Traditional Chinese medicine temporary decoction jelly and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and particularly discloses traditional Chinese medicine temporary prescription decoction jelly and a preparation method of the traditional Chinese medicine temporary prescription decoction jelly. 0.8 to 1.2 parts by weight of konjaku flour, 0.8 to 1.2 parts by weight of carrageenan and 0.05 to 0.2 part by weight of potassium chloride. The traditional Chinese medicine temporary decoction jelly does not need preservatives, the dosage of auxiliary materials is small, the jelly can be flexibly adjusted according to clinical prescriptions, the problems that traditional decoction is inconvenient to take and poor in taste are solved on the premise that the curative effects of traditional Chinese medicines are reserved, and the medication compliance of patients is remarkably improved. The mixing temperature of the auxiliary materials and the temporary decoction concentrated solution is limited to be lower than 50 DEG C, so that the clustering phenomenon of the auxiliary materials is avoided; as a temporary preparation, the traditional Chinese medicine composition can be designed according to short-term treatment requirements of patients, can be rapidly produced by utilizing existing decoction equipment in hospitals, does not need to be additionally arranged, and is adaptive to clinical instant medication requirements.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically, it relates to a method for preparing a traditional Chinese medicine decoction jelly. Background Technology

[0002] Traditional Chinese medicine decoctions are an important dosage form in clinical treatment of traditional Chinese medicine. They have the advantages of concentrated efficacy and convenient long-term use. However, their viscous texture and bitter taste lead to low medication compliance among children, the elderly and patients with chronic diseases.

[0003] In recent years, although some studies have attempted to combine traditional Chinese medicine (TCM) with jelly-like forms, these studies are all geared towards health foods, focusing on nutritional supplementation or flavor improvement. Their formulas generally contain food additives such as preservatives, flavoring agents, and acidulants, and achieve health benefits through fixed formulations. These additives may affect the stability of the effective components of TCM, and the fixed formulas cannot be flexibly adjusted according to clinical prescriptions. For example, Chinese patent CN111772140A discloses nine types of TCM jellies suitable for different TCM constitutions, with the following formulas: 0.8% konjac powder, 0.2% carrageenan, 0.16% potassium chloride, 0.25% citric acid, 0.15% sodium citrate, 3% maltitol, 0.25% vitamin C, and 40% TCM extract (herbal medicine: water ratio 1:20) suitable for nine different constitutions. This formula contains multiple additives, increasing the complexity of the process and potentially introducing safety risks. The content of the herbal extract (herbal ingredients: water ratio 1:20) is only 40%, making it suitable only as a health food product and not for direct clinical use as a traditional Chinese medicine preparation. Furthermore, existing technologies generally lack clear control over temperature parameters during the molding process, leading to uneven dissolution of excipients, poor product transparency, and issues affecting product quality.

[0004] In view of this, the present invention is proposed. Summary of the Invention

[0005] This invention aims to address the problems of inconvenience and poor taste associated with traditional Chinese medicine decoctions, while preserving the efficacy of the herbs. By optimizing the excipient formulation and molding process, it provides a preservative-free, low-excipient-dosage, and customizable traditional Chinese medicine decoction jelly. This invention avoids clumping by limiting the mixing temperature of the excipients and the concentrated decoction solution to below 50°C. Furthermore, it utilizes an integrated decoction preparation and packaging machine to achieve high-temperature sterilization and aseptic sealing, ensuring product safety. In addition, the jelly-like form of this invention effectively improves the taste and portability of traditional decoctions, significantly enhancing patient medication adherence.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0007] The first objective of this invention is to provide a traditional Chinese medicine decoction jelly, the jelly comprising: 200-800 parts by weight of concentrated decoction of Linfang, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride.

[0008] The traditional Chinese medicine decoction jelly provided by this invention is more preferably composed of: 200-800 parts by weight of concentrated decoction of Linfang, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

[0009] The traditional Chinese medicine decoction jelly provided by this invention contains only a concentrated decoction of traditional Chinese medicine and three basic excipients: konjac powder, carrageenan, and potassium chloride. It contains no preservatives, flavoring agents, or any other food additives, thus avoiding the impact of additives on the stability of the effective components of traditional Chinese medicine and potential safety risks. This allows it to be used as a traditional Chinese medicine preparation for clinical treatment, rather than just as a health food. The concentrated decoction of traditional Chinese medicine can be flexibly adjusted according to clinical prescriptions, such as becoming a motherwort paste, astragalus paste, or compound paste, breaking through the limitations of fixed formulations in existing technologies and meeting the personalized treatment needs of patients. The combination of "konjac powder + carrageenan + potassium chloride" determined through experimental screening is the optimal excipient combination. The combination of konjac powder and carrageenan complements each other's deficiencies, forming a uniform and elastic gel network. Potassium chloride accelerates colloid formation and reduces water separation, solving the problem of single excipients failing to form or producing poor forming results, ensuring stable jelly shape and suitable taste. 200-800 parts by weight of the concentrated Linfang decoction requires only a small amount of excipients to form a jelly shape with superior sensory evaluation, significantly reducing excipient costs. The concentrated Linfang decoction is directly derived from clinical prescription decoctions, ensuring that the efficacy of traditional Chinese medicine is not affected, while the jelly shape improves the problems of traditional decoctions being viscous and bitter, enhancing medication compliance for children, the elderly, and patients with chronic diseases.

[0010] In the above technical solution, according to the "General Requirements for Decoction Centers" (GB / T42282-2022), the refractive index concentration of the concentrated decoction should not be less than 4.5%.

[0011] In the above technical solution, when the concentrated liquid of the decoction is motherwort extract, the jelly contains: 200-800 parts by weight of motherwort extract, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride.

[0012] Optional, the jelly contains: 800 parts by weight of motherwort extract, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

[0013] In the above technical solution, when the concentrated extract of the decoction is Astragalus extract, the jelly contains: 200-800 parts by weight of Astragalus extract, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride.

[0014] Optional, the jelly contains: 400 parts by weight of astragalus extract, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

[0015] In the above technical solution, when the concentrated liquid of the decoction is a compound paste, the jelly contains: 200-800 parts by weight of compound paste, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride.

[0016] Optional, the jelly contains: 800 parts by weight of compound paste, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

[0017] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine decoction jelly, comprising the following steps:

[0018] (1) Mix konjac powder, carrageenan, potassium chloride excipients and concentrated liquid of Linfang decoction evenly to obtain the first mixture;

[0019] (2) Heat the first mixture to boiling, stop heating, and immediately aseptically seal it to form a jelly-like shape, thus obtaining the Chinese medicine decoction jelly.

[0020] In the prior art (CN111772140A), the excipients need to be stirred into a paste with cooled boiled water first, then boiling water is added and stirred into a gel, and then mixed with the decoction. This process not only requires the addition of an extra solvent (water) and increases the time required for the steps, but the water introduced during pre-dissolution will dilute the concentration of the decoction and affect the uniformity of subsequent gel formation. At the same time, directly using boiling water to gelatinize the excipients at high temperature may destroy the molecular structure of the excipients. This effect will be particularly significant when the amount of excipients used is small.

[0021] The excipients of this invention do not require pre-dissolution with water and can be directly mixed evenly with the concentrated decoction. The molecular-level dispersion of the excipients is achieved using the temperature of the decoction itself and / or stirring, avoiding the risk of excipient clumping associated with traditional processes. This improvement not only simplifies the preparation process but also avoids the risk of microbial contamination introduced by additional solvents, while preserving the original concentration of the decoction concentrate. The decoction and excipients undergo simultaneous subsequent heating to boiling sterilization, allowing the excipients and the herbal components to form a more stable interpenetrating network. The resulting jelly has a more uniform texture and further enhances the protective effect of the excipients on the effective components of the herbal medicine.

[0022] In the above technical solution, when mixing the excipients and the concentrated liquid of the prescription decoction in step (1), the temperature shall not exceed 50°C.

[0023] Optionally, the mixing temperature of the excipients and the concentrated decoction is 40℃-50℃, excluding 50℃. After the excipients are encapsulated, maintain the temperature at 40-50℃ and stir to disintegrate. Then, heat the first mixture to boiling to make jelly.

[0024] The temperature is high after the decoction is concentrated. If the excipients are added directly, the konjac powder and carrageenan will quickly absorb water and clump together due to local high temperature. Cooling the concentrated decoction to a suitable temperature can ensure that the excipients are evenly dispersed.

[0025] In the concentrated liquid of Linfang decoction, konjac powder and carrageenan need to undergo the process of "water absorption and swelling, molecular dispersion". The surface of the excipient particles quickly absorbs water and swells, the hydrogen bonding between molecular chains is enhanced, and adjacent molecular chains entangle with each other to form a gel network.

[0026] Excessive mixing temperature can cause violent molecular chain movement. Colloidal particles that should be uniformly dispersed will increase the probability of collision due to Brownian motion, leading to aggregation and the formation of large clumps. In this invention, the excipients and the concentrated extract are first mixed uniformly at a lower temperature (<50°C). The excipient molecules absorb water at a slower rate and gradually disperse to form a uniform sol. Then, subsequent heating further strengthens the gel network, which can avoid the problem of excipient aggregation and the formation of hard lumps.

[0027] In the above technical solution, when mixing the excipients and the concentrated liquid of the Linfang decoction in step (1), the mixture is stirred at a speed of 0-200 r / min.

[0028] The stirring speed is optional, ranging from 40 to 120 r / min.

[0029] Alternatively, when making Astragalus decoction jelly, the stirring speed is 40-60 r / min, under which the jelly has fewer air bubbles; when preparing Leonurus japonicus or compound decoction jelly, the stirring speed is 80-120 r / min, under which the air bubbles are fewer and the excipients dissolve faster.

[0030] When mixing the excipients and the concentrated extract of the prescription, the mixture should be stirred to ensure uniformity. The stirring time and speed can be adjusted appropriately according to the temperature of the mixture to prevent local overheating, scorching, or boiling over. It is important to note that if the stirring speed is too low, the uniformity of mixing will be reduced, leading to localized agglomeration; if the stirring speed is too high, air bubbles can be introduced, damaging the density of the gel network and affecting the transparency and elasticity of the jelly. The stirring speed range provided by this invention ensures uniform dispersion of the excipients while avoiding equipment wear and increased energy consumption caused by high-speed stirring, making it particularly suitable for small-batch production of prescription preparations for hospitals.

[0031] In the above technical solution, in step (2), the first mixture is kept boiling for >5 min;

[0032] Optionally, the first mixture is kept boiling for 5-10 minutes;

[0033] Optionally, the boiling temperature of the first mixture is ≥95℃;

[0034] This invention achieves high-temperature sterilization by directly heating the first mixture to boiling, which further strengthens the gel network. The boiling time is controlled within a suitable range to ensure sterilization effectiveness while avoiding prolonged high temperatures that could degrade the effective components of the traditional Chinese medicine (such as volatile oils and heat-sensitive alkaloids). Furthermore, excessive boiling time can easily lead to excessive evaporation of the concentrated extract, increasing its refractive concentration and affecting subsequent gel formation.

[0035] This invention, as a prescription preparation, is designed for patients' short-term treatment needs. When preparing traditional Chinese medicine prescription decoction jelly, it can be produced directly using existing paste preparation equipment (such as an integrated paste preparation and packaging machine) without the need for additional equipment. It is adapted to the clinical need for immediate medication and significantly improves the production efficiency and clinical suitability of prescription preparations.

[0036] Optionally, the first mixture may be stirred during heating at a speed of 0-200 r / min.

[0037] Optionally, the stirring speed is 40-120 r / min, to mix the excipients and concentrate evenly and to minimize the generation of bubbles.

[0038] In the above technical solution, in step (1), after the konjac powder, carrageenan and potassium chloride are mixed evenly, they are quantitatively packaged using pharmaceutical capsules or pharmaceutical packaging bags, and then mixed evenly with the concentrated liquid of the Linfang decoction to obtain the first mixture.

[0039] Optionally, each portion may be pre-packaged in quantities not exceeding 20% ​​of the total amount of konjac powder, carrageenan, and potassium chloride additives to be added.

[0040] Optionally, each portion may be dispensed in quantities not exceeding 0.5g.

[0041] The excipients, including konjac powder, carrageenan, and potassium chloride, are quantitatively packaged in pharmaceutical capsules or repackaged bags at a rate not exceeding 20% ​​of the total amount. This allows for gradual addition of small amounts when mixing with the concentrated decoction, avoiding the problem of excessively high local concentrations caused by adding too much excipient at once. Combined with appropriate stirring and temperature conditions, this ensures more thorough dispersion of the excipients in the concentrated decoction, reducing the risk of clumping and ensuring uniform mixing. Simultaneously, this quantitative packaging method facilitates rapid adjustment of the excipient dosage based on the total amount of decoction in clinical practice, reducing on-site weighing errors and operational time. It meets the needs of small-batch, just-in-time production of hospital-prepared formulations, and the controllable dosage per portion further ensures uniform reaction between the excipients and the herbal components during subsequent heating and boiling, ultimately improving the stability and consistency of the jelly texture, meeting the dual requirements of convenience and quality for hospital-prepared formulations. Using pharmaceutical capsules or repackaged bags also isolates the excipients from air and moisture, preventing them from becoming damp and clumping, ensuring dispersion when added to the decoction, and complying with pharmaceutical packaging hygiene standards.

[0042] By adopting the above technical solution, the present invention has the following beneficial effects compared with the prior art.

[0043] The traditional Chinese medicine decoction jelly excipient provided by this invention contains only three basic ingredients (konjac powder, carrageenan, and potassium chloride), without adding preservatives or flavoring agents. While preserving the efficacy of traditional Chinese medicine, it effectively improves the taste and portability of traditional decoction preparations and significantly enhances patient medication compliance.

[0044] Traditional decoctions are viscous and bitter, leading to low medication adherence among children, the elderly, and patients with chronic diseases. This invention transforms traditional Chinese medicine into a jelly-like form, significantly improving the taste and making it convenient and easy to carry, thus effectively enhancing medication adherence among these special populations.

[0045] This invention avoids the problem of excipient clumping by controlling the mixing temperature of the excipients and the concentrated decoction of the traditional Chinese medicine to <50℃, thereby ensuring uniform dispersion of the excipients and the traditional Chinese medicine ingredients and improving the uniformity of the product composition.

[0046] This invention allows for flexible adjustment of the type of decoction paste (such as motherwort paste, astragalus paste, compound paste, etc.) based on clinical prescriptions, meeting the needs of personalized treatment in traditional Chinese medicine and adapting to short-term treatment plans for different patients.

[0047] This invention can be produced directly using existing hospital decoction equipment (such as an integrated decoction preparation and packaging machine) without the need for additional equipment investment. It can also quickly respond to the immediate clinical medication needs, significantly improving the production efficiency and clinical suitability of clinical preparations.

[0048] The specific embodiments of the present invention will now be described in further detail with reference to the accompanying drawings. Attached Figure Description

[0049] The accompanying drawings, as part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments and descriptions of the invention are used to explain the invention, but do not constitute an undue limitation of the invention. Obviously, the drawings described below are merely some embodiments, and those skilled in the art can obtain other drawings based on these drawings without creative effort. In the drawings:

[0050] Figure 1 This is a diagram showing the forming state of the motherwort extract jelly (200:1:1:0.1) from Example 1;

[0051] Figure 2 This is a diagram showing the forming state of the motherwort extract jelly (400:1:1:0.1) from Example 2;

[0052] Figure 3 This is a diagram showing the forming state of the motherwort extract jelly (800:1:1:0.1) in Example 3;

[0053] Figure 4 This is a diagram showing the forming state of Astragalus extract jelly (200:1:1:0.1) in Example 4;

[0054] Figure 5 This is a diagram showing the forming state of Astragalus extract jelly (400:1:1:0.1) in Example 5;

[0055] Figure 6 This is a diagram showing the forming state of Astragalus extract jelly (800:1:1:0.1) in Example 6;

[0056] Figure 7 This is a diagram showing the molding state of the compound paste jelly (200:1:1:0.1) in Example 7;

[0057] Figure 8 This is a diagram showing the molding state of the compound paste jelly (400:1:1:0.1) in Example 8;

[0058] Figure 9 This is a diagram showing the molding state of the compound paste jelly (800:1:1:0.1) in Example 9;

[0059] Figure 10 This is a diagram showing the solidified state of the concentrate + agar (100:2) from Experiment Example 1;

[0060] Figure 11 This is a diagram showing the formed state of the concentrated solution + konjac powder (100:2) from Experiment Example 2;

[0061] Figure 12 This is a diagram showing the molding state of the concentrated solution of Experiment Example 3 + carrageenan (100:2);

[0062] Figure 13This is a diagram showing the formed state of the concentrate + agar + konjac powder (100:1:1) in Experiment Example 4;

[0063] Figure 14 This is a diagram showing the molding state of the concentrate + konjac powder + carrageenan (100:1:1) from Experiment Example 5;

[0064] Figure 15 This is a diagram showing the formed state of the concentrate + agar + carrageenan (100:1:1) in Experiment Example 6;

[0065] Figure 16 This is a diagram showing the final state of the concentrate + agar + KCl (100:2:0.1) from Experiment Example 7;

[0066] Figure 17 This is a diagram showing the formed state of the concentrated solution of Experiment Example 8 + konjac powder + KCl (100:2:0.1);

[0067] Figure 18 This is a diagram showing the molding state of the concentrate of Experiment Example 9 + carrageenan + KCl (100:2:0.1);

[0068] Figure 19 This is a diagram showing the formed state of the concentrate + agar + konjac powder + KCl (100:1:1:0.1) in Experiment Example 10;

[0069] Figure 20 This is a diagram showing the formed state of the concentrate of Experiment 11 + konjac flour + carrageenan + KCl (100:1:1:0.1);

[0070] Figure 21 This is a diagram showing the state of the concentrate + agar + carrageenan + KCl (100:1:1:0.1) from Experiment Example 12.

[0071] Figure 22 This is a diagram showing the forming state of the compound paste jelly (1000:12:8:0.5) in Experiment Example 13;

[0072] Figure 23 This is a diagram showing the forming state of the compound paste jelly (1000:12:8:1) in Experiment Example 14;

[0073] Figure 24 This is a diagram showing the forming state of the compound paste jelly (1000:12:8:2) in Experiment Example 15;

[0074] Figure 25 This is a diagram showing the forming state of the compound paste jelly (1000:10:10:0.5) in Experiment Example 16;

[0075] Figure 26 This is a diagram showing the forming state of the compound paste jelly (1000:10:10:1) in Experiment Example 17;

[0076] Figure 27 This is a diagram showing the forming state of the compound paste jelly (1000:10:10:2) in Experiment Example 18;

[0077] Figure 28 This is a diagram showing the forming state of the compound paste jelly (1000:8:12:0.5) in Experiment Example 19;

[0078] Figure 29 This is a diagram showing the forming state of the compound paste jelly (1000:8:12:1) in Experiment Example 20;

[0079] Figure 30 This is a diagram showing the forming state of the compound paste jelly (1000:8:12:2) in Experiment Example 21;

[0080] Figure 31 This is a diagram showing the forming state of Motherwort Paste Jelly (1000:10:10:1) from Experiment Example 22;

[0081] Figure 32 This is a diagram showing the forming state of Astragalus extract jelly (1000:10:10:1) in Experiment Example 23;

[0082] Figure 33 This is a diagram showing the forming state of Astragalus extract jelly (200:1:1:0.1) in Experiment Example 27, when it was fed at 60℃.

[0083] Figure 34 It refers to the state in which the excipients are first pre-dissolved in water and then added to the concentrated liquid of the prescription decoction.

[0084] It should be noted that these accompanying drawings and textual descriptions are not intended to limit the scope of the invention in any way, but rather to illustrate the concept of the invention to those skilled in the art by referring to specific embodiments. Detailed Implementation

[0085] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments will be clearly and completely described below with reference to the accompanying drawings. The following embodiments are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0086] It should be noted that in this invention, the formula ratio (200:1:1:0.1) and the traditional Chinese medicine decoction jelly (200:1:1:0.1) both indicate by weight that the ratio of decoction concentrate: konjac powder: carrageenan: potassium chloride is 200:1:1:0.1; and so on, other different formula ratios or traditional Chinese medicine decoction jelly can be named and represented in this way.

[0087] 1. Materials and Methods

[0088] 1.1 Traditional Chinese Medicine Decoction

[0089] Based on clinical TCM prescriptions, three representative decoction formulas were selected:

[0090] A. Motherwort Paste (Motherwort 2000g);

[0091] B. Astragalus Paste (Astragalus 2000g);

[0092] Compound Ointment (Formula: Dioscorea opposita 210g, Cinnamomum cassia twig 21g, Jujube 210g, Achyranthes bidentata (fried) 105g, Polygonatum sibiricum (processed) 140g, Saposhnikovia divaricata 42g, Drynaria fortunei 105g, Angelica sinensis 140g, Dipsacus asper (processed with salt) 140g, Spatholobus suberectus 210g, Poria cocos 105g, Citrus reticulata peel 70g, Paeonia lactiflora (fried with wheat bran) 210g, Glycyrrhiza uralensis (processed) 35g, Atractylodes macrocephala (fried with wheat bran) 140g, Astragalus membranaceus 210g)

[0093] 1.2 Excipients

[0094] Jelly base: konjac flour, carrageenan, potassium chloride

[0095] 1.3 Methods

[0096] The preparation method of traditional Chinese medicine decoction jelly includes the following steps:

[0097] (1) Prepare a concentrated decoction of the formula according to the prescription and set it aside;

[0098] (2) Weigh the konjac powder, carrageenan, and potassium chloride excipients separately and set aside;

[0099] (3) Pour the prepared concentrated liquid of Linfang decoction into the mixing pot of the integrated decoction mixing and packaging machine and turn on the stirring function;

[0100] (4) Slowly add the prepared excipients to the concentrated liquid of the Linfang decoction. When adding the excipients, the temperature of the concentrated liquid should not exceed 50°C. Stir evenly to obtain the first mixture.

[0101] (5) Continue stirring and heating the first mixture until it boils, then stop heating and immediately aseptically seal it.

[0102] 2. Quality evaluation indicators

[0103] 2.1 Indicators of the concentrated decoction of the prescription

[0104] (1) Sensory requirements: No scorching.

[0105] 2.2 Quality Standards for Traditional Chinese Medicine Decoction Paste and Jelly

[0106] (1) Sensory requirements: Comply with the sensory requirements of "Jelly" (GB / T 19883-2018 5.2).

[0107] The specific sensory evaluation criteria are shown in Table 1.

[0108] Table 1 Sensory Evaluation Scale

[0109]

[0110] (2) Physicochemical requirements: Comply with the "Jelly" (GB / T 19883-2018 5.5 Physicochemical requirements).

[0111] 3. Quality Inspection

[0112] 3.1 Detection method: The soluble solids content was detected using a saccharimeter;

[0113] The water separation rate of the jelly is tested as follows: First, accurately weigh the jelly to be tested, and the mass is M1 (g). Then, gently squeeze out the water with gauze and weigh it again accurately, and the mass is M2 (g). Calculate the water separation rate of the jelly gel using formula (1):

[0114] Water separation rate / % = (M1-M2) / M1×100% (1)

[0115] Examples 1-3: Motherwort Extract Jelly

[0116] (1) Prepare a concentrated extract of Leonurus japonicus extract and test its refractive index concentration, which is 4.5%.

[0117] (2) Prepare motherwort extract jelly with formulation ratios of (200:1:1:0.1), (400:1:1:0.1), and (800:1:1:0.1) according to the method in 1.3, as Examples 1-3. The temperatures when mixing the excipients with the concentrated extract are 43℃, 46℃, and 45℃, respectively, the stirring speed is 80-120r / min, and the mixture is kept boiling for 5min.

[0118] Example 1: The forming state of Motherwort Extract Jelly (200:1:1:0.1) is as follows. Figure 1 ,from Figure 1 It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0119] Example 2: The forming state of the motherwort extract jelly (400:1:1:0.1) is as follows. Figure 2 ,from Figure 2 It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0120] Example 3: The forming state of the motherwort extract jelly (800:1:1:0.1) is as follows. Figure 3 ,from Figure 3 It can be clearly seen that the different shapes of this jelly all present a complete form.

[0121] Examples 4-6 Astragalus Extract Jelly

[0122] (1) Prepare the concentrated Astragalus extract and test its refractive index concentration, which is 8.7%.

[0123] (2) Astragalus extract jelly with formulation ratios of (200:1:1:0.1), (400:1:1:0.1), and (800:1:1:0.1) were prepared according to method 1.3, as Examples 4-6. The mixing temperatures of the excipients and the concentrated extract were 45℃, 46℃, and 46℃, respectively, with a stirring speed of 40-60 r / min, and the mixture was kept boiling for 5 min.

[0124] Example 4: The astragalus extract jelly (200:1:1:0.1) was formed as follows: Figure 4 ,from Figure 4 It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0125] Example 5: The astragalus extract jelly (400:1:1:0.1) was formed as follows: Figure 5 ,from Figure 5 It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0126] Example 6: The astragalus extract jelly (800:1:1:0.1) was formed as follows: Figure 6 ,from Figure 6 It can be clearly seen that the different shapes of this jelly all present a complete form.

[0127] Examples 7-9: Compound Paste Jelly

[0128] (1) Prepare the compound ointment concentrate and test its refractive index concentration, which is 19.1%.

[0129] (2) Compound ointment jelly with formulation ratios of (200:1:1:0.1), (200:0.5:0.5:0.05), and (200:0.25:0.25:0.025) were prepared according to method 1.3, as Examples 7-9. The temperatures during mixing of the excipients and the concentrated ointment were 43℃, 44℃, and 48℃, respectively, with a stirring speed of 80-120 r / min, and the mixture was kept boiling for 5 min.

[0130] Example 7: The molding state of the compound paste jelly (200:1:1:0.1) is as follows. Figure 7 ,from Figure 7 It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0131] Example 8: The molding state of the compound paste jelly (400:1:1:0.1) is as follows. Figure 8 ,from Figure 8It can be clearly seen that the different shapes of this jelly all retain their complete form;

[0132] Example 9: The molding state of the compound paste jelly (800:1:1:0.1) is as follows. Figure 9 ,from Figure 9 It can be clearly seen that the different shapes of this jelly all present a complete form.

[0133] The sensory evaluation and physicochemical properties of the traditional Chinese medicine decoction jelly in Examples 1-9 are shown in Table 2.

[0134] Table 2 Evaluation Table of Traditional Chinese Medicine Decoction Paste and Jelly

[0135]

[0136]

[0137] The results showed that different proportions of excipients could alter the morphology and water separation rate of the jelly for different prescriptions. The soluble solids of the jelly were mainly composed of the prescription itself. A thick prescription resulted in a high soluble solids content in the jelly, while a thin prescription resulted in a low soluble solids content. For example, the refractive concentration of the motherwort extract in Examples 1-3 was 4.5%, and the refractive concentration of the astragalus extract in Examples 4-6 was 8.7. Therefore, the soluble solids content of the motherwort jelly (5.0%) was lower than that of the astragalus extract jelly (10.0-14.5%).

[0138] Experiment Example 1: Screening of Excipient Types

[0139] Using Leonurus japonicus concentrate as an example, this experiment screened three jelly-forming excipients: agar, konjac flour, and carrageenan. The jelly-forming speed was compared between conditions with and without the addition of the stabilizer KCl. The experiment found that no single excipient could form a satisfactory jelly shape; under combined conditions, konjac flour and carrageenan could compensate for their respective deficiencies to form a better jelly colloidal state. Adding KCl accelerated the colloidal formation. The sensory evaluation and physicochemical properties of the extract jelly with different excipients are shown in Table 3.

[0140] Table 3 Evaluation table of motherwort decoction jelly with different added ingredients

[0141]

[0142]

[0143] The forming state diagrams of the motherwort decoction jelly prepared in Experiment Examples 1-12 are attached. Figure 10-21 .

[0144] according to Figure 10-21 The sensory evaluation results showed that, among single excipients, agar (Experimental Example 1, Figure 10Although it can help the jelly form, its sensory score is only 25 points, and it has a noticeable fishy smell from the auxiliary ingredients; konjac powder (Experimental Example 2, Figure 11 Carrageenan (Example 3) cannot be molded when used alone; Figure 12 After molding, it was rather hard, with a sensory score of 33 points and a water separation rate of 2.63%, which was better than using agar and konjac powder alone, but the overall effect was still not ideal.

[0145] When two excipients are combined, agar and konjac powder are used together (Experimental Example 4). Figure 13 Unable to form; Konjac flour combined with carrageenan (Experimental Example 5, Figure 14 The score improved to 45 points, with a water separation rate of 2.45%, indicating that the combination of the two can complement each other's defects and form a better colloid; the combination of agar and carrageenan (Experimental Example 6) Figure 15 The score was 34 points, with a water separation rate of 3.45%, which is not as good as the combination of konjac powder and carrageenan.

[0146] After adding potassium chloride, the combination of konjac flour, carrageenan, and potassium chloride (Experimental Example 11) Figure 20 The score was 49 points, with a water separation rate of 1.21%, which was the highest among all the formulas (Experimental Examples 1-12). The low water separation rate resulted in a well-formed, resilient, and uniformly textured jelly. This indicates that when the three ingredients are combined, the synergistic effect of konjac powder and carrageenan, combined with the coagulating effect of potassium chloride, can significantly improve the jelly's formability, fineness, and stability.

[0147] Experiment Example 2: Screening of Compound Excipient Ratios

[0148] Based on the combination of "konjac flour, carrageenan, and potassium chloride" determined in Experiment Example 1, this experiment adopted a three-factor, three-level orthogonal experimental design. Factor A was the proportion of konjac flour (based on 100 portions of decoction, with three levels: 1.2, 1, and 0.8), Factor B was the proportion of carrageenan (with corresponding levels of 0.8, 1, and 1.2), and Factor C was the proportion of potassium chloride (with three levels of 0.05, 0.1, and 0.2). Sensory evaluation and water separation rate were used as evaluation indicators to screen the optimal ratio.

[0149] Table 4. Orthogonal Factors of Konjac Powder and Carrageenan Compound Additives

[0150]

[0151]

[0152] The jelly recipe ratios and experimental results are shown in Table 5.

[0153] Table 5 Evaluation Table of Decoction Jelly

[0154]

[0155] The forming state diagrams of the Linfang decoction jelly prepared in Experiment Examples 13-23 are attached. Figure 22-32 .

[0156] according to Figure 22-32 The sensory evaluation results showed that when the proportion of konjac flour in the konjac flour-carrageenan ratio was too high (as in Experiments 13-15), Figure 22-24 The jelly is more elastic and coarser, with sensory scores mostly between 40 and 44 points; when the proportion of carrageenan is too high (as in Experiments 19-21), Figures 28-30 The jelly took longer to set, the center of the jelly formed slowly, and the set jelly was firmer, scoring between 45 and 47 points. When the ratio of konjac powder to carrageenan was 1:1 (as in Experiments 16-18), Figure 25-27 The jelly exhibited moderate forming speed, uniform texture, and significantly improved sensory evaluation. The amount of potassium chloride added primarily affected the forming speed and mouthfeel; low potassium chloride content resulted in greater water separation, while high potassium chloride content negatively impacted the smooth texture. The orthogonal sensory evaluation table showed that the compound decoction jelly achieved the highest sensory evaluation when the ratio of konjac flour, carrageenan, and potassium chloride was 1:1:0.1. Therefore, the optimal ratio of excipients was determined to be 1:1:0.1.

[0157] Because the jelly in Experiment 2 was slightly firm after setting, the compatibility of different amounts of decoction with the optimal combination of excipients was further investigated based on the orthogonal experiment: 200 parts by weight, 400 parts by weight, and 800 parts by weight of the concentrated decoction of Linfang were mixed with excipients (1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride) to make Leonurus japonicus paste, Astragalus membranaceus paste, and compound paste jelly (see Examples 1-9). The jelly obtained could all be set and the sensory scores were significantly higher than those of Experiments 13-23. This means that by optimizing the preparation method, the present invention can use a small amount of excipients to set (200-800) parts by weight of the concentrated decoction of Linfang, obtaining a traditional Chinese medicine decoction jelly with a better sensory score. When the formula ratio of the traditional Chinese medicine decoction jelly of the present invention is (200-800):1:1:0.1, the jelly setting and taste are optimal, and the amount of excipients used is small, resulting in low cost.

[0158] Experiment Example 3: Screening of Additives under Different Temperature Conditions

[0159] During the preparation process, it was found that as the mixing temperature of the paste increased, the excipients gradually dissolved, but due to the excessively high liquid temperature, large white excipient particles clumped together. After packaging and cooling, it was observed that the paste could be shaped, had a relatively hard texture, and was slightly elastic; the jelly had poor transparency and a white granular feel. Therefore, the optimal feeding temperature was explored. Astragalus decoction is yellow and transparent, making it easy to observe. Following the method in 1.3, by changing the mixing temperature (feeding temperature) of the excipients and the concentrated decoction, an Astragalus jelly with a formula ratio of (200:1:1:0.1) was prepared to explore the optimal feeding temperature range for the jelly (see Table 6).

[0160] Table 6 - Evaluation of Astragalus Decoction Jelly under Different Feeding Temperatures

[0161]

[0162] The results showed that when the excipients were added at around 30℃ and 40℃, they dissolved rapidly in the concentrated Chinese medicine liquid and dispersed evenly after stirring. However, when the temperature reached 50℃ or even 60℃, the added excipients formed large clumps that were difficult to disperse, while the remaining jelly-like colloid was softer, affecting the molding process (e.g., ...). Figure 33 Considering the efficiency of the jelly-making process, the preferred feeding temperature (the mixing temperature of the auxiliary materials and the concentrated decoction) is 40-50℃, excluding 50℃.

[0163] Experiment Example 4: Screening of Boiling Time for the First Mixture

[0164] This invention, through high-temperature sterilization and aseptic packaging of the jelly paste, can largely prevent spoilage, thus achieving the goal of not adding preservatives within the shelf life. When the integrated paste preparation and packaging machine heats to above 95°C, the first mixture gradually boils. By optimizing the boiling time and selecting suitable boiling conditions, the paste spoilage is ensured to be slow. Astragalus, as a tonic, contains polysaccharides that are most prone to spoilage. Following the method in 1.3, the boiling time of the first mixture was changed to prepare an Astragalus paste jelly with a formula ratio of (200:1:1:0.1). The evaluation of the packaged jelly paste is shown in Table 7. The swelling of the jelly bags was observed daily under an accelerated environment of 30°C (normal storage conditions are refrigerator refrigeration at 2-8°C).

[0165] Table 7 - Evaluation of Astragalus Decoction Jelly under Different Boiling Times

[0166]

[0167] The results showed that the sample boiled for 1 minute began to produce bubbles and swell on the third day, the sample boiled for 3 minutes began to produce bubbles and swell on the fourth and fifth days, and both the samples boiled for 5 minutes and 10 minutes began to swell on the sixth day. By comparing the swelling time, it was determined that maintaining the boiling time of the first mixture for 5-10 minutes was more suitable.

[0168] Experiment 5: Screening of different feeding methods

[0169] This invention employs different feeding methods to prepare motherwort extract jelly and astragalus extract jelly with a formula ratio of (200:1:1:0.1), respectively. The jelly evaluation table is shown in Table 8. Among them, the temperature when mixing the excipients with the concentrated extract in Experiments 32-37 was 43℃.

[0170] Feeding methods include:

[0171] A. Direct addition of auxiliary materials: Konjac powder, carrageenan, and potassium chloride are directly added to the concentrated liquid of the Linfang decoction to obtain the first mixture;

[0172] B. Add the excipients by pre-dissolving them in water: Mix konjac powder, carrageenan, and potassium chloride, then dilute them with 10 times their weight of cold water, stir, and then add them to the concentrated liquid of the Linfang decoction to obtain the first mixture.

[0173] C. Adding excipients after capsule filling: After mixing konjac powder, carrageenan, and potassium chloride evenly, the mixture is quantitatively dispensed into pharmaceutical capsules and then added to the concentrated liquid of the Linfang decoction to obtain the first mixture.

[0174] Table 8 - Evaluation of Motherwort and Astragalus Decoction Jelly under Different Feeding Methods

[0175]

[0176]

[0177] As can be seen from Experiments 33 and 36, konjac powder, carrageenan, and KCl, when diluted with 10 times their weight of water, rapidly swell to form a semi-fluid. Even after prolonged stirring in a concentrated traditional Chinese medicine solution, they still clump together and are difficult to dissolve (see...). Figure 34 Method B (pre-dissolving excipients in water before adding them) is not applicable to the preparation of the herbal decoction jelly of this invention.

[0178] In Experiments 34 and 37, when adding capsules, the equipment was pre-cooled to 30°C before heating, and the capsules were added at 43°C. The temperature control switch was turned off, but the stirring function was retained. After the capsules disintegrated and were mixed, the temperature was raised again to make the paste. The jelly production results were not significantly different from those obtained by direct addition (Experiments 32 and 35), meaning that the sensory evaluation of the jellies produced by methods A (direct addition of excipient powder) and C (addition of excipients after encapsulation) was not significantly different. Therefore, in this invention, the excipient addition process can either directly add the excipients to the concentrated extract of the Linfang decoction, or the excipients can be encapsulated before being added to the concentrated extract of the Linfang decoction.

[0179] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine decoction jelly, characterized in that, The jelly contains: 200-800 parts by weight of concentrated decoction of Linfang, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride.

2. The traditional Chinese medicine decoction jelly according to claim 1, characterized in that, When the concentrated extract of the decoction is Leonurus japonicus extract, the jelly contains: 200-800 parts by weight of Leonurus japonicus extract, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride. Preferably, the jelly contains: 800 parts by weight of motherwort extract, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

3. The traditional Chinese medicine decoction jelly according to claim 1, characterized in that, When the concentrated extract of the decoction is Astragalus extract, the jelly contains: 200-800 parts by weight of Astragalus extract, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride; Preferably, the jelly contains: 400 parts by weight of astragalus extract, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

4. The traditional Chinese medicine decoction jelly according to claim 1, characterized in that, When the concentrated extract of the Linfang decoction is a compound paste, the jelly contains: 200-800 parts by weight of compound paste, 0.8-1.2 parts by weight of konjac powder, 0.8-1.2 parts by weight of carrageenan, and 0.05-0.2 parts by weight of potassium chloride; Preferably, the jelly comprises: 800 parts by weight of compound paste, 1 part by weight of konjac powder, 1 part by weight of carrageenan, and 0.1 parts by weight of potassium chloride.

5. A method for preparing a traditional Chinese medicine decoction jelly as described in any one of claims 1-4, comprising the following steps: (1) Mix konjac powder, carrageenan, potassium chloride excipients and concentrated liquid of Linfang decoction evenly to obtain the first mixture; (2) Heat the first mixture to boiling, stop heating, and immediately aseptically seal it to form a jelly-like shape, thus obtaining the Chinese medicine decoction jelly.

6. The preparation method according to claim 5, characterized in that, In step (1), the temperature is <50℃ when the excipients and the concentrated decoction of the prescription are mixed; Preferably, the mixing temperature of the excipients and the concentrated decoction is 40℃-50℃, excluding 50℃.

7. The preparation method according to claim 5, characterized in that, In step (1), when the excipients and the concentrated decoction of the prescription are mixed, the mixture is stirred at a speed of 0-200 r / min. Preferably, the stirring speed is 40-120 r / min.

8. The preparation method according to claim 5, characterized in that, In step (2), the first mixture is kept boiling for >5 min; Preferably, the first mixture is kept boiling for 5-10 minutes; Preferably, the temperature at which the first mixture boils is ≥95℃.

9. The preparation method according to claim 5, characterized in that, In step (2), the first mixture is heated while being stirred at a speed of 0-200 r / min.

10. The preparation method according to claim 5, characterized in that, In step (1), after the konjac powder, carrageenan and potassium chloride are mixed evenly, they are quantitatively packaged using pharmaceutical capsules or pharmaceutical packaging bags, and then mixed evenly with the concentrated liquid of the Linfang decoction to obtain the first mixture.

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