Low-temperature standardized preparation method of Kaixin powder

Abstract

The invention provides a low-temperature standardized preparation method of Kaixin powder, which comprises the following steps: S1, carrying out low-temperature pretreatment, specifically S2, carrying out superfine grinding and efficient mixing; s3, carrying out electron beam irradiation sterilization; s4, carrying out ultrasonic oscillation screening; s5, sub-packaging and boxing are carried out; the method comprises the process steps of low-temperature pretreatment, superfine grinding and mixing combination, electron beam irradiation sterilization, efficient screening, subpackaging and the like, and is suitable for large-scale production of high-quality traditional Chinese medicine compound powder.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compound preparation technology, specifically to a low-temperature standardized preparation method for Kaixin San (a traditional Chinese medicine formula). Background Technology

[0002] "Kaixin San" comes from the Tang Dynasty book "Essential Prescriptions Worth a Thousand Pieces of Gold for Emergency Use". It is composed of four medicinal materials: Polygala tenuifolia, ginseng, Poria cocos, and Acorus tatarinowii. It has the effects of invigorating qi and nourishing the heart, calming the mind and stabilizing the will. It is mainly used to treat insomnia, forgetfulness, palpitations and other symptoms caused by insufficient heart qi.

[0003] Traditional preparation methods are mostly manual, which has the following problems: the pretreatment of medicinal materials is not standardized, and active ingredients are easily lost; high-temperature sterilization is often used, which leads to the degradation of heat-sensitive components such as volatile oils and saponins; uneven particle size and uneven mixing affect the accuracy of dosage and the consistency of efficacy; and it is difficult to achieve industrialized and standardized production.

[0004] In summary, this application proposes a low-temperature standardized preparation method for Kaixin San to solve the above problems. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a low-temperature standardized preparation method for Kaixin San (a traditional Chinese medicine formula), which can effectively solve the aforementioned problems.

[0006] To achieve the above requirements, the technical solution adopted by the present invention is: to provide a low-temperature standardized preparation method for Kaixin San, which includes the following steps:

[0007] S1: The steps for low-temperature pretreatment specifically include: removing impurities from the ginseng, removing the rhizome and separating the roots; using a 2.5mm mesh screen on a sorting table; washing the main root 1-3 times at 10 rpm until clean; rinsing the fibrous roots through a screen; and moistening the main root with a water machine: adding 0.3-0.8 times the amount of water and moistening for 5-7 hours, starting with 0.3 times the amount of water and adding water as needed during the process to keep the surface of the medicinal material moist, but not exceeding 0.8 times the amount of water in total; the fibrous roots are not moistened; the fibrous roots are not cut, the main root is cut into 1-2mm thin slices, and dried in a 50℃ oven for 6-8 hours; Remove impurities and non-medicinal parts from Acorus tatarinowii. Use a 2.5mm mesh screen on a sorting table and a washing machine at 10 rpm for 1-3 washes until clean. Cut into 3-5mm thick slices and dry in a 50℃ oven for 8-10 hours. Remove impurities and unremoved cores from Polygala tenuifolia. Use a 2.5mm mesh screen on a sorting table and a washing machine at 10 rpm for 1-3 washes until clean. Dry in a 55℃ oven for 12-14 hours. Remove impurities from Poria cocos. Use a 2.5mm mesh screen on a sorting table and dry in a 55℃ oven for 12-14 hours.

[0008] S2: The step of ultra-fine grinding and efficient mixing;

[0009] S3: The step of performing electron beam irradiation sterilization;

[0010] Preferably, step S2 specifically includes: adding the four herbs simultaneously according to the prescription, using a vibrating ultrafine pulverizer to pulverize for 15–20 minutes, with the condensate temperature ≤5℃; particle size control: all passing through an 80-mesh sieve, and ≥95% passing through a 100-mesh sieve.

[0011] Preferably, step S3 specifically includes: sterilizing the mixed and pulverized powder by irradiation with an electron accelerator at 8kGy without heating, thus avoiding the loss of heat-sensitive components.

[0012] S4: The step of ultrasonic vibration sieving;

[0013] S5: The step of dispensing;

[0014] Preferably, step S4 specifically includes: passing the electron beam-irradiated powder through a 100-mesh sieve using an ultrasonic vibrating screen. Particle size control: ≥95% can pass through the 100-mesh sieve.

[0015] Preferably, step S5 specifically includes: dispensing the sieved powder into 1g or 3g / bag using a single-row rounded corner back-sealing powder dispensing machine. Operating parameters: horizontal sealing temperature (inner temperature 135-155℃, outer temperature 90-110℃), vertical sealing temperature 160-190℃, vertical sealing time 0.6-2.0 seconds. Packaging speed 20-40 bags / min.

[0016] Preferably, the process also includes step S6: optimizing the overall process route. Each batch of material is fed 6.9 kg, producing approximately 6900 bags of 1 g / bag and approximately 2300 bags of 3 g / bag. The process is continuous and controllable. The amount of material fed can be increased according to the requirements of commercial production. The entire process is carried out at low temperatures, and the crushing and mixing are completed in one step, reducing energy consumption by ≥25%, making it suitable for large-scale production under GMP conditions.

[0017] The advantages of this low-temperature standardized preparation method for Kaixin San are as follows:

[0018] (1) High component retention: Low temperature process + electron beam sterilization, active ingredient retention rate >90%;

[0019] (2) Stable quality: uniform particle size, qualified microorganisms, and mixing uniformity RSD < 3%;

[0020] (3) Advanced technology: crushing and mixing are formed in one step, which is suitable for GMP standardization and continuous production;

[0021] (4) Consistent efficacy: Meets the registration requirements of classic prescriptions, with accurate dosage and reliable efficacy;

[0022] (5) Energy saving and environmental protection: Low temperature process reduces energy consumption by ≥25%. Attached Figure Description

[0023] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, use the same reference numerals to denote the same or similar parts. The illustrative embodiments of this application and their descriptions are used to explain this application and do not constitute an undue limitation of this application. In the drawings:

[0024] Figure 1 A schematic flowchart of a low-temperature standardized preparation method of Kaixin San according to an embodiment of this application is shown. Detailed Implementation

[0025] To make the objectives, technical solutions and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and specific embodiments.

[0026] In the following description, references to "an embodiment," "an embodiment," "an example," "example," etc., indicate that the described embodiment or example may include a particular feature, structure, characteristic, property, element, or limitation, but not every embodiment or example necessarily includes that particular feature, structure, characteristic, property, element, or limitation. Furthermore, the repeated use of the phrase "an embodiment according to this application," while possibly referring to the same embodiment, does not necessarily refer to the same embodiment.

[0027] For simplicity, certain technical features known to those skilled in the art are omitted in the following description.

[0028] According to one embodiment of this application, the low-temperature standardized preparation method of Kaixin San involves feeding materials at 100 times the amount of a single-dose prescription, with a designed weight of 6.9 kg of compound powder per batch. Commercial production can be scaled up to a batch yield of 69 kg depending on equipment requirements.

[0029]

[0030] Based on this, the dosage of the four medicinal ingredients for 100 doses is calculated as shown in the table below:

[0031]

[0032] According to one embodiment of this application, the process design is as follows:

[0033] 1. Low-temperature pretreatment process (to protect active ingredients)

[0034]

[0035] Based on the heat-sensitive properties of different medicinal materials, personalized low-temperature drying parameters are set to maximize the preservation of active ingredients.

[0036] 2. Ultrafine grinding and efficient mixing (improving uniformity and dissolution): The four herbs in the prescription are added simultaneously and ground in a vibrating ultrafine grinder for 15–20 minutes, with the condensate temperature ≤5℃; Particle size control: All particles pass through an 80-mesh sieve, and ≥95% can pass through a 100-mesh sieve; Low-temperature ultrafine grinding, with grinding and mixing functions, significantly improves powder uniformity, dissolution rate and bioavailability.

[0037] 3. Electron beam irradiation sterilization (non-thermal sterilization): The pulverized and mixed powder is sterilized by electron accelerator irradiation (8kGy±1kGy), without heating, avoiding loss of heat-sensitive components; the microbial limits meet the requirements of the Chinese Pharmacopoeia, and sterilization is uniform and residue-free. This is the first time that electron beam irradiation technology has been applied to the sterilization of "Kaixin San" compound powder, replacing traditional moist heat / dry heat sterilization and solving the problem of "sterilization and degradation".

[0038] 4. Ultrasonic oscillation sieving (improving sieving efficiency): After sterilization, the powder is oscillated through a 100-mesh sieve using ultrasonic oscillation, which effectively prevents sieve clogging and increases sieving efficiency by 10 times compared to traditional methods, resulting in a significant increase in output.

[0039] 5. Packaging: The powder is packaged into 1g or 3g bags using a single-row rounded corner back-sealed powder packaging machine.

[0040] 6. Overall optimization of the process route (suitable for continuous production): Each batch feeds 6.9kg (100 times the prescription amount), the process is continuous and controllable, and the feed amount can be increased according to the requirements of commercial production; the whole process is at low temperature (≤55℃), energy consumption is reduced by ≥25%, the crushing and mixing process is integrated, and ultrasonic vibration sieving is used to reduce process difficulties and improve process efficiency, which is suitable for large-scale production under GMP environment; a low-temperature, low-loss, high-efficiency and continuous process route for the preparation of classic prescriptions is constructed.

[0041] like Figure 1 As shown, the process route includes: pretreatment → mixing and pulverizing → sterilization → sieving → dispensing → packaging → finished product warehousing.

[0042] According to one embodiment of this application, the low-temperature standardized preparation method of the Kaixin San is as follows: pretreatment and processing technology.

[0043]

[0044] Formulation process

[0045] Comparative Example 1: High-temperature instantaneous sterilization. After the powder is prepared according to the above process, it is sterilized by high-temperature instantaneous sterilization and the content of each component is tested.

[0046]

[0047] High-temperature sterilization resulted in a 66% loss of volatile oils and β-asarone, a 20% loss of ginsenoside Re, a 16.67% loss of polygalactone III, and a 15.38% loss of 3,6'-disinozyloside sucrose.

[0048] Comparative Example 2: Vacuum steam sterilization. After the powder is prepared according to the above process, the content of each component is tested by vacuum steam sterilization.

[0049] Low-temperature vacuum steam sterilization (water steam) process parameters (batch 1)

[0050]

[0051] Low-temperature vacuum steam sterilization (anhydrous ethanol steam) process parameters (batch 2)

[0052]

[0053] The test results are compared below:

[0054] Because the content of bark and wood in Chinese medicinal materials is inconsistent and the content is low, the detection error is relatively large. Therefore, the content fluctuation within ±10% is a normal phenomenon.

[0055] The above content results show that:

[0056] Compared with the high-temperature instantaneous sterilization in Example 1, the content of each component was severely lost, especially the volatile components volatile oil and β-asarone, which were lost by 67%. Other components such as ginsenosides Rb1, Re, Rg1, polygalactone III, and 3,6'-disinozyloyl sucrose were lost to varying degrees. The loss of content means a reduction in efficacy and insufficient drug effectiveness.

[0057] Compared with vacuum steam sterilization in Example 2, the loss of each content was relatively low, but the microbial limits did not meet the requirements, especially the total number of aerobic bacteria, mold and yeast exceeded the standards. Excessive microbial levels affect the safety of the drug.

[0058] The embodiments described above are merely examples of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the claims.

Claims

1. A low-temperature standardized preparation method for Kaixin San (a traditional Chinese medicine formula), characterized in that, Includes the following steps: S1: The steps for low-temperature pretreatment specifically include: Remove impurities from the ginseng, remove the rhizome and separate the roots and fibrous parts. Use a 2.5mm mesh screen on the sorting table. Wash the main root 1-3 times with a washing machine at 10 rpm until clean. Rinse the fibrous roots with a sieve. Moisten the main root with a water-adding machine, adding 0.3-0.8 times the amount of water, for 5-7 hours. Start with 0.3 times the amount of water and add water as needed during the process to keep the surface of the medicinal material moist, but never exceed 0.8 times the amount of water. Do not moisten the fibrous roots. Do not cut the fibrous roots. Cut the main root into 1-2mm thin slices and dry them in a 50℃ oven for 6-8 hours. Remove impurities and non-medicinal parts from the Acorus tatarinowii. Use a 2.5mm mesh screen on the sorting table and a washing machine at 10 rpm to wash 1-3 times until clean. After washing, cut the herb into 3-5mm thick slices and dry them in a 50℃ oven for 8-10 hours. Remove impurities and unextracted cores from the Polygala tenuifolia. Use a 2.5mm mesh screen on the sorting table, and a washing machine at 10 rpm to wash 1-3 times until clean. Place in a 55℃ oven to dry for 12-14 hours. Remove impurities from Poria cocos, sort it using a sieve with a mesh size of 2.5 mm, and dry it in a 55℃ oven for 12-14 hours. S2: The step of ultra-fine grinding and efficient mixing; S3: The step of performing electron beam irradiation sterilization.

2. The low-temperature standardized preparation method of Kaixin San according to claim 1, characterized in that, Step S2 specifically includes: Add the four herbs simultaneously according to the prescription, and use a vibrating ultra-micro pulverizer to pulverize for 15–20 minutes, with the condensate temperature ≤5℃. Particle size control: All particles pass through an 80-mesh sieve, and ≥95% pass through a 100-mesh sieve; Mixing uniformity control: Mixing uniformity RSD < 3%.

3. The low-temperature standardized preparation method of Kaixin San according to claim 1, characterized in that, Step S3 specifically includes: The pulverized mixed powder is sterilized by electron accelerator irradiation without heating, thus avoiding the loss of heat-sensitive components; S4: The step of ultrasonic oscillation sieving.

4. The low-temperature standardized preparation method of Kaixin San according to claim 1, characterized in that, It also includes step S4, which specifically includes: The powder irradiated by the electron beam was passed through a 100-mesh sieve using an ultrasonic vibrating screen. Particle size control: ≥95% can pass through a 100-mesh sieve; S5: Perform the dispensing and boxing steps.

5. The low-temperature standardized preparation method of Kaixin San according to claim 1, characterized in that, It also includes step S5, which specifically includes: The sieved powder is then packaged into 1g or 3g bags using a single-row rounded corner back-sealed powder dispensing machine. Operating parameters: Horizontal sealing temperature (inner temperature 135-155℃, outer temperature 90-110℃), longitudinal sealing temperature 160-190℃, longitudinal sealing time 0.6-2.0 seconds. Packaging speed 20-40 bags / min.

6. The low-temperature standardized preparation method of Kaixin San according to claim 1, characterized in that, It also includes step S6: the step of optimizing the overall process route, which specifically includes: Each batch of feed is 6.9kg, producing approximately 6900 bags of 1g / bag and approximately 2300 bags of 3g / bag. The process is continuous and controllable. The amount of feed can be increased according to the requirements of commercial production. The entire process is carried out at low temperature, and crushing and mixing are completed in one step, reducing energy consumption by ≥25%. It is suitable for large-scale production under GMP environment.

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