CN114053357A - Heart-opening powder sustained-release tablet and preparation method thereof - Google Patents

Heart-opening powder sustained-release tablet and preparation method thereof Download PDF

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CN114053357A
CN114053357A CN202111418810.5A CN202111418810A CN114053357A CN 114053357 A CN114053357 A CN 114053357A CN 202111418810 A CN202111418810 A CN 202111418810A CN 114053357 A CN114053357 A CN 114053357A
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赵立香
李荣权
王泓淇
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Jilin Agricultural Science and Technology College
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Abstract

The invention discloses a yixinsan sustained release tablet and a preparation method thereof, and the preparation method comprises the following steps: 30mg of ginsenoside extract, 30mg of polygala root extract, 30mg of calamus extract, 60mg of poria cocos extract, 2.5mg of pore-forming agent PEG4000142.5mg, 142.5mg of filler lactose, 2.5mg of magnesium stearate and 12.5ml of wetting agent water are taken to prepare soft materials until the effect of 'hand-holding agglomeration and light pressing and dispersion', the soft materials are sieved by a 20-mesh sieve, then are placed in a constant-temperature drying box at 60 ℃ for drying for 2h, are taken out, are sized, are uniformly mixed with 2.5mg of lubricating agent, are sieved by a 50-mesh sieve, and are tabletted in a 10mm shallow concave die stamping tablet machine to obtain the tablet. The invention realizes the successful preparation of the yixin san sustained-release tablets, the obtained yixin san sustained-release tablets conform to the standard of Chinese pharmacopoeia (2020 edition), and the long-term treatment purpose is achieved by increasing the drug effect time while the drug administration times are reduced so as to reduce the side effect.

Description

Heart-opening powder sustained-release tablet and preparation method thereof
Technical Field
The invention relates to the field of preparation of traditional Chinese medicine preparations, in particular to a yippee powder sustained-release tablet and a preparation method thereof.
Background
The yippee powder is recorded in the traditional Chinese medicine efficacy prescription at the earliest time in the Standby Qianjin prescription of Sun Simiao in Tang Dynasty, consists of calamus, polygala tenuifolia, poria cocos, ginseng and cinnabar, and is mainly used for treating the symptoms of uneasiness of heart qi, deficiency of five internal organs, worry, sadness, joyful forgetfulness, recovery from illness and dizziness, is a classic prescription for treating emotional diseases in traditional Chinese medicine and is one of basic prescriptions for treating depression in traditional Chinese medicine clinical treatment. At present, the traditional Chinese medicine powder is mainly used for treating symptoms such as unsteadiness of mind, deficiency of heart-qi, amnesia, insomnia, heart-timidity, severe palpitation and the like, namely depression, anxiety symptoms, learning and memory disorder and the like in the field of western medicine, and the traditional Chinese medicine powder is mainly used for treating psychogenic diseases.
The sustained-release agent can release the medicine within a preset time, so that the blood concentration is kept in an effective concentration range for a long time; compared with the common preparation, the sustained-release preparation keeps the effective treatment concentration in vivo for a longer time, greatly reduces the administration times, is convenient for patients to take, has the relative bioavailability of 80-120 percent, reduces the peak-valley effect of blood concentration, reduces the toxic and side effect of the medicament, and improves the curative effect. The oral administration system of the traditional Chinese medicine sustained-release agent can be divided into a membrane-controlled type, a skeleton type, a gastric retention type, an osmotic pump type and the like, wherein the membrane-controlled type and the skeleton type are the most common, and because the traditional Chinese medicine is different from chemical medicines with clear structure, single component and definite action target, the theoretical research of the traditional Chinese medicine sustained-release agent is relatively late, a set of complete theoretical system is not formed, so that the theoretical technology of the chemical medicine sustained-release agent cannot be completely applied to the traditional Chinese medicine.
For the traditional Chinese medicine, because the ingredients contained in the medicinal materials are too many, the side effect is inevitable; the common preparation formulation in the traditional Chinese medicine is not only powder, but also other preparation formulations are rapidly developed, and the slow controlled release preparation for treating chronic diseases has good development prospect, however, because the traditional Chinese medicine and compound combined medicine thereof have the characteristics of multiple components, multiple medicine targets, multiple using ways and multiple functions, the research on the slow controlled release preparation for the traditional Chinese medicine is relatively late, and the traditional Chinese medicine is not researched into a system so far.
Disclosure of Invention
In order to solve the problems, the invention provides a yixin san sustained-release tablet and a preparation method thereof.
In order to achieve the purpose, the invention adopts the technical scheme that: the yixinsan sustained-release tablet is prepared from the following components: 30mg of ginsenoside extract; 30mg of polygala root extract; rhizoma Acori Calami extract 30 mg; poria extract 60 mg; pore-forming agent PEG4000142.5mg; lactose bulking agent 142.5 mg; magnesium stearate 2.5 mg; 12.5ml of wetting agent water; lubricant 2.5 mg.
The invention also provides a preparation method of the yixinsan sustained-release tablet, which comprises the following steps: 30mg of ginsenoside extract, 30mg of polygala root extract, 30mg of calamus extract, 60mg of poria cocos extract, 2.5mg of pore-forming agent PEG4000142.5mg, 142.5mg of filler lactose, 2.5mg of magnesium stearate and 12.5ml of wetting agent water are taken to prepare soft materials until the effect of 'hand-holding agglomeration and light pressing and dispersion', the soft materials are sieved by a 20-mesh sieve, then are placed in a constant-temperature drying box at 60 ℃ for drying for 2h, are taken out, are sized, are uniformly mixed with 2.5mg of lubricating agent, are sieved by a 50-mesh sieve, and are tabletted in a 10mm shallow concave die stamping tablet machine to obtain the tablet.
The invention realizes the successful preparation of the yixin san sustained-release tablets, the obtained yixin san sustained-release tablets conform to the standard of Chinese pharmacopoeia (2020 edition), and the long-term treatment purpose is achieved by increasing the drug effect time while the drug administration times are reduced so as to reduce the side effect.
Drawings
FIG. 1 is a graph showing the mean distribution of the dosages of four excipients in different formulations;
fig. 2 shows the release rate of the kaixuan powder sustained-release preparation of the embodiment of the invention.
Detailed Description
In order that the objects and advantages of the invention will be more clearly understood, the invention is further described in detail below with reference to examples. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
Treatment of raw materials:
extracting and separating ginsenoside: pulverizing Ginseng radix 500g into coarse powder with a pulverizer, sieving with 60 mesh sieve, adding 10 times of diethyl ether, refluxing and defatting to colorless, adding methanol into residue, heating and refluxing to extract only antimony trichloride chloroform saturated solution which is negative in reaction, recovering methanol under reduced pressure to obtain extract, dissolving with 10 times of distilled water, extracting with water saturation n-butanol for 6 times, mixing, recovering n-butanol under reduced pressure, and evaporating to dryness. Separating saponin by macroporous numerical column chromatography, dissolving the crude saponin product with water, loading on treated D101 type macroporous resin, adsorbing for 1 hr, eluting with triple column chromatography and distilled water to remove impurities, eluting with 60% buffered elution and antimony trichloride chloroform saturated solution to react negatively, recovering solvent under reduced pressure, and vacuum drying at 60 deg.C to obtain refined saponin.
Extracting polygala tenuifolia-acorus gramineus saponin: 500g of rhizoma acori graminei and polygala tenuifolia are respectively subjected to impurity removal, the rhizoma acori graminei and polygala tenuifolia are respectively crushed and sieved by a 50-mesh sieve, the sieved polygala tenuifolia and rhizoma acori graminei powder are extracted by absolute ethyl alcohol at a liquid-material ratio of 16: 1 for 60min by ultrasonic, the extraction temperature is 50 ℃, and drying is carried out.
Extracting pachyman: pulverizing Poria 500g into coarse powder, sieving with 60 mesh sieve, extracting with water extraction and ethanol precipitation at a ratio of 1: 10 for 1 time (100 min), concentrating the extractive solution to 1/12 of original volume, with ethanol precipitation concentration of 80% and ethanol precipitation time of 12 hr.
Prescription design of yixinsan slow-release tablet
Figure 873409DEST_PATH_IMAGE001
1.3 auxiliary materials for single-factor investigation of Kaixin sustained-release tablets
The traditional Chinese medicine extract prepared by the extraction is prepared according to the following steps: ginseng: polygala root: calamus: poria =1:1:1: 2.
Preparation of yixinsan slow-release tablet
Weighing 60 tablets (each tablet is 500mg of the traditional Chinese medicine extract, the slow-release framework material and the pore-forming agent in the proportion, adding an appropriate amount of wetting agent to prepare a soft material, namely, the soft material is held by hands to form a cluster, and after the effect of dispersing by slight pressure, sieving by a 20-mesh sieve, putting sieved granules into a 60-DEG C constant-temperature drying box to be dried for 2h, taking out the dried granules, weighing 60 tablets of the lubricant, uniformly mixing, sieving by a 50-mesh sieve, and tabletting the total mixed granules by a 10-mm shallow concave die tabletting machine.
Selection of sustained release matrix species
Adding HPMCK100M and EC at a ratio of 12%,25%, and 43% into 6 trays numbered 1, 2, 3, 4, 5, and 6, respectively, making soft material, making powder into mass by hand, dispersing under light pressure, sieving with 20 mesh sieve, drying at 60 deg.C for 2 hr, adding 0.5% lubricant, mixing well, sieving with 50 mesh sieve, granulating, and tabletting. The appearance, hardness, friability, compressibility and dissolution rate of the yinxin sustained-release tablets are used as evaluation indexes.
Selection of porogen species
Taking 2 trays, numbering 1 and 2, respectively adding 12% of EC and 28.5% of PEG600, and 12% of EC and PEG4000 to make soft material to make the powder into mass by hand, lightly pressing to disperse, sieving with 20 mesh sieve, drying at 60 deg.C in a constant temperature drying oven for 2h, adding 0.5% of lubricant, mixing well, sieving with 50 mesh sieve, granulating, and tabletting. The appearance, hardness, friability, compressibility and dissolution rate of the yinxin sustained-release tablets are used as evaluation indexes.
Selection of the type of Filler
Taking 2 trays, numbering 1 and 2, respectively adding 28.5% lactose and 28.5% starch to make into soft materials, holding the powder with hand to form a mass, lightly pressing to disperse, sieving with a 20-mesh sieve, drying at 60 deg.C in a constant temperature drying oven for 2h, adding 0.5% lubricant, mixing, sieving with a 50-mesh sieve, and grading to obtain the tablet with appearance and agglomeration degree as evaluation indexes.
Selection of wetting agent species
Taking 2 trays, numbering 1 and 2, respectively adding 12% EC to make soft material, adding appropriate amount of water and 90% ethanol as wetting agent, holding the powder with hand to form mass, sieving with 20 mesh sieve, drying at constant temperature drying oven at 60 deg.C for 2 hr, adding 0.5% lubricant, mixing, sieving with 50 mesh sieve, and dispersing under light pressure. The appearance and agglomeration degree of the yioxinsan sustained-release tablet granules are used as evaluation indexes.
Auxiliary material dosage of yikaixuan slow-release tablets optimized in orthogonal experiment
After single-factor investigation, the optimal type of the auxiliary materials for preparing the yippee powder sustained-release tablet is screened out, an orthogonal design scheme is adopted on the basis to determine the dosage of each auxiliary material, wherein the gram ratio of the main medicine to the auxiliary material is shown in table 1, and the prepared yippee powder sustained-release tablet is scored according to each index.
TABLE 1 factor level table
Figure 869178DEST_PATH_IMAGE002
1.5 Scoring Standard
The scoring criteria for the orthogonal test are shown in table 2 below. The total score of the four items is 10, the influence degree of the four evaluation indexes on the preparation of the granule in the examination of the slow controlled release tablet in Chinese pharmacopoeia is referred, and the design weight coefficients are respectively: 0.2 appearance, 0.3 hardness, 0.3 friability, 0.2 weight difference.
TABLE 2 Scoring criteria
Figure 117757DEST_PATH_IMAGE003
1.6 validation experiments
The best process for predicting the prescription of the sustained-release tablet comprises 51 mg of HPMCK15M and 92 mg of MCC, namely about 143 mg of auxiliary materials. Accurately weighing 100 g of PNS extract powder, adding 51 g of HPMCK15M and 92 g of MCC, uniformly mixing, spraying 95% ethanol to prepare a soft material, granulating, drying, finishing granules, adding 0.8% of magnesium stearate in the weight of the granules, pressing into 1000 tablets, measuring the drug cumulative release degree of the sustained-release tablets to be 97.74, basically consistent with a theoretical predicted value of 98.96, showing that the model has good fitting and better predictability
1.7 quality inspection
Appearance: complete and smooth, uniform color and no pock mark
Hardness: 10 samples are taken, and the hardness is measured by a tablet hardness tester, and the qualified hardness standard is 40-60N.
Weight: 10 tablets were sampled and weighed using an analytical balance and the results are expressed as the average weight of ten tablets.
Friability: 10 tablets were taken, and the tablets were less than 1% acceptable in terms of abrasion resistance and vibration resistance.
Weight difference: 10 samples were taken, the average (indicated) tablet weight was < 0.50g, and the tablet weight variation limit (%) was ± 7.5%; the average (indicated) tablet weight was 0.5g or more, and the tablet weight variation limit (%) was. + -. 5%.
Dissolution rate: if one of the following conditions is satisfied, the condition is determined to be satisfied: (1) in 6 tablets (grains), the dissolution amount of each tablet (grain) measured at each time point is calculated according to the marked amount and does not exceed the specified range; (2) in 6 tablets (grains), if 1-2 tablets (grains) exceed the specified range but do not exceed 10% of the specified range, and the average elution amount measured at each time point does not exceed the specified range; (3) if the measured dissolution amount of 6 tablets (granules) at each time point is 1-2 tablets (granules) out of the specified range, wherein only 1 tablet (granule) is 10% out of the specified range but not 20% out of the specified range, and the average dissolution amount is not out of the specified range, 6 tablets (granules) should be taken for retesting; in 12 pieces (grains) of the initial and the secondary tests, the elution amount measured at each time point is 1-3 pieces (grains) out of the specified range, wherein only 1 piece (grain) is 10% out of the specified range, but not 20% out of the specified range, and the average elution amount is not out of the specified range. The above results show that 10% and 20% out of the specified ranges are percentages (%) relative to the labeled amounts, wherein 10% out of the specified ranges means: the amount of elution measured at each time point is not less than-10% of the lower limit, or not more than + 10% of the upper limit; the amount of elution measured at each time point should include the amount of elution measured at the final time.
Establishing an in vitro release degree: refer to the first and second methods (sustained release preparation and controlled release preparation) in 0931 dissolution and release determination method in the four ministry of general rules of China pharmacopoeia, 2020 edition. Taking 6 sustained-release tablets, placing in a rotary basket, taking 500ml of water as a dissolution medium, sampling 5ml of each of 2h, 3h, 4h, 6h and 12h at the temperature of 37 +/-0.5 ℃ and 100 r/min, measuring absorbance by an ultraviolet-visible spectrophotometry, and timely supplementing the release medium with the same volume and the same temperature. Then, refer to the guidance principle of 9013 sustained-release and delayed-release preparation in the 2020 edition of Chinese pharmacopoeia in the four ministry of communications. Water is used as a dissolution medium, a comprehensive grading method is adopted, and the cumulative release degrees at 2, 4, 6, 10, 12 and 15 hours are used as evaluation indexes.
Results
2.1 results of single-factor screening of Kaixuan slow-release tablet auxiliary materials
2.1.1 Slow Release matrix Material screening
The results of screening the sustained-release matrix material of the kaixuan sustained-release tablets according to the operation method of 1.32 are shown in Table 3.
TABLE 3 screening of sustained-release matrix material for KAIXIN sustained-release tablet
Figure 778546DEST_PATH_IMAGE004
As can be seen from table 3, the HPMCK100M has a low molding rate and has a caking phenomenon, the HPMCK100M sustained release tablet has a low viscosity, requires a larger pressure in a compressibility experiment, is not easily compressed into a tablet, has a poor dissolution performance in a dissolution experiment, is not as uniform in color as the sustained release tablet prepared by EC, has a smooth surface, and does not meet requirements, so EC is the optimal sustained release matrix material of the prescription, and EC is used as the sustained release matrix material of the yingsan sustained release tablet in the experiment.
Screening of porogens
The pore-forming agent of the kaixuan powder sustained-release tablets was screened according to the operation method of 1.33, and the results are shown in table 4.
TABLE 4 pore-forming agent screening of Kaixin sustained-release tablets
Figure 592918DEST_PATH_IMAGE005
As can be seen from Table 4, PEG600 is sticky and easy to absorb moisture, the prepared particles are high in viscosity and difficult to form, the pressed sustained-release tablet is good in complete light sensation on the surface and high in solubility of PEG600 compared with the sticky tablet, the hole making effect of the sustained-release tablet is poor, the drug release speed is too slow and uneven, and the requirements are not met. PEG4000 is a scaly solid, the shape of the particle prepared after grinding is good, the viscosity is moderate, the hole making effect is good after the PEG4000 with large molecular weight and poor solubility is pressed into the sustained-release tablet, holes are formed on the surface of the sustained-release tablet, and the surface of the sustained-release tablet is complete and has good light sensation. Therefore, PEG4000 is the optimal pore-forming agent in the prescription, so PEG4000 is used as the pore-forming agent of the yixin san sustained-release tablets in the experiment.
Screening of the Filler
The filler of the kaixuan slow-release tablet was selected according to the procedure of 1.34, and the results are shown in table 5.
TABLE 5 Filler screening for Kaixin sustained-release tablets
Figure 477697DEST_PATH_IMAGE006
As can be seen from Table 5, corn starch is not suitable for dissolving in cold water due to its moisture absorption, and the granule is not easy to form and agglomerate, and the pressure required for pressing into sustained release tablets is large, which is not satisfactory. Lactose is white crystal particles, has good particle shape, is not suitable for caking, has sweet taste and can be used for flavoring, so the lactose is the optimal filler of the prescription, and the lactose is used as the filler of the yixin san sustained-release tablets in the experiment.
Screening of wetting Agents
The wetting agent of the kaixuan slow release tablet was screened according to the procedure of 1.35, and the results are shown in table 6.
TABLE 6 wetting agent screening for Kaixin sustained-release tablets
Figure 744731DEST_PATH_IMAGE007
As shown in Table 6, 90% ethanol as the wetting agent has a low forming rate, a caking phenomenon, and an appearance which is not as uniform as that of granules prepared from water, and the granules have smooth surfaces and do not meet requirements, so water is the optimal wetting agent for the prescription, and water is used as the wetting agent for the yingxin sustained-release tablets in the experiment.
Analysis of
From the above, the known polysaccharide extract of traditional Chinese medicine has strong viscosity and hygroscopicity, and causes certain troubles for granulation. In order to reduce the hygroscopicity of the herb extract, the excipients used must have a certain hygroscopicity. Experiments prove that the hygroscopicity can be reduced by uniformly mixing a certain amount of traditional Chinese medicine extract, EC, PEG4000 and lactose, the forming rate is high, the taste is proper, the price is moderate, and the physical and chemical properties are good.
Results of orthogonal experiments
2.3.1 prescription screening results
TABLE 7 scoring results
Figure 943631DEST_PATH_IMAGE008
TABLE 8 visual distribution diagram
Figure 422629DEST_PATH_IMAGE009
As can be seen from tables 7 and 8, the EC level and PEG4000 level had an effect on the final score, resulting in a significant effect on the sustained release tablets prepared. The degree of influence of various factors on the quality of the preparation is A, B and C. Therefore, the optimal combination of the dosage of each auxiliary material is A2B2C1D4. So the prescription is determined as: main ingredients of ginseng, polygala root, calamus and tuckahoe, 30mg, 60mg of extracts, pore-forming agent PEG4000142.5mg, filler lactose 142.5mg and wetting agent water 12.5 ml.
Analysis of
Comparison k1，k2，k3，k4Due to k2 > k1> k3>k4Thereby obtaining A2The level is optimal; from Table 8, it can be seen that B is the largest value2So select B2An optimal level as a factor B; the factor C has little influence on the yixin san sustained-release tablets, so the optimal level of the factor C is compared with the optimal level of the factor C1(ii) a Therefore, when the optimal prescription of the yixin san sustained-release tablet is water as a wetting agent and lactose is used as a filler in the prescription, the prepared sustained-release tablet has good appearance, high compressibility and moderate hardness and friability, so the prescription of the experiment comprises main medicines of ginseng, polygala tenuifolia, calamus and poria cocos, 30mg, 60mg of extracts, a pore-forming agent PEG4000142.5mg, 142.5mg of filler lactose and 12.5ml of wetting agent water.
Preparation of sustained-release tablets
Selecting EC, PEG4000 and lactose as common adjuvants, mixing the Chinese medicinal extract powder, sustained-release matrix material and pore-forming agent at a certain ratio, and making into KAIXIN powder sustained-release tablet. Therefore, the optimum prescription design of the yinxin sustained release tablets after screening by auxiliary materials is shown in table 9.
TABLE 9 prescription of KAIXIN powder sustained-release tablet
Figure 415993DEST_PATH_IMAGE011
Main medicines of ginseng, polygala root, calamus and tuckahoe, 30mg and 60mg of extracts, 30mg and 60mg of pore-forming agent PEG4000142.5mg, 142.5mg of filler lactose, 2.5mg of magnesium stearate and 12.5ml of wetting agent water are sieved by a 20-mesh sieve, the sieved granules are put into a constant-temperature drying box at 60 ℃ to be dried for 2 hours, 2.5mg of lubricant is weighed after the dried granules are taken out and granulated, and the lubricant is uniformly mixed and sieved by a 50-mesh sieve. And tabletting the total mixed granules in a 10mm shallow concave die tabletting machine to finally prepare 500mg sustained release tablets.
Quality inspection results
According to the requirements of sustained-release tablets in pharmacopoeia, 4 aspects of appearance, hardness, friability and weight difference are respectively considered.
Appearance of the product
The yippee powder sustained-release tablets prepared by the experiment are dry, smooth and touch, have no unevenness, consistent size and brown color.
Hardness of
The hardness of the prepared yioxinsan sustained release tablets is checked, 10 tablets are taken, the hardness is measured by a tablet hardness tester, and the average hardness of the 10 sustained release tablets is 60N
And (4) conclusion: the granularity of the rhizoma nelumbinis granules is in accordance with the interval of 40-60N and the regulation.
Degree of friability
The friability of the kaixiong powder sustained-release tablets prepared by the experiment is checked, 10 compressed sustained-release tablets are taken, and the 10 sustained-release tablets have no conditions of breakage, cracking and the like under 60min and 100 revolutions.
And (4) conclusion: the abrasion resistance and vibration resistance of the tablet is less than 1 percent and is qualified.
Difference in weight
Checking the weight difference of the prepared KAIXIN powder sustained release tablet, and taking 10 compressed sustained release tablets, wherein the weight of the 10 sustained release tablets is about 500-520 mg
And (4) conclusion: average (indicated) tablet weight < 0.50g, tablet weight variation limit (%) of ± 7.5%; the average (marked) tablet weight is more than or equal to 0.5g, and the weight difference limit (%) of the tablets is +/-5 percent, which meets the specified requirements.
Dissolution rate
Refer to the first and second methods (sustained release preparation and controlled release preparation) in 0931 dissolution and release determination method in the four ministry of general rules of China pharmacopoeia, 2020 edition. Taking a proper amount of sustained-release tablets, placing in a rotating basket, taking 500ml of water as a dissolution medium, dissolving the tablets in a solvent (37)
Figure 232639DEST_PATH_IMAGE012
Sampling 5ml at 100 r/min at 0.5) ° C for 2h, 3h, 4h, 6h and 12h, measuring absorbance by ultraviolet-visible spectrophotometry, and timely supplementing isovolumetric release medium. Then, refer to the guidance principle of 9013 sustained-release and delayed-release preparation in the 2020 edition of Chinese pharmacopoeia in the four ministry of communications. And (3) taking water as a dissolution medium, adopting a comprehensive grading method, and taking the cumulative release degrees at the 2 nd, 4 th and 12 th hours as evaluation indexes to calculate the dissolution rate.
Dissolution rate results:
Figure 969651DEST_PATH_IMAGE013
2.5.6 degree of release
The release rate of the yixin san sustained-release preparation is shown in fig. 2, and compared with the common preparation, the yixin san sustained-release preparation has many advantages, and can effectively slow down the release rate of the medicine, thereby reducing the dosage and administration times of the medicine and effectively saving the cost. The yippengsan sustained-release tablets researched and prepared by the experiment are the defects that the sustained-release tablets are firstly applied to the preparation process of yippengsan medicines in China, and the yippengsan can be effectively used for multiple times of clinical medication, so that the yippengsan is widely applied to antidepressant treatment.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be construed as the protection scope of the present invention.

Claims (2)

1. The yixinsan sustained-release tablet is characterized in that: prepared from the following components: 30mg of ginsenoside extract; 30mg of polygala root extract; rhizoma Acori Calami extract 30 mg; poria extract 60 mg; pore-forming agent PEG4000142.5mg; lactose bulking agent 142.5 mg; magnesium stearate 2.5 mg; 12.5ml of wetting agent water; lubricant 2.5 mg.
2. A preparation method of a yixinsan sustained release tablet is characterized by comprising the following steps: the method comprises the following steps: 30mg of ginsenoside extract, 30mg of polygala root extract, 30mg of calamus extract, 60mg of poria cocos extract, 2.5mg of pore-forming agent PEG4000142.5mg, 142.5mg of filler lactose, 2.5mg of magnesium stearate and 12.5ml of wetting agent water are taken to prepare soft materials until the effect of 'hand-holding agglomeration and light pressing and dispersion', the soft materials are sieved by a 20-mesh sieve, then are placed in a constant-temperature drying box at 60 ℃ for drying for 2h, are taken out, are sized, are uniformly mixed with 2.5mg of lubricating agent, are sieved by a 50-mesh sieve, and are tabletted in a 10mm shallow concave die stamping tablet machine to obtain the tablet.
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Publication number Priority date Publication date Assignee Title
CN114533802A (en) * 2022-03-11 2022-05-27 山东中医药大学第二附属医院(山东省中西医结合医院) Traditional Chinese medicine preparation for treating insomnia and anxiety and preparation method thereof
CN116688037A (en) * 2023-07-19 2023-09-05 中国人民解放军总医院 Preparation method and application of pistachio-capsule powder active component

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Publication number Priority date Publication date Assignee Title
CN102895432A (en) * 2011-07-26 2013-01-30 王登之 Prescription and preparation method of rejoicing powder having new dosage form

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
CN102895432A (en) * 2011-07-26 2013-01-30 王登之 Prescription and preparation method of rejoicing powder having new dosage form

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114533802A (en) * 2022-03-11 2022-05-27 山东中医药大学第二附属医院(山东省中西医结合医院) Traditional Chinese medicine preparation for treating insomnia and anxiety and preparation method thereof
CN116688037A (en) * 2023-07-19 2023-09-05 中国人民解放军总医院 Preparation method and application of pistachio-capsule powder active component

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