A traditional Chinese medicine composition library based on general and local anesthesia mechanisms, and various dosage forms and preparation methods thereof

Abstract

This invention discloses a library of traditional Chinese medicine (TCM) compositions based on general and local anesthesia mechanisms, along with various dosage forms and preparation methods. The invention constructs a systematic library of TCM anesthetic compositions: the general anesthetic composition consists of extracts from herbs such as Datura stramonium, Datura stramonium, processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Saussurea involucrata, Jasminum sambac root, Rhododendron molle, and Sanqie Sanqie; the local anesthetic composition consists of extracts from herbs such as Asarum heterotropoides, Murraya paniculata, Ephedra sinica, Toad venom, and Corydalis yanhusuo. This invention further develops the above compositions into various modern dosage forms, including injections, tablets, capsules, and sprays. In particular, this invention innovatively introduces a clove-cinnamon natural preservative and flavoring system to replace chemical preservatives. In terms of preparation technology, advanced technologies such as supercritical CO2 extraction, microwave-assisted extraction, nano-embedding, and nanoemulsions are integrated, and a self-extraction scheme is adopted to achieve controllable quality and cost. Simultaneously, a quality detection method based on HPLC fingerprinting is established. This invention achieves full-scenario coverage of anesthesia and analgesia, from general to local, from emergency to routine care, with outstanding advantages of safety, effectiveness, and controllable quality.

Description

Technical Field

[0001] The present invention belongs to the cross - field of traditional Chinese medicine and modern pharmaceutical technology, and specifically relates to a traditional Chinese medicine anesthetic composition library classified based on pharmacological action mechanisms, including two types of compositions for general anesthesia and local anesthesia, as well as various modern dosage forms of these two types of compositions, including injections, tablets, capsules, sprays, and their preparation methods and quality control techniques.

Background Art

[0002] 1. Historical Origin of Traditional Chinese Medicine Anesthesia

[0003] The "Mafeisan" created by Hua Tuo, a famous doctor in the Eastern Han Dynasty, is the earliest record of anesthetic in the history of world medicine. It is recorded in "The Biography of Hua Tuo in the Book of the Later Han Dynasty": "If the disease occurs deep inside and cannot be reached by acupuncture and medicine, then first let the patient take Mafeisan with wine. After getting drunk and feeling nothing, then cut open the abdomen and back." This shows that as early as more than 1,800 years ago, Chinese medical scientists had mastered the technology of achieving general anesthesia using traditional Chinese medicine.

[0004] Later medical experts and modern scholars have conducted a large number of textual research and restoration studies on the formula of "Mafeisan". According to literature records such as "Chinese Journal of Medical History", it is speculated that its core components may include Chinese medicinal materials with neuroactive effects such as Datura stramonium, Flos Daturae, Aconitum carmichaeli, Angelica sinensis, Ligusticum chuanxiong, and Angelica dahurica. Modern pharmacological research has confirmed that alkaloid components such as scopolamine and aconitine contained in these medicinal materials have significant central nervous system inhibition or local nerve conduction block effects.

[0005] 2. Research Progress of Traditional Chinese Medicine Anesthesia in the Existing Technology

[0006] In recent years, domestic and foreign scholars' research on traditional Chinese medicine anesthetics has mainly focused on the following aspects:

[0007]

[0008] 3. Main Defects in the Existing Technology

[0009] Although certain progress has been made in the above - mentioned research, overall, the field of traditional Chinese medicine anesthesia is still in the primary stage of transitioning from "empirical medicine" to "modern medicine", and there are the following technical problems亟待解决 (which should be translated as "urgently to be solved"):

[0010] 3.1 Lack of Systematic Classification Based on Modern Pharmacology

[0011] The existing technology's research on traditional Chinese medicine anesthetics is mostly on single medicinal materials or simple compound prescriptions, without systematic classification according to clear pharmacological action mechanisms (general anesthesia vs. local anesthesia). This results in the inability to accurately select a medication plan according to the type of surgery clinically, and drugs with different action mechanisms cannot achieve scientific compatibility and synergistic effects.

[0012] 3.2 Backward Dosage Forms, Unable to Meet Diverse Clinical Needs

[0013] Traditional dosage forms (powders, decoctions) have inherent drawbacks such as slow onset of action, inaccurate dosage, and inconvenient administration. The development of modern dosage forms lags behind: modern dosage forms capable of precise dosage and rapid onset of action, such as injections, oral solid dosage forms, and nasal delivery systems, are almost entirely absent in the field of traditional Chinese medicine anesthesia. Furthermore, the high viscosity, complex composition, and poor stability of traditional Chinese medicine extracts often present technical challenges when developing them into liquid formulations such as sprays, including nozzle clogging and sedimentation / layering.

[0014] 3.3 Weak security control measures

[0015] While the toxicity of highly toxic components such as aconitine can be partially reduced through processing, traditional methods lack precise quantitative control, and the risk of poisoning still exists. The development of liquid preparations commonly relies on chemical preservatives such as benzalkonium chloride and parabens, which may cause skin and mucous membrane irritation and allergic reactions, posing safety risks.

[0016] 3.4 The quality evaluation system is incomplete.

[0017] Existing traditional Chinese medicine anesthetic products mostly use the content determination of a single component as a quality control indicator, which cannot comprehensively reflect the overall quality of the compound. There is a lack of comprehensive fingerprinting quality control methods that can simultaneously monitor both effective components (to ensure efficacy) and toxic components (to ensure safety).

[0018] 4. The starting point of this invention

[0019] To address the shortcomings of existing technologies, this invention draws inspiration from traditional Chinese medicine theory, but is not limited to simple restoration of ancient texts. The core idea of ​​this invention is: guided by modern pharmacology, it systematically classifies traditional Chinese medicine anesthetics for the first time according to the mechanisms of "general anesthesia" and "local anesthesia"; it integrates advanced technologies such as supercritical CO2 extraction, microwave-assisted extraction, nano-embedding, and nanoemulsions using modern pharmaceutical techniques; it constructs multiple safety safeguards with safety as the bottom line; and it establishes a multi-characteristic peak HPLC fingerprint spectrum with quality control as the goal. This invention aims to provide a safe, effective, quality-controllable, and dosage-rich modern traditional Chinese medicine anesthesia solution. [Summary of the Invention]

[0020] I. Purpose of the Invention

[0021] The purpose of this invention is to provide a systematic library of traditional Chinese medicine anesthetic compositions, and further to provide various modern dosage forms of these compositions, their preparation methods, and quality control technologies, so as to achieve full-scene coverage of anesthesia and analgesia from systemic to local, from emergency to daily, and from hospital to home.

[0022] II. Technical Solution

[0023] First aspect: This invention provides a library of traditional Chinese medicine anesthetic compositions.

[0024] Its characteristic is that it includes:

[0025] a) Traditional Chinese medicine composition for general anesthesia

[0026] Its active ingredients consist of extracts from at least two medicinal materials selected from the first group of medicinal materials, which are composed of Datura stramonium, Datura stramonium, processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Saussurea involucrata, Jasmine root, Rhododendron molle, and San San San.

[0027] Preferably, the general anesthetic composition is made from the following raw materials in parts by weight: 10-15 parts of Datura stramonium, 3-5 parts of Datura stramonium, 5-8 parts of processed Aconitum carmichaelii, 3-6 parts of processed Aconitum kusnezoffii, 1-3 parts of Saussurea involucrata, 5-10 parts of Jasmine root, 2-5 parts of Rhododendron molle, 2-5 parts of Trichosanthes kirilowii, 10-12 parts of Ligusticum chuanxiong, 8-10 parts of Angelica dahurica, and 6-8 parts of Glycyrrhiza uralensis.

[0028] b) Local anesthetic traditional Chinese medicine composition

[0029] Its active ingredients consist of extracts from at least two medicinal materials selected from the second group of medicinal materials, which are Asarum, Murraya paniculata, Ephedra sinica, toad venom, and Corydalis yanhusuo.

[0030] Preferably, the local anesthetic composition is made from the following raw materials in parts by weight: 3-8 parts Asarum, 5-15 parts Murraya paniculata, 5-12 parts Ephedra sinica, 1-3 parts Toad venom, 8-15 parts Corydalis yanhusuo, and 5-10 parts Glycyrrhiza uralensis.

[0031] It should be noted that the processed aconite, snow lotus, rhododendron, three-part herb, and toad venom involved in this invention are all toxic medicinal materials listed in the "Regulations for the Administration of Toxic Drugs for Medical Use". The above dosage ranges are determined based on ancient records, modern literature, and experimental data from the inventors. In actual application, relevant regulations must be strictly followed, and the application must be carried out under the guidance of qualified personnel.

[0032] Secondly, the present invention provides various dosage forms of the above-mentioned composition library.

[0033] 1. General anesthetic composition dosage form

[0034] It can be prepared for use in general anesthesia:

[0035] • Injectable preparations: used for induction and maintenance of surgical anesthesia.

[0036] • Tablets: Used for preoperative sedation or as an adjunct to chronic pain management.

[0037] • Capsules: for oral administration

[0038] Nasal spray: used for non-invasive anesthesia induction and sedation.

[0039] 2. Dosage form of local anesthetic composition

[0040] It can be prepared for use in local anesthesia:

[0041] • Injectable formulation: Used for nerve block anesthesia (e.g., dental, limb surgery).

[0042] • Gel: Used for surface anesthesia of skin, oral ulcers, etc.

[0043] • Spray: Used for surface anesthesia before puncture, small incisions, and endoscopy.

[0044] • Patch: Used for transdermal drug delivery for postoperative incision pain, arthritis, etc.

[0045] Thirdly: This invention provides a natural preservative and flavoring system.

[0046] The above-mentioned spray or gel is characterized by being a compound of clove volatile oil and cinnamon volatile oil in a mass ratio of (1:1) to (3:1). The total content of eugenol and cinnamaldehyde in the system is not less than 0.3% (w / v).

[0047] This natural preservative and flavor-enhancing system has the following three functions:

[0048] Preservative function: Eugenol and cinnamaldehyde have strong inhibitory effects on Gram-positive bacteria, Gram-negative bacteria, and fungi.

[0049] Synergistic analgesic effect: Eugenol and cinnamaldehyde themselves have definite local anesthetic and analgesic activities, which can produce a synergistic effect with the main ingredient.

[0050] • Enhanced user experience: The natural and gentle fragrance completely avoids the odor of chemical preservatives.

[0051] Fourthly: This invention provides methods for preparing the above-mentioned dosage forms.

[0052] 1. Preparation of core extracts (self-extraction method)

[0053] The present invention preferably employs a self-extraction method to obtain an active extract with controllable quality and cost, comprising the following steps:

[0054] • Raw material pretreatment: All kinds of medicinal materials are cleaned, dried, pulverized, and processed. Among them, Aconitum carmichaelii and Aconitum kusnezoffii must be processed according to law until the aconitine content is ≤0.02%.

[0055] • Extraction of active ingredients:

[0056] • Supercritical CO2 extraction was used for Datura stramonium and other plants (pressure 25 MPa, temperature 45℃, CO2 flow rate 20 L / h).

[0057] Microwave-assisted extraction (70% ethanol, 400W, 15min) was used to extract processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Ligusticum chuanxiong, and Angelica dahurica.

[0058] • Steam distillation is used for medicinal materials containing volatile oils, such as Asarum.

[0059] • Ultrasonic-assisted extraction (60% ethanol, 30 min) was used for Murraya paniculata, Ephedra sinica, and Corydalis yanhusuo.

[0060] • For toxic medicinal materials such as Saussurea involucrata, Jasmine root, Rhododendron molle, Trichosanthes kirilowii, and Toad venom, a combination of targeted extraction and detoxification treatment is adopted.

[0061] • Purification and concentration: Refined extracts or dry powders are obtained through steps such as purification with macroporous resins and vacuum concentration.

[0062] 2. Preparation of Injectables

[0063] • Dissolve the refined extract in water for injection and adjust the pH to 6.5-7.5.

[0064] • Aseptically filtered through a 0.22μm microporous membrane

[0065] • Aseptically filled into ampoules or vials

[0066] 3. Tablet preparation

[0067] • Mix the spray-dried powder with fillers (microcrystalline cellulose), disintegrants, and lubricants.

[0068] Granulation, drying, and tableting

[0069] 4. Preparation of Capsules

[0070] • Mix the nanoparticles obtained from nano-encapsulation with excipients

[0071] • Filled into empty capsule shells

[0072] 5. Preparation of spray

[0073] • Local anesthetic spray: Extracts, natural preservatives, and penetration enhancers are homogenized under high pressure to form a nanoemulsion, which is then filled into a pump-type spray bottle.

[0074] • Nasal spray: The general anesthetic composition nanoparticles and absorption enhancer are dissolved in a buffer solution, sterilely filtered, and filled into a nasal spray device.

[0075] Fifth aspect: This invention provides a quality inspection method.

[0076] A fingerprint spectrum was established using high performance liquid chromatography (HPLC) and the content was determined.

[0077] Chromatographic conditions:

[0078] • Column: ZORBAX SB-C18 (4.6×250mm, 5μm)

[0079] • Mobile phase: Acetonitrile-0.1% phosphoric acid aqueous solution, gradient elution

[0080] • Flow rate: 1.0 mL / min

[0081] • Detection wavelength: 210nm

[0082] Column temperature: 30℃

[0083] Quality control standards for general anesthetic compositions:

[0084] • Five characteristic peaks must be observed: scopolamine (~5.2 min), aconitine (~7.8 min), ferulic acid (~9.3 min), imperatorin (~12.1 min), and glycyrrhizic acid (~14.5 min).

[0085] Scopolamine content ≥1.0mg / g (guaranteeing efficacy)

[0086] • Aconitine content ≤ 0.02 mg / g (ensuring safety)

[0087] Quality control standards for local anesthetic compositions:

[0088] • Must exhibit 7 characteristic peaks: methyl eugenol, gentianine, fumarate, eugenol, cinnamaldehyde, bufotalin, and glycyrrhizic acid.

[0089] Eugenol content ≥0.2%, cinnamaldehyde content ≥0.1% (ensuring preservative and synergistic effects)

[0090] III. Beneficial Effects

[0091] Compared with the prior art, the present invention has the following advantages:

[0092] 1. Significantly improved safety: Through precise processing and HPLC quantification of the upper limit of aconitine (≤0.02mg / g), the highly toxic component is strictly controlled within a safe range; the natural clove-cinnamon system is used to replace chemical preservatives, eliminating potential irritation and sensitization risks.

[0093] 2. Significantly enhanced efficacy: rapid onset of action, with the spray formulation directly targeting the site of action; enhanced drug efficacy, with eugenol and cinnamaldehyde producing synergistic effects with the main formulation; high bioavailability, with nanotechnology promoting drug absorption.

[0094] 3. Stable and reliable quality: The multi-characteristic peak HPLC fingerprint spectrum is like the "DNA ID card" of the product, ensuring a high degree of consistency between different batches of products.

[0095] 4. Wide clinical applicability: Mechanism classification guides precision medication; multiple dosage forms meet different clinical needs; non-invasive administration is especially suitable for children, the elderly and patients who are afraid of needles.

[0096] 5. Controllable costs and no dependence on others: This invention adopts a self-extraction method, which allows enterprises to establish full supply chain control from raw materials to finished products, significantly reducing production costs and avoiding dependence on purchased extracts.

[0097] Figure 1 Flowchart of the preparation process for the core extract of general and local anesthetic compositions. It illustrates the complete technical route from raw material pretreatment to obtaining the purified extract.

[0098] Figure 1 Brief description

[0099] Figure 1 This invention demonstrates the complete preparation process of its two core products—general anesthesia composition and local anesthesia composition—from raw materials to refined extracts.

[0100] Core structure: It adopts a two-branch design of "classification and processing, and precise extraction".

[0101] Left branch (general anesthesia composition):

[0102] • Ingredients: Datura stramonium, Datura stramonium, processed Aconitum carmichaelii, processed Aconitum kusnezoffii, Saussurea involucrata, Jasmine root, Rhododendron molle, Sanfen San (a type of herb), Ligusticum chuanxiong, Angelica dahurica, Licorice

[0103] Key technologies: Supercritical CO2 extraction (enrichment of fat-soluble alkaloids) + microwave-assisted extraction (rapid and efficient)

[0104] Right branch (local anesthetic composition):

[0105] Ingredients: Asarum, Murraya paniculata, Hemp seed, Toad venom, Corydalis yanhusuo, Licorice

[0106] Key technologies: Steam distillation (collecting volatile oils) + ultrasound-assisted extraction (high-efficiency extraction)

[0107] Convergence point: After purification and concentration, the two branches jointly enter the nanotechnology (nano-embedding / nanoemulsion) and HPLC fingerprint quality control stages, achieving a unified high-tech endpoint.

[0108] Function: As the "general outline of the process" of this invention, it intuitively reflects the complete technological upgrade path from traditional medicinal materials to modern, standardized, and high-quality refined extracts.

[0109] Figure 2 Flowcharts illustrating the formulation processes of various dosage forms of general and local anesthetic compositions. This demonstrates how the core extract is transformed into multiple final products, including injections, tablets, capsules, and sprays.

[0110] The following is about Figure 2 A brief explanation of the formulation process flow charts for various dosage forms of general and local anesthetic compositions.

[0111] Figure 2 Brief description

[0112] Figure 2 This invention demonstrates how the refined extracts of the two core compositions can be flexibly transformed into final products that meet a variety of clinical needs through different formulation processes.

[0113] Core structure: adopts a "one source, multiple branches" branch design.

[0114] Upper branch (general anesthesia composition):

[0115] Raw material: Refined extract of general anesthetic composition

[0116] • Dosage form route:

[0117] • Dissolve and sterile filter → Injection (for surgical anesthesia induction and maintenance)

[0118] • Mixing, granulation, and compression → Tablets (for preoperative sedation and oral administration)

[0119] • Mixing and filling into capsules → Capsules (for oral administration)

[0120] • Dissolving and aseptic filling → Nasal spray (non-invasive anesthesia induction)

[0121] Lower branch (local anesthetic composition):

[0122] Raw material: Refined extract of local anesthetic composition

[0123] • Dosage form route:

[0124] • Dissolve and sterile filter → Injection (nerve block anesthesia)

[0125] • Mix with gel matrix → Gel (for skin and mucous membrane surface anesthesia)

[0126] • Preparation and filling of nanoemulsions → spray (for topical anesthesia of punctures and small incisions)

[0127] • Application, drying, and cutting → patch (for postoperative incision pain and transdermal drug delivery)

[0128] Key features:

[0129] • All dosage forms are derived from the same refined extract, reflecting the standardization and scalability of the process.

[0130] The spray and gel formulations integrate a natural clove-cinnamon preservative and flavoring system, achieving triple functions of preservation, analgesia, and flavor enhancement. Function: This demonstrates the "product matrix" and "technology platform extensibility" of this invention, proving that it is not a single product, but a technological platform capable of rapidly deriving a series of products based on clinical needs, possessing significant commercial value.

[0131] Figure 3 Typical HPLC fingerprint of a general anesthetic composition. The figure shows five characteristic peaks, including scopolamine (main effect peak) and aconitine (toxicity monitoring peak).

[0132] The following is about Figure 3 A brief description of the typical HPLC fingerprint of a general anesthetic composition.

[0133] Figure 3 Brief description

[0134] Figure 3 It displays the unique chemical composition characteristics of general anesthetic compositions (and their dosage forms such as injections, tablets, capsules, and nasal sprays), which serve as the "chemical identity card" and core basis for quality control of such products.

[0135] Spectral features:

[0136] • Horizontal axis: Retention time (min), representing the elution time of different components.

[0137] • Vertical axis: Detection signal (mAU), representing the relative content of the component.

[0138] It must exhibit 5 characteristic peaks.

[0139]

[0140] Quality control standards:

[0141] • Qualitative analysis: The chromatogram of the test sample must show the above five characteristic peaks, and the retention time deviation must be ≤ ±5%.

[0142] • Quantitative determination: Scopolamine content ≥1.0 mg / g (to ensure efficacy)

[0143] • Quantitative determination: Aconitine content ≤ 0.02 mg / g (to ensure safety)

[0144] Function: This graph allows for simultaneous monitoring of product authenticity, efficacy consistency, and medication safety, serving as the core technological support for achieving "quality controllability" in this invention.

[0145] Figure 4 Typical HPLC fingerprint of the local anesthetic composition. The figure shows seven characteristic peaks, including methyleugenol, gentianine, eugenol, and cinnamaldehyde.

[0146] The following is about Figure 4 A brief description of the typical HPLC fingerprint of a local anesthetic composition.

[0147] Figure 4 Brief description

[0148] Figure 4 This invention presents a unique chemical composition spectrum of local anesthetic compositions (and their dosage forms such as gels, sprays, and patches), serving as the "chemical identity card" for these products and a core basis for quality control. In particular, the spectrum integrates characteristic peaks of natural preservative and flavoring systems, demonstrating the unique innovation of this invention.

[0149] Spectral features:

[0150] • Horizontal axis: Retention time (min), representing the elution time of different components.

[0151] • Vertical axis: Detection signal (mAU), representing the relative content of the component.

[0152] It must exhibit 7 characteristic peaks.

[0153]

[0154]

[0155] Quality control standards:

[0156] • Qualitative analysis: The chromatogram of the test sample must show the above 7 characteristic peaks, and the retention time deviation must be ≤ ±5%.

[0157] • Quantitative determination: Eugenol content ≥ 0.2% (to ensure preservative and synergistic effects)

[0158] • Quantitative: Cinnamaldehyde content ≥ 0.1% (to ensure preservative and synergistic effects)

[0159] effect:

[0160] • Simultaneously monitor the effective components of local anesthetic (to ensure therapeutic efficacy).

[0161] • Simultaneously monitor the components of the natural preservative system (ensuring preservative function and synergistic effects).

[0162] • Simultaneously monitor toxic components (to ensure safety).

[0163] This graph is direct technical evidence of the innovative point of this invention, "natural preservatives replacing chemical preservatives," and is also a core guarantee for the consistency of product quality.

Detailed Implementation Methods

[0164] Example 1: Preparation of the core extract of the general anesthesia composition (self-extraction)

[0165] Ingredients: 120g Datura stramonium, 40g Datura stramonium, 60g processed Aconitum carmichaelii, 40g processed Aconitum kusnezoffii, 15g Artemisia scoparia, 60g Jasmine root, 30g Rhododendron molle, 30g San San San, 100g Ligusticum chuanxiong, 80g Angelica dahurica, 60g Glycyrrhiza uralensis.

[0166] Preparation method:

[0167] 1. Pretreatment: Datura flowers and Datura stramonium are dried at 60℃ until the moisture content is ≤8% and then pulverized through an 80-mesh sieve; Aconitum carmichaelii and Aconitum kusnezoffii are processed according to the method until the aconitine content is ≤0.02%; toxic medicinal materials such as Saussurea involucrata, Rhododendron molle, Sanfensan, Jasmine root, and toad venom are cleaned and processed separately; other medicinal materials are cleaned and dried at 40℃.

[0168] 2. Supercritical CO2 extraction: Datura flower and Datura powder were added to the extraction vessel and extracted under the conditions of pressure 25MPa, temperature 45℃ and CO2 flow rate 20L / h, and the extract was collected.

[0169] 3. Microwave-assisted extraction: Mix prepared Aconitum carmichaelii, prepared Aconitum kusnezoffii, Ligusticum chuanxiong, Angelica dahurica and Glycyrrhiza uralensis powders, add 10 times the amount of 70% ethanol, and microwave extract for 15 minutes at 400W power. Filter and collect the filtrate.

[0170] 4. Targeted extraction: Extract the medicinal materials such as Saussurea involucrata, Jasmine root, Rhododendron molle, Sanfensan, and Toad venom separately or in combination, using appropriate solvents and methods, and simultaneously carry out detoxification treatment.

[0171] 5. Ultrasonic-assisted extraction: Mix Asarum, Murraya paniculata, Ephedra sinica, Corydalis yanhusuo, etc., add 8 times the amount of 60% ethanol, extract with ultrasound for 30 minutes, filter, and collect the filtrate.

[0172] 6. Purification and Concentration: Each extract, individually or in combination, is passed through an AB-8 macroporous adsorption resin column and eluted with 30% ethanol. The eluent is collected. The supercritical extract is combined with each eluent and concentrated under vacuum at ≤50℃ to a relative density of 1.10-1.15 to obtain a purified extract.

[0173] Example 2: Preparation of General Anesthesia Injection

[0174] Formula: The refined extract obtained in Example 1 (50 mg / vial based on scopolamine), appropriate amount of water for injection, and appropriate amount of pH adjuster.

[0175] Preparation method: Dissolve the extract in water for injection, adjust the pH to 6.5-7.5, filter aseptically through a 0.22μm microporous membrane, and aseptically fill into 2mL ampoules.

[0176] Purpose: Used for the induction and maintenance of anesthesia in surgical procedures.

[0177] Example 3: Preparation of General Anesthetic Tablets

[0178] Formula: 50% dry powder of general anesthetic composition, 35% microcrystalline cellulose, 8% sodium croscarmellose, 5% povidone K30, and 2% magnesium stearate.

[0179] Preparation method: After mixing evenly, granulate, dry, and compress into tablets, each weighing 0.5g.

[0180] Purpose: For preoperative sedation or as an adjunct to the management of chronic pain.

[0181] Example 4: Preparation of a nasal spray for general anesthesia

[0182] Formula: 2.0g of general anesthesia composition nanopowder, 0.5g of chitosan, 0.9g of sodium chloride, 0.1g of disodium edetate, and an appropriate amount of pH 6.0 phosphate buffer to 100mL.

[0183] Preparation method: After dissolution, the solution is aseptically filtered through a 0.22μm microporous membrane and filled into a nasal spray device, with each spray being 0.1mL.

[0184] Purpose: Used for preoperative sedation and anesthesia induction.

[0185] Example 5: Preparation of the core extract of the local anesthetic composition (self-extracted)

[0186] Ingredients: 50g Asarum, 100g Murraya paniculata, 80g Ephedra sinica, 15g Toad venom, 100g Corydalis yanhusuo, 60g Glycyrrhiza uralensis.

[0187] Preparation method:

[0188] 1. Pretreatment: Asarum is cleaned and dried at low temperature; Murraya paniculata, Ephedra sinica, and Corydalis yanhusuo are cleaned, dried, and pulverized; toad venom is processed separately.

[0189] 2. Steam distillation: Asarum is steam distilled to collect the volatile oil (rich in methyleugenol).

[0190] 3. Ultrasonic-assisted extraction: Mix Murraya paniculata, Ephedra sinica, Corydalis yanhusuo, and Glycyrrhiza uralensis, add 8 times the amount of 60% ethanol, extract with ultrasound for 30 minutes, filter, and collect the filtrate.

[0191] 4. Toad venom extraction: Toad venom is extracted using appropriate solvents and extraction conditions are strictly controlled to ensure the enrichment of active ingredients and the control of toxicity.

[0192] 5. Purification and concentration: Combine the extracts and concentrate them under vacuum at ≤45℃ until they become a thick paste, then set aside.

[0193] Example 6: Preparation of a local anesthetic spray (containing a natural preservative system)

[0194] Formula: 5.0g of the local anesthetic composition extract obtained in Example 5, 0.3g of clove volatile oil, 0.2g of cinnamon volatile oil, 1.0g of azone, 2.0g of polysorbate 80, and appropriate amount of pH buffered physiological saline to 100mL.

[0195] Preparation method:

[0196] 1. Oil phase preparation: Clove volatile oil, cinnamon volatile oil, azone, and polysorbate 80 were mixed evenly at 40℃.

[0197] 2. Preparation of aqueous phase: Dissolve the extract of the local anesthetic composition in buffered physiological saline preheated to 40°C.

[0198] 3. Colostrum formation: The oil phase is slowly added to the aqueous phase under high-speed shear.

[0199] 4. Nanoemulsion formation: The high-pressure homogenizer is circulated 3 times at a pressure of 50 MPa.

[0200] 5. Fill into pump-type spray bottles.

[0201] Applications: For surface anesthesia before skin puncture, small incisions, and endoscopic examinations.

[0202] Example 7: Preparation of a local anesthetic gel (containing a natural preservative system)

[0203] Formula: 5.0g of the local anesthetic composition extract obtained in Example 5, 0.3g of clove volatile oil, 0.2g of cinnamon volatile oil, 1.0g of carbomer 940, 5.0g of glycerin, appropriate amount of triethanolamine, and appropriate amount of purified water to 100g.

[0204] Preparation method:

[0205] 1. Sprinkle Carbomer 940 onto the surface of an appropriate amount of purified water and let it stand overnight to allow it to fully swell.

[0206] 2. Mix the local anesthetic composition extract with glycerin, add the natural preservative system, and stir until homogeneous.

[0207] 3. Add the above mixture to the carbomer gel matrix and stir until homogeneous.

[0208] 4. Add triethanolamine to adjust the pH to 6.5-7.0 to allow the gel to form.

[0209] 5. Add purified water to the total volume, stir well, and fill into aluminum tubes.

[0210] Applications: For surface anesthesia of the skin, oral ulcers, throat, and other areas.

[0211] Example 8: Quality Inspection Method

[0212] Take 5 mL of the spray prepared in Example 6, dilute it to 25 mL with methanol, filter it through a 0.45 μm filter membrane, and inject 10 μL under the chromatographic conditions described. The chromatogram of the test sample should show characteristic peaks corresponding to the reference standard, with scopolamine content ≥1.0 mg / g, aconitine content ≤0.02 mg / g, eugenol content ≥0.2%, and cinnamaldehyde content ≥0.1%.

[0213] What are the significant novelty, progressiveness, inventiveness, and practicality of this invention compared to existing technologies?

[0214] The following is a systematic description of the invention in five dimensions compared with the prior art: novelty, progress, inventiveness, and practicality.

[0215] I. Novelty (substantial differences not yet disclosed)

[0216]

[0217] II. Progressiveness (significant improvement in technical effectiveness)

[0218]

[0219] III. Creativity (Substantial Innovation that is not obvious)

[0220]

[0221] IV. Practicality (Industrial Application Value and Market Prospects)

[0222]

[0223] V. Solving long-standing unresolved problems

[0224]

[0225]

[0226] In short, this invention is not a simple restoration of ancient books, but an original innovation across the entire chain, from theoretical classification and technical processes to dosage form development and quality control. It represents a fundamental shift in the field of traditional Chinese medicine anesthesia from "empirical medicine" to "precision medicine," and from "empirical prescriptions" to "precision drugs." It is a systematic reconstruction of the technological path in this field.

[0227] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. An environment-adaptive modular traditional Chinese medicine preparation system based on the stage of combat casualty treatment, characterized in that, All active ingredients in the system are extracted and prepared from Chinese medicinal materials that meet the standards of the Chinese Pharmacopoeia. The system includes an oral preparation module and a topical preparation module. The raw materials for the oral preparation module include Panax notoginseng, Arctium lappa, Isatis indigotica, Paeonia lactiflora, Glycyrrhiza uralensis, borneol, and at least one ginseng-type medicinal material selected from the following group: ·(a)Ginseng (b) American ginseng (c) A combination of ginseng and American ginseng; The raw materials for the topical preparation module include dragon's blood, purple gromwell root, frankincense, myrrh, coptis root, gypsum, menthol, and borneol.

2. The system according to claim 1, characterized in that, When option (a), i.e., ginseng, is selected, the weight parts of the ginseng are 8-12 parts, the weight parts of the burdock seed are 6-10 parts, and the weight parts of the isatis root are 6-10 parts.

3. The system according to claim 1, characterized in that, When option (b), i.e., American ginseng, is selected, the weight parts of American ginseng are 10-15 parts, the weight parts of burdock seed are 5-8 parts, and the weight parts of isatis root are 5-8 parts.

4. The system according to claim 1, characterized in that, When option (c) is selected, namely the combination of ginseng and American ginseng, the weight parts of ginseng are 5-8 parts, the weight parts of American ginseng are 5-8 parts, the weight parts of burdock seed are 5-8 parts, and the weight parts of isatis root are 5-8 parts.

5. The system according to any one of claims 2-4, characterized in that, The weight parts of Panax notoginseng are 20-30 parts, the weight parts of Paeonia lactiflora are 5-10 parts, the weight parts of Glycyrrhiza uralensis are 3-5 parts, and the weight parts of Borneol are 1-2 parts.

6. The system according to claim 1, characterized in that, The total ginsenoside content of the ginseng is ≥4.0%, the total ginsenoside content of the American ginseng is ≥4.0%, and the total ginsenoside content of the Panax notoginseng is ≥5.0%.

7. The system according to claim 1, characterized in that, The oral preparation module includes an oral fast-dissolving film and an enteric-coated capsule; the external preparation module includes a fast-acting hemostatic and analgesic powder spray, a wound-cleansing and anti-infective hydrogel, and a hemostatic and analgesic elastic bandage.

8. A method for preparing the oral quick-dissolving film of claim 1, characterized in that, Includes the following steps: (1) Extraction of total saponins from Panax notoginseng raw materials; (2) Extracting total saponins from ginseng-based medicinal materials, wherein the ginseng-based medicinal materials are selected from ginseng, American ginseng, or a combination thereof; (3) Extracting arctigenin from burdock seed raw material; (4) Extracting polysaccharides from Isatis indigotica root raw materials; (5) Extracting red peony extract from red peony raw material; (6) Mix the above extract with the film-forming material, cast the film, and cut and package it.

9. A method for preparing the fast-acting hemostatic and analgesic powder spray according to claim 1. Characterized by... Includes the following steps: (1) Extraction of blood dragon extract from blood dragon raw material and nano-pulverization to D90 < 15 μm; (2) Extracting Lithospermum extract from Lithospermum raw materials; (3) Mix frankincense and myrrh in a 1:1 ratio and extract the co-extract by supercritical CO2 extraction; (4) Calcining the gypsum raw material and then pulverizing it; (5) Mix the above extract with menthol and borneol, fill it into a pressure-resistant spray can, and fill it with propellant.

10. The use of the modular traditional Chinese medicine preparation system according to any one of claims 1-7 in the preparation of a drug for treating hemorrhagic shock, wound bleeding, tissue infection and systemic inflammatory response caused by combat injuries.

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