A method for optimizing the preparation of a traditional Chinese medicine compound extract for daily chemicals based on antibacterial spectrum feedback and a composition
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- BEIJING ANJIETAI TECH CO LTD
- Filing Date
- 2026-06-25
- Publication Date
- 2026-08-07
AI Technical Summary
[0006]本发明的目的在于提供一种基于抑菌谱反馈的日化用中药复方提取物制备优化控制方法及组合物,以解决现有中药复方日化抑菌提取物多依据最终提取液的抑菌结果进行评价,难以区分抑菌率不足与低温预提段、乙醇回流提取段或水提段之间的对应关系,导致后续批次工艺调整缺少直接数据依据的问题
1、本发明通过将复方药材依次进行低温预提、乙醇回流提取和水提,并在同一制备批次内分别保留低温段检测样、醇提段检测样和水提段检测样,使低温预提液、醇提液和水提液不再仅作为最终候选提取物的组成部分,而同时作为批次工艺评价的数据来源,各检测样品和候选提取物在检测前均以每毫升样品对应的投料生药质量为归一化基准调整至相同生药浓度,由此避免因浓度差异造成抑菌率结果不能直接比较的问题,通过上述处理,可以在同一评价条件下获得不同提取段对金黄色葡萄球菌、大肠杆菌、白色念珠菌和皮肤癣菌的抑菌率数据,从而使最终候选提取物的抑菌不足能够对应到具体提取段,为后续批次的合并比例或提取条件调整提供明确依据。
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Figure CN122516062A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of antibacterial control technology in daily chemical products, specifically a method and composition for optimizing the preparation of traditional Chinese medicine compound extracts for daily chemical products based on antibacterial spectrum feedback. Background Technology
[0002] As consumers increasingly demand natural and safe daily chemical products, herbal compound preparations based on plant sources are gradually gaining attention in the daily chemical antibacterial product market. Currently, most commercially available daily chemical antibacterial products rely on chemical antibacterial agents such as chlorhexidine and benzalkonium bromide. Long-term use of these products carries risks of skin irritation, allergies, and drug resistance. Although some herbal compound preparations can replace chemical antibacterial agents, they have certain limitations in terms of preparation processes and formulation schemes.
[0003] Specifically, existing preparations of traditional Chinese medicine compound antibacterial daily chemical products have three main shortcomings: First, some formulas contain restricted or prohibited ingredients in daily chemical products, such as Pseudolarix amabilis bark and rhubarb, affecting safety and regulatory compliance; second, most preparation processes use single water extraction or single alcohol extraction methods, resulting in low extraction efficiency of effective components, easy turbidity or precipitation of compound extracts, uneven distribution of antibacterial activity, and a lack of stability and controllability; third, the combination of compound medicinal materials relies heavily on empirical combinations, lacking segmented extraction data to support different target bacterial spectrums, resulting in an unbalanced overall antibacterial effect and difficulty in ensuring broad-spectrum and highly effective antibacterial activity.
[0004] Furthermore, existing technologies typically only evaluate the antibacterial rate of the final combined extract against the target bacteria, without distinguishing the contributions of low-temperature pre-extraction solution, alcohol extract, and water extract to different target bacteria. They lack a mechanism for batch optimization based on segmented data, which results in a lack of quantifiable feedback loops in the preparation process. This makes it impossible to dynamically adjust extraction conditions or extract ratios according to the antibacterial effects of different bacterial strains, thus limiting the uniformity and process controllability of compound extracts in daily chemical products.
[0005] Therefore, existing Chinese medicine compound antibacterial daily chemical products have gaps in the technical logic closed loop regarding raw material selection, extraction process optimization, and antibacterial effects of different target bacteria. This makes it difficult to ensure that the antibacterial rate of each target bacteria reaches the predetermined standard in the same batch preparation. It is necessary to establish a verifiable and adjustable segmented extraction and ratio optimization system to support stable compound antibacterial effects. Summary of the Invention
[0006] The purpose of this invention is to provide an optimized control method and composition for the preparation of traditional Chinese medicine compound extracts for daily chemical use based on antibacterial spectrum feedback. This addresses the problem that existing evaluations of traditional Chinese medicine compound antibacterial extracts for daily chemical use often rely on the antibacterial results of the final extract, making it difficult to distinguish the correlation between insufficient antibacterial rate and the low-temperature pre-extraction stage, ethanol reflux extraction stage, or water extraction stage, resulting in a lack of direct data for subsequent batch process adjustments.
[0007] To address the aforementioned technical problems, this invention provides an optimized control method for the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback. This method uses compound medicinal materials containing volatile components, alcohol-soluble components, and water-soluble components as raw materials. The compound medicinal materials are purified and pulverized to obtain coarse powder of the compound medicinal materials.
[0008] The compound medicinal materials include honeysuckle, forsythia, dandelion, scutellaria, coptis, phellodendron, purslane, sophora flavescens, dictamnus dasycarpus, cnidium monnieri, kochia scoparia, clove, cinnamon, gallnut, fraxinus rhizome, smilax glabra, polygonum aviculare, atractylodes lancea, stemona japonica, viola yedoensis, and chrysanthemum indicum.
[0009] The above-mentioned compound medicinal materials, by weight, include: honeysuckle 8-12 parts, forsythia 8-12 parts, dandelion 8-12 parts, scutellaria baicalensis 6-10 parts, coptis chinensis 6-10 parts, phellodendron chinense 6-10 parts, purslane 8-12 parts, sophora flavescens 6-10 parts, dictamnus dasycarpus 6-10 parts, cnidium monnieri 5-8 parts, kochia scoparia 5-8 parts, clove 2-4 parts, cinnamon 2-4 parts, gallnut 5-8 parts, fraxinus rhizome 5-8 parts, smilax glabra 6-10 parts, polygonum aviculare 5-8 parts, atractylodes lancea 4-6 parts, stemona japonica 4-6 parts, viola yedoensis 6-10 parts, and chrysanthemum indicum 6-10 parts.
[0010] During the purification and pulverization process, cloves and cinnamon are pulverized separately and temporarily sealed for storage, while the remaining compound medicinal materials are pulverized into coarse powder for low-temperature pre-extraction. The clove powder and cinnamon powder are then mixed with the coarse powder of the remaining compound medicinal materials to obtain the coarse powder of the compound medicinal materials used for low-temperature pre-extraction.
[0011] The crude powder of the compound medicinal materials was subjected to low-temperature pre-extraction, ethanol reflux extraction, and water extraction in sequence. For low-temperature pre-extraction, 5–7 times the amount of pure water was added to the crude powder, and ultrasonic extraction was performed at 40–50℃ for 20–40 min. The mixture was filtered to obtain the low-temperature pre-extract and the first residue. For ethanol reflux extraction, 8–12 times the amount of ethanol (60%–75% by volume) was added to the first residue, and reflux extraction was performed at 65–70℃ for 1.0–2.0 h. After filtration, 6–10 times the amount of ethanol (60%–75% by volume) was added to the residue, and reflux extraction was performed at 65–70℃ for 0.8–1.2 h. The two filtrates were combined to obtain the ethanol extract and the second residue. For water extraction, 8–12 times the amount of pure water was added to the second residue, and the mixture was simmered at a gentle boil for 30–50 min. The mixture was then filtered to obtain the water extract.
[0012] In the same preparation batch, samples were taken from the low-temperature pre-extract, alcohol extract, and water extract to form low-temperature test samples, alcohol extract test samples, and water extract test samples, respectively. The remaining low-temperature pre-extract, alcohol extract, and water extract were combined according to the set volume ratio and concentrated under reduced pressure at 55-60℃ to a crude drug concentration of 1.0-1.5 g / mL. The mixture was then filtered through a 0.45 μm microporous membrane and allowed to stand to obtain the candidate extract.
[0013] Before testing the antibacterial rate of the low-temperature sample, alcohol-extracted sample, water-extracted sample, and candidate extract, the raw medicinal material mass corresponding to each milliliter of sample was used as the normalization benchmark. The low-temperature sample, alcohol-extracted sample, water-extracted sample, and candidate extract were adjusted to the same raw medicinal material concentration. The target bacterial spectrum consisted of Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes, with a target antibacterial rate of 95%.
[0014] At the same concentration of crude drug, the inhibition rates of the low-temperature sample, the alcohol-extracted sample, and the water-extracted sample against each target bacterium in the target bacterial spectrum were measured separately to obtain segmented inhibition rate data. The inhibition rates of the candidate extracts against each target bacterium in the target bacterial spectrum were measured to obtain combined inhibition rate data. The combined inhibition rate data was compared with the target inhibition rate, and the target bacteria with a combined inhibition rate lower than the target inhibition rate were identified as target bacteria to be corrected.
[0015] After identifying the target bacteria to be corrected, the test sample with the highest inhibition rate for the target bacteria to be corrected is selected from the segmented inhibition rate data. The extract corresponding to the test sample is used as the proportion correction object for the next batch of preparation. When the inhibition rate of the test sample for the target bacteria to be corrected reaches the target inhibition rate, the volume merging ratio of the proportion correction object is increased, and the volume merging ratio of the remaining extracts is adjusted accordingly to keep the sum of the volume merging ratios of the low-temperature pre-extract, alcohol extract, and water extract at 100%.
[0016] When the inhibition rate of the target bacteria in the test sample is lower than the target inhibition rate, the extraction conditions for the next batch of preparation are adjusted according to the type of target bacteria. If the target bacteria is Candida albicans or dermatophytes, the low-temperature pre-extraction conditions are adjusted by changing the low-temperature pre-extraction time to 30-40 min or the low-temperature pre-extraction temperature to 45-50 °C. If the target bacteria is Staphylococcus aureus or Escherichia coli, the ethanol reflux extraction conditions are adjusted by changing the ethanol volume fraction to 70%-75% or the first ethanol reflux extraction time to 1.5-2.0 h.
[0017] The next batch of preparation is carried out according to the corrected volume merging ratio or extraction conditions, and the sampling, normalization, antibacterial rate detection, determination of target bacteria to be corrected and batch correction process are repeated until the antibacterial rate of the candidate extract against each target bacteria in the target bacterial spectrum reaches the target antibacterial rate, thus obtaining the compound extract of traditional Chinese medicine for daily chemical use.
[0018] This invention also provides a compound antibacterial composition of traditional Chinese medicine for daily chemical use. The compound antibacterial composition of traditional Chinese medicine for daily chemical use includes a plant-derived compound extract and a topical acceptable matrix. The plant-derived compound extract is prepared using the above-mentioned optimized and controlled preparation method. The dosage form of the compound antibacterial composition of traditional Chinese medicine for daily chemical use is a wash, gel, spray, foot care solution or intimate cleansing solution, and it does not contain chlorhexidine, benzalkonium bromide, Pseudolarix amabilis bark and rhubarb.
[0019] Compared with the prior art, the present invention retains the low-temperature section test sample, the alcohol extraction section test sample, and the water extraction section test sample in the same preparation batch, and adjusts the above three test samples and candidate extracts to the same crude drug concentration before conducting antibacterial rate testing. This allows for obtaining antibacterial rate data of different extraction sections against each target bacterium in the target bacterial spectrum under the same evaluation basis.
[0020] This invention identifies the target bacteria to be corrected by merging antibacterial rate data, and then determines the target for proportional correction or extraction condition correction by segmenting antibacterial rate data. This ensures that the adjustment targets for the next batch of preparation are derived from the test data of the same batch. When the target bacteria to be corrected are Candida albicans or dermatophytes, the volume merging ratio of the low-temperature pre-extraction solution or the low-temperature pre-extraction conditions are corrected. When the target bacteria to be corrected are Staphylococcus aureus or Escherichia coli, the volume merging ratio of the ethanol extract or the ethanol reflux extraction conditions are corrected. This reduces the need to repeatedly adjust the overall process based solely on the antibacterial rate of the final extract.
[0021] The plant-derived compound extract obtained in this invention, when combined with a daily chemical external-use acceptable matrix, can be formulated into a wash, gel, spray, foot care solution, or intimate cleansing solution. The composition does not contain chlorhexidine, benzalkonium bromide, Pseudolarix amabilis bark, or rhubarb, and is suitable for daily chemical external care products for non-therapeutic purposes.
[0022] The beneficial effects of this invention are as follows: 1. This invention involves sequentially subjecting compound medicinal materials to low-temperature pre-extraction, ethanol reflux extraction, and water extraction. Within the same preparation batch, samples from the low-temperature extraction, ethanol extraction, and water extraction stages are retained for testing. This ensures that the low-temperature pre-extraction solution, ethanol extract, and water extract are not merely components of the final candidate extract, but also serve as data sources for batch process evaluation. Before testing, each sample and candidate extract is adjusted to the same raw material concentration using the corresponding raw material mass per milliliter of sample as a normalization benchmark. This avoids the problem of incomparable antibacterial rate results due to concentration differences. Through the above processing, antibacterial rate data against Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes can be obtained under the same evaluation conditions at different extraction stages. This allows the antibacterial insufficiency of the final candidate extract to be mapped to a specific extraction stage, providing a clear basis for adjusting the merging ratio or extraction conditions of subsequent batches.
[0023] 2. This invention identifies the target bacteria to be corrected by merging antibacterial rate data, and then determines the target for proportional correction or extraction condition correction by segmented antibacterial rate data. This forms a preparation control chain from candidate extract evaluation to segmented extract positioning and then to the correction of the next batch. For cases where the antibacterial rate of Candida albicans or dermatophytes is insufficient, correction is prioritized for corresponding low-temperature pre-extraction solution and low-temperature pre-extraction conditions. For cases where the antibacterial rate of Staphylococcus aureus or Escherichia coli is insufficient, correction is prioritized for corresponding alcohol extract and ethanol reflux extraction conditions. This method does not simply adjust the formula or extend the extraction time based on the antibacterial results of the final extract, but rather determines the target for adjustment in the next batch based on the differences in antibacterial rates of the segmented test samples in the same batch. This reduces the problem of unclear adjustment direction in repeated experiments and makes the preparation process of compound extracts more suitable for batch control and process reproducibility.
[0024] 3. This invention utilizes a compound extract of traditional Chinese medicine for daily chemical use, prepared from honeysuckle, forsythia, dandelion, scutellaria, coptis, phellodendron, purslane, sophora flavescens, dictamnus dasycarpus, cnidium monnieri, kochia scoparia, clove, cinnamon, gallnut, fraxinus rhizome, smilax glabra, polygonum aviculare, atractylodes lancea, stemona japonica, violet, and wild chrysanthemum in a predetermined ratio. The extract is obtained through a combination of low-temperature pre-extraction, ethanol reflux extraction, water extraction, and concentration, filtration, and settling. This extract can be combined with acceptable bases for daily chemical external use to form washes, gels, sprays, foot care solutions, or intimate cleansing solutions. The composition does not contain chlorhexidine, benzalkonium bromide, safflower bark, or rhubarb. Using the plant-derived compound extract as the source of antibacterial activity and the antibacterial rate of the target bacterial spectrum as the basis for preparation feedback, the preparation process of the composition corresponds to the antibacterial evaluation requirements in daily chemical external care scenarios, taking into account the plant-derived characteristics of the compound extract, dosage form suitability, and the verifiability of batch-to-batch antibacterial results. Attached Figure Description
[0025] Figure 1 This is a schematic diagram of the optimized control process for the preparation of traditional Chinese medicine compound extracts for daily chemical use based on antibacterial spectrum feedback, as described in this invention. Figure 2 This is a flowchart of the segmented extraction and sampling process of the present invention; Figure 3 This is a flowchart of the antibacterial detection and closed-loop optimization judgment process of the present invention. Detailed Implementation
[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0027] like Figures 1 to 3As shown, the specific implementation of the present invention will be described below with reference to the embodiments. All compound medicinal materials used in this embodiment are plant-derived medicinal materials that can be used in daily chemical external products. The names of the medicinal materials adopt common Chinese medicinal material names. In the same preparation batch, the low-temperature pre-extraction solution, alcohol extract, water extract, low-temperature test sample, alcohol extract test sample, water extract test sample, candidate extract, target bacterial spectrum, target inhibition rate, and volume merging ratio are all determined according to the following method, and test data are not mixed between different batches.
[0028] This embodiment provides an optimization and control method for the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback. The method uses the low-temperature pre-extract, alcohol extract, and water extract obtained from the same preparation batch as the data source for subsequent batch adjustments. Specifically, before preparing candidate extracts, samples are taken from the low-temperature pre-extract, alcohol extract, and water extract to form low-temperature segment test samples, alcohol extract segment test samples, and water extract segment test samples, respectively. Then, the remaining low-temperature pre-extract, alcohol extract, and water extract are combined to form candidate extracts. The target bacteria that need to be adjusted are determined by the candidate extracts, and the proportion of extract or extraction conditions that should be adjusted in the next batch are determined by the three test samples.
[0029] In this embodiment, the crude drug concentration refers to the mass of the original raw medicinal material per milliliter of sample. Before conducting the antibacterial rate test, the low-temperature test samples, alcohol extraction test samples, water extraction test samples, and candidate extracts are all adjusted to the same crude drug concentration. The unified crude drug concentration can be the crude drug concentration of the candidate extract or the test crude drug concentration set before the start of the batch. Only one unified crude drug concentration can be used in the same round of feedback evaluation. If the crude drug concentration of a certain test sample is higher than the unified crude drug concentration, sterile pure water is added for dilution. If the crude drug concentration of a certain test sample is lower than the unified crude drug concentration, it is concentrated to the unified crude drug concentration under reduced pressure at a temperature not exceeding 60 degrees Celsius.
[0030] In this embodiment, the target bacterial spectrum consists of Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes. The dermatophytes are the same standard strains of dermatophytes that were identified and recorded before the start of the test. During the same round of batch feedback, the dermatophyte strains are not changed, and the target inhibition rate is 95%, which is used to determine whether the inhibition rate of the candidate extract against each target bacterium meets the batch preparation requirements.
[0031] Example 1 This embodiment provides an optimized control method for the preparation of compound extracts of traditional Chinese medicine for daily chemical use.
[0032] Weigh out the compound medicinal materials, which include honeysuckle, forsythia, dandelion, scutellaria, coptis, phellodendron, purslane, sophora flavescens, dictamnus dasycarpus, cnidium monnieri, kochia scoparia, clove, cinnamon, gallnut, fraxinus bark, smilax glabra, polygonum aviculare, atractylodes lancea, stemona japonica, viola yedoensis, and chrysanthemum indicum.
[0033] In a specific formulation, the compound medicinal materials, by weight, include: 8 to 12 parts honeysuckle, 8 to 12 parts forsythia, 8 to 12 parts dandelion, 6 to 10 parts scutellaria, 6 to 10 parts coptis, 6 to 10 parts phellodendron, 8 to 12 parts purslane, 6 to 10 parts sophora flavescens, 6 to 10 parts dictamnus dasycarpus, 5 to 8 parts cnidium monnieri, 5 to 8 parts kochia scoparia, 2 to 4 parts clove, 2 to 4 parts cinnamon, 5 to 8 parts gallnut, 5 to 8 parts fraxinus bark, 6 to 10 parts smilax glabra, 5 to 8 parts polygonum aviculare, 4 to 6 parts atractylodes lancea, 4 to 6 parts stemona japonica, 6 to 10 parts viola yedoensis, and 6 to 10 parts chrysanthemum indicum.
[0034] During the purification and pulverization process, cloves and cinnamon are pulverized separately and temporarily sealed for storage. The remaining compound medicinal materials are pulverized into coarse powder and subjected to low-temperature pre-extraction. The clove powder and cinnamon powder are mixed with the coarse powder of the remaining compound medicinal materials to obtain the coarse powder of the compound medicinal materials. Cloves and cinnamon enter the low-temperature pre-extraction step and are not added separately to the alcohol extract or water extract thereafter.
[0035] The crude powder of compound medicinal materials is subjected to low-temperature pre-extraction. Five to seven times the amount of pure water is added to the crude powder of compound medicinal materials, and ultrasonic extraction is performed at 40 to 50 degrees Celsius for 20 to 40 minutes. The mixture is filtered to obtain low-temperature pre-extract and the first residue. The multiples here are calculated according to the mass of compound medicinal materials added. For example, one kilogram of compound medicinal materials corresponds to five to seven liters of pure water. After filtration, a sample that meets the requirements for antibacterial rate testing is taken from the low-temperature pre-extract as the low-temperature test sample.
[0036] The first residue was subjected to ethanol reflux extraction. Eight to twelve times the volume of ethanol (60% to 75% by volume) was added to the first residue, and the mixture was refluxed at 65 to 70 degrees Celsius for 1.0 to 2.0 hours. The residue was then filtered to obtain the first ethanol extract filtrate. Six to ten times the volume of ethanol (60% to 75% by volume) was added to the filtered residue, and the mixture was refluxed at 65 to 70 degrees Celsius for 0.8 to 1.2 hours. The residue was then filtered to obtain the second ethanol extract filtrate. The first and second ethanol extract filtrates were combined to obtain the alcohol extract. The residue after ethanol reflux extraction was used as the second residue. A sample meeting the requirements for antibacterial rate testing was taken from the alcohol extract and used as the test sample for the alcohol extract.
[0037] The second residue was subjected to water extraction. Eight to twelve times the amount of pure water was added to the second residue, and the mixture was boiled for thirty to fifty minutes. The water extract was then filtered to obtain the water extract. A sample that met the requirements for antibacterial rate testing was taken from the water extract and used as the water extraction test sample.
[0038] In the same preparation batch, the low-temperature section test sample, the alcohol extraction section test sample, and the water extraction section test sample were obtained from the low-temperature pre-extract, alcohol extract, and water extract actually obtained in that batch, respectively. After sampling, the remaining low-temperature pre-extract, alcohol extract, and water extract were mixed according to the set volume merging ratio to obtain the combined extract.
[0039] In the first batch of preparation, the volume ratio of the low-temperature pre-extract, alcohol extract, and water extract can be set to 1:1; in subsequent batches, the volume ratio is adjusted according to the feedback rules of this embodiment, and the sum of the volume ratios of the low-temperature pre-extract, alcohol extract, and water extract remains 100% in any batch.
[0040] The combined extracts were concentrated under reduced pressure at 55 to 60 degrees Celsius until the concentration of crude drug was 1.0 to 1.5 grams per milliliter. The concentrate was then filtered through a 0.45-micron microporous membrane. The filtered combined extracts were placed in a sealed container and allowed to stand for 24 hours. The supernatant or homogeneous liquid was taken as the candidate extract. If obvious precipitation occurred after standing, the supernatant was taken as the candidate extract, and the precipitation was recorded for subsequent formulation compatibility evaluation.
[0041] Before testing the antibacterial rate of the low-temperature sample, alcohol-extracted sample, water-extracted sample, and candidate extract, the concentration of the crude drug in the four types of samples was calculated and adjusted to the same concentration. In the same batch of preparation, the four types of samples were subjected to the same bacterial concentration, the same contact time, the same culture conditions, and the same counting method for the same target bacteria.
[0042] When testing the antibacterial rate, a blank control group and a sample group were set up. The blank control group did not contain the test sample, while the sample group contained the low-temperature test sample, the alcohol extract test sample, the water extract test sample, or the candidate extract. The antibacterial rate was calculated as follows: the antibacterial rate was equal to the number of viable bacteria in the blank control group minus the number of viable bacteria in the sample group, then divided by the number of viable bacteria in the blank control group, and multiplied by 100%. The antibacterial rate of each target bacterium was obtained from the low-temperature test sample, the alcohol extract test sample, the water extract test sample, and the candidate extract.
[0043] Based on the inhibition rates of the low-temperature, alcohol-extracted, and water-extracted samples against Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes, segmented inhibition rate data are generated. The segmented inhibition rate data includes the sample name, target bacterium name, uniform drug concentration, and corresponding inhibition rate. Based on the inhibition rates of the candidate extracts against the above target bacteria, combined inhibition rate data is generated. The combined inhibition rate data includes the candidate extract name, target bacterium name, uniform drug concentration, and corresponding inhibition rate.
[0044] The combined antibacterial rate data is compared with the target antibacterial rate. If the antibacterial rate of the candidate extract against a certain target bacterium is less than 95%, the target bacterium is identified as the target bacterium to be corrected. If the antibacterial rate of the candidate extract against two or more target bacteria is less than 95%, each target bacterium to be corrected is identified separately and further judgment is made separately.
[0045] After identifying the target bacterium to be corrected, the sample with the highest inhibition rate against the target bacterium is selected from the segmented inhibition rate data. If the inhibition rate of the sample in the low-temperature segment is the highest, the low-temperature pre-extract is identified as the proportional correction target for the target bacterium in the next preparation batch. If the inhibition rate of the sample in the alcohol extraction segment is the highest, the alcohol extract is identified as the proportional correction target. If the inhibition rate of the sample in the water extraction segment is the highest, the water extract is identified as the proportional correction target. If two or more samples have the same and the highest inhibition rate against the same target bacterium, the extracts corresponding to the two or more samples are identified as proportional correction targets.
[0046] If the inhibition rate of the test sample corresponding to the proportional correction object reaches 95% for the target bacteria to be corrected, while the inhibition rate of the candidate extract for the target bacteria to be corrected is less than 95%, the volume merging ratio of the proportional correction object will be increased in the next preparation batch, and the volume merging ratio of the non-proportional correction object will be decreased accordingly. After adjustment, the sum of the volume merging ratios of the low-temperature pre-extract, alcohol extract, and water extract will still be 100%.
[0047] When the inhibition rate of the target bacteria in the test sample corresponding to the proportional correction object is less than 95%, the extraction conditions of the next batch of preparation are adjusted according to the type of target bacteria. When the target bacteria is Candida albicans or dermatophytes, the low-temperature pre-extraction conditions are adjusted, specifically by adjusting the low-temperature pre-extraction time to 30 to 40 minutes, or adjusting the low-temperature pre-extraction temperature to 45 to 50 degrees Celsius. When the target bacteria is Staphylococcus aureus or Escherichia coli, the ethanol reflux extraction conditions are adjusted, specifically by adjusting the ethanol volume fraction to 70% to 75%, or adjusting the first ethanol reflux extraction time to 1.5 to 2.0 hours. All the above adjustments are made within the parameter range disclosed in this embodiment and do not change the order of low-temperature pre-extraction, ethanol reflux extraction and water extraction.
[0048] The next preparation batch is carried out according to the corrected volume merging ratio or extraction conditions. The next preparation batch still takes samples from the low temperature section, the alcohol extraction section, and the water extraction section, and repeats the normalization of crude drug concentration, antibacterial rate detection, determination of target bacteria to be corrected, and batch correction. When the antibacterial rate of the candidate extract against Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes all reach 95%, the compound extract of traditional Chinese medicine for daily chemical use is obtained.
[0049] In this embodiment, the low-temperature pre-extraction solution, alcohol extract, and water extract are not only the source of the candidate extracts but also the source of data for the adjustment of the next batch. The combined antimicrobial rate data of the candidate extracts are used to determine the target bacteria to be corrected, and the segmented antimicrobial rate data of the three test samples are used to determine the proportional correction object. When the antimicrobial rate of the proportional correction object is lower than the target antimicrobial rate, the corresponding extraction conditions are then corrected according to the category of the target bacteria to be corrected. This process ensures that each batch correction has corresponding test data as a basis.
[0050] Example 2 This embodiment provides a compound antibacterial composition of traditional Chinese medicine for daily chemical use. The composition includes a plant-derived compound extract and a topical acceptable matrix for daily chemical use. The plant-derived compound extract is the compound extract of traditional Chinese medicine for daily chemical use obtained in Example 1.
[0051] The acceptable matrix for topical use in daily chemical products is an aqueous matrix, a gel matrix, or a water-based matrix for spraying. The aqueous matrix is used to prepare washes, foot care solutions, or feminine hygiene solutions; the gel matrix is used to prepare gels; and the water-based matrix for spraying is used to prepare sprays. Plant-derived compound extracts are added to the acceptable matrix for topical use in daily chemical products and stirred until evenly dispersed to obtain a compound antibacterial composition of traditional Chinese medicine for daily chemical use. This composition does not contain chlorhexidine, benzalkonium bromide, Pseudolarix amabilis bark, or rhubarb.
[0052] In this embodiment, the dosage form of the daily chemical herbal compound antibacterial composition is a wash, gel, spray, foot care solution, or intimate cleansing solution. When preparing the wash, foot care solution, or intimate cleansing solution, the plant-derived compound extract is added to the aqueous external matrix and stirred evenly to obtain the corresponding liquid dosage form. When preparing the gel, the plant-derived compound extract is added to the gel matrix and stirred evenly to obtain the gel dosage form. When preparing the spray, the plant-derived compound extract is added to the aqueous spray matrix, mixed, and filtered to obtain the spray dosage form.
[0053] The plant-derived compound extract in this embodiment is derived from the preparation optimization and control method of Example 1. Its preparation process includes segmented sampling of the same batch, detection of the same crude drug concentration, and feedback correction for the next preparation batch. After being combined with an acceptable matrix for daily chemical external use, the plant-derived compound extract is used in daily chemical external care products for non-therapeutic purposes.
[0054] In the above specific embodiments, the technical terms are consistent throughout: low-temperature pre-extraction yields a low-temperature pre-extract and a first residue; ethanol reflux extraction yields an ethanol extract and a second residue; water extraction yields an aqueous extract; the low-temperature pre-extract, ethanol extract, and aqueous extract correspond to the low-temperature test sample, ethanol extract test sample, and aqueous extract test sample, respectively; candidate extracts form combined antimicrobial rate data; the combined antimicrobial rate data determines the target bacteria to be corrected; the segmented antimicrobial rate data determines the proportional correction object; the category of the target bacteria to be corrected determines the extraction condition correction object. The input, output, and subsequent reference relationships of the above steps are continuous and clear, and those skilled in the art can complete the preparation, detection, and batch correction according to this specific embodiment.
[0055] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.
[0056] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.
Claims
1. A method for optimizing and controlling the preparation of traditional Chinese medicine compound extracts for daily chemical use based on antibacterial spectrum feedback, characterized in that, Includes the following steps: S1. The pre-prepared compound medicinal materials containing volatile components, alcohol-soluble components and water-soluble components are purified and pulverized to obtain compound medicinal material coarse powder. S2. The crude powder of the compound medicinal materials is subjected to low-temperature pre-extraction, ethanol reflux extraction and water extraction in sequence to obtain low-temperature pre-extraction solution, ethanol extract and water extract respectively; S3. Take samples from the same batch of low-temperature pre-extract, alcohol extract and water extract to form low-temperature test sample, alcohol extract test sample and water extract test sample. Combine the remaining three extracts according to volume ratio, and obtain candidate extracts by concentration, filtration and standing. S4. Using the mass of raw medicinal material corresponding to each milliliter of sample as the normalization benchmark, adjust the low-temperature test sample, alcohol extraction test sample, water extraction test sample and candidate extract to the same raw medicinal material concentration, and detect the inhibition rate of each target bacterium in the target bacterial spectrum respectively. S5. Segmented antibacterial rate data are formed from the antibacterial rates of the three types of test samples, and combined antibacterial rate data are formed from the antibacterial rates of candidate extracts. Target bacteria with combined antibacterial rates lower than the target antibacterial rate are identified as weak plate bacteria. S6. Identify the sample with the highest antibacterial rate against Plasminogen valerate from the segmented antibacterial rate data, and determine the extract corresponding to this sample as the target for proportion correction in the next batch. When the antibacterial rate of this sample against Plasminogen valerate reaches the target antibacterial rate, increase the volume merging ratio of the target for proportion correction, and keep the sum of the volume merging ratios of the three extracts at 100%. When the antibacterial rate of this sample against Plasminogen valerate is lower than the target antibacterial rate, adjust the extraction conditions corresponding to the next batch according to the Plasminogen valerate category until the antibacterial rate of the candidate extract against each target bacterium reaches the target antibacterial rate, thus obtaining the compound extract of traditional Chinese medicine for daily chemical use.
2. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 1, characterized in that: The pre-set compound medicinal materials include honeysuckle, forsythia, dandelion, scutellaria, coptis, phellodendron, purslane, sophora flavescens, dictamnus dasycarpus, cnidium monnieri, kochia scoparia, clove, cinnamon, gallnut, fraxinus rhizome, smilax glabra, polygonum aviculare, atractylodes lancea, stemona japonica, viola yedoensis, and chrysanthemum indicum.
3. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 2, characterized in that: The pre-prepared compound medicinal materials, by weight, include: 8-12 parts honeysuckle, 8-12 parts forsythia, 8-12 parts dandelion, 6-10 parts scutellaria, 6-10 parts coptis, 6-10 parts phellodendron, 8-12 parts purslane, 6-10 parts sophora flavescens, 6-10 parts dictamnus dasycarpus, 5-8 parts cnidium monnieri, 5-8 parts kochia scoparia, 2-4 parts clove, 2-4 parts cinnamon, 5-8 parts gallnut, 5-8 parts fraxinus bark, 6-10 parts smilax glabra, 5-8 parts polygonum aviculare, 4-6 parts atractylodes lancea, 4-6 parts stemona japonica, 6-10 parts violet, and 6-10 parts wild chrysanthemum.
4. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 3, characterized in that: The target bacterial spectrum consists of Staphylococcus aureus, Escherichia coli, Candida albicans, and dermatophytes, and the target antibacterial rate is 95%.
5. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 4, characterized in that: During the purification and pulverization process, cloves and cinnamon are pulverized separately and temporarily sealed for storage, while the remaining pre-prepared compound medicinal materials are pulverized into coarse powder. Before the low-temperature pretreatment, mix clove powder, cinnamon powder and the coarse powder of the remaining medicinal materials.
6. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 5, characterized in that: The low-temperature pre-extraction includes: adding 5 to 7 times the amount of pure water to the crude powder of the compound medicinal materials, ultrasonically extracting at 40 to 50°C for 20 to 40 minutes, and filtering to obtain the low-temperature pre-extract and the first residue.
7. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 6, characterized in that: The ethanol reflux extraction includes: adding 8-12 times the amount of ethanol with a volume fraction of 60%-75% to the first residue, refluxing at 65-70°C for 1.0-2.0 h, filtering, adding 6-10 times the amount of ethanol with a volume fraction of 60%-75% to the residue again, refluxing at 65-70°C for 0.8-1.2 h, and combining the two filtrates to obtain the ethanol extract.
8. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 7, characterized in that: The water extraction includes: adding 8 to 12 times the amount of pure water to the residue after ethanol reflux extraction, simmering for 30 to 50 minutes, and filtering to obtain the water extract; the concentration is carried out under reduced pressure at 55 to 60°C to a crude drug concentration of 1.0 to 1.5 g / mL; and the filtration is carried out through a 0.45 μm microporous membrane.
9. The method for optimizing and controlling the preparation of compound extracts of traditional Chinese medicine for daily chemical use based on antibacterial spectrum feedback as described in claim 8, characterized in that: When the short-chain bacteria are Candida albicans or dermatophytes, the corresponding extraction conditions are low-temperature pre-extraction conditions. The low-temperature pre-extraction conditions are modified by adjusting the low-temperature pre-extraction time to 30-40 min, or adjusting the low-temperature pre-extraction temperature to 45-50 °C. When the short-chain bacteria are Staphylococcus aureus or Escherichia coli, the corresponding extraction conditions are ethanol reflux extraction conditions. The ethanol reflux extraction conditions are modified by adjusting the ethanol volume fraction to 70%-75%, or adjusting the first ethanol reflux extraction time to 1.5-2.0 h.
10. A compound antibacterial composition of traditional Chinese medicine for daily chemical use, characterized in that... The product comprises a plant-derived compound extract and a daily chemical topical acceptable matrix, wherein the plant-derived compound extract is prepared by the preparation optimization and control method according to any one of claims 1 to 9; the dosage form of the daily chemical traditional Chinese medicine compound antibacterial composition is a wash, gel, spray, foot care solution or intimate cleansing solution, and the daily chemical traditional Chinese medicine compound antibacterial composition does not contain chlorhexidine, benzalkonium bromide, Pseudolarix amabilis bark and rhubarb.