CN116421634B - Cs-4 cordyceps sinensis powder extract and preparation method and application thereof - Google Patents
Cs-4 cordyceps sinensis powder extract and preparation method and application thereof Download PDFInfo
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- CN116421634B CN116421634B CN202310686929.3A CN202310686929A CN116421634B CN 116421634 B CN116421634 B CN 116421634B CN 202310686929 A CN202310686929 A CN 202310686929A CN 116421634 B CN116421634 B CN 116421634B
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- chloroform
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/066—Clavicipitaceae
- A61K36/068—Cordyceps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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Abstract
The invention relates to a Cs-4 cordyceps sinensis powder extract, a preparation method and application thereof, and belongs to the technical field of medicines. And (3) carrying out in-vivo efficacy screening experiments on the obtained extracts, finding that the Cs-4 chloroform extract and the Cs-4 diethyl ether extract are effective components for resisting renal failure, and unexpectedly finding that the Cs-4 chloroform extract and the Cs-4 diethyl ether extract have a synergistic effect through animal efficacy experiments. The combined use of the two can reduce the administration dosage of the Cs-4 cordyceps sinensis powder of patients. And researching the fluidity of the Cs-4 cordyceps sinensis powder extract, and developing four dosage forms of tablets, powder and granules by taking the Cs-4 cordyceps sinensis powder extract component as a raw material according to the fluidity.
Description
Technical Field
The invention relates to a Cs-4 cordyceps sinensis powder extract, a preparation method and application thereof, wherein the Cs-4 cordyceps sinensis powder extract has a pharmacological effect of treating chronic renal failure, and belongs to the technical field of medicines.
Background
In the market, cs-4 cordyceps sinensis powder used by the Jinshuibao series products has the advantages of clinical application such as pulmonary fibrosis resistance, renal failure resistance, immunosuppression and the like. The literature reports that Cs-4 Cordyceps sinensis powder mainly contains nucleoside, sterol, fatty acid and amino acid small molecule components, and polysaccharide and polypeptide macromolecule components. In the case of the renal failure resisting medicine, the Cs-4 Cordyceps sinensis powder is usually taken directly, and the minimum dosage of the taking amount is 3 g/day. In addition, the Cs-4 cordyceps sinensis powder has more components, has weak pertinence to renal failure diseases, and may have other influences on the body by other components. The Cs-4 cordyceps sinensis powder is not suitable for being used together with certain medicines, such as antihypertensive medicines, hypoglycemic medicines and the like, and if the medicines are used together, medicine interaction is easily caused, medicine effect is influenced, and even adverse effects are caused on a body.
Disclosure of Invention
The invention aims to provide a Cs-4 cordyceps sinensis bacterial powder extract, a preparation method and application thereof, and the two extracts can be used for synergistically treating chronic renal failure and reducing the dosage through an in-vivo animal efficacy experiment and an animal pharmacodynamics evaluation experiment.
A preparation method of Cs-4 Cordyceps powder extract comprises extracting small molecular components with different polarities with ethanol as solvent, and sequentially extracting with petroleum ether, chloroform and diethyl ether to obtain components with different polarities; secondly, using the components with different properties for in vivo efficacy experiments; and finally, carrying out animal pharmacodynamics evaluation experiments on the effective components.
Preferably, the preparation method of the invention is as follows: reflux extracting Cs-4 Cordyceps powder with 8-10 times of ethanol for at least three times, each time for 0.5-1.5 hr, and mixing the ethanol extractive solutions; concentrating the ethanol extractive solution under reduced pressure to obtain soft extract, drying under reduced pressure, and pulverizing to obtain ethanol extract;
dissolving the ethanol extract in 8-10 times of water, and mixing; adding petroleum ether with the same volume, stirring and standing; separating and extracting, combining petroleum ether layers, and discarding; taking the lower layer liquid, adding equal volume of chloroform, stirring, and standing; separating and extracting, combining chloroform layers, and concentrating the chloroform layers under reduced pressure to obtain Cs-4 chloroform extract;
adding equal volume diethyl ether into the upper liquid extracted by the chloroform, stirring, and standing; separating and extracting, and combining diethyl ether layers; concentrating diethyl ether layer under reduced pressure, drying under reduced pressure, and pulverizing to obtain Cs-4 diethyl ether extract.
The invention also discloses the Cs-4 cordyceps sinensis powder extract prepared by the preparation method.
The invention also discloses application of the Cs-4 cordyceps sinensis powder extract in preparing medicines for treating chronic renal failure.
As a preferred embodiment of the present invention, the active substance of the drug comprises Cs-4 chloroform extract and Cs-4 diethyl ether extract in a mass ratio of 2-4:4.
As a preferred embodiment of the present invention, the medicament comprises one of the following formulations: capsules, tablets, powders and granules.
As a preferred embodiment of the present invention, the tablet comprises the following raw materials in parts by weight: 20-40 parts of Cs-4 cordyceps sinensis powder extract and 10-15 parts of auxiliary materials.
As a preferable mode of the invention, the auxiliary material comprises at least one of filler, adhesive and lubricant.
The invention has the beneficial effects that:
the invention utilizes Cs-4 cordyceps sinensis bacterial powder to obtain Cs-4 chloroform extract and Cs-4 diethyl ether extract. In vivo efficacy experiments are carried out on the obtained components, and the obtained components are found to be effective components for resisting renal failure; animal pharmacodynamics evaluation experiments prove that the two have synergistic effect. The administration dosage of the Cs-4 cordyceps sinensis powder of a patient can be effectively reduced by the synergistic use of the two (the minimum administration dosage of the Cs-4 cordyceps sinensis powder is 3 g/day); and the dosage of the Cs-4 cordyceps sinensis powder extracted component is only 0.6 g/day.
According to the invention, the flowability of the Cs-4 chloroform extract and the Cs-4 diethyl ether extract is researched, and the preparation research is carried out according to the flowability of the Cs-4 chloroform extract and the Cs-4 diethyl ether extract, so that an effective medicine for treating chronic renal failure is obtained.
Detailed Description
The invention is further illustrated by the following examples, which are not intended to be limiting.
Example 1 preparation of Cs-4 extract
Adding 10 times of 80% ethanol (weight) into 1000gCs-4 Cordyceps powder, reflux extracting for three times for 1 hr, and mixing the ethanol extractive solutions; concentrating the ethanol extract at 65deg.C under reduced pressure until the density is 1.15-1.20 (measured by heat); drying the soft extract at 70deg.C under reduced pressure, and pulverizing to obtain 280.6gCs-4 ethanol extract (brown yellow powder).
Dissolving 280.6gCs-4 ethanol extract in 10 times of water, and stirring; adding petroleum ether with the same volume, stirring at 250rpm for 15 minutes, and standing for 30 minutes; separating and extracting for 3 times, combining petroleum ether layers, and discarding; adding equal volume of chloroform into the lower liquid, stirring at 250rpm for 15 minutes, and standing for 30 minutes; separating and extracting for 3 times, and combining chloroform layers; concentrating under reduced pressure at 70deg.C to 1.20 (80deg.C) to obtain 30.2. 30.2gCs-4 chloroform extract (brown yellow powder).
Taking the chloroform extraction upper layer liquid, adding an equal volume of diethyl ether, stirring for 15 minutes at 250rpm, and standing for 30 minutes; separating and extracting for 3 times, and combining diethyl ether layers; concentrating under reduced pressure at 30deg.C to a density of 1.20 (thermal measurement); drying under reduced pressure at 70deg.C, and pulverizing to obtain 40gCs-4 diethyl ether extract (brown yellow powder).
Example 2 in vivo efficacy experiment in animals
The 2 extracts prepared in example 1 were subjected to in vivo efficacy experiments, the procedure of which is as follows:
summary of the method: 50 SD rats, male and female halves, were randomly grouped by body weight, 10 per group: normal control, model, test 2 (Cs-4 chloroform, cs-4 diethyl ether), dexamethasone. Before the test, rats were placed in a metabolic cage and fasted for 24 hours (water intake as usual), urine volume was recorded for 24 hours, and urinary proteins and urinary creatinine were detected. After weighing the rat, 1mL of blood is taken from the orbit, the rat is placed in a 1.5mL centrifuge tube, and centrifuged at 3000 rpm for 10min, and urea nitrogen (BUN) is taken as a basic value for blood taking and detection. The administration dosage is converted according to the extraction yield of each group and the administration dosage of the bacterial powder (1.6 g/kg). The rats in the other groups except the normal control group are subjected to gastric lavage and adenine (dissolved by normal saline) 200mg/kg once daily, and are subjected to continuous molding change administration for 28 days, and finally, are not subjected to molding change administration for 29-35 days; and blood was collected from the orbits of rats on days 7, 14, 21, 28 and 35, respectively, centrifuged at 3000 rpm for 10min, serum was taken to test urea nitrogen (BUN) values, and 24h urine was recorded. The experimental grouping and BUN results are shown in table 1 below:
TABLE 1 Experimental grouping and BUN results
Group of | Moulding | Administration of drugs | BUNmmol/L at day 7 | BUNmmol/L at day 14 | BUNmmol/L at day 21 | BUNmmol/L at day 28 | BUNmmol/L at day 35 |
Normal control group | Physiological saline | Physiological saline | 5.22±1.16 | 5.39±0.74 | 5.43±0.55 | 5.16±0.6 | 4.81±1.06 |
Model group | Adenine (A) | Physiological saline | 24.94±4.10 | 28.00±9.87 | 47.73±16.59 | 75.00±22.95 | 55.43±25.10 |
Dexamethasone group | Adenine (A) | Po.1 g/kg/day | 24.93±3.42 | 19.26±3.50 | 23.03±13.66 | 15.06±20.87 | 14.81±23.22 |
Cs-4 chloroform group | Adenine (A) | Po.48 mg/kg/day | 24.93±2.60 | 19.06±9.65 | 16.87±8.32 | 12.19±23.83 | 8.56±13.95 |
Cs-4 diethyl ether group | Adenine (A) | Po.64 mg/kg/day | 26.37±3.21 | 27.98±4.44 | 33.70±10.55 | 25.35±17.78 | 15.62±9.94 |
The results show that: compared with a model group, the BUN level of the normal control group on the 7 th day of modeling is 5.22+/-1.16 mmol/L, the BUN level of the model group is 24.94+/-4.10 mmol/L, and the two groups have very obvious difference; on experiment day 14, compared with day 7, the BUN level of dexamethasone group and Cs-4 chloroform fraction group is obviously reduced; on day 21 of the experiment, BUN levels were significantly reduced in the Cs-4 chloroform group compared to day 14; on day 28 of the experiment, BUN levels were significantly reduced in the dexamethasone, cs-4 chloroform and Cs-4 diethyl ether groups compared to day 21; on day 35 of the experiment, BUN levels were significantly reduced in the Cs-4 chloroform group and the Cs-4 diethyl ether group compared to day 28.
Conclusion of the test: compared with the model group, the Cs-4 chloroform group and the Cs-4 diethyl ether group can reduce the effect of chronic renal failure caused by adenine.
The in vivo experiments of the drug effect of different parts of the Cs-4 fermented cordyceps sinensis bacterial powder show that the Cs-4 chloroform extract and the Cs-4 diethyl ether extract have the effect of improving chronic renal failure.
Example 3 animal pharmacodynamics evaluation experiment
Pharmacodynamics evaluation: the effect of the combination of the Cs-4 chloroform group and the Cs-4 diethyl ether group on the rat 5/6 nephrectomy chronic kidney disease model is achieved, and the combination of the two has a synergistic effect. The specific experiment is as follows:
summary of the method: the experimental animals 110 are divided into 11 groups, and specifically include: a blank control group, a Cs-4 chloroform low dose group, a Cs-4 chloroform medium dose group, a Cs-4 chloroform high dose group, a Cs-4 diethyl ether low dose group, a Cs-4 diethyl ether medium dose group, a Cs-4 diethyl ether high dose group, a low dose group combined with the two, a medium dose group combined with the two, a high dose group combined with the two and a dexamethasone group, wherein 10 groups each; the blank control group was not operated, and the other groups were operated. After the rats are anesthetized after 12 hours of preoperative fasted, the skin is prepared for fixation and disinfection, a longitudinal incision is made from the lower edge of the left rib and the side of the spine, the left rib is accessed into the retroperitoneal cavity, the fat layer is separated, the left kidney is exposed, the fat capsule is separated passively, the kidney capsule and the adrenal gland are carefully peeled off, the adrenal gland is prevented from being damaged, the upper and lower 2/3 kidney parenchyma of the left kidney are sheared off, the gelatin sponge compresses the wound surface to stop bleeding, the residual kidney is also brought into the abdominal cavity, and the muscular layer, the subcutaneous layer and the skin are sutured layer by layer, and the local disinfection is performed. The postoperative rats were injected intramuscularly with antibiotics once a day for 3 days. After 1 week of anesthesia and sterilization, the entire right kidney was surgically removed. The postoperative rats were injected intramuscularly with antibiotics once a day for 3 days. The second surgery was ended and the next day the group dosing was started. Rats in the blank control group and the test subject group were given the corresponding drugs by intragastric administration, and rats in the model group were given dexamethasone by intragastric administration 1 time a day for 12 weeks. The specific doses and experimental results are shown in table 2 below:
table 2 dose and experimental results for each group
Group of | Dosage for administration | BUN level | Survival rate |
Blank control group | Purified water | Unchanged | 100% |
Cs-4 chloroform low dose group | 30mg/kg | Unchanged | 57.1% |
Dosage group in Cs-4 chloroform | 60mg/kg | Lowering | 65.2% |
Cs-4 chloroform high dose group | 90mg/kg | Lowering | 76.2% |
Cs-4 diethyl ether low dose group | 30mg/kg | Unchanged | 61.0% |
Cs-4 diethyl ether dosage group | 60mg/kg | Lowering | 70.6% |
High dose group of Cs-4 diethyl ether | 90mg/kg | Significantly reduce | 80.3% |
Low dose group for both | 30mg/kg | Lowering | 78.4% |
Medium dosage group for both | 60mg/kg | Significantly reduce | 87.8% |
High combination of the twoDose group | 90mg/kg | Significantly reduce | 94.2% |
Model group | 1.08mg/kg | Significantly reduce | 73.6% |
Note that: the dosage of dexamethasone in rats is converted according to the clinical dosage, wherein the mass ratio of the Cs-4 chloroform extract to the Cs-4 diethyl ether extract in the combined dosage is 3.02:4.
Conclusion of the test: from the above table, it can be seen that: the BUN level in the Cs-4 chloroform and the high-dose group is reduced, but the BUN level is not significantly reduced, and the survival rate is not more than 80%; the BUN level of the dosage group in Cs-4 diethyl ether is reduced, the BUN level of the high dosage group is obviously reduced, and the survival rate is not more than 90 percent; the Cs-4 chloroform group and the Cs-4 diethyl ether group are combined to form a medium dose of 60mg/kg and a high dose of 90mg/kg, so that the kidney function of the 5/6 nephrectomized rat is improved to a certain extent, the BUN level is obviously reduced, and the survival rate of the 5/6 nephrectomized rat can be improved to a certain extent by the high dose of the BUN; the dosage is converted into an effective dosage of 190 mg/day and 380 mg/day for adults (60 kg).
EXAMPLE 4 Cs-4 flowability study of Cordyceps powder extract
The extract of two components of Cs-4 chloroform and Cs-4 diethyl ether is named as Cs-4 cordyceps sinensis powder extract component, the effective dosage of the extract is suitable for various oral conventional dosage forms, and 4 oral dosage forms of capsules, tablets, powder and granules are preferably prepared.
Investigation of the powder properties of the extracted component of Cs-4 cordyceps sinensis powder:
the extracted component of the Cs-4 Cordyceps powder is separated into two parts of more than 80 meshes and less than 80 meshes, and the other part of the powder is granulated with 90% ethanol for standby.
Material flowability: and pouring the powder into an upper funnel along the funnel wall until the powder below forms a cone by using an ERWEKA powder particle flowability tester, measuring the diameter of the bottom of the cone, and calculating the repose angle according to tga=H/R. The results are shown in Table 3 below
TABLE 3 Cs-4 results of extraction of component repose angle from Cordyceps powder
Cs-4 cordyceps sinensis fungus powder extraction component | Cs-4 Cordyceps sinensis powder extract component (less than 80 mesh) | Cs-4 Cordyceps sinensis powder extract component (more than 80 mesh) | Cs-4 cordyceps sinensis powder extraction component particles | |
Angle of repose | 29.56° | 33.8° | 30.6° | 30.6° |
The repose angle of the extracted component of the Cs-4 cordyceps sinensis powder is 29.56 degrees, the repose angle after sieving to be smaller than 80 meshes and larger than 80 meshes and the repose angle after granulating is also above and below 30 degrees, the fluidity of the powder is good, and the powder is directly produced without treatment of equipment suitable for mass production of capsules, powder split charging and the like.
EXAMPLE 5 Cs-4 research on preparation of Cordyceps powder extract component
The preparation method of the capsule comprises the following steps: the Cs-4 Cordyceps powder has good fluidity, and can be directly filled into capsule, and the amount of Cs-4 Cordyceps powder extract components of each capsule is shown in table 4 below:
TABLE 4 extraction component amounts of Cs-4 Cordyceps powder from different types of capsule shells
Capsule number | 00# | 0# | 1# | 2# | 3# | 4# |
Volume (ml) | 0.95 | 0.68 | 0.50 | 0.32 | 0.25 | 0.21 |
Cs-4 Cordyceps sinensis powder extraction component amount (mg/granule) | 817 | 584.8 | 430 | 356.2 | 258 | 180.6 |
Remarks: the capsule number is an industry standard of the implementation of the hollow capsule specification and size and appearance quality in the year 2020, month and 16.
As shown by the calculation of the capsule volume of each model, when the effective dose of adult (60 kg) is 260 mg/day-520 mg/day, the Cs-4 Cordyceps sinensis powder extract component is suitable for being directly filled by No. 2 capsules, each capsule is filled with 0.3g, and the daily dose is 2 capsules.
Stability investigation of capsule samples: the process of directly filling the Cs-4 cordyceps sinensis powder extract component powder into a No. 2 capsule comprises the steps of filling each granule with 0.3 g/granule, and controlling the relative humidity of the environment to be below 65% RH to prepare a capsule sample; the sample is subjected to acceleration stability investigation under the following conditions: the mixture was allowed to stand at 40.+ -. 2 ℃ and a relative humidity of 75.+ -. 5% for 6 months. During the test period, the sample was taken once every 0 th month, 3 rd month and 6 th month, and the test was performed. The results of the accelerated stability study are shown in Table 5 below:
TABLE 5 results of accelerated stability investigation
Project | For 0 month | For 3 months | 6 months of |
Moisture content | 2.35% | 2.35% | 2.55% |
Difference in loading | Meets the regulations | Meets the regulations | Meets the regulations |
Time limit of disintegration | For 5 minutes | For 6 minutes | For 5 minutes |
Total amino acid content (mg/grain) | 182 | 176 | 168 |
From all the data analysis above, it follows that: the sample prepared by adopting the preferred preparation method has good moisture, different loading, good disintegration time limit and content stability, and the obtained product has strong stability and stable curative effect; and the whole process is easy to operate, is suitable for popularization and application, and has a daily dosage of 2 granules per day.
The preparation method of the tablet comprises the following steps: the particles of the extracted component of the Cs-4 cordyceps sinensis powder screened by the prescription have good fluidity, and can be prepared into tablets by adding auxiliary materials such as a filler, an adhesive, a lubricant and the like, wherein the specification of the tablets is 0.45 g/tablet (each tablet contains 0.3g of the extracted component of the Cs-4 cordyceps sinensis powder), and the trial production amount is 1000 tablets. Prescription screening is shown in table 6 below and trial results are shown in table 7 below:
table 6 tablet prescription screening
Prescription/lot number | 20220501 | 20220502 | 20220503 |
Cs-4 cordyceps sinensis fungus powder extraction component | 300g | 300g | 300g |
Microcrystalline cellulose | 86g | 86g | 76g |
Sodium carboxymethyl starch | 20g | 22g | 28g |
Silica dioxide | 20g | 26g | 20g |
10wt% starch slurry | 226 | 0 | 0 |
5wt% hypromellose | 0 | 268 | 0 |
10wt% gelatin paste | 0 | 0 | 240g |
Magnesium stearate | 2.5g | 2.5g | 2.5g |
TABLE 7 trial production results
Detecting item/lot number | 20220501 | 20220502 | 20220503 |
Moisture content | 5.2% | 4.9% | 4.95% |
Hardness of | 3-4kg | 5-6kg | 8-9kg |
Disintegration of | 16min | 25min | 46min |
Total amino acid content (mg/tablet) | 176 | 172 | 179 |
From the above results, 20220502 batches of prescriptions are screened as the optimal prescriptions, and the obtained sample detection items all meet the regulations, and the effective dose of the Cs-4 Cordyceps sinensis powder extract is 190 mg/day-380 mg/day according to adult (60 kg) and 2 tablets per day.
Tablet stability study: three pilot scale-up pilot studies (10000 pilot scale-up) were performed according to 20220502 prescriptions, resulting in pilot sample lot numbers 20220601, 20220602, 20220603; the acceleration stability of the three pilot samples is inspected under the following conditions: the mixture was allowed to stand at 40.+ -. 2 ℃ and a relative humidity of 75.+ -. 5% for 6 months. During the test period, the sample was taken once every 0 th month, 3 rd month and 6 th month, and the test was performed. The results of the accelerated stability test for tablets are shown in Table 8 below:
TABLE 8 accelerated stability test results for tablets
From all the data analysis above, it follows that: the sample prepared by the preferred preparation method has good stability of moisture, disintegration time, appearance and content, and the obtained product has strong stability and stable curative effect; and the whole process is easy to operate and suitable for popularization and application.
Research on powder preparation
And (3) process screening: because the Cs-4 Cordyceps sinensis powder has good fluidity of the extracted components, the powder can be prepared without adding any auxiliary materials, and the specification is 0.3 g/bag; at present, the influence of fineness of the extracted components of the Cs-4 cordyceps sinensis powder on the powder loading is examined, and the test result is shown in the following table 9:
TABLE 9 results of powder trials (Unit: g/bag)
Project | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | Average loading | RSD% |
Medicine powder (g/bag) | 0.316 | 0.318 | 0.312 | 0.306 | 0.315 | 0.316 | 0.316 | 0.308 | 0.315 | 0.318 | 0.314 | 1.300 |
80 mesh (g/bag) | 0.321 | 0.323 | 0.308 | 0.312 | 0.32 | 0.318 | 0.319 | 0.306 | 0.315 | 0.318 | 0.316 | 1.790 |
60 mesh (g/bag) | 0.215 | 0.312 | 0.306 | 0.300 | 0.21 | 0.206 | 0.215 | 0.28 | 0.303 | 0.268 | 0.262 | 17.186 |
As can be seen from the results in Table 9, the powder and 80 mesh powder are packaged in a split manner so that the difference of the powder loading amounts meets the pharmacopoeia requirement, and the RSD% index of the powder is lower than 80 mesh, so that the optimal process is adopted, the loading amount meets the expectations, and the daily dosage is 2 bags/day.
Powder stability investigation: split charging the Cs-4 Cordyceps powder extract into three batches of pilot samples, the pilot samples having batch numbers 20220501, 20220502, 20220503; the acceleration stability of the three pilot samples is inspected under the following conditions: the mixture was allowed to stand at 40.+ -. 2 ℃ and a relative humidity of 75.+ -. 5% for 6 months. During the test period, the sample was taken once every 0 th month, 3 rd month and 6 th month, and the test was performed. The results of the powder acceleration stability test are shown in Table 10 below:
TABLE 10 results of accelerated powder stability experiments
From all the data analysis above, it follows that: the powder sample prepared by extracting components from the Cs-4 cordyceps sinensis powder has good stability of moisture, loading and content, and the obtained product has strong stability and stable curative effect; and the whole process is easy to operate and suitable for popularization and application.
Study on preparation of granules
Prescription screening: because the Cs-4 Cordyceps powder has good fluidity, the extract component can be prepared into granule by adding adjuvants, the specification of granule is 1 g/bag, and the trial production amount is 500g. Prescription screening is shown in Table 11 below and trial results are shown in Table 12 below:
table 11 screening of granule formulations
Prescription/lot number | 20220501 | 20220502 | 20220503 | 20220504 | 20220505 |
Extraction component of fermented cordyceps sinensis bacterial powder Cs-4 | 150g | 150g | 150g | 150g | 150g |
Sugar powder | 150g | 170g | 135g | 0 | 130g |
Starch | 60g | 180g | 0 | 140g | 65g |
Dextrin | 140g | 0 | 215g | 210g | 155g |
Purified water | 176g | 168g | 184g | 162g | 180g |
TABLE 12 trial production results
From the above results, the obtained samples were not in compliance with the specifications except for 20220503 lot test items, so 20220503 lot prescriptions were preferable as the optimal prescriptions; according to the effective dose of 190 mg/day-380 mg/day of adult (60 kg), the daily dose of the Cs-4 Cordyceps powder extract component granule is 2 bags per day.
Powder stability investigation: three pilot scale up pilot scale studies were completed according to 20220503 prescriptions, resulting in pilot sample lot numbers 20220601, 20220602, 20220603; the acceleration stability of the three pilot samples is inspected under the following conditions: the mixture was allowed to stand at 40.+ -. 2 ℃ and a relative humidity of 75.+ -. 5% for 6 months. During the test period, the sample was taken once every 0 th month, 3 rd month and 6 th month, and the test was performed. The results of the accelerated stability test are shown in Table 13 below:
TABLE 13 accelerated stability test results
From all the data analysis above, it follows that: the sample prepared by the preferred preparation method has good properties, solubility, taste and content stability, and the obtained product has strong stability and stable curative effect; and the whole process is easy to operate and suitable for popularization and application.
The foregoing examples have shown only the preferred embodiments of the invention, which are described in more detail and are not to be construed as limiting the scope of the invention. It should be pointed out that various other corresponding changes and modifications can be made by those skilled in the art in light of the above description of the technical solution and the idea, and all such changes and modifications are intended to be within the scope of the invention as defined in the appended claims.
Claims (4)
1. The application of the Cs-4 cordyceps sinensis powder extract in preparing the medicine for treating chronic renal failure is characterized in that the preparation method of the Cs-4 cordyceps sinensis powder extract comprises the following steps:
reflux extracting Cs-4 Cordyceps powder with 8-10 times of 80% ethanol for 0.5-1.5 hr for at least three times, and mixing the ethanol extractive solutions; concentrating the ethanol extractive solution under reduced pressure to obtain soft extract, drying under reduced pressure, and pulverizing to obtain ethanol extract;
dissolving the ethanol extract in 8-10 times of water, and mixing; adding petroleum ether, stirring, and standing; separating and extracting, combining petroleum ether layers, and discarding; taking the lower layer liquid, adding chloroform, stirring, and standing; separating and extracting, combining chloroform layers, and concentrating the chloroform layers under reduced pressure to obtain Cs-4 chloroform extract;
adding diethyl ether into the upper liquid extracted by the chloroform, stirring and standing; separating and extracting, and combining diethyl ether layers; concentrating diethyl ether layer under reduced pressure, drying under reduced pressure, and pulverizing to obtain Cs-4 diethyl ether extract;
the active substances of the medicine comprise the following components in mass ratio of 3.02:4 and Cs-4 diethyl ether extract.
2. The use according to claim 1, wherein the medicament comprises one of the following formulations: capsules, tablets, powders and granules.
3. The use according to claim 1, characterized in that the tablet comprises the following raw materials in parts by weight: 20-40 parts of Cs-4 cordyceps sinensis powder extract and 10-15 parts of auxiliary materials.
4. The use according to claim 1, wherein the auxiliary material comprises at least one of a filler, a binder, a lubricant.
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