A detoxification traditional Chinese medicine Kedu capsule and a manufacturing method thereof

Abstract

The application discloses a kind of traditional Chinese medicine for drug addiction treatment Keduo capsule and its manufacturing method, belong to traditional Chinese medicine drug addiction treatment technical field.The capsule is made of ten kinds of traditional Chinese medicinal materials such as Corydalis, Astragalus, Polygala, etc., with fixed weight ratio, without addictive components and western medicine addition.The preparation method uses subsection differentiation extraction process, first extracts volatile oil of Asarum, Chuanxiong, Acorus calamus and is stabilized by β-cyclodextrin inclusion, then alcohol extraction is carried out on Radix Angelicae Dahuricae, and the remaining medicinal materials and dregs are extracted by water, the combined medicinal liquid is concentrated, mixed with Corydalis superfine powder, dried, crushed, mixed with volatile oil inclusion compound, granulated, and the finished product is obtained.The formula of the application follows the logic of monarch, minister, assistant and guide, can relieve the symptoms of physical pain, mental anxiety and other symptoms during drug withdrawal period, regulate visceral function, and reduce the relapse rate.The process parameters are accurately controllable, the drug efficacy retention rate is high, the finished product is stable in storage, convenient to take, safe, the production cost is reasonable, suitable for industrial mass production and popularization and application in grass-roots drug rehabilitation institutions.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation and drug rehabilitation technology, and particularly to a drug rehabilitation capsule and its preparation method. Background Technology

[0002] Drug dependence is essentially a chronic relapsing brain disease. Its core harm lies in causing irreversible organic damage to the heart, liver, kidneys, brain, and other core organs. At the same time, it triggers strong and stubborn physical withdrawal reactions and psychological dependence. Once addicts stop using drugs, they will experience a series of intolerable withdrawal symptoms in a short period of time, which seriously affects the withdrawal effect and leads to a high relapse rate, placing a heavy burden on individuals, families, and society.

[0003] Specifically, during the withdrawal process, drug addicts generally experience severe body pain (such as bone pain, muscle pain, and joint pain), runny nose, night sweats, nausea and vomiting, abdominal pain and diarrhea, fatigue and drowsiness, chills and fever. Some severe cases may even experience convulsions, confusion and other critical situations. On the mental and psychological level, they may experience severe insomnia and anxiety, irritability, panic and anxiety, depression, poor concentration, memory loss, and a strong psychological craving for drugs. These symptoms overlap, making it difficult for most addicts to persist in withdrawal. Even if they succeed in short-term withdrawal, the long-term relapse rate is as high as 80% or more, which has become the core pain point of drug rehabilitation work.

[0004] Currently, mainstream drug rehabilitation programs are mainly divided into three categories: Western medicine substitution therapy, pure traditional Chinese medicine drug rehabilitation therapy, and integrated traditional Chinese and Western medicine therapy. Among them, Western medicine substitution therapy and integrated traditional Chinese and Western medicine therapy generally rely on Western medicine components and have many insurmountable drawbacks. Although pure traditional Chinese medicine drug rehabilitation therapy has the advantage of not causing secondary addiction, the current technology also has many fundamental shortcomings, as follows: Firstly, the limitations of Western medicine substitution therapy: This therapy is currently the most widely used drug rehabilitation method in clinical practice. It mainly uses addictive narcotic drugs or antagonist drugs such as methadone, buprenorphine, and naltrexone for tapering and replacement therapy. Its core principle is to use the drug components to replace the drug's effect on the central nervous system, quickly suppressing physical withdrawal reactions in the short term. However, this therapy has fatal flaws: Methadone and buprenorphine themselves have extremely strong secondary addictive properties. Addicts are very likely to develop a lifelong dependence of "using drugs to replace drugs" during use. Long-term use will not only increase the burden on the liver and kidneys, but also cause serious side effects such as respiratory depression, dizziness, drowsiness, constipation, and mental disorders. Although antagonist drugs such as naltrexone are not addictive, they can cause a sharp increase in withdrawal symptoms. Addicts have extremely poor tolerance and clinical compliance, making it impossible to widely promote and apply. In addition, Western medicine substitution therapy can only relieve physical withdrawal symptoms and cannot improve psychological dependence. After withdrawal, psychological cravings remain strong, and the relapse rate cannot be effectively controlled.

[0005] Secondly, the core shortcomings of existing pure traditional Chinese medicine (TCM) detoxification techniques: As people's requirements for the safety of drug withdrawal increase, pure TCM detoxification has gradually gained attention due to its advantages such as no secondary addiction and fewer side effects. However, currently available pure TCM detoxification techniques generally have many problems and cannot meet actual clinical needs: The formulations of existing traditional Chinese medicine (TCM) detoxification formulas are often disorganized and lack specific targeting: Most existing TCM detoxification formulas blindly pile up large quantities of herbs, ranging from a dozen to dozens, with a complex variety of herbs and arbitrary proportions. They lack a scientific logic of principal, assistant, and adjuvant herbs, focusing primarily on single sedative, analgesic, or tranquilizing effects, failing to simultaneously address physical withdrawal pain relief, organ and blood circulation regulation, and improvement of psychological dependence, resulting in poor withdrawal outcomes. Some formulas, in pursuit of rapid pain relief, blindly add potent sedative and analgesic herbs, even containing addictive components, violating the core principle of pure TCM detoxification. Other formulas ignore the core pathogenesis of drug withdrawal (disorders of Qi and blood, deficiency of organs, malnourishment of the mind and spirit, and meridian blockage), simply adding a few heat-clearing, detoxifying, and blood-activating herbs, failing to address the root cause of withdrawal problems.

[0006] The preparation processes are crude and outdated, resulting in significant loss of efficacy: Existing traditional Chinese medicine (TCM) detoxification preparations generally employ simple processes, mostly involving direct mixing and decoction of all medicinal materials, followed by ordinary pulverization and incorporation. Differentiated extraction processes are not designed to address the unique characteristics of the active ingredients in different herbs. For example, herbs containing volatile aromatic, orifice-opening, and analgesic components, such as Asarum, Ligusticum chuanxiong, and Acorus tatarinowii, will experience substantial loss of volatile oils through direct decoction, significantly reducing efficacy. Herbs containing fat-soluble active ingredients, such as Angelica dahurica, cannot fully extract their effective components through decoction alone, leading to extremely low utilization rates. Furthermore, existing processes lack stabilization treatment for volatile oils. Even if a small amount of volatile oil is extracted, it will rapidly oxidize and dissipate during subsequent drying and storage, resulting in unstable efficacy, slow onset of action, short shelf life, and significant batch-to-batch differences in efficacy.

[0007] Limited efficacy and inability to achieve simultaneous physical and mental rehabilitation: Existing traditional Chinese medicine (TCM) detoxification products generally only provide temporary relief from superficial physical withdrawal symptoms. They cannot fundamentally address the deficiencies in the internal organs and imbalances in Qi and blood caused by long-term drug use, nor can they improve the psychological dependence and aftereffects of addiction. After the physical withdrawal symptoms subside, most addicts still experience severe insomnia, anxiety, depression, memory decline, and lethargy. Their psychological craving for drugs cannot be effectively suppressed, leading to a persistently high long-term relapse rate and preventing true detoxification and rehabilitation.

[0008] Vague process parameters prevent industrial-scale mass production: Most of the publicly disclosed traditional Chinese medicine detoxification preparation methods do not specify detailed process parameters, such as soaking time, number of extractions, extraction time, solvent volume, concentration temperature, concentration density, and drying temperature. These parameters are all broad ranges and lack precise definition, resulting in huge differences in the quality and efficacy of finished products prepared in different batches. Stable industrial-scale mass production cannot be achieved, and the consistency and safety of clinical use cannot be guaranteed.

[0009] Low raw material utilization rate leads to resource waste: Most existing processes adopt a single extraction method, which does not fully extract the effective components in medicinal materials. A large amount of active ingredients remain in the residue and are directly discarded, which not only causes serious waste of medicinal materials, but also results in insufficient efficacy of the finished product. It is necessary to increase the amount of medicinal materials to achieve the expected effect, which increases the production cost. Summary of the Invention

[0010] In view of this, the present invention provides a traditional Chinese medicine detoxification capsule and its manufacturing method, in order to solve or alleviate one of the technical problems existing in the prior art, and at least provide a beneficial alternative.

[0011] The technical solution of this invention is implemented as follows: a traditional Chinese medicine for drug addiction treatment, Kedu Capsule and its preparation method, is prepared from the following raw materials in parts by weight: 200 parts of Corydalis Rhizome, 300 parts of Astragalus Root, 200 parts of Polygala Root, 60 parts of Asarum Root, 200 parts of Angelica Root, 200 parts of Ligusticum Rhizome, 200 parts of Acorus Root, 120 parts of Arborvitae Seed, 240 parts of Bombyx Batryticatus, and 120 parts of Aconitum Carmichaelii.

[0012] Furthermore, its preparation process includes a specific volatile oil stabilization and inclusion pretreatment step, specifically: After pulverizing the three raw materials—Asarum heterotropoides, Ligusticum chuanxiong, and Acorus tatarinowii—into coarse powder of a specified mesh size, the materials are completely submerged in room temperature water. The soaking time is strictly controlled to 2 hours in a sealed container at room temperature. Then, the volatile oil is continuously extracted by steam distillation for 8 hours. The distillation temperature and condensation efficiency are controlled throughout the process to ensure complete collection of the volatile oil. After extraction, the remaining residue and decoction are separately sealed and stored for later use. This step differs from the conventional operation of directly pulverizing the medicine and extracting it by short-time distillation, which significantly improves the retention rate and long-term stability of volatile analgesic and orifice-opening components.

[0013] Furthermore, the specific encapsulation process for the volatile oil is as follows: The volatile oil prepared above was diluted and dispersed with 40 times its volume of purified water. Then, 4 times its volume of β-cyclodextrin was added as the sole inclusion carrier. The mixture was then placed in a colloid mill and ground at a constant speed for 10 minutes to ensure that the inclusion system was microscopically uniform and that the host and guest molecules were completely intercalated. After grinding, the mixture was filtered under normal pressure to remove incompletely included solid residues. The resulting wet inclusion complex was then dried at a constant temperature of 80°C until it reached constant weight. It was then sealed and stored separately in the dark for later use. This method completely solves the technical defects of existing traditional Chinese medicine for drug addiction, such as easy loss and oxidation of volatile oils, short efficacy retention period, and unstable onset of action.

[0014] Furthermore, it also includes a targeted alcohol extraction step for the exclusive Angelica dahurica active components, specifically: Angelica dahurica raw material was separately pulverized into coarse powder suitable for reflux extraction. 800 ml of 90% ethanol solution was added to the coarse Angelica dahurica powder at one time as the extraction solvent. The extraction was carried out twice continuously by heating and reflux extraction. The extraction time of each reflux extraction was strictly controlled to 1.5 hours. The extraction parameters were kept completely consistent in the two extraction processes. After the extraction was completed, all the ethanol extracts from the two extractions were combined, and the solid residue was filtered off at room temperature and pressure to obtain a clear Angelica dahurica ethanol extract.

[0015] Furthermore, the subsequent purification steps for the Angelica dahurica alcohol extract are as follows: The filtered Angelica dahurica ethanol extract was placed in a vacuum recovery device, and the ethanol solvent was completely recovered under low temperature and negative pressure conditions until the system was completely free of ethanol odor residue, resulting in an alcohol-free Angelica dahurica concentrated extract. The solid residue remaining after Angelica dahurica extraction was uniformly mixed and combined with all the residue remaining after the extraction of volatile oils from Asarum, Ligusticum chuanxiong, and Acorus tatarinowii in claim 2, so as to achieve unified subsequent water extraction treatment of all solid medicinal materials and maximize the recovery of residual active ingredients of medicinal materials.

[0016] Furthermore, the specific decoction extraction steps for the remaining medicinal herbs are as follows: Take the five raw materials of Astragalus membranaceus, Polygala tenuifolia, Platycladus orientalis seed, Bombyx mori, and Aconitum carmichaelii from the prescription, and put them together with the mixed residue of the above-mentioned combination into a decoction container. Add 13920ml of purified water as the decoction solvent at one time. Maintain a gentle boil throughout the process and decoct continuously for 3 times. The decoction time for each time is strictly set to 1.5 hours instead of the existing conventional short decoction time. After each decoction, filter and separate the decoction and residue separately. Combine all the water extracts obtained from the three decoctions and discard all the final solid residues for no further use.

[0017] Furthermore, the specific vacuum concentration and purification process for the pharmaceutical solution is as follows: All the water-decocted medicinal liquids obtained above are thoroughly and evenly mixed with the alcohol-free concentrated Angelica dahurica liquid. The total mixed liquid is then transferred to a vacuum decompression concentration device. The concentration temperature is controlled and maintained at a stable 70°C for thermal monitoring. The concentration is continued under reduced pressure until the relative density of the concentrated extract accurately reaches 1.3. This specific combination of relative density and thermal monitoring temperature parameters is unique to this invention, which is different from the existing broad concentration density range, ensuring that the concentration of effective ingredients and subsequent molding properties reach the optimal balance.

[0018] Furthermore, the processing steps for using Corydalis Rhizome's specific fine powder in medicine are as follows: All the raw materials of Corydalis rhizome in the prescription were individually ultra-finely pulverized to meet the requirements of capsule filling. No additional sterilization or modification treatment was performed. The resulting ultra-fine Corydalis rhizome powder was completely added into the ointment with a specific relative density prepared above. The mixture was thoroughly stirred and mixed evenly using a three-dimensional mixing device to obtain a uniform ointment-powder mixture without lumps.

[0019] Furthermore, the specific drying and pulverizing steps for pharmaceutical intermediates are as follows: The above uniform paste-powder mixture is spread evenly in a constant temperature drying oven and dried with a constant low temperature hot air of 80°C until the material reaches the required moisture content. The temperature is strictly controlled during the drying process to avoid thermal damage to the active ingredients. After drying, the dried solid material is pulverized again into a uniform and fine ultrafine powder. Then, it is thoroughly mixed with the volatile oil β-cyclodextrin inclusion complex prepared in claim 3 in a sealed environment to obtain a capsule-specific mixed powder intermediate.

[0020] Furthermore, the final capsule molding process is as follows: The mixed powder is then processed into uniform dry granules using conventional dry or wet granulation processes. Once the granules are uniform in size and meet the flowability standards, they are quantitatively filled into empty medicinal capsules according to conventional pharmaceutical capsule filling specifications, ultimately yielding the finished product of the traditional Chinese medicine detoxification capsule.

[0021] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: 1. This invention features a precise ratio of ten medicinal herbs, strictly adhering to the principle of monarch, minister, assistant, and guide in herbal combinations. There are no superfluous or redundant herbs, no addictive ingredients, no Western medicine ingredients, and no additional excipients. It absolutely avoids secondary drug dependence and is completely different from existing haphazardly piled-up and arbitrarily proportioned traditional Chinese medicine formulas for drug addiction treatment, as well as alternative therapies that rely on addictive Western medicines. Among them, Astragalus membranaceus, as the principal herb, is used in the largest dosage (300g). Its core functions are to replenish qi and strengthen the body, invigorate the spleen and benefit the lungs, and regulate the damage to the internal organs caused by long-term drug use. It fundamentally improves the physical weakness and mental lethargy of addicts, laying the foundation for withdrawal and recovery. Corydalis yanhusuo, as the assistant herb, is used in a dosage of 200g. It is specifically used to promote qi circulation, relieve pain, invigorate blood circulation, and unblock the meridians. It can quickly relieve severe physical pain such as bone pain, muscle pain, and joint pain during the withdrawal period. Its analgesic effect is mild and long-lasting, and it is non-addictive, which is different from the strong anesthetic analgesia of existing Western medicines and the blind sedation and analgesia of traditional Chinese medicine. Polygala tenuifolia and Platycladus orientalis seed are used as adjuvant herbs, with dosages of 200g and 120g respectively. They work together to nourish the heart and calm the mind, improve intelligence and open the orifices. They are specifically for severe insomnia, dreaminess and easy awakening during the withdrawal period. This formula addresses mental and psychological symptoms such as anxiety, irritability, and memory decline, aiming to calm the mind and alleviate psychological cravings. The dosage of Asarum, Ligusticum chuanxiong, and Acorus tatarinowii is 200g each. Asarum warms and unblocks the meridians, dispels cold and relieves pain; Ligusticum chuanxiong invigorates blood circulation, removes blood stasis, and promotes qi flow; Acorus tatarinowii opens the orifices, refreshes the mind, and resolves dampness and stimulates appetite. The three herbs work synergistically to improve blood circulation, alleviate lethargy and emotional disturbances, and enhance the analgesic effect of Corydalis yanhusuo, promoting physical recovery. Angelica dahurica (200g), Bombyx mori (240g), and Aconitum carmichaelii (120g) are used as guiding herbs. Angelica dahurica dispels wind, relieves pain, reduces swelling and drains pus; Bombyx mori dispels wind, relieves spasms, resolves phlegm and dissipates nodules; Aconitum carmichaelii dispels wind and phlegm, and calms convulsions. The three herbs work synergistically to relieve general discomfort and muscle spasms during withdrawal, while guiding other herbs directly to the affected area and enhancing overall efficacy. The entire formula is designed specifically for the core pathogenesis of drug withdrawal, namely "disorders of Qi and blood, deficiency of internal organs, malnourishment of the mind and spirit, and blockage of meridians". It achieves simultaneous relief of physical pain, regulation of Qi and blood in internal organs, and improvement of mental and psychological state, addressing both the symptoms and the root cause, and completely solving the problems of poor targeting and single efficacy of existing formulas.

[0022] This invention breaks away from the outdated conventional process of uniformly mixing and decocting all medicinal materials. It innovatively adopts a four-stage differentiated extraction scheme: "separate oil extraction and encapsulation of volatile medicinal materials, exclusive ethanol reflux extraction of fat-soluble medicinal materials, long-term slow decoction of remaining tonifying medicinal materials, and direct use of Corydalis powder as medicine." It adopts exclusive and suitable extraction methods for medicinal materials with different active properties, maximizes the retention of various effective medicinal components that are difficult to preserve and easily destroyed, and significantly improves the utilization rate of medicinal materials, avoiding resource waste. Specifically, the volatile oils in Asarum, Ligusticum chuanxiong, and Acorus tatarinowii are the core analgesic and orifice-opening components. Extracting and encapsulating them separately avoids loss during decoction. The fat-soluble active components in Angelica dahurica (such as angelicin) can only be fully dissolved through high-concentration ethanol reflux extraction; a dedicated ethanol extraction step significantly improves the extraction rate of its effective components. The water-soluble components in tonifying herbs such as Astragalus membranaceus and Polygala tenuifolia can be fully dissolved through long-term slow decoction, ensuring tonifying efficacy. The effective components in Corydalis yanhusuo, such as corydaline, are heat-sensitive; pulverizing them into raw powder separately avoids component destruction caused by high-temperature extraction while ensuring rapid analgesic effect. Experimental verification shows that the segmented extraction process of this invention increases the overall effective utilization rate of medicinal materials by more than 60% and the finished product's efficacy intensity by more than 30% compared to existing conventional processes, completely solving the problems of severe efficacy loss and low utilization rate of medicinal materials in existing processes.

[0023] This invention specifically employs a unique β-cyclodextrin colloidal grinding and inclusion process on the core analgesic and stimulating volatile oil components of Asarum, Ligusticum chuanxiong, and Acorus tatarinowii. Compared to existing technologies that directly spray-powder the volatile oils without stabilization, this method offers significant advantages: the molecular structure of β-cyclodextrin can form hydrophobic cavities, embedding volatile oil molecules within them to form stable inclusion complexes. This effectively isolates the volatile oils from air, light, and moisture, significantly improving their thermal and storage stability and preventing oxidation and loss. Simultaneously, the included volatile oils can be slowly released in the body, prolonging the duration of efficacy and addressing the issue of existing products having a rapid onset but short duration of action. Furthermore, the inclusion process can mask the irritating odor of the volatile oils, improving the palatability and patient compliance of the finished product. Tests have shown that the volatile oil encapsulated in this invention can have a shelf life of more than 2 years under sealed storage conditions at room temperature, while the existing unencapsulated volatile oil has a shelf life of only 3-6 months and its efficacy is significantly reduced. This invention completely solves the industry pain points of volatile oils in existing traditional Chinese medicine for drug addiction, such as easy oxidation, easy loss, short shelf life, and unstable efficacy.

[0024] This invention precisely and uniquely defines every step and process parameter in the preparation process, unlike the broad and vague range of process parameters in existing technologies. Each parameter has undergone extensive screening and verification to obtain the optimal combination, ensuring completely consistent quality and efficacy for each batch of finished product, and exhibiting strong replicability for industrial-scale production. Specifically, the soaking time for Asarum and two other herbs is strictly controlled to 2 hours to ensure sufficient wetting of the herbs, facilitating the extraction of volatile oils; the steam distillation extraction time for volatile oils is strictly controlled to 8 hours to ensure full extraction, avoiding wasted time and the introduction of ineffective components; the ethanol extraction of Angelica dahurica uses a 90% ethanol concentration, a volume of 800 ml, two extractions, and a single extraction time of 1.5 hours to maximize the extraction of fat-soluble active ingredients while avoiding excessive ethanol usage. The increased cost is mitigated by the following: The water volume for decoction is 13920ml, the number of decoctions is 3, and the single decoction time is 1.5 hours, which fully dissolves the water-soluble active ingredients; the concentration temperature is 70℃, and the relative density of the extract is 1.3 (thermal measurement), ensuring a suitable concentration of active ingredients while also considering subsequent molding properties; the drying temperature is 80℃, avoiding damage to heat-sensitive active ingredients by high temperatures; the grinding time for volatile oil encapsulation is 10 minutes, and the amount of β-cyclodextrin is 4 times the normal amount, ensuring thorough encapsulation. These precise parameters completely solve the problem of huge batch-to-batch quality differences in the finished product and the inability to achieve industrial-scale mass production in existing technologies, realizing the standardization and controllability of finished product quality.

[0025] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a flowchart illustrating the manufacturing process of the present invention. Detailed Implementation

[0028] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0029] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0030] Example 1 The dosage of the following raw materials for the traditional Chinese medicine detoxification capsules in this embodiment is as follows: Corydalis rhizome 200g, Astragalus membranaceus 300g, Polygala tenuifolia 200g, Asarum heterotropoides 60g, Angelica dahurica 200g, Ligusticum chuanxiong 200g, Acorus tatarinowii 200g, Platycladus orientalis seed 120g, Bombyx mori 240g, and Aconitum carmichaelii 120g.

[0031] Preparation steps: 1. Take Asarum, Ligusticum chuanxiong, and Acorus tatarinowii and grind them into coarse powder of 8-20 mesh. Soak them in room temperature water for 2 hours and extract the volatile oil by steam distillation for 8 hours. Collect the volatile oil. Add 40 times the amount of purified water and 4 times the amount of β-cyclodextrin to the volatile oil, grind it into a colloid for 10 minutes, filter it, dry the inclusion complex at 80℃, seal it for later use, and keep the remaining residue.

[0032] Angelica dahurica is crushed into coarse powder, 800ml of 90% ethanol is added, and the mixture is refluxed twice. The extracts are combined and the ethanol is recovered until there is no alcohol taste. The Angelica dahurica residue is combined with the residue from step 1.

[0033] Take Astragalus membranaceus, Polygala tenuifolia, Platycladus orientalis seed, Bombyx batryticatus, and Aconitum carmichaelii, and add them together with the combined dregs to 13920ml of purified water. Boil gently for 3 times (1.5 hours each time), combine the liquids and discard the dregs.

[0034] The decoction was combined with the concentrated extract of Angelica dahurica, and concentrated under reduced pressure at 70°C to a relative density of 1.3 to obtain a clear extract.

[0035] Corydalis rhizome was ultra-finely pulverized and passed through a 120-mesh sieve. It was then mixed with the clear extract, dried at 80°C, pulverized again, and mixed with the volatile oil inclusion complex in a sealed container to obtain a mixed powder.

[0036] After wet granulation, the contents are filled into No. 0 empty capsules (0.5g per capsule), sterilized and packaged to obtain the finished product.

[0037] Example 2 The active pharmaceutical ingredient formulation, dosage, and core process parameters in this embodiment are the same as in Example 1, with only the operation optimized for industrial production.

[0038] Preparation steps: 1. Asarum, Ligusticum chuanxiong, and Acorus tatarinowii were pulverized using a large-scale pulverizer, and then fed into a large-scale distillation equipment in batches. After soaking at room temperature for 2 hours, the volatile oil was collected by steam distillation for 8 hours. The oil was then encapsulated with β-cyclodextrin in proportion, dried, sealed, and stored for later use. The residue was collected in batches.

[0039] Add 90% ethanol to Angelica dahurica at a ratio of 800ml / 200g, extract twice in a large reflux extraction tank, recover the ethanol after centrifugation and filtration, and combine the residue with the residue from step 1 and mix well.

[0040] Five medicinal herbs, including Astragalus membranaceus, were cut into sections in batches and added to a large decoction pot along with the combined dregs. Purified water was added in proportion, and the decoction was boiled three times under gentle simmering. The combined liquid was then filtered to remove impurities.

[0041] The combined medicinal liquid and Angelica dahurica extract were concentrated in a large concentrator at 70°C under reduced pressure to a relative density of 1.3.

[0042] Corydalis rhizome is pulverized into a large-scale ultrafine powder, then added to a clear paste, mixed evenly in a large mixer, dried and pulverized, and then mixed in batches with volatile oil inclusion compounds.

[0043] After dry granulation, the capsules are filled (0.5g per capsule) on a fully automated capsule filling production line, then polished, sterilized, and packaged to obtain batches of finished products.

[0044] Example 3 The active pharmaceutical ingredient formulation, dosage, and core process parameters in this embodiment are consistent with those in Example 1, with optimized details to improve the stability and dissolution of the finished product.

[0045] Preparation steps: 1. After pulverizing Asarum, Ligusticum chuanxiong, and Acorus tatarinowii, soak them for 2 hours, distill to extract the volatile oil, package them, and dry them under vacuum at 80℃ (vacuum degree 0.08MPa). Seal them for later use, and keep the residue.

[0046] Add 800ml of 90% ethanol to the crude powder of Angelica dahurica and reflux to extract. Recover the ethanol to obtain the extract. Combine the residue with the residue from step 1.

[0047] Five medicinal herbs, including Astragalus membranaceus, were boiled three times with the combined dregs and purified water. The decoction was then precisely filtered to remove impurities.

[0048] Combine the liquid and extract, concentrate at 70°C to a relative density of 1.3, and cool for later use.

[0049] After ultrafine grinding of Corydalis rhizome, add it to the clear extract at low speed and mix well. Dry it in stages (first at 60℃ for 1 hour, then at 80℃ until it meets the standard). Grind it through a 100-mesh sieve and mix it with the volatile oil inclusion complex for a long time.

[0050] After granulation, the product is left to stand for 2 hours to balance the moisture content, then filled into capsules, sterilized, and individually packaged in aluminum-plastic packaging to obtain the finished product.

[0051] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine for drug addiction treatment, Kedu capsule, and its preparation method, characterized in that: It is prepared from the following raw materials in parts by weight: Corydalis 200 parts, Astragalus 300 parts, Polygala 200 parts, Asarum 60 parts, Angelica dahurica 200 parts, Ligusticum chuanxiong 200 parts, Acorus tatarinowii 200 parts, Platycladus orientalis seed 120 parts, Bombyx mori 240 parts, and Aconitum carmichaelii 120 parts.

2. The drug addiction treatment capsule and its preparation method according to claim 1, characterized in that: Its preparation process includes a specific volatile oil stabilization and inclusion pretreatment step, specifically: After pulverizing the three raw materials—Asarum heterotropoides, Ligusticum chuanxiong, and Acorus tatarinowii—into coarse powder of a specified mesh size, the materials are completely submerged in room temperature water. The soaking time is strictly controlled to 2 hours in a sealed container at room temperature. Then, the volatile oil is continuously extracted by steam distillation for 8 hours. The distillation temperature and condensation efficiency are controlled throughout the process to ensure complete collection of the volatile oil. After extraction, the remaining residue and decoction are separately sealed and stored for later use. This step differs from the conventional operation of directly pulverizing the medicine and extracting it by short-time distillation, which significantly improves the retention rate and long-term stability of volatile analgesic and orifice-opening components.

3. The drug addiction treatment capsule and its preparation method according to claim 2, characterized in that: The specific encapsulation process for the volatile oil is as follows: The volatile oil prepared above was diluted and dispersed with 40 times its volume of purified water. Then, 4 times its volume of β-cyclodextrin was added as the sole inclusion carrier. The mixture was then placed in a colloid mill and ground at a constant speed for 10 minutes to ensure that the inclusion system was microscopically uniform and that the host and guest molecules were completely intercalated. After grinding, the mixture was filtered under normal pressure to remove incompletely included solid residues. The resulting wet inclusion complex was then dried at a constant temperature of 80°C until it reached constant weight. It was then sealed and stored separately in the dark for later use. This method completely solves the technical defects of existing traditional Chinese medicine for drug addiction, such as easy loss and oxidation of volatile oils, short efficacy retention period, and unstable onset of action.

4. The drug addiction treatment capsule and its preparation method according to claim 1, characterized in that: It also includes a targeted alcohol extraction process for the exclusive active components of Angelica dahurica, specifically: Angelica dahurica raw material was separately pulverized into coarse powder suitable for reflux extraction. 800 ml of 90% ethanol solution was added to the coarse Angelica dahurica powder at one time as the extraction solvent. The extraction was carried out twice continuously by heating and reflux extraction. The extraction time of each reflux extraction was strictly controlled to 1.5 hours. The extraction parameters were kept completely consistent in the two extraction processes. After the extraction was completed, all the ethanol extracts from the two extractions were combined, and the solid residue was filtered off at room temperature and pressure to obtain a clear Angelica dahurica ethanol extract.

5. The drug addiction treatment capsule and its preparation method according to claim 4, characterized in that: The subsequent purification process of Angelica dahurica alcohol extract is as follows: The filtered Angelica dahurica ethanol extract was placed in a vacuum recovery device, and the ethanol solvent was completely recovered under low temperature and negative pressure conditions until the system was completely free of ethanol odor residue, resulting in an alcohol-free Angelica dahurica concentrated extract. The solid residue remaining after Angelica dahurica extraction was uniformly mixed and combined with all the residue remaining after the extraction of volatile oils from Asarum, Ligusticum chuanxiong, and Acorus tatarinowii in claim 2, so as to achieve unified subsequent water extraction treatment of all solid medicinal materials and maximize the recovery of residual active ingredients of medicinal materials.

6. The drug addiction treatment capsule and its preparation method according to claim 5, characterized in that: The remaining medicinal herbs require specific decoction and extraction steps: Take the five raw materials of Astragalus membranaceus, Polygala tenuifolia, Platycladus orientalis seed, Bombyx mori, and Aconitum carmichaelii from the prescription, and put them together with the mixed residue of the above-mentioned combination into a decoction container. Add 13920ml of purified water as the decoction solvent at one time. Maintain a gentle boil throughout the process and decoct continuously for 3 times. The decoction time for each time is strictly set to 1.5 hours instead of the existing conventional short decoction time. After each decoction, filter and separate the decoction and residue separately. Combine all the water extracts obtained from the three decoctions and discard all the final solid residues for no further use.

7. The drug addiction treatment capsule and its preparation method according to claim 6, characterized in that: The specific vacuum concentration and purification steps for the pharmaceutical solution are as follows: All the water-decocted medicinal liquids obtained above are thoroughly and evenly mixed with the alcohol-free concentrated Angelica dahurica liquid. The total mixed liquid is then transferred to a vacuum decompression concentration device. The concentration temperature is controlled and maintained at a stable 70°C for thermal monitoring. The concentration is continued under reduced pressure until the relative density of the concentrated extract accurately reaches 1.

3. This specific combination of relative density and thermal monitoring temperature parameters is unique to this invention, which is different from the existing broad concentration density range, ensuring that the concentration of effective ingredients and subsequent molding properties reach the optimal balance.

8. The drug addiction treatment capsule and its preparation method according to claim 7, characterized in that: The processing steps for using Corydalis Rhizome's fine powder in medicine are as follows: All the raw materials of Corydalis rhizome in the prescription were individually ultra-finely pulverized to meet the requirements of capsule filling. No additional sterilization or modification treatment was performed. The resulting ultra-fine Corydalis rhizome powder was completely added into the ointment with a specific relative density prepared above. The mixture was thoroughly stirred and mixed evenly using a three-dimensional mixing device to obtain a uniform ointment-powder mixture without lumps.

9. The drug addiction treatment capsule and its preparation method according to claim 8, characterized in that: The specific drying and pulverizing steps for pharmaceutical intermediates are as follows: The above uniform paste-powder mixture is spread evenly in a constant temperature drying oven and dried with a constant low temperature hot air of 80°C until the material reaches the required moisture content. The temperature is strictly controlled during the drying process to avoid thermal damage to the active ingredients. After drying, the dried solid material is pulverized again into a uniform and fine ultrafine powder. Then, it is thoroughly mixed with the volatile oil β-cyclodextrin inclusion complex prepared in claim 3 in a sealed environment to obtain a capsule-specific mixed powder intermediate.

10. The traditional Chinese medicine detoxification capsule and its preparation method according to claim 9, characterized in that: The final capsule molding process is as follows: The mixed powder is then processed into uniform dry granules using conventional dry or wet granulation processes. Once the granules are uniform in size and meet the flowability standards, they are quantitatively filled into empty medicinal capsules according to conventional pharmaceutical capsule filling specifications, ultimately yielding the finished product of the traditional Chinese medicine detoxification capsule.

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