Ganoderma Capsule (Reishi Capsule/Lingzhi
capsule) is made of USDA certified organic Ganoderma Lucidum spore powder. The
Ganoderma used for this product is 100% organic and comes from our self-built
Ganoderma farm, which has acquired 4 organic certificates from China, Japan,
the US and the EU. During the cultivation process, not any pesticide,
herbicide, or chemical fertilizer was used at all. The capsule shell we used is
called Vcap vegetable capsule shell which is made of 100% plant fiber and is
more stable and safer compared to regular gelatin capsule. GANOHERB guarantees
that all of our product do not contain any additive, hormone, or chemically
synthesized matter.
The Ganoderma spore powder inside the capsule
is rich in Ganoderma Lucidum polysaccharides and triterpenes, which help
enhance overall immunity, preventing
diseases and infections. In order to make the nutrients inside can be easily
absorbed by human body and prevent oxidation at the same time, we use a
patented technology called low temperature physical shell-breaking technology
to break the cell wall of the spore powder. The wall-broken rate can reach as
high as 99.5%.
Ganoderma Capsule Ganoderma Capsule,Reishi Capsule,Reishi Mushroom Capsule,Ganoderma Lucidum Capsule,Herbal Capsule,Lingzhi Capsule Ganoherb International Inc. , http://www.ganoherb.us
The drug must be formulated into a suitable dosage form for clinical use. The purpose of formulation research and development is to ensure the safety, effectiveness, stability and ease of use of the drug. If the dosage form is not properly selected, the prescription and process design are unreasonable, which will have a certain impact on the product quality, and even affect the efficacy and safety of the product. Therefore, formulation research plays an important role in drug development.
This guiding principle is based on the actual situation of domestic drug research and development, based on the technical guidelines for formulation research at home and abroad, taking into account the key issues that are easily overlooked in current formulation research.
Due to the numerous pharmaceutical dosage forms and production processes, and various new dosage forms and new processes are also emerging, the specific conditions in the formulation research vary widely. This guiding principle mainly describes the basic ideas and methods of formulation research, and provides basic technical guidance and assistance for formulation research. The detailed technical requirements for the study of various dosage forms are not detailed in this guidance. Drug applicants can carry out the corresponding research work with reference to the basic ideas of formulation research described in these guidelines.
Second, the basic content of preparation research
There are many types of pharmaceutical dosage forms, and the preparation process also has its own characteristics. There are many specific situations and special problems in the research. However, the overall goal of preparation research is consistent, that is, through a series of research work, the basis for ensuring the selection of dosage forms is sufficient, the prescription is reasonable, the process is stable, the production process can be effectively controlled, and it is suitable for industrial production. The basic content of preparation research generally includes the following aspects:
(1) Selection of dosage form: The drug applicant selects a suitable dosage form according to the needs of clinical treatment and application by examining the physical and chemical properties and biological properties of the raw material.
(2) Prescription research: According to the physical properties of the drug, the stability test results and the drug absorption, combined with the characteristics of the selected dosage form, determine the appropriate indicators, select appropriate excipients, conduct prescription screening and optimization, and initially determine the prescription.
(III) Research on preparation technology: According to the characteristics of the dosage form, combined with the physical properties and stability of the drug, considering the production conditions and equipment, the process research is carried out, the preparation process of the laboratory sample is initially determined, and the corresponding process control index is established. In order to ensure the industrial production of the preparation, it is necessary to carry out the process enlargement study and make appropriate adjustments to the prescription, process and equipment as necessary.
(4) Selection of pharmaceutical packaging materials (containers): The main focus is on the inspection of pharmaceutical packaging materials (containers). The inner packaging materials (containers) can be initially selected through literature research, or compatibility studies between preparations and packaging materials, and continued to be investigated through accelerated testing and long-term retention testing.
(5) Quality research and stability research: Quality research and stability research have respectively formulated corresponding guiding principles. The work involved in this part can be carried out in accordance with relevant guiding principles. The work of preparation research has its own focus and key issues to be solved, and it is closely related to each other. The choice of dosage form is based on a comprehensive analysis of the physical and chemical properties, biological characteristics and clinical application requirements of the drug, and these aspects are also important issues in prescription and process research. Quality research and stability investigation are important scientific foundations for prescription screening and process optimization. At the same time, the information obtained in prescription and process research provides reference for the establishment and establishment of projects in drug quality control (central control indicators and quality standards). in accordance with. Therefore, the study needs to pay attention to strengthen communication and coordination between the various work, and the research results need to pay attention to comprehensive and comprehensive analysis. In summary, the formulation research is a gradual and continuous improvement process, and it is necessary to pay attention to the close combination of formulation research and related research work in formulation research and development. In the initial stage of research and development, according to the physical properties of the drug, the stability test results and the drug absorption in the body, the formulation and preparation process are initially determined. As the research progresses, after completing relevant clinical research (such as pharmacokinetic tests, bioavailability comparison studies) and post-process amplification studies, the prescriptions and processes may need to be adjusted as necessary. If these adjustments may affect the in vitro and in vivo behavior of the drug, in addition to re-involving the in vitro research work (such as dissolution testing), relevant clinical studies are also needed when necessary. For specific requirements, refer to relevant technical guidelines.
Third, the choice of dosage form
The choice of dosage form should firstly fully understand the characteristics of the relevant dosage forms and related research and production status at home and abroad, and provide reference for the selection of dosage forms.
The choice and design of the dosage form focuses on the following three aspects:
(1) Physical and chemical properties and biological characteristics of the drug
The physical and chemical properties and biological properties of the drug are important basis for the selection of the dosage form. For example, drugs that are unstable in gastric juice are generally not suitable for development as a gastric preparation. For some drugs whose stability is poorly stored in the solid state (such as some cephalosporin antibiotics), it is easy to degrade or produce polymer in solution. The clinical use will cause safety problems, and it is not suitable for developing solutions such as injection and infusion. Dosage form. For drugs with significant hepatic first-pass effects, preparations for non-oral routes of administration may be considered.
(two) the need for clinical treatment
The choice of dosage form should take into account the needs of clinical treatment. For example, drugs used for emergency treatment such as hemorrhage, shock, poisoning, etc., should generally choose the type of injection; arrhythmia rescue medication should be selected, intravenous injection of injection; control of acute asthma attacks, should choose inhalation.
(3) Compliance with clinical medication
The compliance of clinical medications is also an important factor in the choice of dosage form. The development of sustained-release and controlled-release preparations can reduce the number of administrations, reduce the fluctuation coefficient, stabilize the blood concentration, reduce the side effects, and improve the patient's compliance. For elderly, children and patients with dysphagia, the choice of oral solution, effervescent tablets, dispersible tablets and other dosage forms have certain advantages. In addition, the choice of dosage form should also consider the feasibility and production cost of industrial production of the preparation. Some antibacterial drugs should be considered in the selection of dosage forms to minimize the production of drug-resistant bacteria and prolong the clinical application cycle of drugs.
Fourth, prescription research
Prescription studies include investigations into drug substances and excipients, prescription design, prescription screening, and optimization. Prescription studies are closely related to formulation quality studies, stability experiments, and safety and efficacy evaluations. The results of prescription research provide reference and basis for the establishment and evaluation of preparation quality standards, and also provide reference for the setting of control parameters of pharmaceutical production process. Prescription research needs to pay attention to the accumulation and analysis of experimental data.
(1) APIs
The results of research on the physical and chemical properties, biological properties and compatibility of raw materials can provide a basis for prescription design.
1. Physical and chemical properties
Some physical and chemical properties of the drug substance may affect the quality of the preparation and the production of the preparation, including the color, smell, pH, pka, particle size, crystal form, specific rotation, optical isomer, melting point, moisture, solubility, Oil/water partition coefficient, solvation/hydration state, etc., and stability of the drug substance under conditions of light, heat, humidity, oxygen, etc. in a solid state and/or a solution state. Therefore, it is recommended to understand the key physicochemical properties of the drug substance according to the characteristics of the dosage form and the route of drug administration, and to examine its effect on the preparation through experiments. For example, the solubility of a drug may have an impact on formulation performance and analytical methods, and is one of the important physicochemical constants to be considered when designing a prescription. The particle size of the drug substance may affect the solubility of the poorly soluble drug, the suspension in the liquid, the uniformity of the content of the preparation, and sometimes have a significant impact on the bioavailability and clinical efficacy. If the above situation exists, it is necessary to examine the effect of the particle size of the drug substance on the properties of the formulation. If the results of the study prove that some parameters are highly variable, and these parameters are very important to ensure the quality of the preparation, then it is necessary to pay attention to the improvement of the quality control standards of the API, increase the inspection of these parameters and set limits. For important parameters (such as particle size, crystal form, etc.) that affect the bioavailability of the formulation, the formulation of the limits needs to be based on the results of clinical studies.
2, biological properties
The biological properties of the drug substance include the permeability to the biofilm, the stability under the physiological environment, the pharmacokinetic properties of the absorption, distribution, metabolism, elimination of the drug substance, the toxic side effects of the drug and the therapeutic window. The biological properties of APIs have important guiding effects on formulation research. For drugs that are poorly absorbed orally, it is possible to improve the absorption of the drug by selecting appropriate formulation techniques and prescriptions. For example, the results of pharmacokinetic studies suggest that the oral absorption of drugs is extremely poor, and it may be considered to select a dosage form such as an injection. The sustained-release and controlled-release preparations have certain requirements on the half-life, therapeutic index and absorption site of the drug, and special attention is needed in research and development.
3. Compatibility study
This compatibility study refers to the study of the interaction between drugs and excipients and between drugs and drugs. The former will be explained in the accessories section below. The latter is mainly a problem to be considered in the study of compound preparations, and the experiment can be carried out according to the experimental method of influencing factors in the guiding principle of drug stability.
(2) Accessories
1. General principles for the selection of excipients
Excipients are the general term for other materials other than the main drug in the preparation, and are an important part of the pharmaceutical preparation. Excipients can be selected according to the characteristics of the dosage form and the needs of the drug administration route. The auxiliary materials used should not adversely interact with the main drug, and do not affect the determination of the content of the preparation and the inspection of related substances. The excipients required to produce the drug must meet the medicinal requirements.
2. Compatibility study
Drug and excipient compatibility studies provide useful information and references for the selection of excipients in the formulation. Drug applicants can learn about the interaction between excipients and excipients, excipients and drugs through preliminary research to avoid the selection of unsuitable excipients during prescription design. For lack of relevant research data, compatibility studies may be considered. For example, oral solid preparations can be selected from several kinds of excipients. If the amount of auxiliary materials is large (such as diluent), it can be mixed according to the ratio of main drug: auxiliary material = 1:5. If the dosage is small (such as lubricant, etc.), Can be mixed according to the ratio of main drug: auxiliary material = 20:1, take a certain amount, refer to the experimental method of influencing factors in the guiding principle of drug stability or other suitable experimental methods, focus on the traits, content, related substances, etc., if necessary The raw material medicine and the auxiliary material may be separately subjected to a parallel control experiment to determine whether the change of the raw material medicine itself or the auxiliary material. If the prescription uses an excipient that interacts with the drug, experimental data is needed to justify the prescription.
3. Physical and chemical properties and dosage of auxiliary materials
The variation of the auxiliary cooking properties (including molecular weight and its distribution, degree of substitution, viscosity, traits, particle size and distribution, fluidity, moisture, pH, etc.) affects the quality of the formulation. For example, the particle size and density of the diluent may change to solids. The content uniformity of the preparation has an influence, and the molecular weight or viscosity change of the polymer material used in the sustained-release and controlled-release preparation may have a significant influence on the drug release behavior. Changes in the nature of the auxiliary cooking may be caused by the production process of the excipients and may also be related to changes in the source of the excipients. Therefore, according to the characteristics of the preparation and the route of drug administration, it is necessary to analyze the physical and chemical properties of the excipients in the prescription, which may affect the quality of the preparation. If the research proves that these parameters are very important to ensure the quality of the preparation, in order to ensure the stability of the quality of the excipients, the corresponding Quality control indicators, pay attention to choose the appropriate source of supply, clear the specifications and models of the accessories.
Understanding the route of administration of excipients in marketed drugs and their reasonable dosage range is an important part of pre-prescription work, and this information can provide a scientific basis for prescription design. Drug applicants can search for the FDA and other authoritative databases at home and abroad to understand the rational use of the excipients examined in the listed drugs. For certain physiologically active excipients, excipients that are beyond the usual dosage and without literature support, and excipients that change the route of administration, the necessary safety tests are required. 
Basic technical guidelines for the study of chemical pharmaceutical preparations
I. Overview