CN112494572A - Preparation process of wick hemostatic capsule - Google Patents
Preparation process of wick hemostatic capsule Download PDFInfo
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Abstract
The invention discloses a preparation process of a wick hemostatic capsule, which comprises the steps of respectively treating each medicinal material component for preparing the wick hemostatic capsule, mixing the prepared liquid for later use, carrying out multiple treatment again, extracting effective components from the medicinal materials by centrifugal separation, distillation concentration and other modes, and finally preparing the effective components into powder and filling the powder into a capsule shell to prepare the wick hemostatic capsule. The process can furthest extract the effective components in the medicinal materials, fully utilize the medicinal materials, avoid resource waste, and compared with the prior art, on the premise of ensuring the medicinal effect, the equivalent medicinal materials can be prepared to obtain more medicines, so that the material cost of a medicine enterprise is reduced, the consumed time of the new medicinal material treatment process is shortened by nearly 50 percent compared with the traditional process, and the productivity of the medicine enterprise can be greatly improved.
Description
Technical Field
The invention relates to the technical field of pharmacy, in particular to a preparation process of a wick hemostatic capsule.
Background
The corduroy hemostatic capsule is an ideal good hemostatic medicine and is mainly used for treating symptoms such as long-time colporrhagia after medical abortion, increased menstrual flow within half a year after intrauterine contraceptive ring placement, vaginal dripping bleeding within half a year, anovulatory functional excessive bleeding in puberty, climacteric functional bleeding, long-term small bleeding of hysteromyoma patients, internal hemorrhoid chronic bleeding and the like. The pharmacy standard of the drug administration discloses a general preparation method of a wick hemostatic capsule, but the method has rough treatment on medicinal materials, so that effective ingredients in the medicinal materials are not fully utilized, and resource waste is caused.
Disclosure of Invention
The invention aims to provide a preparation process of a wick hemostatic capsule, which aims to solve the problems in the background technology.
In order to achieve the purpose, the invention provides the following technical scheme: a preparation process of a wick hemostatic capsule comprises the following steps:
step a: taking 3-5 parts by mass of common rush and 0.5-1 part by mass of akebia stem, crushing to 200 meshes and 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 70 ℃, decocting at constant temperature for 30min to obtain a first standby liquid, naturally cooling the first standby liquid to 30 ℃, and preserving heat for later use;
step b: taking 3-5 parts by mass of agrimony tomentosa and 0.5-1 part by mass of circium japonicum, crushing to 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 75 ℃, decocting for 45min at constant temperature to obtain a second standby solution, naturally cooling the second standby solution to 30 ℃, and preserving heat for later use;
step c: taking 3-5 parts by mass of acalypha australis, crushing to 250 meshes of 200 meshes, then adding 30-40 parts by mass of water, fully and uniformly mixing, heating to 70 ℃, decocting for 30min at constant temperature to obtain a third standby liquid, naturally cooling the third standby liquid to 30 ℃, and preserving heat for standby;
step d: mixing the first, second and third standby liquids, fully stirring, adding 60-80 parts by mass of water, heating to 70 ℃, decocting at constant temperature for 90min, then adding 30-40 parts by mass of water, heating to 75 ℃, decocting at constant temperature for 30min, and finally naturally cooling to normal temperature to obtain a crude product mixed liquid;
step e: d, subpackaging the crude product mixed solution obtained in the step d into a plurality of centrifuge tubes, then placing the centrifuge tubes into a centrifuge, centrifuging for 30min at the speed of 2000r/min, separating supernatant liquor in the centrifuge tubes after centrifuging is finished, sealing and storing, adding 50% ethanol with the same amount into the bottom sediment left in the centrifuge tubes, fully stirring uniformly, standing for 12h, then placing the centrifuge tubes into the centrifuge again, centrifuging for 20min at the rotating speed of 2000r/min, separating supernatant liquor in the centrifuge tubes again after centrifuging is finished, and combining the supernatant liquor with the previous supernatant liquor;
step f: distilling and concentrating the combined supernatant until the relative density is 1.12-1.15, adding 0.1 part by mass of dextrin while the supernatant is hot, uniformly mixing, spray-drying, collecting spray-dried medicinal powder, adding 0.1 part by mass of dextrin, 0.15 part by mass of calcium hydrogen phosphate and 1.5 parts by mass of starch, and fully mixing to obtain powder;
step g: and f, preparing soft materials from the powder in the step f by using 80% ethanol, granulating, drying the prepared granules at 50 ℃, adding magnesium stearate into the dried granules, mixing uniformly, and subpackaging into capsule shells to obtain the required medulla Junci hemostatic capsules.
Preferably, in the step d, the wick hemostatic capsule is stirred every 10min during heating, and the stirring time is 30s each time.
Preferably, in the step a, 3 parts by mass of common alstonia and 0.5 part by mass of akebia stem are taken, crushed to 200 meshes, then 30 parts by mass of water is added, the mixture is fully stirred, heated to 70 ℃ and decocted for 30min at constant temperature to obtain a first standby liquid, and the first standby liquid is cooled to 30 ℃ and then kept warm for standby.
Preferably, in the step b, 3 parts by mass of fine agrimony and 0.5 part by mass of circium japonicum are taken, crushed to 200 meshes, then 30 parts by mass of water is added, the mixture is fully stirred, heated to 75 ℃ and decocted for 45min at constant temperature to obtain a second standby liquid, and the second standby liquid is cooled to 30 ℃ and then kept warm for standby.
Preferably, in the preparation process of the wick hemostatic capsule, in the step c, 3 parts by mass of acalypha australis taken, crushed to 200 meshes, then 30 parts by mass of water is added, the mixture is fully and uniformly mixed, heated to 70 ℃ and decocted for 30min at constant temperature to obtain a third standby liquid, and the third standby liquid is naturally cooled to 30 ℃ and then kept warm for standby.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention adopts a new process to treat the medicinal materials, can extract the effective components in the medicinal materials to the maximum extent, fully utilizes the medicinal materials and avoids resource waste;
2. by efficiently extracting the effective components in the medicinal materials, the effective components in the finished medicinal product can be higher, so that the medicament has better curative effect;
3. compared with the traditional process, the time consumption of the new medicinal material treatment process is shortened by nearly 50%, and the productivity of the medicinal enterprise can be greatly improved.
Detailed Description
The present invention is described in further detail below to enable those skilled in the art to practice the invention with reference to the description.
The following description is presented to disclose the invention so as to enable any person skilled in the art to practice the invention. The preferred embodiments described below are intended as examples only, and other obvious variations will occur to those skilled in the art. The basic principles of the invention defined in the following description may be applied to other embodiments, variations, modifications, equivalents, and other technical solutions without departing from the spirit and scope of the invention.
It will be understood by those skilled in the art that the terms "longitudinal," "lateral," "up," "down," "front," "back," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in the present disclosure for the purpose of describing a particular invention only and to simplify the description, but are not intended to indicate or imply that the referenced device or component must be in a particular orientation, constructed and operated in a particular orientation, and thus the terms are not to be construed as limiting the invention.
It is understood that the terms "a" and "an" should be interpreted as meaning that a number of one element can be one in one embodiment, or "one or more" in another embodiment, or that a number of elements can be in multiple embodiments, and the terms "a" and "an" should not be interpreted as limiting the number.
Example 1
A preparation process of a wick hemostatic capsule comprises the following steps:
step a: taking 3-5 parts by mass of common rush and 0.5-1 part by mass of akebia stem, crushing to 200 meshes and 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 70 ℃, decocting at constant temperature for 30min to obtain a first standby liquid, naturally cooling the first standby liquid to 30 ℃, and preserving heat for later use;
step b: taking 3-5 parts by mass of agrimony tomentosa and 0.5-1 part by mass of circium japonicum, crushing to 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 75 ℃, decocting for 45min at constant temperature to obtain a second standby solution, naturally cooling the second standby solution to 30 ℃, and preserving heat for later use;
step c: taking 3-5 parts by mass of acalypha australis, crushing to 250 meshes of 200 meshes, then adding 30-40 parts by mass of water, fully and uniformly mixing, heating to 70 ℃, decocting for 30min at constant temperature to obtain a third standby liquid, naturally cooling the third standby liquid to 30 ℃, and preserving heat for standby;
step d: mixing the first, second and third standby liquids, fully stirring, adding 60-80 parts by mass of water, heating to 70 ℃, decocting at constant temperature for 90min, then adding 30-40 parts by mass of water, heating to 75 ℃, decocting at constant temperature for 30min, and finally naturally cooling to normal temperature to obtain a crude product mixed liquid;
step e: d, subpackaging the crude product mixed solution obtained in the step d into a plurality of centrifuge tubes, then placing the centrifuge tubes into a centrifuge, centrifuging for 30min at the speed of 2000r/min, separating supernatant liquor in the centrifuge tubes after centrifuging is finished, sealing and storing, adding 50% ethanol with the same amount into the bottom sediment left in the centrifuge tubes, fully stirring uniformly, standing for 12h, then placing the centrifuge tubes into the centrifuge again, centrifuging for 20min at the rotating speed of 2000r/min, separating supernatant liquor in the centrifuge tubes again after centrifuging is finished, and combining the supernatant liquor with the previous supernatant liquor;
step f: distilling and concentrating the combined supernatant until the relative density is 1.12-1.15, adding 0.1 part by mass of dextrin while the supernatant is hot, uniformly mixing, spray-drying, collecting spray-dried medicinal powder, adding 0.1 part by mass of dextrin, 0.15 part by mass of calcium hydrogen phosphate and 1.5 parts by mass of starch, and fully mixing to obtain powder;
step g: and f, preparing soft materials from the powder in the step f by using 80% ethanol, granulating, drying the prepared granules at 50 ℃, adding magnesium stearate into the dried granules, mixing uniformly, and subpackaging into capsule shells to obtain the required medulla Junci hemostatic capsules.
Example 2
A preparation process of a rush hemostatic capsule comprises the following steps:
step a: taking 3 parts by mass of common rush and 0.5 part by mass of akebia stem, crushing to 200 meshes, then adding 30 parts by mass of water, fully stirring uniformly, heating to 70 ℃, decocting for 30min at constant temperature to obtain a first standby liquid, naturally cooling the first standby liquid to 30 ℃, and preserving heat for later use;
step b: taking 3 parts by mass of fine agrimony and 0.5 part by mass of circium japonicum, crushing to 200 meshes, then adding 30 parts by mass of water, fully stirring uniformly, heating to 75 ℃, decocting for 45min at constant temperature to obtain a second standby liquid, naturally cooling the second standby liquid to 30 ℃, and preserving heat for standby;
step c: taking 3 parts by mass of acalypha australis, crushing to 200 meshes, then adding 30 parts by mass of water, fully and uniformly mixing, heating to 70 ℃, decocting for 30min at constant temperature to obtain a third standby liquid, naturally cooling the third standby liquid to 30 ℃, and preserving heat for standby;
step d: mixing the first, second and third standby liquids, fully stirring, adding 60-80 parts by mass of water, heating to 70 ℃, decocting at constant temperature for 90min, then adding 30-40 parts by mass of water, heating to 75 ℃, decocting at constant temperature for 30min, and finally naturally cooling to normal temperature to obtain a crude product mixed liquid;
step e: d, subpackaging the crude product mixed solution obtained in the step d into a plurality of centrifuge tubes, then placing the centrifuge tubes into a centrifuge, centrifuging for 30min at the speed of 2000r/min, separating supernatant liquor in the centrifuge tubes after centrifuging is finished, sealing and storing, adding 50% ethanol with the same amount into the bottom sediment left in the centrifuge tubes, fully stirring uniformly, standing for 12h, then placing the centrifuge tubes into the centrifuge again, centrifuging for 20min at the rotating speed of 2000r/min, separating supernatant liquor in the centrifuge tubes again after centrifuging is finished, and combining the supernatant liquor with the previous supernatant liquor;
step f: distilling and concentrating the combined supernatant until the relative density is 1.12-1.15, adding 0.1 part by mass of dextrin while the supernatant is hot, uniformly mixing, spray-drying, collecting spray-dried medicinal powder, adding 0.1 part by mass of dextrin, 0.15 part by mass of calcium hydrogen phosphate and 1.5 parts by mass of starch, and fully mixing to obtain powder;
step g: and f, preparing soft materials from the powder in the step f by using 80% ethanol, granulating, drying the prepared granules at 50 ℃, adding magnesium stearate into the dried granules, mixing uniformly, and subpackaging into capsule shells to obtain the required medulla Junci hemostatic capsules.
Example 3
A preparation process of a wick hemostatic capsule comprises the following steps:
step a: taking 3 parts by mass of common rush and 0.5 part by mass of akebia stem, crushing to 200 meshes, then adding 30 parts by mass of water, fully stirring uniformly, heating to 70 ℃, decocting for 30min at constant temperature to obtain a first standby liquid, naturally cooling the first standby liquid to 30 ℃, and preserving heat for later use;
step b: taking 3 parts by mass of fine agrimony and 0.5 part by mass of circium japonicum, crushing to 200 meshes, then adding 30 parts by mass of water, fully stirring uniformly, heating to 75 ℃, decocting for 45min at constant temperature to obtain a second standby liquid, naturally cooling the second standby liquid to 30 ℃, and preserving heat for standby;
step c: taking 3 parts by mass of acalypha australis, crushing to 200 meshes, then adding 30 parts by mass of water, fully and uniformly mixing, heating to 70 ℃, decocting for 30min at constant temperature to obtain a third standby liquid, naturally cooling the third standby liquid to 30 ℃, and preserving heat for standby;
step d: mixing the first, second and third standby liquids, fully stirring, adding 60-80 parts by mass of water, heating to 70 ℃, decocting at constant temperature for 90min, then adding 30-40 parts by mass of water, heating to 75 ℃, decocting at constant temperature for 30min, naturally cooling to normal temperature to obtain a crude product mixed liquid, and stirring once every 10min in the heating process, wherein the stirring time is 30s each time;
step e: d, subpackaging the crude product mixed solution obtained in the step d into a plurality of centrifuge tubes, then placing the centrifuge tubes into a centrifuge, centrifuging for 30min at the speed of 2000r/min, separating supernatant liquor in the centrifuge tubes after centrifuging is finished, sealing and storing, adding 50% ethanol with the same amount into the bottom sediment left in the centrifuge tubes, fully stirring uniformly, standing for 12h, then placing the centrifuge tubes into the centrifuge again, centrifuging for 20min at the rotating speed of 2000r/min, separating supernatant liquor in the centrifuge tubes again after centrifuging is finished, and combining the supernatant liquor with the previous supernatant liquor;
step f: distilling and concentrating the combined supernatant until the relative density is 1.12-1.15, adding 0.1 part by mass of dextrin while the supernatant is hot, uniformly mixing, spray-drying, collecting spray-dried medicinal powder, adding 0.1 part by mass of dextrin, 0.15 part by mass of calcium hydrogen phosphate and 1.5 parts by mass of starch, and fully mixing to obtain powder;
step g: and f, preparing soft materials from the powder in the step f by using 80% ethanol, granulating, drying the prepared granules at 50 ℃, adding magnesium stearate into the dried granules, mixing uniformly, and subpackaging into capsule shells to obtain the required medulla Junci hemostatic capsules.
The clinical test results of the wick hemostatic capsule prepared by the preparation process provided by the invention are given below.
First, drug effect test
The results are shown in table 1 below:
TABLE 1 control table of efficacy test results of mouse Wick hemostatic capsules
Object | Dosage form | Bleeding time | Increased platelet count |
Mice with normal bleeding | 10g/Kg | 1.5-2s | 20%-26% |
Mice with normal bleeding | 0g/Kg | 4-5s | 0 |
Mice with normal bleeding | 16g/Kg | 1-1.5s | 25%-28% |
Cyclophosphamide mice | 10g/Kg | 2-3s | 14%-17% |
As can be seen from the above table, the bleeding time and the blood coagulation time of the mice taking the wick hemostatic capsule are obviously shortened, and the number of platelets is obviously increased compared with the mice not taking the medicine, which indicates that the wick hemostatic capsule prepared by the process has normal hemostatic efficacy. In addition, the medicine also has obvious curative effect on the mouse blood platelet number reduction, bleeding time and blood coagulation time prolonging symptoms caused by cyclophosphamide.
Second, pharmacological toxicological test
1. Acute toxicity test
After the dendrimus hemostatic capsule is administrated by oral gavage, the median Lethal Dose (LD) of the mice is calculated by a Bliss method50) 267.1g/Kg, the 95% confidence limit is 252.5-282.4 g/Kg. LD of Wick hemostatic capsule50The value is equivalent to 534 times of the daily dosage (0.5g/kg) of an adult, which indicates that the wick hemostatic capsule prepared by the process is safer in clinical application.
2. Long term toxicity test
The experimental result shows that after the 20, 40 and 80g/Kg wick hemostatic capsules are administrated for 40 days for a long time, the counts of peripheral hemogram erythrocytes and platelets of rats are obviously increased by the three dosage groups; hemoglobin and white blood cells have no obvious difference compared with a control group. After 40 days of administration and 2 weeks after discontinuation, no significant changes in pathological morphology were observed in each group as determined by histopathological examination: the weight, liver and kidney functions of the rats have no obvious influence compared with those of the control group. After stopping taking the medicine for 2 weeks, the recovery observation shows that all the function and morphological indexes have no obvious influence.
Third, clinical trial
The results are shown in table 2 below:
TABLE 2 comparison table of curative effect of Wick hemostatic capsule taken in different cases
Cases of disease | Number of samples | Dosage form | Number of cure | High efficiency |
Thrombocytopenia | 100 persons | 0.5g/Kg | 96 persons | 96% |
Epistaxis | 100 persons | 0.5g/Kg | 95 people | 95% |
Haemorrhoid hemorrhage | 100 persons | 0.5g/Kg | 100 persons | 100% |
Metrorrhagia | 100 persons | 0.5g/Kg | 89 people | 89% |
Hemorrhage of digestive tract | 100 persons | 0.5g/Kg | 94 persons | 94% |
The final result shows that the denuclear officinalis hemostatic capsule prepared by the process has obvious curative effects on symptoms such as thrombocytopenia, epistaxis, hemorrhoidal bleeding, metrorrhagia, gastrointestinal bleeding and the like. Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (5)
1. A preparation process of a wick hemostatic capsule is characterized by comprising the following steps:
step a: taking 3-5 parts by mass of common rush and 0.5-1 part by mass of akebia stem, crushing to 200 meshes and 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 70 ℃, decocting at constant temperature for 30min to obtain a first standby liquid, naturally cooling the first standby liquid to 30 ℃, and preserving heat for later use;
step b: taking 3-5 parts by mass of agrimony tomentosa and 0.5-1 part by mass of circium japonicum, crushing to 250 meshes, adding 30-40 parts by mass of water, fully stirring, heating to 75 ℃, decocting at constant temperature for 45min to obtain a second standby liquid, naturally cooling the second standby liquid to 30 ℃, and preserving heat for later use;
step c: taking 3-5 parts by mass of acalypha australis, crushing to 250 meshes of 200 meshes, then adding 30-40 parts by mass of water, fully and uniformly mixing, heating to 70 ℃, decocting for 30min at constant temperature to obtain a third standby liquid, naturally cooling the third standby liquid to 30 ℃, and preserving heat for standby;
step d: mixing the first, second and third stock solutions, stirring, adding 60-80 parts by mass of water, heating to 70 deg.C, decocting at constant temperature for 90min, adding 30-40 parts by mass of water, heating to 75 deg.C, decocting at constant temperature for 30min, and naturally cooling to normal temperature to obtain crude product mixed solution;
step e: d, subpackaging the crude product mixed solution obtained in the step d into a plurality of centrifuge tubes, then placing the centrifuge tubes into a centrifuge, centrifuging for 30min at the speed of 2000r/min, separating supernatant liquor in the centrifuge tubes after centrifuging is finished, sealing and storing, adding 50% ethanol with the same amount into the bottom sediment left in the centrifuge tubes, fully stirring uniformly, standing for 12h, then placing the centrifuge tubes into the centrifuge again, centrifuging for 20min at the rotating speed of 2000r/min, separating supernatant liquor in the centrifuge tubes again after centrifuging is finished, and combining the supernatant liquor with the previous supernatant liquor;
step f: distilling and concentrating the combined supernatant until the relative density is 1.12-1.15, adding 0.1 part by mass of dextrin while the supernatant is hot, uniformly mixing, spray-drying, collecting spray-dried medicinal powder, adding 0.1 part by mass of dextrin, 0.15 part by mass of calcium hydrogen phosphate and 1.5 parts by mass of starch, and fully mixing to obtain powder;
step g: and f, preparing soft materials from the powder in the step f by using 80% ethanol, granulating, drying the prepared granules at 50 ℃, adding magnesium stearate into the dried granules, mixing uniformly, and subpackaging into capsule shells to obtain the required dendranthema sinensis hemostatic capsules.
2. The process for preparing a wick hemostatic capsule according to claim 1, wherein in the step d, the stirring is performed every 10min for 30 s.
3. The preparation process of the wick hemostatic capsule according to claim 1, wherein in the step a, 3 parts by mass of the juncus effusus and 0.5 part by mass of the akebia stem are taken, crushed to 200 meshes, then 30 parts by mass of water is added, after being fully stirred, the mixture is heated to 70 ℃ and decocted for 30min at constant temperature to obtain a first standby liquid, and the first standby liquid is naturally cooled to 30 ℃ and then kept warm for standby.
4. The preparation process of the wick hemostatic capsule according to claim 1, wherein in the step b, 3 parts by mass of fine agrimony and 0.5 part by mass of Japanese thistle herb are taken, crushed to 200 meshes, then 30 parts by mass of water is added, after being fully stirred, the mixture is heated to 75 ℃ and decocted for 45min at constant temperature to obtain a second standby solution, and the second standby solution is naturally cooled to 30 ℃ and then kept warm for standby.
5. The preparation process of the wick hemostatic capsule according to claim 1, wherein in the step c, 3 parts by mass of copperleaf is taken, crushed to 200 meshes, added with 30 parts by mass of water, fully mixed, heated to 70 ℃ and decocted for 30min at constant temperature to obtain a third standby liquid, and the third standby liquid is naturally cooled to 30 ℃ and then kept warm for standby.
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CN104524041A (en) * | 2015-01-29 | 2015-04-22 | 湖北福人金身药业有限公司 | Common rush hemostatic capsule as well as preparation and identification method thereof |
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Title |
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张炳鑫主编: "《临床中药炮制学》", 30 November 1994, 人民卫生出版社 * |
薛丽君主编: "《中药材百科》", 31 January 2019, 黑龙江科学技术出版社 * |
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