Preparation method of traditional Tibetan medicine three-component rose powder
Through the use of damp -heat method and strict control process in the preparation of Sanwei Rose San, the problem of insufficient sterilization, unstable quality, and imperfect control standards were solved, and the product safety and quality consistency were ensured.
Patent Information
- Application Number
- CN202411499529.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-25
- Publication Date
- 2025-01-24
AI Technical Summary
The lack of sterilization treatment in the preparation of Sanwei Qiangwei Powder, resulting in excess of microorganisms; the process control is not strict, resulting in unstable product quality; the quality control standards are incomplete, and the quality consistency of each batch of products cannot be guaranteed.
The use of damp heat sterilization, the control temperature is between 100 ° C and 130 ° C, to ensure that the active ingredients of the medicinal materials are not lost, and the moisture content is below 6 %. At the same time, strictly control the crushing, sieve and mixing process to ensure that the appearance uniformity and amount of the product are small.
Through the appropriate sterilization method and strict process control, the problems of microorganisms, unstable product quality, and imperfect quality control were solved, and the microorganisms of the three -flavored rose scattered are in line with the regulations of Chinese pharmacopoeia.
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Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of traditional Chinese medicine and traditional Tibetan medicine, and particularly relates to a preparation method of traditional Tibetan medicine Sanwei Qiangwei powder. Background Art
[0002] The word "Tripa" is Tibetan, which means "fire" or "gallbladder" in Chinese. Its function is to generate heat energy and maintain body temperature, strengthen the function of the stomach to digest food, know hunger and temperature, grow complexion, strengthen courage, and generate wisdom. It has a fiery nature and is a factor responsible for the functional activities of the internal organs in the human body and the "heat" required for physiological activities. Tibetan medicine believes that the main part of the "Tripa" in the human body is the liver and gallbladder, which is in the abdomen of the human body. The gallbladder is the base of the "Tripa", the organ on which the "Tripa" relies to ensure nutrition or from which "Tripa-type" diseases occur, and the gallbladder is the main organ of the "Tripa". The juice is the material manifestation of Tripa Gyase (digestive Tripa). In treatment and prevention, since most gallbladder diseases are hot diseases, the methods used by Tibetan medicine to treat gallbladder diseases are consistent with those used to treat hot "Tripa diseases". For example, water-based drugs and bitter, sweet, and astringent drugs are often used. In terms of daily life, it is forbidden to be exposed to the sun, do strenuous exercise, and eat greasy food. In general, "Tripa" has a huge impact on the gallbladder. When the function of the human body's "Tripa" is abnormal, it is easy to cause gallbladder diseases.
[0003] Sanwei Qiangwei Powder is a commonly used Tibetan medicine and a classic Tibetan prescription. The prescription is included in the classic Tibetan medicine book "Secrets and Supplements Key Collection" (China Library CIP Data Verification (2007) No. 196384) page 206 and "Ministry of Health Drug Standards" (Tibetan Medicine) Volume 1 1995 Edition page 262. Tibetan medicine has used it for detoxification, gallbladder, heat clearing, and treatment of "triba disease" and gallbladder diseases for more than 300 years.
[0004] The preparation of Sanwei Qiangwei Powder has not been standardized, resulting in unstable efficacy and quality, affecting the efficacy. However, there are the following main shortcomings and deficiencies:
[0005] Lack of sterilization: In the traditional process, the raw materials are not sterilized, which may lead to excessive microbial content in the finished product, affecting the safety of the drug. In particular, the inventors accidentally found that different sterilization methods will lead to the loss of effective ingredients of the medicinal materials of Pueraria lobata and Terminalia chebula during the screening of sterilization methods, and it is necessary to select a suitable sterilization method.
[0006] Lax process control: Lack of strict process control during the crushing, screening, mixing and other processes leads to unstable product quality and large differences between batches.
[0007] Imperfect quality control standards: The quality control standards for product moisture, appearance uniformity, and filling volume differences are imperfect, and the quality consistency of each batch of products cannot be guaranteed. Summary of the invention
[0008] Aiming at the shortcomings of the preparation of Sanwei Qiangwei Powder, the present invention provides a method for preparing Sanwei Qiangwei Powder, a traditional Tibetan medicine. The method successfully solves the technical problems of Sanwei Qiangwei Powder not being sterilized, resulting in excessive microorganisms, and large differences in filling volume.
[0009] The invention discloses a method for preparing a traditional Tibetan medicine Sanwei Qiangwei powder, wherein the Sanwei Qiangwei powder is prepared from three medicinal materials: 48.75 g of rose flower, 24.35 g of melon seeds and 32.5 g of Terminalia chebula (coreless), and the method comprises the following steps:
[0010] 1) Pre-treating the medicinal materials: selecting three medicinal materials, namely, rose flower, melon seeds and terminalia chebula, in a production batch manner according to the prescription quantity, washing them, and drying them in the shade or in the sun;
[0011] 2) Sterilize the three pre-treated herbs, crush them into fine powders, sieve them, mix them evenly, and package them.
[0012] The invention is characterized in that: the sterilization adopts moist heat sterilization.
[0013] Preferably, in the preparation method of the present invention, the pretreatment further comprises taking seeds from the fruit of the Melon seeds and removing the core of the Terminalia chebula.
[0014] Preferably, in the preparation method of the present invention, the sieving is to sieve the fine powder through a 100-mesh sieve.
[0015] Preferably, in the preparation method of the present invention, the sterilization temperature of the moist heat sterilization is 100° C. to 130° C. More preferably, the sterilization temperature is 110° C.
[0016] Preferably, in the preparation method of the present invention, the fine powder in step 2) has a moisture content of less than 9.0%, more preferably, a moisture content of less than 6.0%.
[0017] Technical effect: The preparation method of the present invention, by selecting a suitable sterilization method for medicinal materials to ensure that the effective ingredients of the medicinal materials are not lost, and controlling the moisture, successfully solves the technical problems of unstable product quality, large differences in loading between batches, imperfect quality control standards, and inability to ensure the consistency of quality of each batch of products in the existing production process. The microorganisms of the Sanwei Qiangwei powder prepared by the preparation method of the present invention meet the requirements of the Chinese Pharmacopoeia, the granules have a uniform appearance, and the loading difference is small, which meets the requirements of the Chinese Pharmacopoeia. DETAILED DESCRIPTION
[0018] The following examples are representative and are used to further understand and illustrate the essence of the present invention, but are not intended to limit the scope of the present invention in any way.
[0019] Example 1 Preparation of Sanwei Qiangwei Powder
[0020] Prescription rose flower 48.75g, melon seeds 24.35g, Terminalia chebula (pitted) 32.5g
[0021] Pretreatment of medicinal materials:
[0022] 1. Rose
[0023] Dried petals of the Rosaceae plant Emei rose are identified according to the method on page 121 of the 1995 edition of the Ministry of Health Drug Standards (Volume 1 of Tibetan Medicine). Harvested in summer and autumn, dried in the shade, and free of impurities, and set aside.
[0024] 2. Pear melon seeds
[0025] This product is the dried seeds of the Cucurbitaceae plant, Bolenggua. It is identified according to the method on page 64 of the 1995 edition of the Ministry of Health Drug Standards (Volume 1 of Tibetan Medicine). The ripe fruits are harvested in autumn, dried, and the seeds are removed for later use. Its processing method refers to the processing method under Bolenggua seeds on page 87 of the 2010 edition of the Qinghai Province Tibetan Medicine Processing Specifications.
[0026] 3. Terminalia chebula (pitted)
[0027] Terminalia chebula is the dried mature fruit of Terminalia chebula or Terminalia chebula of the Combretaceae family. It is identified according to the method on page 187 of the 2015 edition of the first volume of the Chinese Pharmacopoeia. The fruit is harvested when it is ripe in autumn and winter, and impurities are removed, dried in the sun, and pitted for later use. Its processing method is carried out in accordance with the processing method under Terminalia chebula on page 110 of the 2008 edition of the Tibetan Medicine Processing Specifications of the Tibet Autonomous Region.
[0028] Preparation process of Sanwei Qiangwei powder:
[0029] 1. Take the pre-treated rose flower, melon seeds and terminalia chebula (pitted) as the three medicinal materials, and expand the production batch by a certain multiple according to the prescription quantity of each medicinal material for formulation.
[0030] 2. Sterilize the three medicinal materials separately using the heat and moisture method, control the temperature at around 110°C, and dry them in the sun to control the moisture content of the medicinal materials below 6%.
[0031] 3. Grind the three medicinal materials into fine powder, pass through a 100-mesh sieve, mix evenly, and control the moisture content to less than 6%. Then package them, put them into aluminum-plastic inner packaging, outer packaging, and store the finished products.
[0032] A total of three batches were produced, with batch numbers: 20170902, 20180203, and 20190405.
[0033] Example 2 Identification of Sanwei Qiangwei Powder
[0034] Properties:
[0035] Through the observation of the properties of 3 batches of samples and the study of the production process, the properties of the samples are described, that is, this product is a yellow-green powder, the particles have a uniform appearance, a fragrant smell, and a bitter taste.
[0036] Moisture content: Moisture: not more than 9.0%.
[0037] After testing, the contents of three batches of Sanwei Qiangwei Powder are shown in Table 1.
[0038] Table 1. Test results of water content of Sanwei Qiangwei powder
[0039]
[0040] Appearance uniformity: The three batches of samples were tested according to the appearance uniformity inspection method under 0115 powder in the fourth general rule of the 2015 edition of the Chinese Pharmacopoeia. Take an appropriate amount of the test sample, place it on a smooth paper, and spread it flat for about 5cm 2 , press its surface flat and observe it in a bright place. The color is uniform and there are no patterns or spots.
[0041] Filling quantity difference: The three batches of samples were measured according to the filling quantity difference method under 0115 Powders of Part IV of the 2015 edition of the Chinese Pharmacopoeia. The labeled amount was 3g. Ten bags of test samples were taken and the weight of the contents of each bag was weighed. The filling quantity difference of the test samples was within ±7%, and the results met the requirements.
[0042] Microbial limits: The three batches of samples were tested according to 1105, 1106, and 1107 of Part IV of the 2015 edition of the Chinese Pharmacopoeia. The aerobic bacteria count did not exceed 10,000 cfu / g, the total number of molds and yeasts did not exceed 100 cfu / g, the bile-resistant Gram-negative bacteria did not exceed 100 cfu / g, and Escherichia coli and Salmonella were not detected. The results were in compliance with the regulations.
[0043] Example 3: Method for sterilizing medicinal materials
[0044] Sterilization effect of different sterilization methods
[0045] Take the rose flower, melon seeds and terminalia chebula picked from the same batch, clean them, and divide them into 4 groups: the first group is wet sterilized, the second group is dry sterilized, the third group is radiation sterilized (microwave method), and the fourth group is chemically sterilized (ozone method). After the medicinal materials are sterilized, the powders of each group of medicinal materials are mixed, and the colony count of the powders is detected (0 month). After being stored at room temperature for 6 months, the colony data is detected again. The sterilization qualified standard is: the total number of aerobic bacteria: less than 10000 cfu / g, the total number of molds and yeasts: less than 100 cfu / g or cfu / ml 1, and Escherichia coli: less than 10 cfu / g. If the colony count is greater than the above range, it is judged as unqualified. The results are shown in Table 2 below.
[0046] Table 2. Sterilization effect of different sterilization processes
[0047]
[0048] The results in Table 2 show that only wet sterilization can ensure that the colony count of medicinal materials in the 0th and 6th months is qualified.
[0049] Effects of sterilization methods on the components of medicinal materials
[0050] Take the same batch of picked melon seeds and terminalia chebula medicinal materials, wash them and divide them into 5 groups, the first group is the control group, the second group is wet sterilization, the third group is dry sterilization, the fourth group is radiation sterilization (microwave method), and the fifth group is chemical sterilization (ozone method). After the medicinal materials are sterilized, they are extracted twice with 8 times the amount of anhydrous ethanol, and the high performance liquid chromatography method recorded in the Chinese Pharmacopoeia is used to detect the content of herpetolide in melon seeds and the content of terminalia chebula acid in terminalia chebula. The results are shown in Table 3 below.
[0051] Table 3. Effects of different sterilization processes on medicinal material components
[0052] Medicinal Materials Ingredients Group 1 Group 2 Group 3 Group 4 Group 5 Pear melon seeds herpetolide 0.62％ 0.58％ 0.31％ 0.21％ 0.48％ Terminalia chebula Chebulic acid 32.35％ 31.01％ 23.13％ 19.56％ 30.62％
[0053] The results in Table 3 show that after wet sterilization of the second group and ozone sterilization of the fifth group, the content of herpetolide, a representative active ingredient in Melon seeds, and the content of chebulic acid in Chebulic acid were comparable to those in the control group (the first group). Sterilization of other groups, such as dry sterilization and radiation sterilization, would result in the loss of active ingredients in the medicinal materials.
[0054] The results in Table 2 and Table 3 show that wet sterilization is the preferred method of the present invention.
[0055] The above embodiments are representative, and any modifications and variations made within the essential scope of the present invention belong to the scope of the present invention.
Claims
1. A method for preparing a traditional Tibetan medicine Sanwei Qiangwei powder, wherein the Sanwei Qiangwei powder is prepared from three medicinal materials: 48.75g of rose flower, 24.35g of melon seeds and 32.5g of Terminalia chebula (pitted), and the method comprises the following steps: 1) Pre-treating the medicinal materials: selecting three medicinal materials, namely, rose flower, melon seeds and terminalia chebula, in a production batch manner according to the prescription quantity, washing them, and drying them in the shade or in the sun; 2) Sterilize the three pre-treated herbs, crush them into fine powders, sieve them, mix them evenly, and package them. The invention is characterized in that: the sterilization adopts moist heat sterilization.
2. The use according to claim 1, wherein the pretreatment further comprises removing the seeds from the fruit of the Melon seeds and removing the stones from the Terminalia chebula.
3. The preparation method according to claim 1, wherein the sieving is to pass the fine powder through a 100 mesh sieve.
4. The preparation method according to claim 1, wherein the moist heat sterilization has a sterilization temperature of 100°C to 130°C. The preparation method according to claim 4 , wherein the sterilization temperature is 110° C.
6. The preparation method according to claim 1, wherein the fine powder in step 2) has a moisture content of less than 9.0%.
7. The preparation method according to claim 6, wherein the moisture content is controlled within 6.0%.