after lyophilizing need to carry out micronizing under the condition of low temperature, and to avoid the loss of active ingredient, the temperature that Cryogenic Ultrafine is pulverized is higher than 50 ℃, and further preferred value is not for higher than 40 ℃.Beating equipment in literary composition can adopt beater.
Compared with prior art, the present invention has following beneficial effect:
(1) the present invention can obtain highly active direct oral Omphalia, it can be when obtaining high activity Omphalia to greatest extent, no longer need cobalt-60 to carry out irradiation sterilization, just can make its microorganism reach the requirement of direct oral formulations, thereby reduce, because of irradiation sterilization, bring the unknown and potential risk, reduce irradiation cost.
(2) this preparation technology is simple, equipment investment is little, and production cost is low.
The specific embodiment
Embodiment mono-
Taking fresh high-quality Omphalia after sodium bicarbonate solution cleans 200 grams (water content of fresh Omphalia is by 70%), to add volume ratio be 6% acetic acid solution 140ml, and making its final acetic acid volumetric concentration is 3% (the acetic acid volumetric concentration of final solution is 3%).Making beating obtains the Omphalia serosity that contains acetic acid.By the static placement of this serosity 6h, carry out lyophilizing to moisture and be less than 5%, then it is broken to carry out low-temperature fine powder.Obtain the direct oral Omphalia micropowder of the non-irradiation of high activity.
Separately get 200 grams of fresh high-quality Omphalias after sodium bicarbonate solution cleans, add 140ml water, after making beating, according to same parameter, carry out lyophilizing to moisture and be less than 5%.Carry out again low-temperature fine powder broken, obtain lyophilizing Omphalia micropowder.This Omphalia micropowder is product in contrast.
Omphalin content balance
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Omphalin content % | 1.83 | 1.82 | 0.66 |
Microbial limit
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Total plate count, cfu/g | 170 | 6×10 5 | 4×10 5 |
| Molds and yeasts, cfu/g | 20 | 860 | 1054 |
| Coliform, cfu/g | 0 | 574 | 658 |
| Escherichia coli, cfu/g | Negative | Positive | Positive |
Embodiment bis-
Taking fresh high-quality Omphalia after sodium bicarbonate solution cleans 200 grams (water content of fresh Omphalia is by 70%), to add volume ratio be 7% acetic acid solution 140ml, and making its final acetic acid volumetric concentration is that 3.5% (in final solution, acetic acid volumetric concentration is 3.5%) making beating obtains the Omphalia serosity that contains acetic acid.By the static placement of this serosity 8h, carry out lyophilizing to moisture and be less than 5%, then it is broken to carry out low-temperature fine powder.Obtain the direct oral Omphalia micropowder of the non-irradiation of high activity.
Separately get 200 grams of fresh high-quality Omphalias after sodium bicarbonate solution cleans, add 140ml water, after making beating, according to same parameter, carry out lyophilizing to moisture and be less than 5%.Carry out again low-temperature fine powder broken, obtain lyophilizing Omphalia micropowder.This Omphalia micropowder is product in contrast.
Omphalin content balance
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Omphalin % | 1.92 | 1.94 | 0.67 |
Microbial limit
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Total plate count, cfu/g | 20 | 6×10 5 | 1×10 6 |
| Molds and yeasts, cfu/g | 0 | 2034 | 2508 |
| Coliform, cfu/g | 0 | 560 | 320 |
| Escherichia coli, cfu/g | Fail to detect | Positive | Positive |
Embodiment tri-
Taking fresh high-quality Omphalia after sodium bicarbonate solution cleans 200 grams (water content of fresh Omphalia is by 70%), to add volume ratio be 7% acetic acid solution 140ml, and making beating obtains the Omphalia serosity that contains acetic acid.Making its final acetic acid volumetric concentration is 3.5% (in final solution, acetic acid volumetric concentration is 3.5%).By the static placement of this serosity 24h, carry out lyophilizing to moisture and be less than 5%, then it is broken to carry out low-temperature fine powder.Obtain the direct oral Omphalia micropowder of the non-irradiation of high activity.
Separately get 200 grams of fresh high-quality Omphalias after sodium bicarbonate solution cleans, add 140ml water, after making beating, according to same parameter, carry out lyophilizing to moisture and be less than 5%.Carry out again low-temperature fine powder broken, obtain lyophilizing Omphalia micropowder.This Omphalia micropowder is product in contrast.
Omphalin content balance
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Omphalin % | 1.86 | 1.79 | 0.77 |
Microbial limit
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Total plate count, cfu/g | 10 | 7×10 5 | 1×10 5 |
| Molds and yeasts, cfu/g | 1 | 1034 | 1508 |
| Coliform, cfu/g | 0 | 560 | 320 |
[0045]?
| Escherichia coli, cfu/g | Negative | Positive | Negative |
Embodiment tetra-
Taking fresh high-quality Omphalia after sodium bicarbonate solution cleans 200 grams (water content of fresh Omphalia is by 70%), to add volume ratio be 8% acetic acid solution 140ml, and making its final acetic acid volumetric concentration is that 4.0% (in final solution, acetic acid volumetric concentration is 4.0%) making beating obtains the Omphalia serosity that contains acetic acid.By the static placement of this serosity 12h, carry out lyophilizing to moisture and be less than 5%, then it is broken to carry out low-temperature fine powder.Obtain the direct oral Omphalia micropowder of the non-irradiation of high activity.
Separately get 200 grams of fresh high-quality Omphalias after sodium bicarbonate solution cleans, add 140ml water, after making beating, according to same parameter, carry out lyophilizing to moisture and be less than 5%.Carry out again low-temperature fine powder broken, obtain lyophilizing Omphalia micropowder.This Omphalia micropowder is product in contrast.
Omphalin content balance
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Omphalin % | 1.85 | 1.83 | 0.72 |
Microbial limit
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Total plate count, cfu/g | 220 | 2×10 5 | 8×10 3 |
| Molds and yeasts, cfu/g | 20 | 1960 | 1258 |
| Coliform, cfu/g | 0 | 380 | 80 |
| Escherichia coli, cfu/g | Negative | Positive | Negative |
Embodiment five
Take fresh 200 grams of high-quality Omphalias (water content of fresh Omphalia is by 70%) after sodium bicarbonate solution cleans, thinly slice, adding volume ratio is 10% acetic acid solution 140ml, volume ratio be 5% acetic acid solution 140ml. to make its final acetic acid volumetric concentration be 5.0% (in final solution, acetic acid volumetric concentration is 5.0%), do not had.Static placement 8h, carries out lyophilizing to moisture and is less than 5%, obtains direct oral Omphalia thin slice.
Separately get 200 grams of fresh high-quality Omphalias after sodium bicarbonate solution cleans, thinly slice, add 280ml not have, according to same parameter, carry out lyophilizing to moisture and be less than 5%.Obtain the direct lyophilizing thin slice of Omphalia.
Omphalin contrast
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Omphalin % | 1.82 | 1.79 | 0.62 |
Microbial limit
| ? | Acetic acid treatment technique | Directly lyophilizing | Pharmacy is bought |
| Total plate count, cfu/g | 120 | 2×10 5 | 8×10 3 |
| Molds and yeasts, cfu/g | 10 | 860 | 458 |
| Coliform, cfu/g | 0 | 280 | 85 |
| Escherichia coli, cfu/g | Negative | Positive | Positive |
The foregoing is only the preferred embodiment of the present invention, protection scope of the present invention is not limited in above-mentioned embodiment, and every technical scheme that belongs to the principle of the invention all belongs to protection scope of the present invention.For a person skilled in the art, some improvement of carrying out under the prerequisite that does not depart from principle of the present invention, these improvement also should be considered as protection scope of the present invention.
Claims (5)
1. a preparation technology for the direct oral Omphalia of high activity, is characterized in that, step is as follows:
Step 1: get fresh Omphalia, reject Omphalia inferior wherein;
Step 2: the Omphalia of fresh high-quality is cleaned up with sodium bicarbonate solution, drain;
Step 3: the Omphalia cleaning up is placed in to beating equipment, adds 1-2 doubly to measure acetic acid solution making beating, or after directly thinly slicing, do not have with acetic acid;
Step 4: the semi-finished product in step 3 are placed in to the 20-35 ℃ of standing 6-24 hour of environment;
Step 5: the semi-finished product in step 4 are packed in lyophilizing dish in dust proof workshop into lyophilization;
Step 6: after lyophilizing completes, take out and obtain direct oral high activity Omphalia thin slice or further pulverize the direct oral Omphalia powder of acquisition.
2. the preparation technology of the oral Omphalia of a kind of high activity according to claim 1, is characterized in that, in step 2, sodium bicarbonate solution pH value is 8.
3. the preparation technology of the oral Omphalia of a kind of high activity according to claim 1, is characterized in that, in step 3, together with the water content of Omphalia itself, interior, makes the acetic acid volumetric concentration of final solution maintain 3.0-5.0%.
4. the preparation technology of the oral Omphalia of a kind of high activity according to claim 1, is characterized in that, in step 4, time of repose is 6-12 hour.
5. the preparation technology of the oral Omphalia of a kind of high activity according to claim 1, is characterized in that, in step 6, the order number of direct oral Omphalia powder is not less than 100 orders, is carrying out Omphalia while beating powder, and its temperature is not higher than 50 ℃.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114392286A (en) * | 2021-12-21 | 2022-04-26 | 河北万邦复临药业有限公司 | Preparation method of omphalia powder |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103349672A (en) * | 2013-05-23 | 2013-10-16 | 浙江农林大学 | Preparation method of traditional Chinese medicinal preparation Omphalia powder for auxiliary treatment of cancers |
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2014
- 2014-06-24 CN CN201410288553.1A patent/CN104095885A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103349672A (en) * | 2013-05-23 | 2013-10-16 | 浙江农林大学 | Preparation method of traditional Chinese medicinal preparation Omphalia powder for auxiliary treatment of cancers |
Non-Patent Citations (1)
| Title |
|---|
| 冉憨雄等: "《现代中药炮制手册》", 30 January 2002, 中国中医药出版社 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114392286A (en) * | 2021-12-21 | 2022-04-26 | 河北万邦复临药业有限公司 | Preparation method of omphalia powder |
| CN114392286B (en) * | 2021-12-21 | 2023-03-07 | 河北万邦复临药业有限公司 | Preparation method of omphalia powder |
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